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All-trans retinoic acid (systemic tretinoin): Pediatric drug information

All-trans retinoic acid (systemic tretinoin): Pediatric drug information
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For additional information see "All-trans retinoic acid (systemic tretinoin): Drug information" and "All-trans retinoic acid (systemic tretinoin): Patient drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Embryo-fetal toxicity:

Tretinoin can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin and for 1 week after the last dose.

Differentiation syndrome:

Differentiation syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with acute promyelocytic leukemia (APL) who received tretinoin. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin for moderate and severe differentiation syndrome until resolution.

Brand Names: Canada
  • JAMP-Tretinoin;
  • Vesanoid
Therapeutic Category
  • Antineoplastic Agent, Miscellaneous;
  • Antineoplastic Agent, Retinoic Acid Derivatives;
  • Retinoic Acid Derivative
Dosing: Pediatric

Dosage guidance:

Dosing: Frequency, number of doses, timing of doses during cycles/phases, and concomitant therapy may vary; refer to individual protocols.

Acute promyelocytic leukemia

Acute promyelocytic leukemia (APL):

Children and Adolescents:

Note: In pediatric trials, daily doses should be rounded to the nearest 10 mg (ie, if <5 mg round down; if ≥5 mg round up); if necessary, the morning dose may differ from the evening dose (Ref).

Induction: Note: Induction treatment of APL with tretinoin should be initiated early; discontinue if pending cytogenetic analysis does not confirm t(15;17) translocation or the presence of the PML/RARα fusion protein.

Oral: 25 mg/m2/day in 2 divided doses (Ref). Discontinue 30 days after complete remission or after 90 days of therapy, whichever occurs first. Note: Although dosing (higher) is provided in manufacturer labeling (22.5 mg/m2/dose twice daily), it is not reflective of the contemporary protocols in pediatric patients; serious adverse effects (pseudotumor cerebri) have been more commonly observed in children than adults (Ref).

Consolidation cycles: Dosage regimens variable: Oral: 25 mg/m2/day in 2 divided doses for 14 days on and 14 days off; in combination with other chemotherapy, refer to the protocols for further details (Ref).

Maintenance: Oral: 25 mg/m2/day in 2 divided doses on days 1 to 14 (in combination with oral methotrexate, mercaptopurine, and intrathecal cytarabine [first cycle only]) (Ref).

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: Note: Refer to specific protocol(s) for detailed information related to management for the following and other drug-related toxicities.

Children and Adolescents:

APL differentiation syndrome: Hold tretinoin and initiate dexamethasone 0.25 mg/kg/dose (maximum dose: 10 mg) IV or orally every 12 hours for 3 days; resume tretinoin after resolution of signs/symptoms if occurs within 3 days; if symptoms persist longer than 3 days or recur with therapy, hold tretinoin therapy and evaluate case on an individual basis (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

Baseline: There are no dosage adjustments provided in the manufacturer's labeling.

Hepatotoxicity during treatment:

Children and Adolescents: Liver function tests >5 × ULN: Consider withholding tretinoin until resolution (Ref); however, some pediatric protocols suggest if bilirubin 2 to 3 × ULN hold tretinoin until <2 × ULN and then resume at usual dose; if AST >5 × ULN and/or bilirubin >3 × ULN, hold tretinoin until AST <3 × ULN or bilirubin <2 × ULN then resume with 50% dose reduction; refer to protocol for further details (Ref).

Dosing: Adult

(For additional information see "All-trans retinoic acid (systemic tretinoin): Drug information")

Dosage guidance:

Clinical considerations: Acute promyelocytic leukemia (APL) induction treatment with tretinoin should be initiated early; discontinue if pending cytogenetic analysis does not confirm t(15;17) translocation or the presence of the PML/RARα fusion protein. In patients presenting with WBC ≥5,000/mm3 or serum creatinine >1.39 mg/dL, consider systemic corticosteroids (eg, dexamethasone, prednisone) for prophylaxis of differentiation syndrome (Ref). Refer to the protocol or institutional guidance for additional details on off-label dosing.

Acute promyelocytic leukemia

Acute promyelocytic leukemia:

Remission induction: Note: For non–high-risk APL patients (WBC ≤10,000/mm3), induction therapy consists of tretinoin with arsenic trioxide, although tretinoin with anthracycline-based chemotherapy is an option when arsenic trioxide cannot be used. For patients with high-risk APL (WBC >10,000/mm3), induction therapy generally consists of tretinoin and anthracycline-based chemotherapy ± arsenic trioxide (Ref).

Oral: 45 mg/m2/day in 2 equally divided doses until documentation of complete remission (CR); discontinue 30 days after CR or after 90 days of treatment, whichever occurs first (Ref).

Tretinoin with arsenic trioxide: Oral: 45 mg/m2/day in 2 equally divided doses until <5% blasts in marrow and no abnormal promyelocytes or complete remission, up to a maximum of 60 or 85 days; refer to protocol(s) for further information (Ref).

Tretinoin with idarubicin: Oral: 45 mg/m2/day in 2 equally divided doses until complete hematologic remission (Ref).

Tretinoin with daunorubicin and cytarabine: Oral: 45 mg/m2/day in 2 equally divided doses until complete remission or 90 days (Powell 2010) or until complete hematologic remission (Ref).

Tretinoin with arsenic trioxide and gemtuzumab ozogamicin: Oral: 45 mg/m2/day in 2 equally divided doses until <5% blasts in marrow and no abnormal promyelocytes (Ref).

Tretinoin with gemtuzumab ozogamicin: Oral: 45 mg/m2/day in 2 equally divided doses until complete remission (Ref).

Consolidation therapy (off-label use):

Tretinoin with arsenic trioxide: Oral: 45 mg/m2/day in 2 equally divided doses days 1 to 14 every 28 days for 7 cycles (Ref) or for 2 weeks every 28 days for 7 cycles (Ref).

Tretinoin with idarubicin/mitoxantrone: Oral: 45 mg/m2/day in 2 equally divided doses for 15 days each month for 3 months (in combination with idarubicin [courses 1 and 3] and mitoxantrone [course 2]) (Ref).

Tretinoin and daunorubicin after arsenic trioxide: Oral: 45 mg/m2/day in 2 equally divided doses for 7 days of each cycle (in combination with daunorubicin for 2 cycles; begin after 2 arsenic trioxide consolidation cycles) (Ref).

Maintenance therapy (off-label use): Oral: 45 mg/m2/day in 2 equally divided doses for 15 days every 3 months (in combination with mercaptopurine and methotrexate) for 2 years (Ref) or 45 mg/m2/day in 2 equally divided doses for 7 days every other week (± mercaptopurine and methotrexate) for 1 year (Ref). Note: For non–high-risk patients (WBC ≤10,000/mm3) receiving chemotherapy-free therapy, maintenance therapy is not needed (Ref).

Missed doses: Do not administer a missed dose unless it is >10 hours until the next scheduled dose. If <10 hours until the next scheduled dose, skip the missed dose and resume dosing at the next regular scheduled time. If vomiting occurs after administration, do not administer an additional dose; resume dosing at the next regular 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

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Hepatotoxicity during treatment: Liver function tests >5 × ULN: Consider withholding tretinoin until resolution. Most liver function test abnormalities will resolve without interruption of treatment or after completion of tretinoin therapy.

Adverse Reactions

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

>10%:

Cardiovascular: Cardiac arrhythmia (23%), chest discomfort (32%), edema (29%), flushing (23%), hypertension (11%), hypotension (14%), peripheral edema (52%), phlebitis (11%)

Dermatologic: Alopecia (14%), diaphoresis (20%), pruritus (20%), skin changes (14%), skin rash (54%), xeroderma (≤77%)

Endocrine & metabolic: Hypercholesterolemia (≤60%), hypertriglyceridemia (≤60%), weight gain (23%), weight loss (17%)

Gastrointestinal: Abdominal distention (11%), abdominal pain (31%), anorexia (17%), constipation (17%), diarrhea (23%), dry mucous membranes (≤77%), dyspepsia (14%), gastrointestinal hemorrhage (34%), nausea (≤57%), stomatitis (26%), vomiting (≤57%)

Hematologic & oncologic: Differentiation syndrome (≤26%), disseminated intravascular coagulation (26%), hemorrhage (60%), leukocytosis (40% to 49%)

Hepatic: Increased liver enzymes (50% to 60%)

Infection: Infection (58%)

Nervous system: Anxiety (17%), confusion (11%), depression (14%), dizziness (20%), headache (86%), insomnia (14%), malaise (66%), pain (37%), paresthesia (17%), shivering (63%)

Neuromuscular & skeletal: Myalgia (14%), ostealgia (77%)

Ophthalmic: Eye disease (17%), visual disturbance (17%)

Otic: Otalgia (23%; including a feeling of ear fullness)

Renal: Kidney impairment (11%)

Respiratory: Dyspnea (60%), pleural effusion (20%), pneumonia (14%), rales (14%), respiratory insufficiency (26%), upper respiratory system symptoms (63%), wheezing (expiratory: 14%)

Miscellaneous: Fever (83%)

1% to 10%:

Cardiovascular: Acute myocardial infarction (3%), cardiomegaly (3%), cardiomyopathy (3%), heart failure (6%), heart murmur (3%), ischemia (3%), myocarditis (3%), pericarditis (3%)

Dermatologic: Cellulitis (8%), pallor (6%)

Endocrine & metabolic: Acidosis (3%), fluid volume disorder (6%)

Gastrointestinal: Gastrointestinal ulcer (3%)

Genitourinary: Benign prostatic hypertrophy (3%), dysuria (9%), urinary frequency (3%)

Hematologic & oncologic: Disorder of the lymphatic system (6%)

Hepatic: Ascites (3%), hepatitis (3%), hepatosplenomegaly (9%)

Hypersensitivity: Facial edema (6%)

Nervous system: Abnormal gait (3%), agitation (9%), agnosia (3%), aphasia (3%), asterixis (3%), ataxia (3%), brain edema (3%), central nervous system depression (3%), cerebellar disorder (3%), cerebral hemorrhage (9%), cerebrovascular accident (3%), coma (3%), dementia (3%), drowsiness (3%), dysarthria (3%), encephalopathy (3%), facial nerve paralysis (3%), forgetfulness (3%), hallucination (6%), hemiplegia (3%), hyporeflexia (3%), hypothermia (3%), intracranial hypertension (9%), loss of consciousness (3%), seizure (3%), speech disturbance (slowing: 3%), tremor (3%)

Neuromuscular & skeletal: Lower extremity weakness (3%), osteomyelitis (3%)

Ophthalmic: Decreased pupillary reflex (3%), decreased visual acuity (6%), visual field defect (3%)

Otic: Hearing loss (≤6%; may be irreversible)

Renal: Acute kidney injury (3%), flank pain (9%), renal tubular necrosis (3%)

Respiratory: Asthma (3%), laryngeal edema (3%), lower respiratory signs and symptoms (9%), pulmonary edema (3%), pulmonary hypertension (3%), pulmonary infiltrates (6%)

Postmarketing:

Cardiovascular: Arterial thrombosis, atrioventricular block (Shih 2015), bradycardia (Karakatsanis 2014), venous thrombosis

Dermatologic: Dermal ulcer (genital) (Yanamandra 2016), erythema nodosum, Sweet syndrome (van Der Vliet 2000), vasculitis of the skin

Endocrine & metabolic: Hypercalcemia

Gastrointestinal: Pancreatitis

Hematologic & oncologic: Basophilia (Koike 1992), thrombocythemia (Aldapt 2018)

Hypersensitivity: Histamine release (hyperhistaminemia) (Koike 1992)

Neuromuscular & skeletal: Myositis (van Der Vliet 2000)

Renal: Renal infarction

Contraindications

Hypersensitivity (eg, dyspnea, face edema, pruritus, rash) to tretinoin, other retinoids, or any component of the formulation.

Canadian labeling: Additional contraindications (not in the US labeling): Pregnancy; breastfeeding; patients at risk of becoming pregnant who are unable to follow or comply with required contraceptive measures; concurrent use with vitamin A, tetracyclines, or other retinoids.

Warnings/Precautions

Concerns related to adverse effects:

• Differentiation syndrome: Differentiation syndrome, which can be life-threatening or fatal, occurred in approximately one-fourth of patients with acute promyelocytic leukemia (APL) who received tretinoin. Differentiation syndrome is characterized by fever, dyspnea, acute respiratory distress, weight gain, radiographic pulmonary infiltrates, pleural and pericardial effusions, edema, and hepatic, renal, and/or multiorgan failure. Differentiation syndrome may be accompanied by impaired myocardial contractility and episodic hypotension. It has been observed with or without concomitant leukocytosis. Endotracheal intubation and mechanical ventilation have been required in some cases due to progressive hypoxemia; fatalities due to multiorgan failure have occurred. Differentiation syndrome generally occurs during the first month of treatment, with some cases reported following the first dose.

• Hepatotoxicity: Elevated LFT results occur in 50% to 60% of patients during tretinoin treatment. Most LFT abnormalities will resolve without interruption of treatment or after therapy completion.

• Intracranial hypertension: Retinoids, including tretinoin, have been associated with intracranial hypertension, especially in pediatric patients. Concurrent use of other drugs associated with this effect (eg, tetracyclines) may increase risk. Early signs and symptoms include papilledema, headache, nausea, vomiting, and visual disturbances.

• Leukocytosis: During treatment, ~40% of patients will develop rapidly evolving leukocytosis. Patients who present with a high baseline WBC count (>5,000/mm3) are at increased risk, and patients who receive chemotherapy in combination with tretinoin may be at decreased risk. Rapidly evolving leukocytosis is associated with a higher risk of life-threatening complications.

• Lipid abnormalities: Up to 60% of patients experienced hypercholesterolemia or hypertriglyceridemia, which were reversible upon completion of treatment.

• Thromboembolic events: Venous and arterial thromboembolic events, including cerebrovascular accident, myocardial infarction, and renal infarction, have been reported with tretinoin; usually occurrence was during the first month of treatment. Avoid use with antifibrinolytic agents (eg, aminocaproic acid, aprotinin, tranexamic acid).

Dosage form specific issues:

• Do not interchange: Tretinoin (which is also known as all-trans retinoic acid, or ATRA) and isotretinoin may be confused; while both products may be used in cancer treatment, they are not interchangeable. Verify product prior to dispensing and administration to prevent medication errors.

Other warnings/precautions:

• Appropriate use: Confirm the diagnosis of APL by detection of the t(15;17) translocation using cytogenetic studies or PML/RARα fusion using molecular diagnostic techniques; tretinoin is not recommended for use in patients without these genetic markers.

Dosage Forms: US

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

Capsule, Oral:

Generic: 10 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Tretinoin Oral)

10 mg (per each): $37.35

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:

Vesanoid: 10 mg [contains soybean oil]

Generic: 10 mg

Extemporaneous Preparations

Although the manufacturer does not recommend the use of the capsule contents to extemporaneously prepare a suspension of tretinoin (due to reports of low plasma levels) (Vesanoid data on file), there are limited case reports of use in patients who are unable to swallow the capsules whole. In a patient with a nasogastric (NG) tube, tretinoin capsules were cut open, with partial aspiration of the contents aspirated into a glass syringe. The residual capsule contents were mixed with soybean oil, aspirated into the syringe, and administered (Shaw 1995). Tretinoin capsules have also been mixed with sterile water (~20 mL) and heated in a water bath to melt the capsules and create an oily suspension for NG tube administration (Bargetzi 1996). A tretinoin 2.5 mg/mL slurry has been prepared using 10 mg tretinoin capsules, SWFI, and mineral oil; add six 10 mg tretinoin capsules to a 30 mL syringe, then add 16.5 mL SWFI, cap syringe securely, place in hazardous material bag, and place in warmer for 10 to 15 minutes to allow capsules to dissolve; transfer into a separate 35 mL enteral syringe containing 7.5 mL mineral oil and gently shake; use within 24 hours (Przybylski 2021).

Bargetzi MJ, Tichelli A, Gratwohl A, et al. Oral all-transretinoic acid administration in intubated patients with acute promyelocytic leukemia. Schweiz Med Wochenschr. 1996;126(45):1944-1945.8946598
Przybylski DJ, Jared JR, Fallon MJ. Extemporaneous compounding and administration of tretinoin slurry for acute promyelocytic leukemia. J Oncol Pharm Pract. 2021;27(7):1779-1783. doi:10.1177/107815522199009133499747
Shaw PJ, Atkins MC, Nath CE, et al. ATRA administration in the critically ill patient. Leukemia. 1995;9(7):1288.7630206
Vesanoid data on file, Roche Pharmaceuticals
Administration: Pediatric

Oral: Administer with a meal.

Capsule : For patients unable to swallow capsules, the following options may be considered and contents consumed within 1 hour: Poke a small hole in the capsule and patients may chew the capsule; capsules may be softened in water and then softened capsule chewed, swallowed, or mixed with jam/fatty food and then consumed; or puncture the capsule and squeeze contents onto a fatty food, mix, and consume (for this method, it is ideal to have patient suck on empty capsule to assist with getting full dose) (Ref).

Administration via feeding tube:

Nasogastric tube: In a patient with a nasogastric (NG) tube, tretinoin capsules were cut open, with partial aspiration of the contents into a glass syringe; the residual capsule contents were mixed with soy bean oil and aspirated into the same syringe and administered (Ref). Tretinoin capsules have also been mixed with sterile water (~20 mL) and heated in a water bath (37°C) to melt the capsules and create an oily suspension for NG tube administration (Ref). For pediatric patients, some centers have suggested contents of capsule may be mixed with milk and administered NG (Ref). Low plasma levels have been reported when contents of tretinoin capsules were administered directly through a feeding tube, although patient-specific impaired absorption may have been a contributing factor (Ref).

Sublingual : Capsule: Tretinoin has been administered sublingually by squeezing the capsule contents beneath the tongue in an adult patient (Ref).

Administration: Adult

Oral: Administer with a meal. Swallow whole with water; do not chew, dissolve, or open capsule.

Tretinoin has also been administered sublingually by squeezing the capsule contents beneath the tongue (Ref).

Low plasma concentrations have been reported when tretinoin has been administered through a feeding tube, although patient-specific impaired absorption or a lack of excipient (eg, soybean oil) may have been a contributing factor (Ref).

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 2]).

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 2023; NIOSH 2024; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep bottle closed tightly. Protect from light.

Use

Induction of remission in patients with acute promyelocytic leukemia (APL) characterized by t(15;17) translocation and/or PML/RARα gene presence and who are refractory to or relapsed following anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated (FDA approved in ages ≥1 year and adults); has also been used in post consolidation and maintenance therapy in APL.

Medication Safety Issues
Sound-alike/look-alike issues:

Tretinoin may be confused with alitretinoin, ISOtretinoin, trientine

Vesanoid may be confused with VESIcare

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

Other safety concerns:

Tretinoin (which is also called all-trans retinoic acid, or ATRA) may be confused with isotretinoin; while both products may have uses in cancer treatment, they are not interchangeable.

Metabolism/Transport Effects

Substrate of CYP2C8 (Minor), CYP2C9 (Minor), CYP2E1 (Minor), CYP3A4 (Major), UGT2B7; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Induces CYP2E1 (Weak);

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

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 drug interactions program

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Amisulpride (Oral): May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Antifibrinolytic Agents: Tretinoin (Systemic) may increase thrombogenic effects of Antifibrinolytic Agents. Management: Concomitant use of antifibrinolytics and tretinoin is not recommended. If combined, monitor patients closely for any signs of thrombotic complications. Risk D: Consider Therapy Modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Blood Pressure Lowering Agents: May increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CYP3A4 Inducers (Moderate): May decrease serum concentration of Tretinoin (Systemic). Risk C: Monitor

CYP3A4 Inducers (Strong): May decrease serum concentration of Tretinoin (Systemic). Management: Avoid use of tretinoin and strong CYP3A4 inducers when possible. If combined, monitor for reduced tretinoin concentrations and efficacy. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Tretinoin (Systemic). Risk C: Monitor

CYP3A4 Inhibitors (Strong): May increase serum concentration of Tretinoin (Systemic). Management: Avoid use of tretinoin and strong CYP3A4 inhibitors when possible. If combined, monitor for increased tretinoin concentrations and toxicities (eg, pseudotumor cerebri, hypercalcemia). Risk D: Consider Therapy Modification

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Tretinoin (Systemic). Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methotrexate: Retinoic Acid Derivatives may increase hepatotoxic effects of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Multivitamins/Fluoride (with ADE): May increase adverse/toxic effects of Retinoic Acid Derivatives. Risk X: Avoid

Multivitamins/Minerals (with ADEK, Folate, Iron): May increase adverse/toxic effects of Retinoic Acid Derivatives. Risk X: Avoid

Multivitamins/Minerals (with AE, No Iron): May increase adverse/toxic effects of Retinoic Acid Derivatives. Risk X: Avoid

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Progestins (Contraceptive): Retinoic Acid Derivatives may decrease therapeutic effects of Progestins (Contraceptive). Retinoic Acid Derivatives may decrease serum concentration of Progestins (Contraceptive). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Microdosed progesterone-only preparations (ie, minipills that do not contain estrogen) are considered an inadequate method of contraception. Risk D: Consider Therapy Modification

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Tetracyclines: May increase adverse/toxic effects of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin A: May increase adverse/toxic effects of Retinoic Acid Derivatives. Risk X: Avoid

Food Interactions

Absorption of retinoids has been shown to be enhanced when taken with food. Management: Administer with food.

Dietary Considerations

Capsule contains soybean oil.

Reproductive Considerations

Verify pregnancy status prior to use in patients who could become pregnant. A serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL must be done within 1 week prior to the institution of tretinoin capsules.

Two reliable forms of contraception must be used simultaneously during therapy and for 1 month following discontinuation of tretinoin. Contraception must be used even when there is a history of infertility unless a hysterectomy has been performed. Patients with partners who could become pregnant should also use effective contraception during treatment and for 1 week after the last dose of tretinoin.

Consult drug interactions database for more detailed information related to the use of tretinoin and specific contraceptives.

Pregnancy Considerations

Tretinoin was detected in the serum of a neonate at birth following maternal use of standard doses during pregnancy (Takitani 2005).

Based on the mechanism of action and data from animal reproduction studies, in utero exposure to tretinoin may cause fetal harm. Major fetal abnormalities and spontaneous abortions have been reported with retinoids; some of these abnormalities were fatal. Birth defects associated with exposure to retinoids include facial dysmorphia, cleft palate, eye, external ear, thymus and great vessel abnormalities and abnormalities of the central nervous system, musculoskeletal system, and parathyroid hormone deficiencies. IQ scores <85 have also been reported in pediatric persons exposed to retinoids in utero, with or without obvious CNS abnormalities.

Outcome data for the treatment of acute promyelocytic leukemia (APL) during pregnancy are limited and exposure occurred after the first trimester in most cases (Khosla 2020; Ni 2023; Salter 2024; Santolaria 2020). If the clinical condition of a patient presenting with APL during pregnancy warrants immediate treatment, tretinoin use should be avoided in the first trimester; treatment with tretinoin may be considered in the second and third trimester with careful fetal monitoring, including cardiac monitoring (ELN [Sanz 2019]). The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team) approach (ESMO [Peccatori 2013]).

A long-term observational research study is collecting information about the diagnosis and treatment of cancer during pregnancy. For additional information about the pregnancy and cancer registry or to become a participant, contact Cooper Health (1-877-635-4499).

Monitoring Parameters

Bone marrow cytology to confirm t(15;17) translocation or the presence of the PML/RARα fusion protein (do not withhold treatment initiation for results); monitor CBC with differential, coagulation profile, liver function test results, and triglyceride and cholesterol levels frequently; monitor closely for signs of acute promyelocytic leukemia differentiation syndrome (eg, monitor volume status, pulmonary status, temperature, respiration), signs/symptoms of pseudotumor cerebri.

Mechanism of Action

Tretinoin appears to bind one or more nuclear receptors and decreases proliferation and induces differentiation of APL cells; initially produces maturation of primitive promyelocytes and repopulates the marrow and peripheral blood with normal hematopoietic cells to achieve complete remission.

Pharmacokinetics (Adult Data Unless Noted)

Note: Reported pediatric values similar to adult (Smith 1992; Takitani 2004).

Absorption: Well absorbed.

Protein binding: >95%, predominantly to albumin.

Metabolism: Hepatic via CYP3A4, CYP2C8, and CYP2E, and glucuronidation via UGT2B7; displays auto metabolism. Metabolites include 9-cis-retinoic acid, 13-cis-retinoic acid, 4-oxo trans-retinoic acid, 4-oxo cis retinoic acid, and 4-oxo trans retinoic acid glucuronide; metabolites 4-oxo retinoic acid and 4-oxo trans retinoic acid glucuronide have one-third of the pharmacological activity of the parent compound.

Bioavailability: Absolute: ~50%.

Half-life elimination: Terminal: Parent drug: 0.5 to 2 hours.

Time to peak, serum: 1 to 2 hours.

Excretion: Urine (~63%); feces (31%).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Vesanoid;
  • (AR) Argentina: Vesanoid;
  • (AT) Austria: Vesanoid;
  • (AU) Australia: Vesanoid;
  • (BE) Belgium: Vesanoid;
  • (BR) Brazil: Vesanoid;
  • (CH) Switzerland: Vesanoid;
  • (CL) Chile: Vesanoid;
  • (CN) China: Di wei;
  • (CO) Colombia: Vesanoid;
  • (CZ) Czech Republic: Vesanoid;
  • (DE) Germany: Vesanoid;
  • (DO) Dominican Republic: Vesanoid;
  • (EE) Estonia: Ca atra 10 | Vesanoid;
  • (EG) Egypt: Vesanoid;
  • (ES) Spain: Vesanoid;
  • (FI) Finland: Vesanoid;
  • (FR) France: Vesanoid;
  • (GB) United Kingdom: Vesanoid;
  • (GR) Greece: Tretin | Vesanoid;
  • (HK) Hong Kong: Vesanoid;
  • (HU) Hungary: Vesanoid;
  • (ID) Indonesia: Vesanoid;
  • (IE) Ireland: Vesanoid;
  • (IN) India: Vesanoid;
  • (IT) Italy: Vesanoid;
  • (JO) Jordan: Vesanoid;
  • (JP) Japan: Vesanoid;
  • (KR) Korea, Republic of: Vesanoid;
  • (KW) Kuwait: Vesanoid;
  • (LB) Lebanon: Vesanoid;
  • (LT) Lithuania: Vesanoid;
  • (LU) Luxembourg: Vesanoid;
  • (LV) Latvia: Vesanoid;
  • (MX) Mexico: Amilogen;
  • (MY) Malaysia: Vesanoid;
  • (NL) Netherlands: Vesanoid;
  • (NO) Norway: Vesanoid | Vesanoid farma mondo | Vesanoid specific | Vesanoid unimedic;
  • (NZ) New Zealand: Vesanoid;
  • (PE) Peru: Vesanoid;
  • (PH) Philippines: Vesanoid;
  • (PK) Pakistan: Oratane | Vesanoid;
  • (PL) Poland: Vesanoid;
  • (PR) Puerto Rico: Vesanoid;
  • (PT) Portugal: Vesanoid;
  • (PY) Paraguay: Vesanoid;
  • (QA) Qatar: Vesanoid;
  • (RO) Romania: Vesanoid;
  • (RU) Russian Federation: Vesanoid;
  • (SA) Saudi Arabia: Vesanoid;
  • (SE) Sweden: Vesanoid;
  • (SG) Singapore: Vesanoid;
  • (SI) Slovenia: Vesanoid;
  • (SK) Slovakia: Vesanoid;
  • (TH) Thailand: Vesanoid;
  • (TN) Tunisia: Vesanoid;
  • (TR) Turkey: Vesanoid;
  • (TW) Taiwan: Vesanoid;
  • (UA) Ukraine: Vesanoid;
  • (UY) Uruguay: Vesanoid;
  • (ZA) South Africa: Vesanoid
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