ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

Vinorelbine: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Bone marrow suppression:

Severe myelosuppression resulting in serious infection, septic shock, hospitalization, and death can occur. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications.

Brand Names: US
  • Navelbine [DSC]
Pharmacologic Category
  • Antineoplastic Agent, Antimicrotubular;
  • Antineoplastic Agent, Vinca Alkaloid
Dosing: Adult

Note: Begin a prophylactic bowel regimen (including adequate dietary fiber intake, hydration, and routine stool softeners) to minimize potential constipation, bowel obstruction, and/or paralytic ileus. Do not administer if ANC <1,000/mm3.

Breast cancer, metastatic

Breast cancer, metastatic (off-label use): IV: 25 mg/m2 every 7 days (as a single agent) until disease progression or unacceptable toxicity (Ref) or 30 mg/m2 every 7 days (as a single agent); after 13 weeks, may change dosing interval to every 14 days (for patient convenience), continue until disease progression or unacceptable toxicity (Ref) or 25 mg/m2 every 7 days (in combination with trastuzumab) until disease progression or unacceptable toxicity (Ref) or 30 or 35 mg/m2 days 1 and 8 every 21 days (in combination with trastuzumab) until disease progression or unacceptable toxicity (Ref).

Cervical cancer

Cervical cancer (off-label use): IV: 30 mg/m2 days 1 and 8 of a 21-day treatment cycle (Ref).

Hodgkin lymphoma, relapsed or refractory

Hodgkin lymphoma, relapsed or refractory (off-label use):

GVD regimen: IV: 20 mg/m2 (15 mg/m2 if post transplant) on days 1 and 8 of a 21-day cycle (in combination with gemcitabine and doxorubicin liposomal) for 2 to 6 cycles (Ref).

IGEV regimen: IV: 20 mg/m2 on day 1 of a 21-day cycle (in combination with ifosfamide, mesna, gemcitabine, and prednisolone) for 4 cycles (Ref).

Malignant pleural mesothelioma

Malignant pleural mesothelioma (off-label use): IV: 30 mg/m2 (maximum dose: 60 mg) once weekly for 6 doses (each cycle consists of 6 once-weekly doses), continue until disease progression (Ref).

Non–small cell lung cancer

Non–small cell lung cancer:

Metastatic (single-agent therapy): IV: 30 mg/m2 once a week.

Locally advanced or metastatic (in combination with cisplatin): IV: 25 mg/m2 on days 1, 8, 15, and 22 of a 28-day cycle or 30 mg/m2 once a week.

Advanced disease (off-label dosing): IV: 25 to 30 mg/m2 days 1, 8, and 15 every 28 days (in combination with gemcitabine) for 6 cycles or until disease progression or unacceptable toxicity (Ref).

Ovarian cancer, relapsed

Ovarian cancer, relapsed (off-label use): IV: 25 mg/m2 every 7 days (Ref) or 30 mg/m2 days 1 and 8 of a 21-day treatment cycle (Ref) until disease progression or unacceptable toxicity.

Salivary gland cancer, recurrent

Salivary gland cancer, recurrent (off-label use): IV: 25 mg/m2 on days 1 and 8 of a 21-day cycle (in combination with cisplatin) for a minimum of 3 cycles and for up to 6 cycles (Ref).

Small cell lung cancer, refractory

Small cell lung cancer, refractory (off-label use): IV: 25 or 30 mg/m2 every 7 days until disease progression or unacceptable toxicity (Ref).

Soft tissue sarcoma, advanced

Soft tissue sarcoma, advanced (off-label use): IV: 25 mg/m2 days 1 and 8 of a 21-day treatment cycle (in combination with gemcitabine) until disease progression or unacceptable toxicity (Ref).

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; however, no dosage adjustment is necessary (Ref).

Hemodialysis: No need for dosage adjustment is expected (Ref); however, some sources suggest reducing the dose as well as administering either after dialysis (on dialysis days) or on nondialysis days (Ref).

Dosing: Hepatic Impairment: Adult

Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations.

Use with caution in patients with hepatic impairment. In patients with hepatic impairment or who develop hyperbilirubinemia during treatment with vinorelbine, adjust dose for total bilirubin as follows:

Serum bilirubin ≤2 mg/dL: Administer 100% of vinorelbine dose.

Serum bilirubin 2.1 to 3 mg/dL: Administer 50% of vinorelbine dose (Ref).

Serum bilirubin >3 mg/dL: Administer 25% of vinorelbine dose (Ref).

Patients (breast cancer) with extensive liver metastases (>75% of liver volume): Administer 50% of vinorelbine dose (Ref).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Non–small cell lung cancer:

Note: Adjust dose based on blood counts obtained on the day of treatment. In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations.

Hematological toxicity (based on neutrophil counts):

Neutrophils ≥1,500/mm3 on day of treatment: Administer 100% of vinorelbine starting dose.

Neutrophils 1,000 to 1,499/mm3 on day of treatment: Administer 50% of vinorelbine starting dose.

Neutrophils <1,000/mm3 on day of treatment: Do not administer vinorelbine. Repeat neutrophil count in 1 week. If 3 consecutive doses are held because neutrophil count is <1,000/mm3, discontinue vinorelbine.

Adjustment: For patients who, during treatment, have experienced fever or sepsis while neutrophils were <1,500/mm3 or had 2 consecutive weekly doses held due to neutropenia, subsequent vinorelbine doses should be:

Neutrophils ≥1,500/mm3: Administer 75% of vinorelbine starting dose.

Neutrophils 1,000 to 1,499/mm3: Administer 37.5% of vinorelbine starting dose.

Neutrophils <1,000/mm3: Do not administer vinorelbine; repeat neutrophil count in 1 week.

Nonhematologic toxicity:

Neurotoxicity: Neurotoxicity (peripheral neuropathy or autonomic neuropathy causing constipation) ≥ grade 2: Discontinue vinorelbine treatment.

Pulmonary toxicity: Interrupt vinorelbine treatment in patients who develop unexplained dyspnea or with any evidence of pulmonary toxicity. Permanently discontinue vinorelbine with confirmed interstitial pneumonitis or acute respiratory distress syndrome.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

Note: Dosing may be based on either BSA (mg/m2) or weight (mg/kg); use extra precautions to verify dosing parameters during calculations. Protocol-specific details concerning dosing, frequency, and combination regimens should be consulted.

Hodgkin lymphoma, refractory or recurrent

Hodgkin lymphoma, refractory or recurrent: Limited data available; dosing regimens and combinations variable: Children ≥10 years and Adolescents:

GV regimen: IV: 25 mg/m2 on days 1 and 8 of a 21-day cycle in combination with gemcitabine (Ref).

GVD regimen: IV: 20 mg/m2 on day 1 and 8 of a 21-day cycle in combination with gemcitabine and pegylated liposomal doxorubicin (Ref).

IVB regimen: IV: 25 mg/m2 on days 1 and 5 of a 21-day cycle in combination with ifosfamide and bortezomib (Ref).

Leukemias, refractory or recurrent

Leukemias (acute ALL, AML), refractory or recurrent: Limited data available:

TVTC regimen:

Infants: IV: 0.67 mg/kg once weekly on days 0, 7, 14 of a 14-day cycle in combination with topotecan, clofarabine, and thiotepa (Ref).

Children and Adolescents: IV: 20 mg/m2 once weekly on days 0, 7, and 14 of a 14-day cycle in combination with topotecan, clofarabine, and thiotepa (Ref).

BDMV regimen: Infants ≥9 months, Children, and Adolescents: IV: 25 mg/m2 on days 3, 10, and 17 in combination with bortezomib, dexamethasone, and mitoxantrone (Ref).

Solid tumors, refractory or recurrent

Solid tumors, refractory or recurrent: Limited data available: Children and Adolescents:

Monotherapy: IV: 30 mg/m2 once weekly for weeks 1 to 6 of an 8-week cycle for 10 courses; may reduce dosage to 27 mg/m2 for Grade 3 or 4 hematologic toxicity in patients who demonstrate objective response or who have had treatment delay beyond 63 days (week 9) from the previous course (Ref).

Combination therapy: IV: 25 mg/m2 on days 1, 8, and 15 of each 28-day cycle in combination with cyclophosphamide (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: The presented dosing adjustments are based on experience in adult patients. Refer to specific protocol for management in pediatric patients if available.

Adult: Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations.

Neutrophil counts should be ≥1,000 cells/mm3 prior to the administration of vinorelbine. Adjustments in the dosage of vinorelbine should be based on neutrophil counts obtained on the day of treatment as follows:

Neutrophils ≥1,500 cells/mm3 on day of treatment: Administer 100% of starting dose.

Neutrophils 1,000 to 1,499 cells/mm3 on day of treatment: Administer 50% of starting dose.

Neutrophils <1,000 cells/mm3 on day of treatment: Do not administer. Repeat neutrophil count in 1 week; if 3 consecutive doses are held because neutrophil count is <1,000 cells/mm3, discontinue vinorelbine.

For patients who, during treatment, have experienced fever and/or sepsis while neutropenic or had 2 consecutive weekly doses held due to neutropenia, subsequent doses of vinorelbine should be:

Neutrophils ≥1,500 cells/mm3: Administer 75% of starting dose.

Neutrophils 1,000 to 1,499 cells/mm3 on day of treatment: Administer 37.5% of starting dose.

Neutrophils <1,000 cells/mm3 on day of treatment: Do not administer. Repeat neutrophil count in 1 week.

Neurotoxicity (peripheral neuropathy or autonomic neuropathy causing constipation) ≥ grade 2: Discontinue treatment.

Severe adverse events: Reduce dose or discontinue treatment.

Dosing: Kidney Impairment: Pediatric

There are no pediatric-specific recommendations; consult individual protocols. Based on experience in adult patients, dosing adjustment suggested.

Dosing: Hepatic Impairment: Pediatric

All patients: Note: In patients with concurrent hematologic toxicity and hepatic impairment, administer the lower of the doses determined from the adjustment recommendations. Administer with caution in patients with hepatic insufficiency. In patients who develop hyperbilirubinemia during treatment with vinorelbine, the dose should be adjusted for total bilirubin as follows:

Serum bilirubin ≤2 mg/dL: Administer 100% of dose

Serum bilirubin 2.1 to 3 mg/dL: Administer 50% of dose (Ref)

Serum bilirubin >3 mg/dL: Administer 25% of dose (Ref)

Adverse Reactions

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

>10%:

Central nervous system: Neurotoxicity (44%), peripheral neuropathy (20%; grades 3/4: 1%)

Dermatologic: Alopecia (12% to 30%)

Gastrointestinal: Nausea (≤34%), vomiting (≤31%), constipation (29%), diarrhea (12% to 13%)

Hematologic & oncologic: Neutropenia (80% to 85%; grades 3/4: 29% to 69%), leukopenia (81% to 83%; grades 3/4: 12% to 32%), anemia (77%; grades 3/4: 1% to 9%)

Hepatic: Increased serum aspartate aminotransferase (54%)

Local: Injection site reaction (22% to 38%; includes erythema at injection site, vein discoloration), pain at injection site (13%)

Neuromuscular & skeletal: Asthenia (27%)

Renal: Increased serum creatinine (13%)

1% to 10%:

Cardiovascular: Localized phlebitis (10%), chest pain (5%)

Central nervous system: Neuropathy (grades 3/4: 1%)

Hematologic & oncologic: Febrile neutropenia (≤8%), thrombocytopenia (3% to 4%; grades 3/4: 1%)

Hepatic: Increased serum bilirubin (9%)

Infection: Sepsis (≤8%)

Otic: Ototoxicity (1%)

Respiratory: Dyspnea (3%)

Frequency not defined:

Gastrointestinal: Intestinal necrosis, intestinal obstruction, intestinal perforation, paralytic ileus

Hematologic & oncologic: Bone marrow depression

Hepatic: Hepatotoxicity

Respiratory: Interstitial pulmonary disease, pulmonary toxicity (including acute respiratory distress syndrome, interstitial pneumonitis, severe acute bronchospasm)

<1%, postmarketing, and/or case reports: Abdominal pain, abnormal gait, anaphylaxis, angioedema, arthralgia, auditory impairment, back pain, decreased deep tendon reflex, deep vein thrombosis, dermatitis, dysphagia, electrolyte disorder, esophagitis, exfoliation of skin, flushing, headache, hemorrhagic cystitis, hypertension, hyponatremia, hypotension, jaw pain, localized rash, mucositis, myalgia, myasthenia, myocardial infarction, palmar-plantar erythrodysesthesia, pancreatitis, pneumonia, pruritus, pulmonary edema, pulmonary embolism, radiation recall phenomenon, SIADH, skin blister, skin rash, tachycardia, tumor pain, urticaria, urticaria at injection site, vasodilation, vestibular disturbance

Contraindications

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

Canadian labeling: Hypersensitivity to vinorelbine or any component of the formulation; drug-induced severe granulocytopenia or severe thrombocytopenia.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Severe myelosuppression resulting in serious infection, septic shock, hospitalization, and death may occur. Neutropenia, thrombocytopenia, and anemia may occur with vinorelbine (either as a single agent or in combination with other chemotherapy); neutropenia is the major dose-limiting toxicity (grade 3 or 4 neutropenia has commonly occurred). Neutropenia has resulted in hospitalization (for fever) and/or sepsis. The neutrophil nadir occurs between 7 to 10 days after administration, and recovery occurs within the following 7 to 14 days.

• Extravasation: Vesicant; ensure proper catheter or needle position prior to (and during) infusion. Avoid extravasation. Extravasation may cause local tissue necrosis and/or thrombophlebitis.

• GI toxicity: Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation may occur with vinorelbine. Begin a prophylactic bowel regimen (including adequate dietary fiber intake, hydration, and routine stool softeners) to minimize potential constipation, bowel obstruction and/or paralytic ileus.

• Hepatotoxicity: Drug-induced liver injury (transaminase and bilirubin elevations) may occur in patients receiving vinorelbine (either as a single-agent or in combination with other chemotherapy). Vinorelbine elimination is predominantly hepatic; use with caution in patients with hepatic impairment.

• Neuropathy: Sensory and motor neuropathies may occur in patients receiving vinorelbine; may be severe. Signs/symptoms of neuropathy include paresthesia, hyperesthesia, hyporeflexia, and muscle weakness.

• Pulmonary toxicity: Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, and/or acute respiratory distress syndrome (ARDS) may occur with vinorelbine; fatalities due to interstitial pneumonitis and ARDS have occurred. The mean time to onset of interstitial pneumonitis and ARDS was 1 week (range: 3 to 8 days).

Other warnings/precautions:

• For IV use only: Vinorelbine is for IV administration only. Administration of other vinca alkaloids by other routes has been fatal. The Institute for Safe Medication Practices (ISMP) strongly recommends dispensing vinca alkaloids in a minibag (NOT a syringe) (ISMP 2020). Vinorelbine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications (ASCO/ONS [Neuss 2016]).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Generic: 50 mg/5 mL (5 mL [DSC])

Solution, Intravenous [preservative free]:

Navelbine: 10 mg/mL (1 mL [DSC]); 50 mg/5 mL (5 mL [DSC])

Generic: 10 mg/mL (1 mL); 50 mg/5 mL (5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Vinorelbine Tartrate Intravenous)

10 mg/mL (per mL): $21.60 - $90.24

50 mg/5 mL (per mL): $21.60 - $90.29

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.

Solution, Intravenous:

Generic: 10 mg/mL (1 mL, 5 mL)

Administration: Adult

IV: For IV use only; fatal if given by other routes. Administer over 6 to 10 minutes (the manufacturer recommends infusing into the side port of a free-flowing IV line); follow the infusion with at least 75 to 125 mL of a compatible solution to reduce the incidence of phlebitis and inflammation.

Vesicant; ensure proper needle or catheter position prior to administration. Avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote; remove needle/cannula; apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (Ref). Remaining portion of the vinorelbine dose should be infused through a separate vein.

Hyaluronidase: If needle/cannula still in place, administer 1 to 6 mL hyaluronidase (150 units/mL) into the existing IV line; the usual dose is 1 mL hyaluronidase for each 1 mL of extravasated drug (Ref). If needle/cannula was removed, inject 1 to 6 mL (150 units/mL) subcutaneously in a clockwise manner using 1 mL for each 1 mL of drug extravasated (Ref) or administer 1 mL (150 units/mL) as 5 separate 0.2 mL injections (using a 25-gauge needle) subcutaneously into the extravasation site (Ref).

Administration: Pediatric

IV: For IV use only; FATAL IF GIVEN INTRATHECALLY. Administer as a direct intravenous push or rapid bolus over 6 to 10 minutes (up to 30 minutes); in pediatric trials, vinorelbine was typically administered over 6 to 10 minutes; use of a side port of a free-flowing IV line is suggested. Longer infusions may increase the risk of pain and phlebitis. Intravenous doses should be followed by at least 75 to 125 mL of NS or D5W to reduce the incidence of phlebitis and inflammation.

Vesicant; avoid extravasation. Assure proper needle or catheter position prior to administration. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote (See Management of Drug Extravasations for more details); apply dry warm compresses for 20 minutes 4 times a day for 1 to 2 days; elevate extremity (Ref). Remaining portion of the vinorelbine dose should be infused through a separate vein.

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).

Use: Labeled Indications

Non-small cell lung cancer: Treatment (first-line; in combination with cisplatin) of locally advanced or metastatic non-small cell lung cancer (NSCLC); single-agent treatment of metastatic NSCLC.

Use: Off-Label: Adult

Breast cancer, metastatic; Cervical cancer, persistent or recurrent; Hodgkin lymphoma, relapsed or refractory; Malignant pleural mesothelioma; Ovarian cancer, relapsed; Salivary gland cancer, recurrent; Small cell lung cancer, refractory; Soft tissue sarcoma, advanced

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

Vinorelbine may be confused with vinBLAStine, vinCRIStine

Vinorelbine (50 mg/5 mL; Hospira manufacturer) may be confused with conventional cytarabine (100 mg/5 mL; Hospira manufacturer) due to similar packaging; potential for inadvertent intrathecal administration of vinorelbine may occur (ISMP [Smetzer 2015]).

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.

Administration issues:

Vinorelbine is for IV administration only: Inadvertent intrathecal administration of other vinca alkaloids has resulted in death. The ISMP strongly recommends dispensing vinca alkaloids in a minibag, and NOT a syringe (ISMP 2020). Vinorelbine should NOT be prepared during the preparation of any intrathecal medications. After preparation, keep vinorelbine in a location away from the separate storage location recommended for intrathecal medications

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

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.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

CISplatin: May enhance the adverse/toxic effect of Vinorelbine. Specifically, the combination may be associated with a higher risk of granulocytopenia. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Vinorelbine. Risk C: Monitor therapy

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

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Gefitinib: May enhance the neutropenic effect of Vinorelbine. Risk C: Monitor therapy

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider therapy modification

MitoMYcin (Systemic): Antineoplastic Agents (Vinca Alkaloids) may enhance the adverse/toxic effect of MitoMYcin (Systemic). Specifically, the risk of pulmonary toxicity may be increased. Risk C: Monitor therapy

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

PACLitaxel (Conventional): May enhance the adverse/toxic effect of Vinorelbine. Specifically hematologic toxicity may be increased. PACLitaxel (Conventional) may enhance the neurotoxic effect of Vinorelbine. Risk C: Monitor therapy

PACLitaxel (Protein Bound): May enhance the adverse/toxic effect of Vinorelbine. Specifically hematologic toxicity may be increased. PACLitaxel (Protein Bound) may enhance the neurotoxic effect of Vinorelbine. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider therapy modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

Patients who could become pregnant should use effective contraception during vinorelbine treatment and for 6 months after the final vinorelbine dose. Patients with partners who could become pregnant should use effective contraception during treatment and for 3 months following the last vinorelbine dose.

Vinorelbine may damage spermatozoa and may cause decreased fertility in male patients.

Pregnancy Considerations

Based on the mechanism and on findings in animal reproduction studies, vinorelbine may cause fetal harm if administered during pregnancy.

Breastfeeding Considerations

It is not known if vinorelbine is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer does not recommend breastfeeding during treatment and for 9 days after the final vinorelbine dose.

Monitoring Parameters

CBC with differential and platelet count (prior to each dose, and after treatment), hepatic function tests (prior to treatment initiation and periodically during treatment). Verify pregnancy status prior to treatment initiation (in patients who could become pregnant). Monitor for new-onset pulmonary symptoms (or worsening from baseline); monitor for neuropathy (new or worsening symptoms, including paresthesia, hyperesthesia, hyporeflexia, and muscle weakness); monitor for signs/symptoms of constipation/ileus. Monitor infusion site.

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.

Mechanism of Action

Vinorelbine is a semisynthetic vinca alkaloid which binds to tubulin and inhibits microtubule formation, therefore, arresting the cell at metaphase by disrupting the formation of the mitotic spindle; it is specific for the M and S phases. Vinorelbine may also interfere with nucleic acid and protein synthesis by blocking glutamic acid utilization.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: binds extensively to human platelets and lymphocytes (80% to 91%)

Children and Adolescents 2 to 17 years: 21.1 ± 12.2 L/kg (Johansen 2006)

Adults: 25 to 40 L/kg

Protein binding: 80% to 91%

Metabolism: Extensively hepatic, via CYP3A4, to two metabolites, deacetylvinorelbine (active) and vinorelbine N-oxide

Half-life elimination: Triphasic:

Children and Adolescents 2 to 17 years: Terminal: 16.5 ± 9.7 hours (Johansen 2006)

Adults: Terminal: ~28 to 44 hours

Excretion: Feces (~46%); urine (~18%, 10% to 12% as unchanged drug)

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

  • (AE) United Arab Emirates: Navelbine;
  • (AR) Argentina: Fada vinorelbina | Neocitec | Vinorel | Vinorelbina kemex | Vinorgen;
  • (AT) Austria: Eberelbin | Navelbine | Vinorelbin accord | Vinorelbin actavis | Vinorelbin Medac | Vinorelbin sandoz;
  • (AU) Australia: As Vinorelbine | Navelbine | Vinorelbine Kabi | Vinorelbine Link | Vinorelbine tart;
  • (BE) Belgium: Navelbine | Vinorelbin actavis | Vinorelbine accord | Vinorelbine ebewe | Vinorelbine teva;
  • (BG) Bulgaria: Navelbin | Vinorelbin actavis | Vinorelbin ebewe;
  • (BR) Brazil: Evotabina | Navelbine | Neocitec | Tevavinor | Vilne;
  • (CH) Switzerland: Navelbine | Vinorelbin actavis | Vinorelbin Cancernova | Vinorelbin ebewe | Vinorelbin sandoz | Vinorelbin teva;
  • (CL) Chile: Navelbine;
  • (CN) China: Ai ke qing | Vinorelbine | Vinorelbine ditartrate;
  • (CO) Colombia: Fada vinorelbina | Labdosa vilne | Navelbine | Vinobina | Vinorel | Vinorelbina;
  • (CZ) Czech Republic: Navelbin | Navirel | Nibrevin | Vinorelbine accord | Vinorelbine glenmark;
  • (DE) Germany: Bendarelbin | Eurovinorelbin | Navelbine | Navin | Navirel | Riborelbin | Vinorelbin | Vinorelbin accord | Vinorelbin actavis | Vinorelbin aurobindo | Vinorelbin axios | Vinorelbin cell pharm | Vinorelbin haemato | Vinorelbin hexal | Vinorelbin NC | Vinorelbin Omnicare | Vinorelbin oncotrade | Vinorelbin Onkovis | Vinorelbin phares | Vinorelbin vitane;
  • (DO) Dominican Republic: Navelbine | Vinelbine;
  • (EC) Ecuador: Vinorelbina;
  • (EE) Estonia: Navelbine | Vinorelbin accord | Vinorelbin ebewe;
  • (EG) Egypt: Navelbine | Vinorelbin ebewe | Vinorelbina aurovitas | Vinorelbine | Vinorelbine actavis;
  • (ES) Spain: Eunades | Navelbine | Vinorelbina accord | Vinorelbina Actavis | Vinorelbina Ferrer Farma | Vinorelbina Glenmark | Vinorelbina Ips | Vinorelbina sandoz;
  • (FI) Finland: Navelbine | Navirel | Vinorelbin actavis | Vinorelbin Bmm Pharma | Vinorelbine accord | Vinorelbine orifarm;
  • (FR) France: Navelbine | Vinorelbine accord | Vinorelbine actavis | Vinorelbine Dci | Vinorelbine ebewe | Vinorelbine Mylan | Vinorelbine pierre fabre | Vinorelbine sandoz;
  • (GB) United Kingdom: Navelbine | Vinorelbine;
  • (GR) Greece: Navelbine | Vinorelbin/ebewe | Zaolin;
  • (HK) Hong Kong: Navelbine | Vinorelbin ebewe | Vinorelbine;
  • (HU) Hungary: Navelbin | Neocitec | Vinorelbine Polpharma;
  • (ID) Indonesia: Navelbine | Relubin | Vinorelbine | Vinorelsin | Vinorkal;
  • (IE) Ireland: Navelbine | Vinorelbine;
  • (IL) Israel: Navelbine;
  • (IN) India: Navelbine | Vinbicel | Vinbine;
  • (IT) Italy: Eunades | Navelbine | Vinorelbina | Vinorelbina accord | Vinorelbina Actavis | Vinorelbina doc | Vinorelbina HOS;
  • (JO) Jordan: Navelbine;
  • (JP) Japan: Navelbine | Rozeus;
  • (KR) Korea, Republic of: Navelbine | Pfizer vinorelbine | Vinolbin | Vinorelbine;
  • (KW) Kuwait: Navelbine;
  • (LB) Lebanon: Eberelbin | Navelbine;
  • (LT) Lithuania: Navelbine | Vinorelbin | Vinorelbine accord;
  • (LV) Latvia: Cipla vinorelbine | Navelbine | Vinorelbin accord | Vinorelbin ebewe | Vinorelbine actavis;
  • (MA) Morocco: Navelbine;
  • (MX) Mexico: Bagovir | Navelbine | Setroxin | Vanevin | Viessia | Vincanorel | Vinilex;
  • (MY) Malaysia: DBL Vinorelbine | Navelbine | Vinelbine;
  • (NL) Netherlands: Navelbine | Navirel | Vinorelbine accord | Vinorelbine actavis | Vinorelbine allgen | Vinorelbine ebewe | Vinorelbine pch;
  • (NO) Norway: Navelbine | Navirel | Vinorelbin | Vinorelbin accord | Vinorelbin Bmm Pharma | Vinorelbin mayne | Vinorelbin meda | Vinorelbine orifarm;
  • (NZ) New Zealand: Navelbine | Sagent vinorelbine | Vinorelbine;
  • (PE) Peru: Eunexon;
  • (PH) Philippines: Navelbine | Vinotel;
  • (PK) Pakistan: Navalbine | Navelbine;
  • (PL) Poland: Navelbine | Navirel | Neocitec | Vinorelbin ebewe | Vinorelbine accord | Vinorelbine Alvogen | Vinorelbine Polpharma;
  • (PR) Puerto Rico: Navelbine | Vinorelbine;
  • (PT) Portugal: Navelbine | Navirel | Vinorelbina | Vinorrelbin | Vinorrelbina accord | Vinorrelbina Actavis | Vinorrelbina Sandoz;
  • (PY) Paraguay: Navelbine | Vinorelbina sandoz;
  • (QA) Qatar: Navelbine;
  • (RO) Romania: Navelbine | Vinorelbin | Vinorelbin actavis | Vinorelbin ebewe | Vinorelbina accord | Vinorelbina alvogen | Vinorelbine;
  • (RU) Russian Federation: Cituvin | Firelbin | Maverex | Navelbine | Velbin | Vincatera | Vinelbine | Vinorelbine | Vinorelbine kelun kazfarm | Vinorelbine medac | Vinorelbine teva;
  • (SA) Saudi Arabia: Navelbine;
  • (SE) Sweden: Navelbine | Vinorelbin actavis | Vinorelbin ebewe | Vinorelbin hospira | Vinorelbine accord | Vinorelbine orifarm;
  • (SG) Singapore: Vinorelbine dbl;
  • (SI) Slovenia: Vinorelbin accord | Vinorelbin caduceus | Vinorelbin ebewe;
  • (SK) Slovakia: Navelbin | Navirel | Vinorelbin Hikma | Vinorelbin sandoz | Vinorelbine glenmark | Vinorelbine Hikma | Visera;
  • (TH) Thailand: DBL Vinorelbine | Navelbine | Viessia;
  • (TN) Tunisia: Cytorelbine | Navelbine | Vinorel | Vinorelbine;
  • (TR) Turkey: Navelbine | Renovel | Vinalbin;
  • (TW) Taiwan: Navelbine | Vinelbine | Vinobin | Vinorelbine;
  • (UA) Ukraine: Navelbine | Navelik | Navirel | Oncobine | Velbimeda | Vinelbin | Vinorelbine ebewe | Vinorelbine teva;
  • (UY) Uruguay: Filcrin | Navelbine | Vinorelbina | Vinorelbina FU;
  • (ZA) South Africa: Aspen Vinorelbin | Carcyt | Cipla vinorelbine | Eurovin | Navelbine | Teva Vinorelbine | Vinorel | Vinorelbin ebewe | Vinorelbine
  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Airoldi M, Pedani F, Succo G, et al, “Phase II Randomized Trial Comparing Vinorelbine versus Vinorelbine Plus Cisplatin in Patients With Recurrent Salivary Gland Malignancies,” Cancer, 2001, 91(3):541-7. [PubMed 11169936]
  3. Andersson M, Lidbrink E, Bjerre K, et al, “Phase III Randomized Study Comparing Docetaxel Plus Trastuzumab With Vinorelbine Plus Trastuzumab as First-Line Therapy of Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The HERNATA Study,” J Clin Oncol, 2011, 29(3):264-71. [PubMed 21149659]
  4. Bajetta E, Di Leo A, Biganzoli L, et al, “Phase II Study of Vinorelbine in Patients With Pretreated Advanced Ovarian Cancer: Activity in Platinum-Resistant Disease,” J Clin Oncol, 1996, 14(9):2546-51. [PubMed 8823334]
  5. Bartlett NL, Niedzwiecki D, Johnson JL, et al, "Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD), a Salvage Regimen in Relapsed Hodgkin's Lymphoma: CALGB 59804," Ann Oncol, 2007, 18(6):1071-9. [PubMed 17426059]
  6. Burstein HJ, Keshaviah A, Baron AD, et al. Trastuzumab Plus Vinorelbine or Taxane Chemotherapy for HER2-Overexpressing Metastatic Breast Cancer: The Trastuzumab and Vinorelbine or Taxane Study. Cancer. 2007;110(5):965-972. [PubMed 17614302]
  7. Burstein HJ, Kuter I, Campos SM, et al, "Clinical Activity of Trastuzumab and Vinorelbine in Women With HER2-Overexpressing Metastatic Breast Cancer," J Clin Oncol, 2001, 19(10):2722-30. [PubMed 11352965]
  8. Casanova M, Ferrari A, Bisogno G, et al, “Vinorelbine and Low-Dose Cyclophosphamide in the Treatment of Pediatric Sarcomas: Pilot Study for the Upcoming European Rhabdomyosarcoma Protocol,” Cancer, 2004, 101(7):1664-71. [PubMed 15378498]
  9. Casanova M, Ferrari A, Spreafico F, et al, “Vinorelbine in Previously Treated Advanced Childhood Sarcomas: Evidence of Activity in Rhabdomyosarcoma,” Cancer, 2002, 94(12):3263-8. [PubMed 12115359]
  10. Cole PD, Schwartz CL, Drachtman RA, et al. Phase II study of weekly gemcitabine and vinorelbine for children with recurrent or refractory Hodgkin's Disease: a children's oncology group report. J Clin Oncol. 2009;27(9):1456-1461. [PubMed 19224841]
  11. Dileo P, Morgan JA, Zahrieh D, et al, “Gemcitabine and Vinorelbine Combination Chemotherapy for Patients With Advanced Soft Tissue Sarcomas: results of a phase II trial.” Cancer, 2007, 109(9):1863-9. [PubMed 17385194]
  12. Dupuis LL, Boodhan S, Sung L, et al; Pediatric Oncology Group of Ontario. Guideline for the classification of the acute emetogenic potential of antineoplastic medication in pediatric cancer patients. Pediatr Blood Cancer. 2011;57(2):191-198. [PubMed 21465637]
  13. Eklund JW, Trifilio S, Mulcahy MF. Chemotherapy dosing in the setting of liver dysfunction. Oncology (Williston Park). 2005;19(8):1057-1063; discussion 1063-1064, 1069. [PubMed 16131047]
  14. Floyd J, Mirza I, Sachs B, Perry MC. Hepatotoxicity of chemotherapy. Semin Oncol. 2006;33(1):50-67. doi:10.1053/j.seminoncol.2005.11.002 [PubMed 16473644]
  15. Furuse K, Kubota K, Kawahara M, et al, “Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer. Japan Lung Cancer Vinorelbine Study Group,” Oncology, 1996, 53(2):169-172. [PubMed 8604245]
  16. Greco FA, Spigel DR, Kuzur ME, et al, “Paclitaxel/Carboplatin/Gemcitabine versus Gemcitabine/Vinorelbine in Advanced Non-Small-Cell Lung Cancer: A Phase II/III Study of the Minnie Pearl Cancer Research Network,” Clin Lung Cancer, 2007, 8(8):483-7. [PubMed 17922972]
  17. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  18. Herbst RS, Khuri FR, Lu C, et al, “The Novel and Effective Nonplatinum, Nontaxane Combination of Gemcitabine and Vinorelbine in Advanced Nonsmall Cell Lung Carcinoma: Potential for Decreased Toxicity and Combination With Biological Therapy,” Cancer, 2002, 95(2):340-53. [PubMed 12124835]
  19. Hesketh PJ, Kris MG, Basch E, et al. Antiemetics: ASCO guideline update. J Clin Oncol. 2020;38(24):2782-2797. doi:10.1200/JCO.20.01296 [PubMed 32658626]
  20. Horton TM, Drachtman RA, Chen L, et al. A phase 2 study of bortezomib in combination with ifosfamide/vinorelbine in paediatric patients and young adults with refractory/recurrent Hodgkin lymphoma: a Children's Oncology Group study. Br J Haematol. 2015;170(1):118-122. [PubMed 25833390]
  21. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  22. Institute for Safe Medicine Practices (ISMP). ISMP Targeted Medication Safety Best Practices for Hospitals. https://www.ismp.org/sites/default/files/attachments/2020-02/2020-2021%20TMSBP-%20FINAL_1.pdf. Published February 21, 2020. Accessed January 11, 2022.
  23. Jacobson JO, Polovich M, McNiff KK, et al, “American Society of Clinical Oncology/ Oncology Nursing Society Chemotherapy Administration Safety Standards,” J Clin Oncol, 2009, 27(32):5469-75. [PubMed 19786650]
  24. Jaffray M, Buchbinder N, Lutun A, Schneider P, Piquenot JM, Vannier JP. Salvage therapy with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin for relapsed or refractory pediatric Hodgkin lymphoma. Results of a retrospective series of four children. Ann Hematol. 2015;94(8):1401-1406. [PubMed 25862234]
  25. Janus N, Thariat J, Boulanger H, et al, “Proposal for Dosage Adjustment and Timing of Chemotherapy in Hemodialyzed Patients,” Ann Oncol, 2010, 21(7):1395-403. [PubMed 20118214]
  26. Jassem J, Karnicka-Mlodkowska H, van Pottelsberghe C, et al, “Phase II Study of Vinorelbine (Navelbine) in Previously Treated Small Cell Lung Cancer Patients. EORTC Lung Cancer Cooperative Group,” Eur J Cancer, 1993, 29(12):1720-2. [PubMed 8398301]
  27. Johansen M, Kuttesch J, Bleyer WA, Krailo M, Ames M, Madden T. Phase I evaluation of oral and intravenous vinorelbine in pediatric cancer patients: a report from the Children's Oncology Group. Clin Cancer Res. 2006;12(2):5165-5122. doi: 10.1158/1078-0432.CCR-05-1541. [PubMed 16428494]
  28. Kindler HL, Ismaila N, Armato SG 3rd, et al. Treatment of malignant pleural mesothelioma: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2018;36(13):1343-1373. doi:10.1200/JCO.2017.76.6394 [PubMed 29346042]
  29. Krens SD, Lassche G, Jansman FGA, et al. Dose recommendations for anticancer drugs in patients with renal or hepatic impairment. Lancet Oncol. 2019;20(4):e200-e207. doi:10.1016/S1470-2045(19)30145-7 [PubMed 30942181]
  30. Kuttesch JF, Krailo MD, Madden T, et al. Phase II evaluation of intravenous vinorelbine (Navelbine) in recurrent or refractory pediatric malignancies: a children's oncology group study. Pediatr Blood Cancer. 2009;53(4):590-593. [PubMed 19533657]
  31. LeVeque D and Jehl F, “Clinical Pharmacokinetics of Vinorelbine,” Clin Pharmacokinet, 1996, 31(3):184-97. [PubMed 8877249]
  32. Masters GA, Temin S, Azzoli CG. Systemic therapy for stage IV non-small-cell lung cancer: American Society of Clinical Oncology clinical practice guideline update [published correction appears in J Clin Oncol. 2016;34(11):1287]. J Clin Oncol. 2015;33(30):3488-3515. [PubMed 26324367]
  33. Minard-Colin V, Ichante JL, Nguyen L, et al. Phase II study of vinorelbine and continuous low doses cyclophosphamide in children and young adults with relapsed or refractory malignant solid tumour: good tolerance profile and efficacy in rhabdomyosarcoma – a report from the Société Française des Cancers et leucémies de l’Enfant et de l’adolescent (SFCE). Eur J Cancer. 2012;48:2409-2416. [PubMed 22633624]
  34. Monk BJ, Sill MW, McMeekin DS, et al, "Phase III Trial of Four Cisplatin-Containing Doublet Combinations in Stage IVB, Recurrent, or Persistent Cervical Carcinoma: A Gynecologic Oncology Group Study," J Clin Oncol, 2009, 27(28):4649-55. [PubMed 19720909]
  35. Morgan C, Tillett T, Braybrooke J, et al, “Management of Uncommon Chemotherapy-Induced Emergencies,” Lancet Oncol, 2011, 12(8):806-14. [PubMed 21276754]
  36. Muggia FM, Blessing JA, Method M, et al, “Evaluation of Vinorelbine in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study,” Gynecol Oncol, 2004, 92(2):639-43. [PubMed 14766259]
  37. Muggia FM, Blessing JA, Waggoner S, et al, “Evaluation of Vinorelbine in Persistent or Recurrent Nonsquamous Carcinoma of the Cervix: A Gynecologic Oncology Group Study,” Gynecol Oncol, 2005, 96(1):108-11. [PubMed 15589588]
  38. Navelbine (vinorelbine) [prescribing information]. Parsippany, NJ: Pierre Fabre Pharmaceuticals Inc; January 2020.
  39. Neuss MN, Gilmore TR, Belderson KM, et al. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards, including standards for pediatric oncology. J Oncol Pract. 2016;12(12):1262-1271. doi:10.1200/JOP.2016.017905 [PubMed 27868581]
  40. Pedrazzoli P, Silvestris N, Santoro A, et al. Management of patients with end-stage renal disease undergoing chemotherapy: recommendations of the Associazione Italiana di Oncologia Medica (AIOM) and the Società Italiana di Nefrologia (SIN). ESMO Open. 2017;2(3):e000167. doi:10.1136/esmoopen-2017-000167 [PubMed 29209521]
  41. Pérez Fidalgo JA, García Fabregat L, Cervantes A, et al, “Management of Chemotherapy Extravasation: ESMO-EONS Clinical Practice Guidelines,” Ann Oncol, 2012, 23(Suppl 7):167-73. [PubMed 22997449]
  42. Polovich M, Whitford JN and Olsen M, Chemotherapy and Biotherapy Guidelines and Recommendations for Practice, 3rd ed, Pittsburgh, PA: Oncology Nursing Society, 2009.
  43. Roila F, Herrstedt J, Aapro M, et al; ESMO/MASCC Guidelines Working Group. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010;21(suppl 5):v232-v243. [PubMed 20555089]
  44. Roila F, Molassiotis A, Herrstedt J, et al; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. [PubMed 27664248]
  45. Rothenberg ML, Liu PY, Wilczynski s, et al, “Phase II Trial of Vinorelbine for Relapsed Ovarian Cancer: A Southwest Oncology Group Study,” Gynecol Oncol, 2004, 95(3):506-12. [PubMed 15581954]
  46. Santoro A, Magagnoli M, Spina M, et al, “Ifosfamide, Gemcitabine, and Vinorelbine: A New Induction Regimen for Refractory and Relapsed Hodgkin's Lymphoma,” Haematologica, 2007, 92(1):35-41. [PubMed 17229633]
  47. Schulmeister L, "Extravasation Management: Clinical Update," Semin Oncol Nurs, 2011, 27(1):82-90. [PubMed 21255716]
  48. Shukla N, Kobos R, Renaud T, et al. Phase II trial of clofarabine with topotecan, vinorelbine and thiotepa for pediatric patients with relapsed or refractory acute leukemia. Pediatr Blood Cancer. 2014;61:431-435. [PubMed 24115731]
  49. Smetzer J, Cohen M, eds. Potentially dangerous mix-up between cancer drugs. ISMP Medication Safety Alert! Acute Care Edition. 2015;20(20):1.
  50. Stebbing J, Powles T, McPherson K, et al. The efficacy and safety of weekly vinorelbine in relapsed malignant pleural mesothelioma. Lung Cancer. 2009;63(1):94-97. [PubMed 18486273]
  51. Steele JP, Shamash J, Evans MT, Gower NH, Tischkowitz MD, Rudd RM. Phase II study of vinorelbine in patients with malignant pleural mesothelioma. J Clin Oncol. 2000;18(23):3912-3917. doi:10.1200/JCO.2000.18.23.3912 [PubMed 11099320]
  52. Steinherz PG, Shukla N, Kobos R, et al. Remission re-induction chemotherapy with clofarabine, topotecan, thiotepa and vinorelbine for patients with relapsed or refractory leukemia. Pediatr Blood Cancer. 2010;54:687-693. [PubMed 20205253]
  53. Superfin D, Iannucci AA, Davies AM. Commentary: oncologic drugs in patients with organ dysfunction: a summary. Oncologist. 2007;12(9):1070-1083. doi:10.1634/theoncologist.12-9-1070 [PubMed 17914077]
  54. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/. Updated September 2016. Accessed October 5, 2016.
  55. Vinorelbine Injection [product monograph]. Toronto, Ontario, Canada: Fresenius Kabi Canada Ltd; January 2021.
  56. Vogel C, O'Rourke M, Winer E, et al. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol. 1999;10(4):397-402. [PubMed 10370781]
  57. Winton T, Livingston R, Johnson D, et al. Vinorelbine plus cisplatin vs. observation in resected non-small-cell lung Cancer. N Engl J Med. 2005;352(25):2589-2597. [PubMed 15972865]
  58. Yeo KK, Gaynon PS, Fu CH, Wayne AS, Sun W. Bortezomib, dexamethasone, mitoxantrone, and vinorelbine (BDMV): an active reinduction regimen for children with relapsed acute lymphoblastic leukemia and asparaginase intolerance. J Pediatr Hematol Oncol. 2016;38(5):345-349. [PubMed 27352191]
  59. Zelek L, Barthier S, Riofrio M, et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer. 2001;92(9):2267-2272. [PubMed 11745280]
Topic 10046 Version 346.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟