Dabrafenib: Drug information

(For additional information see "Dabrafenib: Patient drug information" and see "Dabrafenib: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

Tafinlar

Brand Names: Canada

Tafinlar

Pharmacologic Category

Antineoplastic Agent, BRAF Kinase Inhibitor

Dosing: Adult

Note: Confirm BRAF V600 mutation status (in tumor specimens) prior to dabrafenib treatment initiation. Secondary prophylaxis with antipyretics may be required when resuming dabrafenib following a severe febrile drug reaction.

Melanoma, adjuvant treatment, with BRAF V600E or BRAF V600K mutation

Melanoma, adjuvant treatment, with BRAF V600E or BRAF V600K mutation: Oral: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue for up to 1 year in the absence of disease recurrence or unacceptable toxicity (Ref).

Melanoma, metastatic or unresectable, with BRAF V600E or BRAF V600K mutation

Melanoma, metastatic or unresectable, with BRAF V600E or BRAF V600K mutation

Melanoma, metastatic or unresectable, with BRAF V600E mutation (single-agent therapy): Oral: 150 mg twice daily, approximately every 12 hours (single-agent therapy); continue until disease progression or unacceptable toxicity (Ref).

Melanoma, metastatic or unresectable, with BRAF V600E or BRAF V600K mutation (combination therapy): Oral: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Non–small cell lung cancer, metastatic, with BRAF V600E mutation

Non–small cell lung cancer, metastatic, with BRAF V600E mutation: Oral: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Solid tumors, unresectable or metastatic, with BRAF V600E mutation

Solid tumors, unresectable or metastatic, with BRAF V600E mutation: Oral: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Thyroid cancer, anaplastic, locally advanced or metastatic, with BRAF V600E mutation

Thyroid cancer, anaplastic, locally advanced or metastatic, with BRAF V600E mutation: Oral: 150 mg twice daily, approximately every 12 hours (in combination with trametinib); continue until disease progression or unacceptable toxicity (Ref).

Missed or vomited doses: A missed dose may be administered up to 6 hours prior to the next dose; do not administer if <6 hours until the next dose (do not make up for the missed dose). If a dose is vomited, do not administer an additional dose; administer the next dose at its scheduled time.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

eGFR ≥15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetic differences with eGFR ≥15 mL/minute/1.73 m²are not considered clinically relevant.

eGFR <15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

Mild impairment (bilirubin ≤ ULN and AST > ULN or bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.

Moderate (bilirubin >1.5 to 3 times ULN and any AST) to severe (bilirubin >3 to 10 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (an appropriate dose has not been established); however, hepatic metabolism and biliary excretion are the primary elimination routes for dabrafenib, and exposure may be increased in patients with moderate to severe impairment.

Dosing: Adjustment for Toxicity: Adult

**Dabrafenib Capsule Dosage Reduction Levels**
Usual (initial) dose	150 mg twice daily
First dose reduction	100 mg twice daily
Second dose reduction	75 mg twice daily
Third dose reduction	50 mg twice daily
If unable to tolerate 50 mg twice daily, permanently discontinue dabrafenib.

Note: If using combination therapy, refer to Trametinib monograph for recommended trametinib dose modification.

**Dabrafenib Dosage Modifications for Adverse Reactions**
Adverse reactions	Description/severity	Dabrafenib dosage modification
^a LVEF = left ventricular ejection fraction.
Cardiomyopathy	>20% absolute decrease in LVEF^a from baseline that is below institutional LLN	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Cardiomyopathy	Symptomatic heart failure	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Dermatologic toxicity	Intolerable grade 2 adverse reaction or grade 3 or 4 adverse reaction	Interrupt dabrafenib for up to 3 weeks. If improved, resume dabrafenib at a lower dose. If not improved, permanently discontinue dabrafenib.
	New primary cutaneous malignancy	No dabrafenib dosage modification is necessary.
	Severe cutaneous adverse reactions	Permanently discontinue dabrafenib.
Febrile reactions	Fever of 38°C to 40°C (100.4°F to 104°F), or first symptoms in case of recurrence	Interrupt dabrafenib until fever resolves and then resume at the same or lower dose.
Febrile reactions	Fever >40°C (104°F) and/or fever complicated by rigors, hypotension, dehydration, or renal failure	Interrupt dabrafenib until febrile reaction resolves for at least 24 hours, then resume at a lower dose or permanently discontinue. Administer antipyretics (as secondary prophylaxis) upon dabrafenib resumption if patient had a prior episode of severe febrile reaction or fever associated with complications. Administer corticosteroids (eg, prednisone 10 mg daily or equivalent) for at least 5 days for second or subsequent pyrexia if temperature does not return to baseline within 3 days of onset of fever, or for fever associated with complications (eg, dehydration, renal failure, hypotension, severe chills/rigors with no evidence of active infection).
Hemophagocytic lymphohistiocytosis	Suspected	Interrupt dabrafenib treatment.
Hemophagocytic lymphohistiocytosis	Confirmed	Discontinue dabrafenib and manage as appropriate.
Hemorrhage	Intolerable grade 2 or grade 3 hemorrhage	Interrupt dabrafenib therapy. If hemorrhage improves to ≤ grade 1, resume dabrafenib at a lower dose. If grade 3 hemorrhage does not improve following therapy interruption, permanently discontinue dabrafenib.
Hemorrhage	Grade 4 hemorrhage	Permanently discontinue dabrafenib.
Hyperglycemia		Hyperglycemia may require initiation or optimization of insulin or oral hypoglycemic agent therapy (as clinically indicated).
Ocular toxicity	Retinal pigment epithelial detachment	No dabrafenib dosage modification is necessary.
	Retinal vein occlusion	No dabrafenib dosage modification is necessary.
	Uveitis, including iritis and iridocyclitis	Manage symptomatically with local ophthalmic therapy (steroid and mydriatic drops were used in clinical trials) while continuing dabrafenib. For mild or moderate uveitis that does not respond to local ocular therapy (or for severe uveitis), interrupt dabrafenib for up to 6 weeks; if improved to ≤ grade 1, resume dabrafenib at the same or lower dose. If not improved, or for persistent grade 2 or higher uveitis of >6 weeks duration, permanently discontinue dabrafenib.
Pulmonary toxicity	Interstitial lung disease or pneumonitis	No dabrafenib dosage modification is necessary.
Venous thromboembolism	Uncomplicated	No dabrafenib dosage modification is necessary.
Other toxicities	Intolerable grade 2 or any grade 3 adverse reaction	Interrupt dabrafenib therapy until resolution to ≤ grade 1; then resume dabrafenib at a lower dose. If adverse reaction does not improve, permanently discontinue dabrafenib.
	Grade 4 adverse reaction (first occurrence)	Interrupt dabrafenib until resolution to ≤ grade 1; then resume dabrafenib at lower dose or permanently discontinue.
	Grade 4 adverse reaction (recurrent after dosage reduction)	Permanently discontinue dabrafenib.
	New primary noncutaneous malignancy (RAS mutation-positive)	Permanently discontinue dabrafenib.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Dabrafenib: Pediatric drug information")

Dosage guidance:

Dosage form information: Dabrafenib is available as tablets for oral suspension and capsules; weight-band dosing is product specific in patients <18 years of age due to product strengths.

Glioma, low-grade

Glioma, low-grade (LGG) (with BRAF V600E mutation): Note: Use in combination with trametinib and continue therapy until disease progression or unacceptable toxicity. Twice-daily doses should be separated by 12 hours.

Weight-directed dosing: Limited data available: Note: In clinical trial experience, both dosage forms, tablets for oral suspension and capsules, were used based on patient's ability to swallow capsules (Ref).

Children 1 to <12 years: Oral: 2.63 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Children ≥12 years and Adolescents <18 years: Oral: 2.25 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Weight-band dosing: Children ≥1 year and Adolescents: Oral:

**Dabrafenib Weight-Band Dosing for Low-Grade Glioma in Children ≥1 Year and Adolescents**
Patient Weight (kg)	Tablets for Oral Suspension	Capsules
8 to <10 kg	20 mg twice daily	N/A
10 to <14 kg	30 mg twice daily	N/A
14 to <18 kg	40 mg twice daily	N/A
18 to <22 kg	50 mg twice daily	N/A
22 to <26 kg	60 mg twice daily	N/A
26 to <30 kg	70 mg twice daily	75 mg twice daily
30 to <34 kg	80 mg twice daily	75 mg twice daily
34 to <38 kg	90 mg twice daily	75 mg twice daily
38 to <42 kg	100 mg twice daily	100 mg twice daily
42 to <46 kg	110 mg twice daily	100 mg twice daily
46 to <51 kg	130 mg twice daily	100 mg twice daily
≥51 kg	150 mg twice daily	150 mg twice daily

Solid tumors, unresectable or metastatic

Solid tumors, unresectable or metastatic (BRAF V600E mutation):

Note: For use in patients who have progressed following prior treatment and have no satisfactory alternative treatment options. Approval for solid tumors is from an accelerated process and subject to change as data evolves. Use in combination with trametinib and continue therapy until disease progression or unacceptable toxicity. Twice-daily doses should be separated by 12 hours.

Weight-directed dosing: Limited data available: Note: In the trial, both dosage forms, tablets for oral suspension and capsules, were used based on patient's ability to swallow capsules (Ref).

Children 1 to <12 years: Oral: 2.63 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Children ≥12 years and Adolescents <18 years: Oral: 2.25 mg/kg/dose every 12 hours; maximum dose: 150 mg/dose (Ref).

Weight-band dosing:

Children ≥1 year and Adolescents: Oral:

**Dabrafenib Weight-Band Dosing for Solid Tumors (Unresectable or Metastatic) in Children ≥1 Year and Adolescents**
Patient Weight (kg)	Tablets for Oral Suspension	Capsules
8 to <10 kg	20 mg twice daily	N/A
10 to <14 kg	30 mg twice daily	N/A
14 to <18 kg	40 mg twice daily	N/A
18 to <22 kg	50 mg twice daily	N/A
22 to <26 kg	60 mg twice daily	N/A
26 to <30 kg	70 mg twice daily	75 mg twice daily
30 to <34 kg	80 mg twice daily	75 mg twice daily
34 to <38 kg	90 mg twice daily	75 mg twice daily
38 to <42 kg	100 mg twice daily	100 mg twice daily
42 to <46 kg	110 mg twice daily	100 mg twice daily
46 to <51 kg	130 mg twice daily	100 mg twice daily
≥51 kg	150 mg twice daily	150 mg twice daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

Dose reduction levels: Note: In patients <18 years of age, dosage adjustments are dosage form specific (tablets for oral suspension or capsules).

Tablets for oral suspension:

**Dabrafenib Tablets for Oral Suspension Dosage Level Reductions in Ages 1 to <18 Years**
Patient Weight (Usual Dose)	First Dose Reduction	Second Dose Reduction	Third Dose Reduction
8 to <10 kg (20 mg twice daily)	10 mg twice daily	N/A	N/A
10 to <14 kg (30 mg twice daily)	20 mg twice daily	10 mg twice daily	N/A
14 to <18 kg (40 mg twice daily)	30 mg twice daily	20 mg twice daily	10 mg twice daily
18 to <22 kg (50 mg twice daily)	30 mg twice daily	20 mg twice daily	10 mg twice daily
22 to <26 kg (60 mg twice daily)	40 mg twice daily	30 mg twice daily	20 mg twice daily
26 to <30 kg (70 mg twice daily)	50 mg twice daily	40 mg twice daily	20 mg twice daily
30 to <34 kg (80 mg twice daily)	50 mg twice daily	40 mg twice daily	30 mg twice daily
34 to <38 kg (90 mg twice daily)	60 mg twice daily	50 mg twice daily	30 mg twice daily
38 to <42 kg (100 mg twice daily)	70 mg twice daily	50 mg twice daily	30 mg twice daily
42 to <46 kg (110 mg twice daily)	70 mg twice daily	60 mg twice daily	40 mg twice daily
46 to <51 kg (130 mg twice daily)	90 mg twice daily	70 mg twice daily	40 mg twice daily
≥51 kg (150 mg twice daily)	100 mg twice daily	80 mg twice daily	50 mg twice daily

Capsules:

**Dabrafenib Capsule Dosage Level Reductions in Ages 1 to <18 Years Weighing ≥26 kg**
Patient Weight (Usual Dose)	First Dose Reduction	Second Dose Reduction	Third Dose Reduction	Subsequent Modifications
26 to <38 kg (75 mg twice daily)	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily
38 to <51 kg (100 mg twice daily)	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily
≥51 kg (150 mg twice daily)	100 mg twice daily	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily

**Dabrafenib Capsule Dosage Level Reductions in Ages ≥18 Years**
Usual Dose	First Dose Reduction	Second Dose Reduction	Third Dose Reduction	Subsequent Modifications
150 mg twice daily	100 mg twice daily	75 mg twice daily	50 mg twice daily	Permanently discontinue if unable to tolerate 50 mg twice daily

Dosage adjustments: Note: If using combination therapy with trametinib, other adverse reactions related to trametinib may occur; refer to Trametinib monograph for detailed information.

**Dabrafenib Dosage Modifications for Adverse Reactions in Pediatric Patients ≥1 Year of Age**
Adverse Reactions	Description/Severity	Dabrafenib Dosage Modification
^a LVEF = left ventricular ejection fraction.
Cardiomyopathy	>20% absolute decrease in LVEF^a from baseline that is below institutional LLN	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Cardiomyopathy	Symptomatic heart failure	Interrupt dabrafenib until LVEF^a improves to at least the institutional LLN and absolute decrease to ≤10% (compared to baseline), then resume at the same dose.
Dermatologic toxicity	Intolerable grade 2 adverse reaction or grade 3 or 4 adverse reaction	Interrupt dabrafenib for up to 3 weeks. If improved, resume dabrafenib at a lower dose. If not improved, permanently discontinue dabrafenib.
Dermatologic toxicity	Severe cutaneous adverse reactions	Permanently discontinue dabrafenib.
Febrile reactions	Fever of 38°C to 40°C (100.4°F to 104°F), or first symptoms in case of recurrence	Interrupt dabrafenib until fever resolves and then resume at the same or lower dose.
Febrile reactions	Fever >40°C (104°F) and/or fever complicated by rigors, hypotension, dehydration, or kidney failure	Interrupt dabrafenib until febrile reaction resolves for at least 24 hours, then resume at a lower dose or permanently discontinue. Administer antipyretics (as secondary prophylaxis) upon dabrafenib resumption if patient had a prior episode of severe febrile reaction or fever associated with complications. Administer corticosteroids (eg equivalent of prednisone 10 mg daily in adults) for ≥5 days for a second or subsequent pyrexia if temperature does not return to baseline within 3 days of onset of fever, or for fever associated with complications (eg, dehydration, kidney failure, hypotension, severe chills/rigors with no evidence of active infection).
Hemorrhage	Intolerable grade 2 or any grade 3 hemorrhage	Interrupt dabrafenib therapy. If hemorrhage improves to grade 0 or 1, resume dabrafenib at a lower dose. If grade 3 does not improve, discontinue dabrafenib.
	Grade 4 first occurrence	Discontinue or interrupt dabrafenib therapy until improves to grade 0 or 1, then resume at lower dose. If no improvement, permanently discontinue.
	Grade 4 recurrent	Permanently discontinue dabrafenib.
Hyperglycemia		Hyperglycemia may require initiation or optimization of insulin or oral hypoglycemic agent therapy (as clinically indicated).
New primary malignancies	New primary cutaneous malignancy	No dabrafenib dosage modification is necessary.
New primary malignancies	Noncutaneous RAS mutation-positive malignancies	Permanently discontinue dabrafenib.
Ocular toxicity	Uveitis, including iritis and iridocyclitis	Manage symptomatically with local ophthalmic therapy (steroid and mydriatic drops were used in clinical trials) while continuing dabrafenib without dose modification. For iritis, administer ocular treatment. For severe uveitis or mild/moderate uveitis that does not respond to therapy, interrupt dabrafenib and treat as clinically indicated. If improves to grade 0 or 1, resume dabrafenib at the same or lower dose. If not improved, or for persistent grade 2 or higher uveitis of >6 weeks duration, permanently discontinue dabrafenib.
Other toxicities	Intolerable grade 2 or any grade 3 adverse reaction	Interrupt dabrafenib therapy until resolution to ≤ grade 1; then resume dabrafenib at a lower dose. If adverse reaction does not improve, permanently discontinue dabrafenib.
	Grade 4 adverse reaction (first occurrence)	Interrupt dabrafenib until resolution to ≤ grade 1; then resume dabrafenib at a lower dose or permanently discontinue.
	Grade 4 adverse reaction (recurrent after dosage reduction)	Permanently discontinue dabrafenib.

Dosing: Kidney Impairment: Pediatric

Children ≥1 year and Adolescents: Oral:

eGFR <15 mL/minute/1.73 m²: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

Children ≥1 year and Adolescents: Oral:

Mild impairment (bilirubin ≤ ULN and AST > ULN or bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.

Moderate (bilirubin >1.5 to 3 times ULN and any AST) to severe (bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (an appropriate dose has not been established); however, hepatic metabolism and biliary excretion are the primary elimination routes for dabrafenib and exposure may be increased in patients with moderate to severe impairment.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%:

Dermatologic: Alopecia (22%), hyperkeratosis (37%), palmar-plantar erythrodysesthesia (20%), skin rash (17% to 27%), squamous cell carcinoma of skin (7% to 11%; grade 3: 4%), xeroderma (16%)

Endocrine & metabolic: Hyperglycemia (50% to 57%), hyponatremia (8% to 14%), hypophosphatemia (35% to 37%)

Gastrointestinal: Constipation (10% to 11%)

Hematologic & oncologic: Papilloma (27%)

Hepatic: Increased serum alkaline phosphatase (19% to 25%)

Nervous system: Chills (17%), headache (30% to 32%)

Neuromuscular & skeletal: Arthralgia (27% to 31%), back pain (12%), myalgia (11% to 13%)

Respiratory: Cough (12% to 21%)

Miscellaneous: Fever (28% to 33%)

1% to 10%:

Dermatologic: Basal cell carcinoma of skin (4%), bullous rash (<10%), malignant melanoma (new primary: 1%)

Gastrointestinal: Pancreatitis (<10%)

Hematologic & oncologic: Keratoacanthoma (4%), malignant neoplasm (≤1%)

Nervous system: Dizziness (7%)

Ophthalmic: Uveitis (1%)

Renal: Interstitial nephritis (<10%)

Respiratory: Nasopharyngitis (10%)

Miscellaneous: Febrile reaction (serious: 6%)

Frequency not defined: Nervous system: Fatigue

Postmarketing: Hematologic & oncologic: Kaposi sarcoma (Parakh 2016)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to dabrafenib or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiomyopathy: Cardiomyopathy (a decrease in left ventricular ejection fraction [LVEF] ≥10% from baseline and below the institutional lower limit of normal) has occurred when used in combination with trametinib. Cardiomyopathy resolved in most patients receiving dabrafenib in combination with trametinib following dose adjustments, treatment interruption, and/or permanent discontinuation.

• Dermatologic toxicity: Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), may occur when dabrafenib is administered with trametinib and could be life-threatening or fatal. Other serious skin toxicities have also occurred (rare).

• Febrile reactions: Serious febrile reactions and fever (any severity) complicated by hypotension, rigors or chills, dehydration, or renal failure were observed during dabrafenib single-agent therapy and when used in combination with trametinib. The incidence and severity of fevers were increased when dabrafenib was used in combination with trametinib. Some patients experienced multiple discrete episodes.

• Hemophagocytic lymphohistiocytosis: Hemophagocytic lymphohistiocytosis, a life-threatening immune system reaction, has been reported when dabrafenib is used in combination with trametinib.

• Hemorrhage: Hemorrhage (including major hemorrhage), defined as symptomatic bleeding in a critical area/organ, may occur with dabrafenib in combination with trametinib. Serious bleeding events (some fatal) included intracranial, cerebral, brainstem, or GI hemorrhage.

• Hyperglycemia: Hyperglycemia may occur in patients with a history of diabetes while on dabrafenib therapy (either as a single agent or in combination with trametinib).

• Malignancy: Cutaneous squamous cell carcinoma (cuSCC) and keratoacanthoma, basal cell carcinoma (BCC), and new primary melanoma were observed during single-agent dabrafenib therapy. When used in combination with trametinib, cuSCCs (including keratoacanthomas), BCC, and new primary melanoma were reported in small percentages of patients. Noncutaneous malignancies were reported in a small percentage of patients with monotherapy and combination therapy.

• Ocular toxicity: Uveitis, including iritis and iridocyclitis, has been reported with dabrafenib single-agent therapy and when used in combination with trametinib. Retinal pigment epithelial detachments (RPED) were seen in clinical trials when used in combination with trametinib (a known complication of trametinib single-agent therapy). Detachments may be bilateral and multifocal, and occurred in the central macular area or elsewhere in the retina.

• QT prolongation: QTcF prolongation >60 msec above baseline or to >500 msec was reported (rare), both as a single agent or when used in combination with trametinib.

• Venous thromboembolism: Venous thromboembolism events such as deep venous thrombosis (DVT) and pulmonary embolism (PE) (some fatal) may occur (rare) when dabrafenib is used in combination with trametinib. Patients should seek immediate medical attention with symptoms of DVT or PE (shortness of breath, chest pain, arm/leg swelling).

Special populations:

• Glucose-6-phosphate dehydrogenase deficiency: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at risk for hemolytic anemia when administered dabrafenib.

Other warnings/precautions:

• Appropriate use: Exposing wild-type cells to BRAF inhibitors such as dabrafenib may result in paradoxical activation of MAP-kinase signaling and increased cell proliferation. Prior to initiating therapy, confirm BRAF V600E or BRAF V600K mutation status (in tumor specimens) with an approved test. Information on approved tests for detection of BRAF V600 mutations is available at http://www.fda.gov/CompanionDiagnostics. An approved test for BRAF V600E mutation detection in anaplastic thyroid cancer and low-grade glioma is not available.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Tafinlar: 50 mg, 75 mg

Tablet Soluble, Oral, as mesylate:

Tafinlar: 10 mg

Generic Equivalent Available: US

Pricing: US

Capsules (Tafinlar Oral)

50 mg (per each): $113.03

75 mg (per each): $145.67

Tablet,Dispersible (Tafinlar Oral)

10 mg (per each): $22.61

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Tafinlar: 50 mg, 75 mg

Tablet Soluble, Oral, as mesylate:

Tafinlar: 10 mg

Administration: Adult

Oral: Capsules: Administer at least 1 hour before or 2 hours after a meal; doses should be administered ~12 hours apart at approximately the same time(s) each day. Do not open, crush, or break capsules. When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning or evening dose of dabrafenib.

Administration: Pediatric

Oral: Administer at least 1 hour before or 2 hours after a meal; doses should be ~12 hours apart. When administered in combination with trametinib, take the once-daily dose of trametinib at the same time each day with either the morning or evening dose of dabrafenib. If vomiting occurs after dose administration, do not repeat or take an additional dose.

Capsules: Do not open, crush, or break capsules.

Tablets for oral suspension: Do not swallow whole, chew, or crush tablets for oral suspension. Place tablets for dose in the provided cup. The volume of water to add depends on number of tablets: ~5 mL if dose is 1 to 4 tablets; ~10 mL if dose is 5 to 15 tablets. Stir with the handle of a teaspoon until tablets are fully dissolved; may take ≥3 minutes to fully dissolve; the suspension will be cloudy white once dissolved. Administer dissolved dose immediately via the dosing cup, or pull into an oral dosing syringe to administer by mouth or feeding tube. If not used within 30 minutes of preparation, discard dose.

Missed doses: A missed dose may be administered up to 6 hours prior to the next dose; do not administer if <6 hours until the next dose (do not make up for the missed dose).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s027lbl.pdf#page=46, must be dispensed with this medication.

Use: Labeled Indications

Glioma, low-grade, with BRAF V600E mutation: Treatment of low-grade glioma with a BRAF V600E mutation (in combination with trametinib) in pediatric patients ≥1 year of age who require systemic therapy.

Melanoma, adjuvant treatment, with BRAF V600E or BRAF V600K mutation: Adjuvant treatment of melanoma (in combination with trametinib) in patients with BRAF V600E or BRAF V600K mutations (as detected by an approved test), and lymph node(s) involvement, following complete resection.

Melanoma, metastatic or unresectable, with BRAF V600E or BRAF V600K mutation : Treatment of unresectable or metastatic melanoma in patients with a BRAF V600E mutation (single agent therapy) or in patients with BRAF V600E or BRAF V600K mutations (in combination with trametinib); confirm BRAF V600E or BRAF V600K mutation status with an approved test prior to treatment.

Non-small cell lung cancer, metastatic, with BRAF V600E mutation: Treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation as detected by an approved test (in combination with trametinib).

Solid tumors, unresectable or metastatic, with BRAF V600E mutation: Treatment (in combination with trametinib) of unresectable or metastatic solid tumors with a BRAF V600E mutation in adults and pediatric patients ≥1 year of age who have progressed following prior treatment and have no satisfactory alternative treatment options.

Thyroid cancer, anaplastic, locally advanced or metastatic, with BRAF V600E mutation: Treatment of locally advanced or metastatic anaplastic thyroid cancer (ATC) (in combination with trametinib) in patients with BRAF V600E mutation and with no satisfactory locoregional treatment options.

Limitations of use: Dabrafenib is not indicated for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for treatment of wild-type BRAF solid tumors.

Medication Safety Issues

Sound-alike/look-alike issues:

Dabrafenib may be confused with cobimetinib, dacomitinib, dasatinib, duvelisib, encorafenib, trametinib, vemurafenib

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

Substrate of BCRP/ABCG2, CYP2C8 (major), CYP3A4 (major), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP2C9 (weak), CYP3A4 (moderate)

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abemaciclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Abemaciclib. Risk X: Avoid combination

Abiraterone Acetate: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Abiraterone Acetate. Risk C: Monitor therapy

Acalabrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Acalabrutinib. Risk C: Monitor therapy

ALfentanil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of ALfentanil. Management: If concomitant use of alfentanil and moderate CYP3A4 inducers is necessary, consider dosage increase of alfentanil until stable drug effects are achieved. Monitor patients for signs of opioid withdrawal. Risk D: Consider therapy modification

ALPRAZolam: CYP3A4 Inducers (Moderate) may decrease the serum concentration of ALPRAZolam. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy

AmLODIPine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of AmLODIPine. Risk C: Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Antihepaciviral Combination Products: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Antihepaciviral Combination Products. Risk X: Avoid combination

Apremilast: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Apremilast. Risk C: Monitor therapy

Aprepitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Aprepitant. Risk C: Monitor therapy

ARIPiprazole: CYP3A4 Inducers (Moderate) may decrease the serum concentration of ARIPiprazole. Risk C: Monitor therapy

ARIPiprazole Lauroxil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of ARIPiprazole Lauroxil. Risk C: Monitor therapy

Artemether and Lumefantrine: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Artemether and Lumefantrine. Specifically, concentrations of dihydroartemisinin (DHA), the active metabolite of artemether may be decreased. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Artemether and Lumefantrine. Risk C: Monitor therapy

Asunaprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Asunaprevir. Risk X: Avoid combination

Atogepant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Atogepant. Management: For treatment of episodic migraine, the recommended dose of atogepant is 30 mg once daily or 60 mg once daily when combined with CYP3A4 inducers. When used for treatment of chronic migraine, use of atogepant with CYP3A4 inducers should be avoided. Risk D: Consider therapy modification

Atorvastatin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Atorvastatin. Risk C: Monitor therapy

Avacopan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Avacopan. Risk X: Avoid combination

Avanafil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Avanafil. Risk X: Avoid combination

Avapritinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Avapritinib. Risk X: Avoid combination

Axitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Axitinib. Risk X: Avoid combination

Bedaquiline: Dabrafenib may enhance the QTc-prolonging effect of Bedaquiline. Dabrafenib may decrease serum concentrations of the active metabolite(s) of Bedaquiline. Dabrafenib may decrease the serum concentration of Bedaquiline. Risk X: Avoid combination

Belumosudil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Belumosudil. Risk C: Monitor therapy

Benzhydrocodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Benzhydrocodone. Specifically, the serum concentrations of hydrocodone may be reduced. Risk C: Monitor therapy

Bortezomib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bortezomib. Risk C: Monitor therapy

Bosutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Bosutinib. Risk C: Monitor therapy

Brexpiprazole: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Brexpiprazole. Risk C: Monitor therapy

Brigatinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inducers when possible. If combined, increase the daily dose of brigatinib in 30 mg increments after 7 days of treatment with the current brigatinib dose, up to maximum of twice the dose. Risk D: Consider therapy modification

Buprenorphine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Buprenorphine. Risk C: Monitor therapy

BusPIRone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of BusPIRone. Risk C: Monitor therapy

Cabozantinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cabozantinib. Risk C: Monitor therapy

Cannabis: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cannabis. More specifically, tetrahydrocannabinol and cannabidiol serum concentrations may be decreased. Risk C: Monitor therapy

Capivasertib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Capivasertib. Risk X: Avoid combination

Capmatinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Capmatinib. Risk X: Avoid combination

CarBAMazepine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of CarBAMazepine. Risk C: Monitor therapy

Cariprazine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cariprazine. Risk X: Avoid combination

Clarithromycin: Dabrafenib may enhance the QTc-prolonging effect of Clarithromycin. Dabrafenib may increase serum concentrations of the active metabolite(s) of Clarithromycin. Clarithromycin may increase serum concentrations of the active metabolite(s) of Dabrafenib. Clarithromycin may increase the serum concentration of Dabrafenib. Dabrafenib may increase the serum concentration of Clarithromycin. Management: If coadministration is unavoidable, monitor for decreased clarithromycin efficacy, increased dabrafenib adverse effects, and QTc interval prolongation and ventricular arrhythmias when these agents are combined. Risk D: Consider therapy modification

Clindamycin (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Clindamycin (Systemic). Risk C: Monitor therapy

Clofazimine: May enhance the QTc-prolonging effect of Dabrafenib. Clofazimine may increase the serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

CloZAPine: Dabrafenib may enhance the QTc-prolonging effect of CloZAPine. Dabrafenib may decrease the serum concentration of CloZAPine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Additionally, monitor for decreased clozapine concentrations and efficacy. Risk C: Monitor therapy

Cobimetinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Cobimetinib. Risk X: Avoid combination

Codeine: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Codeine. Risk C: Monitor therapy

Copanlisib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Copanlisib. Risk C: Monitor therapy

Crizotinib: Dabrafenib may enhance the QTc-prolonging effect of Crizotinib. Dabrafenib may decrease the serum concentration of Crizotinib. Crizotinib may increase the serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Additionally, monitor for decreased crizotinib efficacy and increased dabrafenib adverse effects. Risk C: Monitor therapy

CycloSPORINE (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP2C8 Inhibitors (Moderate): May increase the serum concentration of Dabrafenib. Risk C: Monitor therapy

CYP2C8 Inhibitors (Strong): May increase the serum concentration of Dabrafenib. Management: Consider alternatives to strong CYP2C8 inhibitors in patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for evidence of dabrafenib-related adverse effects. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Dabrafenib. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Dabrafenib. Management: Consider alternatives to any strong CYP3A4 inhibitor for patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for evidence of dabrafenib-related adverse effects. Risk D: Consider therapy modification

Daclatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Daclatasvir. Management: Increase the daclatasvir dose to 90 mg once daily if used with a moderate CYP3A4 inducer. Risk D: Consider therapy modification

Dapsone (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dapsone (Systemic). Risk C: Monitor therapy

Daridorexant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Daridorexant. Risk X: Avoid combination

Dasabuvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dasabuvir. Risk X: Avoid combination

Dasatinib: CYP3A4 Inducers (Moderate) may increase the serum concentration of Dasatinib. Risk C: Monitor therapy

Deflazacort: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Deflazacort. Risk X: Avoid combination

Delavirdine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Delavirdine. Risk C: Monitor therapy

DexAMETHasone (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of DexAMETHasone (Systemic). Risk C: Monitor therapy

DiazePAM: CYP3A4 Inducers (Moderate) may decrease the serum concentration of DiazePAM. Risk C: Monitor therapy

Dienogest: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dienogest. Risk C: Monitor therapy

DilTIAZem: CYP3A4 Inducers (Moderate) may decrease the serum concentration of DilTIAZem. Risk C: Monitor therapy

Disopyramide: Dabrafenib may enhance the QTc-prolonging effect of Disopyramide. Dabrafenib may decrease the serum concentration of Disopyramide. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced disopyramide efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Doravirine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Doravirine. Risk C: Monitor therapy

DOXOrubicin (Conventional): CYP3A4 Inducers (Moderate) may decrease the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination

DroNABinol: CYP3A4 Inducers (Moderate) may decrease the serum concentration of DroNABinol. Risk C: Monitor therapy

Dronedarone: Dabrafenib may enhance the QTc-prolonging effect of Dronedarone. Dabrafenib may decrease the serum concentration of Dronedarone. Dronedarone may increase the serum concentration of Dabrafenib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias. Also monitor for decreased dronedarone and increased dabrafenib concentrations. Risk D: Consider therapy modification

Duvelisib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Duvelisib. Management: Avoid if possible. If used, on day 12 of combination increase duvelisib from 25 mg twice daily to 40 mg twice daily or from 15 mg twice daily to 25 mg twice daily. Resume prior duvelisib dose 14 days after stopping moderate CYP3A4 inducer. Risk D: Consider therapy modification

Dydrogesterone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Dydrogesterone. Risk C: Monitor therapy

Efavirenz: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Efavirenz. Risk C: Monitor therapy

Elacestrant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elacestrant. Risk X: Avoid combination

Elbasvir and Grazoprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elbasvir and Grazoprevir. Risk X: Avoid combination

Elexacaftor, Tezacaftor, and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elexacaftor, Tezacaftor, and Ivacaftor. Risk C: Monitor therapy

Eliglustat: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Eliglustat. Risk C: Monitor therapy

Elvitegravir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Elvitegravir. Risk C: Monitor therapy

Encorafenib: Dabrafenib may enhance the QTc-prolonging effect of Encorafenib. Encorafenib may decrease the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Encorafenib. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and reduced encorafenib and dabrafenib concentrations and efficacy when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Entrectinib: Dabrafenib may enhance the QTc-prolonging effect of Entrectinib. Dabrafenib may decrease the serum concentration of Entrectinib. Risk X: Avoid combination

Enzalutamide: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Enzalutamide. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Enzalutamide. Risk C: Monitor therapy

Erdafitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Erdafitinib. Management: Dose modifications of erdafitinib may be required. See full monograph for details. Risk D: Consider therapy modification

Erlotinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Erlotinib. Risk C: Monitor therapy

Estrogen Derivatives: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy

Etoposide: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Etoposide. Risk C: Monitor therapy

Etoposide Phosphate: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Etoposide Phosphate. Risk C: Monitor therapy

Etravirine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Etravirine. Risk C: Monitor therapy

Everolimus: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Everolimus. Risk C: Monitor therapy

Exemestane: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Exemestane. Risk C: Monitor therapy

Fedratinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Fedratinib. Risk X: Avoid combination

Felodipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Felodipine. Risk C: Monitor therapy

FentaNYL: CYP3A4 Inducers (Moderate) may decrease the serum concentration of FentaNYL. Risk C: Monitor therapy

Fexinidazole: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Fexinidazole. Risk X: Avoid combination

Finerenone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Finerenone. Risk X: Avoid combination

Flibanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Flibanserin. Risk X: Avoid combination

Fluorouracil Products: May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Fosamprenavir: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Fosamprenavir. Risk C: Monitor therapy

Fosaprepitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Fosaprepitant. Specifically, CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite aprepitant. Risk C: Monitor therapy

Fosnetupitant: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Fosnetupitant. Risk C: Monitor therapy

Fostamatinib: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Fostamatinib. Risk C: Monitor therapy

Fruquintinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Fruquintinib. Management: Avoid this combination when possible. If combined, continue the same fruquintinib dose, but monitor for reduced fruquintinib efficacy. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Ganaxolone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ganaxolone. Management: Avoid concomitant use of ganaxolone and moderate CYP3A4 inducers whenever possible. If combined, consider increasing the dose of ganaxolone, but do not exceed the maximum recommended daily dose. Risk D: Consider therapy modification

Gefitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Gefitinib. Risk C: Monitor therapy

Gemigliptin: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Gemigliptin. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Gemigliptin. Risk C: Monitor therapy

Gepirone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Gepirone. Risk C: Monitor therapy

Glasdegib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Glasdegib. Management: Avoid use of glasdegib and moderate CYP3A4 inducers whenever possible. If combined, increase glasdegib dose from 100 mg daily to 200 mg daily or from 50 mg daily to 100 mg daily. Resume previous glasdegib dose 7 days after discontinuation of the inducer. Risk D: Consider therapy modification

Glecaprevir and Pibrentasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor therapy

GuanFACINE: CYP3A4 Inducers (Moderate) may decrease the serum concentration of GuanFACINE. Management: Increase extended-release guanfacine dose by up to double when initiating guanfacine in patients taking CYP3A4 inducers or if initiating a CYP3A4 inducer in a patient already taking extended-release guanfacine. Monitor for reduced guanfacine efficacy. Risk D: Consider therapy modification

Haloperidol: May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Hormonal Contraceptives: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Hormonal Contraceptives. Management: Advise patients to use an alternative method of contraception or a back-up method during coadministration, and to continue back-up contraception for 28 days after discontinuing a moderate CYP3A4 inducer to ensure contraceptive reliability. Risk D: Consider therapy modification

HYDROcodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of HYDROcodone. Risk C: Monitor therapy

Hydrocortisone (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Hydrocortisone (Systemic). Risk C: Monitor therapy

Ibrexafungerp: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ibrexafungerp. Risk X: Avoid combination

Ibrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ibrutinib. Risk C: Monitor therapy

Ifosfamide: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Ifosfamide. CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Ifosfamide. Risk C: Monitor therapy

Imatinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Imatinib. Risk C: Monitor therapy

Indinavir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Indinavir. Management: Consider avoiding the combination of indinavir and moderate CYP3A4 inducers whenever possible due to the risk for decreased indinavir concentrations, reduced efficacy, and development of resistance. If combined, monitor for indinavir treatment failure. Risk D: Consider therapy modification

Infigratinib: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Infigratinib. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Infigratinib. Risk X: Avoid combination

Irinotecan Products: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Irinotecan Products. Specifically, concentrations of SN-38 may be reduced. Risk C: Monitor therapy

Isavuconazonium Sulfate: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Isavuconazonium Sulfate. Specifically, CYP3A4 Inducers (Moderate) may decrease isavuconazole serum concentrations. Risk C: Monitor therapy

Isradipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Isradipine. Risk C: Monitor therapy

Istradefylline: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Istradefylline. Risk C: Monitor therapy

Ivabradine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ivabradine. Risk X: Avoid combination

Ivacaftor: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ivacaftor. Risk C: Monitor therapy

Ixabepilone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ixabepilone. Risk C: Monitor therapy

Ixazomib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ixazomib. Risk C: Monitor therapy

Ketamine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ketamine. Risk C: Monitor therapy

Lapatinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lapatinib. Risk C: Monitor therapy

Larotrectinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Larotrectinib. Management: Double the larotrectinib dose if used together with a moderate CYP3A4 inducer. Following discontinuation of the moderate CYP3A4 inducer, resume the previous dose of larotrectinib after a period of 3 to 5 times the inducer's half-life. Risk D: Consider therapy modification

Lefamulin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin with moderate CYP3A4 inducers unless the benefits outweigh the risks. Risk D: Consider therapy modification

Lefamulin (Intravenous): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lefamulin (Intravenous). Management: Avoid concomitant use of lefamulin (intravenous) with moderate CYP3A4 inducers unless the benefits outweigh the risks. Risk D: Consider therapy modification

Lemborexant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lemborexant. Risk X: Avoid combination

Lenacapavir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lenacapavir. Risk X: Avoid combination

Leniolisib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Leniolisib. Risk X: Avoid combination

Lercanidipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lercanidipine. Risk C: Monitor therapy

Levamlodipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Levamlodipine. Risk C: Monitor therapy

Levoketoconazole: Dabrafenib may enhance the QTc-prolonging effect of Levoketoconazole. Levoketoconazole may increase the serum concentration of Dabrafenib. Risk X: Avoid combination

Levomethadone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Levomethadone. Risk C: Monitor therapy

LinaGLIPtin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of LinaGLIPtin. Risk C: Monitor therapy

Lonafarnib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lonafarnib. Risk X: Avoid combination

Lorlatinib: CYP3A4 Inducers (Moderate) may enhance the hepatotoxic effect of Lorlatinib. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lorlatinib. Management: Avoid use of lorlatinib with moderate CYP3A4 inducers. If such a combination must be used, increase lorlatinib to 125 mg daily. Monitor for reduced lorlatinib efficacy and consider closer monitoring of AST, ALT, and bilirubin. Risk D: Consider therapy modification

Lovastatin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lovastatin. Risk C: Monitor therapy

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Lumacaftor and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lumacaftor and Ivacaftor. Risk C: Monitor therapy

Lumateperone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lumateperone. Risk X: Avoid combination

Lurasidone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Lurasidone. Management: Monitor for decreased lurasidone effects if combined with moderate CYP3A4 inducers and consider increasing the lurasidone dose if coadministered with a moderate CYP3A4 inducer for 7 or more days. Risk D: Consider therapy modification

Macitentan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Macitentan. Risk C: Monitor therapy

Maraviroc: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Maraviroc. Management: Increase maraviroc adult dose to 600 mg twice/day, but only if not receiving a strong CYP3A4 inhibitor. Not recommended for pediatric patients not also receiving a strong CYP3A4 inhibitor. Contraindicated in patients with CrCl less than 30 mL/min. Risk D: Consider therapy modification

Maribavir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Maribavir. Risk C: Monitor therapy

Mavacamten: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mavacamten. Risk X: Avoid combination

Mefloquine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mefloquine. Risk C: Monitor therapy

Meperidine: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Meperidine. Specifically, concentrations of normeperidine, the CNS stimulating metabolite, may be increased. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Meperidine. Risk C: Monitor therapy

Methadone: Dabrafenib may enhance the QTc-prolonging effect of Methadone. Dabrafenib may decrease the serum concentration of Methadone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced methadone efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

MethylPREDNISolone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of MethylPREDNISolone. Risk C: Monitor therapy

Mianserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mianserin. Risk C: Monitor therapy

Midazolam: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Midazolam. Risk C: Monitor therapy

Midostaurin: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Midostaurin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased midostaurin efficacy. Risk C: Monitor therapy

MiFEPRIStone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of MiFEPRIStone. Management: Avoid combined use in patients treated for Cushing's disease. When used for pregnancy termination, mifepristone efficacy may be reduced and an alternative pregnancy termination procedure may be warranted. Ensure a follow-up assessment after combined use. Risk D: Consider therapy modification

Mirodenafil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mirodenafil. Risk C: Monitor therapy

Mitapivat: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Mitapivat. Management: Consider alternatives to this combination when possible. If combined, monitor hemoglobin and titrate mitapivat beyond 50 mg twice daily, if needed, but do not exceed doses of 100 mg twice daily. Risk D: Consider therapy modification

Mobocertinib: Dabrafenib may enhance the QTc-prolonging effect of Mobocertinib. Dabrafenib may decrease serum concentrations of the active metabolite(s) of Mobocertinib. Dabrafenib may decrease the serum concentration of Mobocertinib. Risk X: Avoid combination

Naldemedine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Naldemedine. Risk C: Monitor therapy

Naloxegol: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Naloxegol. Risk C: Monitor therapy

Neratinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Neratinib. Risk X: Avoid combination

Netupitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Netupitant. Risk C: Monitor therapy

Nevirapine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nevirapine. Risk C: Monitor therapy

NIFEdipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of NIFEdipine. Risk C: Monitor therapy

Nilotinib: Dabrafenib may enhance the QTc-prolonging effect of Nilotinib. Nilotinib may increase serum concentrations of the active metabolite(s) of Dabrafenib. Nilotinib may increase the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Nilotinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased nilotinib efficacy and increased dabrafenib adverse effects. Risk C: Monitor therapy

Nilvadipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nilvadipine. Risk C: Monitor therapy

NiMODipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of NiMODipine. Risk C: Monitor therapy

Nirogacestat: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nirogacestat. Risk X: Avoid combination

Nisoldipine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Nisoldipine. Risk X: Avoid combination

Olaparib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olaparib. Risk X: Avoid combination

Oliceridine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Oliceridine. Risk C: Monitor therapy

Olmutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olmutinib. Risk C: Monitor therapy

Olutasidenib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Olutasidenib. Risk X: Avoid combination

Omaveloxolone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Omaveloxolone. Risk X: Avoid combination

Ondansetron: May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Orelabrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Orelabrutinib. Risk X: Avoid combination

Osimertinib: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Osimertinib. Management: Monitor for decreased osimertinib efficacy, QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Risk C: Monitor therapy

OxyCODONE: CYP3A4 Inducers (Moderate) may decrease the serum concentration of OxyCODONE. Risk C: Monitor therapy

PACLitaxel (Conventional): CYP3A4 Inducers (Moderate) may decrease the serum concentration of PACLitaxel (Conventional). Risk C: Monitor therapy

PACLitaxel (Protein Bound): CYP3A4 Inducers (Moderate) may decrease the serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor therapy

Pacritinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pacritinib. Risk X: Avoid combination

Palbociclib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Palbociclib. Risk C: Monitor therapy

Palovarotene: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Palovarotene. Risk X: Avoid combination

PAZOPanib: Dabrafenib may enhance the QTc-prolonging effect of PAZOPanib. Dabrafenib may decrease the serum concentration of PAZOPanib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced pazopanib efficacy. Risk C: Monitor therapy

Pemigatinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pemigatinib. Risk X: Avoid combination

Pentamidine (Systemic): May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Perampanel: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Perampanel. Management: Increase perampanel starting dose to 4 mg/day if used with moderate CYP3A4 inducers. Increase perampanel dose by 2 mg/day no more than once weekly based on response and tolerability. Dose adjustments may be needed if the inducer is discontinued. Risk D: Consider therapy modification

Pimavanserin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pimavanserin. Risk X: Avoid combination

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Piperaquine: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Piperaquine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased piperaquine efficacy. Risk C: Monitor therapy

Pirtobrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pirtobrutinib. Management: Avoid concomitant use if possible. If combined, if the current pirtobrutinib dose is 200 mg once daily, increase to 300 mg once daily. If current pirtobrutinib dose is 50 mg or 100 mg once daily, increase the dose by 50 mg. Risk D: Consider therapy modification

PONATinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of PONATinib. Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Pralsetinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pralsetinib. Management: If this combo cannot be avoided, increase pralsetinib dose from 400 mg daily to 600 mg daily; from 300 mg daily to 500 mg daily; and from 200 mg daily to 300 mg daily. Risk D: Consider therapy modification

Praziquantel: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Praziquantel. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for reduced praziquantel efficacy. If possible, stop the moderate CYP3A4 inducer 2 to 4 weeks before praziquantel initiation. Risk D: Consider therapy modification

PrednisoLONE (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of PrednisoLONE (Systemic). Risk C: Monitor therapy

PredniSONE: CYP3A4 Inducers (Moderate) may decrease the serum concentration of PredniSONE. Risk C: Monitor therapy

Pretomanid: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Pretomanid. Risk X: Avoid combination

QT-prolonging Agents (Highest Risk): Dabrafenib may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Antidepressants (Moderate Risk): Dabrafenib may enhance the QTc-prolonging effect of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): Dabrafenib may enhance the QTc-prolonging effect of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Dabrafenib. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and dabrafenib adverse effects when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): Dabrafenib may enhance the QTc-prolonging effect of QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk). QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase the serum concentration of Dabrafenib. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Dabrafenib. QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of Dabrafenib. Management: Consider alternatives to these QT-prolonging strong CYP3A4 inhibitors for patients being treated with dabrafenib. If such a combination cannot be avoided, monitor closely for dabrafenib-related adverse effects, including QTc interval prolongation. Risk D: Consider therapy modification

QUEtiapine: Dabrafenib may enhance the QTc-prolonging effect of QUEtiapine. Dabrafenib may decrease the serum concentration of QUEtiapine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced quetiapine efficacy. Risk C: Monitor therapy

QuiNIDine: Dabrafenib may enhance the QTc-prolonging effect of QuiNIDine. Dabrafenib may decrease the serum concentration of QuiNIDine. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quinidine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QuiNINE: Dabrafenib may enhance the QTc-prolonging effect of QuiNINE. Dabrafenib may decrease the serum concentration of QuiNINE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quinine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Quizartinib: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Quizartinib. Risk X: Avoid combination

Ranolazine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ranolazine. Risk X: Avoid combination

Regorafenib: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Regorafenib. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Regorafenib. Risk C: Monitor therapy

Repaglinide: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Repaglinide. Risk C: Monitor therapy

Repotrectinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Repotrectinib. Risk X: Avoid combination

Ribociclib: Dabrafenib may enhance the QTc-prolonging effect of Ribociclib. Ribociclib may increase serum concentrations of the active metabolite(s) of Dabrafenib. Ribociclib may increase the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Ribociclib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Also monitor for decreased ribociclib efficacy and increased dabrafenib adverse effects. Risk C: Monitor therapy

Rilpivirine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Rilpivirine. Risk C: Monitor therapy

Rimegepant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Rimegepant. Risk X: Avoid combination

Ripretinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ripretinib. Management: Avoid this combination if possible. If concomitant use is required, increase ripretinib to 150 mg twice daily. Decrease ripretinib to 150 mg once daily 14 days after stopping a moderate CYP3A4 inducer. Monitor patients for ripretinib response and toxicity Risk D: Consider therapy modification

RisperiDONE: Dabrafenib may enhance the QTc-prolonging effect of RisperiDONE. Dabrafenib may decrease the serum concentration of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced risperidone efficacy. Risk C: Monitor therapy

Ritlecitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ritlecitinib. Risk C: Monitor therapy

Roflumilast (Systemic): CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Roflumilast (Systemic). CYP3A4 Inducers (Moderate) may decrease the serum concentration of Roflumilast (Systemic). Risk C: Monitor therapy

Rolapitant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Rolapitant. Risk C: Monitor therapy

Samidorphan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Samidorphan. Risk C: Monitor therapy

Selpercatinib: Dabrafenib may enhance the QTc-prolonging effect of Selpercatinib. Dabrafenib may decrease the serum concentration of Selpercatinib. Risk X: Avoid combination

Selumetinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Selumetinib. Risk X: Avoid combination

Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Sertraline: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sertraline. Risk C: Monitor therapy

Sildenafil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sildenafil. Risk C: Monitor therapy

Simeprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Simeprevir. Risk X: Avoid combination

Simvastatin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Simvastatin. Risk C: Monitor therapy

Sirolimus (Conventional): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sirolimus (Conventional). Risk C: Monitor therapy

Sirolimus (Protein Bound): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sirolimus (Protein Bound). Risk C: Monitor therapy

Sonidegib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sonidegib. Risk X: Avoid combination

SORAfenib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of SORAfenib. Risk C: Monitor therapy

Sotorasib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sotorasib. Risk C: Monitor therapy

Sparsentan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Sparsentan. Risk C: Monitor therapy

SUFentanil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of SUFentanil. Risk C: Monitor therapy

SUNItinib: Dabrafenib may enhance the QTc-prolonging effect of SUNItinib. Dabrafenib may decrease the serum concentration of SUNItinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced sunitinib efficacy. Risk C: Monitor therapy

Suvorexant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Suvorexant. Risk C: Monitor therapy

Tacrolimus (Systemic): CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Tadalafil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tadalafil. Risk C: Monitor therapy

Tamoxifen: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tamoxifen. Risk C: Monitor therapy

Tasimelteon: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tasimelteon. Risk C: Monitor therapy

Tazemetostat: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tazemetostat. Risk X: Avoid combination

Temsirolimus: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Temsirolimus. Specifically, sirolimus concentrations may be decreased. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Temsirolimus. Risk C: Monitor therapy

Tetrahydrocannabinol: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tetrahydrocannabinol. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tetrahydrocannabinol and Cannabidiol. Risk C: Monitor therapy

Tezacaftor and Ivacaftor: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tezacaftor and Ivacaftor. Risk C: Monitor therapy

Thiotepa: CYP3A4 Inducers (Moderate) may increase serum concentrations of the active metabolite(s) of Thiotepa. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Thiotepa. Risk C: Monitor therapy

Ticagrelor: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Ticagrelor. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ticagrelor. Risk C: Monitor therapy

Tivozanib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tivozanib. Risk C: Monitor therapy

Tofacitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tofacitinib. Risk C: Monitor therapy

Tolvaptan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Tolvaptan. Risk C: Monitor therapy

Toremifene: May enhance the QTc-prolonging effect of Dabrafenib. Dabrafenib may decrease the serum concentration of Toremifene. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced toremifene efficacy. Risk C: Monitor therapy

Trabectedin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Trabectedin. Risk C: Monitor therapy

TraMADol: CYP3A4 Inducers (Moderate) may decrease the serum concentration of TraMADol. Risk C: Monitor therapy

Trametinib: May enhance the adverse/toxic effect of Dabrafenib. Trametinib may increase the serum concentration of Dabrafenib. Risk C: Monitor therapy

TraZODone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of TraZODone. Risk C: Monitor therapy

Triazolam: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Triazolam. Risk C: Monitor therapy

Ubrogepant: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 100 mg and second dose (if needed) of 100 mg when used with a moderate CYP3A4 inducer. Risk D: Consider therapy modification

Ulipristal: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Ulipristal. Risk X: Avoid combination

Upadacitinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Upadacitinib. Risk C: Monitor therapy

Valbenazine: CYP3A4 Inducers (Moderate) may decrease serum concentrations of the active metabolite(s) of Valbenazine. CYP3A4 Inducers (Moderate) may decrease the serum concentration of Valbenazine. Risk C: Monitor therapy

Vandetanib: Dabrafenib may enhance the QTc-prolonging effect of Vandetanib. Dabrafenib may increase serum concentrations of the active metabolite(s) of Vandetanib. Dabrafenib may decrease the serum concentration of Vandetanib. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and changes in vandetanib efficacy or toxicity. Risk D: Consider therapy modification

Velpatasvir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

Vemurafenib: Dabrafenib may enhance the QTc-prolonging effect of Vemurafenib. Dabrafenib may decrease the serum concentration of Vemurafenib. Management: Monitor for decreased vemurafenib efficacy, QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Risk C: Monitor therapy

Venetoclax: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Venetoclax. Risk X: Avoid combination

Verapamil: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Verapamil. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vilazodone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Vilazodone. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): CYP2C9 Inducers (Weak) may decrease the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Voclosporin: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Voclosporin. Risk X: Avoid combination

Vonoprazan: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Vonoprazan. Risk X: Avoid combination

Vorapaxar: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Vorapaxar. Risk X: Avoid combination

Vortioxetine: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Vortioxetine. Risk C: Monitor therapy

Voxelotor: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Voxelotor. Management: Avoid concomitant use of voxelotor and moderate CYP3A4 inducers. If unavoidable, increase the voxelotor dose to 2,000 mg once daily. For children ages 4 to less than 12 years, weight-based dose adjustments are required. See full monograph for details. Risk D: Consider therapy modification

Voxilaprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Voxilaprevir. Risk X: Avoid combination

Zaleplon: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zaleplon. Risk C: Monitor therapy

Zanubrutinib: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zanubrutinib. Management: Avoid this combination if possible. If coadministration of zanubrutinib and a moderate CYP3A4 inducer is required, increase the zanubrutinib dose to 320 mg twice daily. Risk D: Consider therapy modification

Zolpidem: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zolpidem. Risk C: Monitor therapy

Zopiclone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zopiclone. Risk C: Monitor therapy

Zuranolone: CYP3A4 Inducers (Moderate) may decrease the serum concentration of Zuranolone. Risk X: Avoid combination

Food Interactions

Administration of capsules with a high-fat meal (~1,000 calories; 58 to 75 grams of fat, 58 g of carbohydrates, 33 g of protein) decreased C_maxand AUC by 51% and 31%, respectively, and delayed median T_maxby 3.6 hours (compared to a fasted state). Management: Administer 1 hour before or 2 hours after a meal.

Reproductive Considerations

Verify pregnancy status prior to treatment initiation in patients who could become pregnant. Dabrafenib may cause hormonal contraceptives to be ineffective. Patients who could become pregnant should use a highly effective nonhormonal contraceptive during dabrafenib therapy and for 2 weeks after the last dabrafenib dose. Males (including those with vasectomies) with pregnant partners or partners who could become pregnant should use condoms during dabrafenib treatment and for 2 weeks after the last dabrafenib dose.

Pregnancy Considerations

Based on its mechanism of action and on findings in animal reproduction studies, in utero exposure to dabrafenib may cause fetal harm.

Breastfeeding Considerations

It is not known if dabrafenib is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during dabrafenib treatment and for 2 weeks after the last dabrafenib dose.

Monitoring Parameters

BRAF V600K or V600E mutation status (prior to treatment); serum glucose at baseline and as clinically necessary (particularly in patients with preexisting diabetes mellitus or hyperglycemia); electrolytes; renal function. Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Perform dermatologic evaluations prior to initiation, every 2 months during therapy, and for up to 6 months following discontinuation to assess for new cutaneous malignancies. Monitor for febrile drug reactions and signs/symptoms of infections; monitor serum creatinine and other evidence of renal function during and after serious fever. Monitor for signs/symptoms of uveitis (eg, eye pain, photophobia, vision changes). Monitor for signs/symptoms of hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency, new or worsening dermatologic toxicity (including severe cutaneous adverse reactions), and for noncutaneous malignancies.

For patients receiving combination therapy with trametinib: Hepatic function; CBC (baseline and periodically during therapy); assess left ventricular ejection fraction (by echocardiogram or multigated acquisition scan [MUGA] scan) at baseline, 1 month after therapy initiation, and then at 2- to 3-month intervals while on treatment. Monitor for signs/symptoms of hemorrhage, venous thromboembolism, interstitial lung disease, and hemophagocytic lymphohistiocytosis. Monitor for signs/symptoms of retinal pigment epithelial detachment or retinal vein occlusion; promptly (within 24 hours) refer patients for ophthalmological evaluations if loss of vision or other visual disturbances occur; ophthalmic exams (including retinal evaluation) should be performed periodically during treatment with combination therapy.

Monitor adherence.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Cardiovascular monitoring specifics: Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking (ASCO [Armenian 2017]). Assess BP at baseline and each clinical visit (as well as outpatient monitoring weekly for initial 3 months, then monthly thereafter), obtain a baseline echocardiography in high- and very-high risk patients scheduled to receive BRAF-MEK inhibitor combination therapy (consider repeating every 4 months during the first year); consider echocardiography in low- and moderate-risk patients scheduled to receive BRAF-MEK inhibitor combination therapy (ESC [Lyon 2022]).

Mechanism of Action

Dabrafenib selectively inhibits some mutated forms of the protein kinase B-raf (BRAF). BRAF V600 mutations result in constitutive activation of the BRAF pathway; through BRAF inhibition, dabrafenib inhibits tumor cell growth. The combination of dabrafenib and trametinib allows for greater inhibition of the MAPK pathway, resulting in BRAF V600 melanoma cell death (Flaherty 2012). Dabrafenib plus trametinib has been reported to synergistically inhibit cell growth in lung cancer cell lines which are BRAF V600E-mutant (Planchard 2016). Induction of EGFR-mediated MAPK pathway reactivation in the setting of BRAF-mutant colorectal cancer has been identified as a mechanism of intrinsic resistance to BRAF inhibitors.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Decreased when capsules are administered with a high-fat meal (~1,000 calories; 58 to 75 grams of fat).

Distribution: 70.3 L.

Protein binding: 99.7% to plasma proteins.

Metabolism: Hepatic via CYP2C8 and CYP3A4 to hydroxy-dabrafenib (active) which is further metabolized via CYP3A4 oxidation to desmethyl-dabrafenib (active).

Bioavailability: Capsules: 95%; Tablets for oral suspension: 76%.

Half-life elimination: Parent drug: 8 hours; Hydroxy-dabrafenib (active metabolite): 10 hours; Desmethyl-dabrafenib (active metabolite): 21 to 22 hours; Carboxy-dabrafenib (21 to 22 hours).

Time to peak: 2 hours; delayed with a high-fat meal (~1,000 calories; 58 to 75 grams of fat).

Excretion: Feces (71%); urine (23%; metabolites only).

Clearance: 17 L/hour (single dose); 34.4 L/hour (after 2 weeks of twice-daily dosing).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Patients with moderate (bilirubin >1.5 to 3 times ULN and any AST) or severe (bilirubin >3 to 10 times ULN and any AST) hepatic impairment may have increased dabrafenib exposure.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Tafinlar;
(AR) Argentina: Tafinlar;
(AT) Austria: Tafinlar;
(BE) Belgium: Tafinlar;
(BG) Bulgaria: Tafinlar;
(BR) Brazil: Tafinlar;
(CH) Switzerland: Tafinlar;
(CL) Chile: Tafinlar;
(CO) Colombia: Tafinlar;
(CZ) Czech Republic: Tafinlar;
(DE) Germany: Tafinlar;
(EE) Estonia: Tafinlar;
(EG) Egypt: Tafinlar;
(ES) Spain: Tafinlar;
(FI) Finland: Tafinlar;
(FR) France: Tafinlar;
(GB) United Kingdom: Tafinlar;
(GR) Greece: Tafinlar;
(HK) Hong Kong: Tafinlar;
(HR) Croatia: Tafinlar;
(HU) Hungary: Tafinlar;
(IE) Ireland: Tafinlar;
(IN) India: Rafinlar;
(IT) Italy: Tafinlar;
(JO) Jordan: Tafinlar;
(JP) Japan: Tafinlar;
(KR) Korea, Republic of: Rafinlar;
(LT) Lithuania: Tafinlar;
(LV) Latvia: Tafinlar;
(MX) Mexico: Tafinlar;
(NL) Netherlands: Tafinlar;
(NO) Norway: Tafinlar;
(NZ) New Zealand: Tafinlar;
(PH) Philippines: Tafinlar;
(PL) Poland: Tafinlar;
(PT) Portugal: Tafinlar;
(QA) Qatar: Tafinlar;
(RO) Romania: Tafinlar;
(RU) Russian Federation: Rafinlar | Tafinlar;
(SE) Sweden: Tafinlar;
(SG) Singapore: Tafinlar;
(SI) Slovenia: Tafinlar;
(SK) Slovakia: Tafinlar;
(TH) Thailand: Tafinlar;
(TN) Tunisia: Tafinlar;
(TR) Turkey: Tafinlar;
(TW) Taiwan: Tafinlar;
(UA) Ukraine: Tafinlar;
(UY) Uruguay: Tafinlar;
(ZA) South Africa: Tafinlar

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Dabrafenib: Drug information