vinorelbine (Rx)

Brand and Other Names:Navelbine
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/1mL
  • 50mg/5mL

Non-small Cell Lung Cancer

Monotherapy

  • Indicated for metastatic non-small cell lung cancer (NSCLC)
  • 30 mg/m² IV infused over 6-10 minutes qWeek  

Combination therapy

  • Indicated in combination with cisplatin for first-line treatment of locally advanced or metastatic NSCLC
  • 25 mg/m² IV qWeek on Days 1, 8, 15, and 22 of a 28-day cycle with IV cisplatin 100 mg/m² on Day 1 OR
  • 30 mg/m² IV qWeek with cisplatin 120 mg/m² IV on Days 1 and 29, and then q6Weeks

Dosage Modifications

Neutrophils on day of treatment

  • >1500 cells/mm³: 100 % of dose
  • 1000-1499 cells/mm³: Decrease dose 50%
  • <1000 cells/mm³: Do not administer; repeat neutrophil count in 1 week
  • If 3 consecutive weekly doses are held owing to neutrophils <1000 cell/mm³, discontinue
  • Fever or sepsis while neutrophil count <1500 or dose held for 2 weeks
    • >1500 cells/mm³: 75% of dose
    • 1000-1499 cells/mm³: 37.5% of dose
    • <1000 cells/mm³: Do not administer; repeat neutrophil count in 1 week

Neurotoxicity

  • Grade ≥2: Discontinue

Renal impairment

  • Dose adjustment not necessary

Hepatic impairment or toxicity

  • Total bilirubin (TB) <2 mg/dL: Dose adjustment not necessary
  • TB 2.1-3 mg/dL: Decrease dose 50%
  • TB >3 mg/dL: Decrease dose 75%

Breast Cancer (Off-label)

20-30 mg/m² qWeek, has been administered as IV infusion, slow (3-5 minutes) or rapid IV injection  

Ovarian Cancer (Off-label)

25 mg/m² q7Days  

25-30 mg/m²/day on days 1 & 8 of 21 day cycle

Soft Tissue Sarcoma (Orphan)

Liposomal vinorelbine

Orphan designation for treatment of soft tissue sarcoma

Sponsor

  • Taiwan Liposome Company, Ltd; 3 Yuanqu Street; Taiwan

Safety and efficacy not established

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Interactions

Interaction Checker

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            Contraindicated (0)

              Serious - Use Alternative (16)

              • abametapir

                abametapir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

              • adenovirus types 4 and 7 live, oral

                vinorelbine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • apalutamide

                apalutamide will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

              • deferiprone

                deferiprone, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • fexinidazole

                fexinidazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

              • idelalisib

                idelalisib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

              • influenza virus vaccine quadrivalent, adjuvanted

                vinorelbine decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                vinorelbine decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • ivosidenib

                ivosidenib will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

              • lonafarnib

                vinorelbine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

                lonafarnib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

              • nefazodone

                nefazodone will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • palifermin

                palifermin increases toxicity of vinorelbine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • selinexor

                selinexor, vinorelbine. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • tofacitinib

                vinorelbine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • tucatinib

                tucatinib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

              • voxelotor

                voxelotor will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

              Monitor Closely (62)

              • acalabrutinib

                acalabrutinib, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • avapritinib

                vinorelbine will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                vinorelbine increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belatacept

                belatacept and vinorelbine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • carbamazepine

                carbamazepine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • chloramphenicol

                chloramphenicol will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cimetidine

                cimetidine will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • clarithromycin

                clarithromycin will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cobicistat

                cobicistat will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • crizotinib

                crizotinib increases levels of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

              • cyclosporine

                cyclosporine will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                cyclosporine will increase the level or effect of vinorelbine by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • dabrafenib

                dabrafenib will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

              • deferasirox

                deferasirox will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • denosumab

                vinorelbine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • diltiazem

                diltiazem will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • elagolix

                elagolix decreases levels of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

              • elvitegravir/cobicistat/emtricitabine/tenofovir DF

                elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

              • encorafenib

                encorafenib, vinorelbine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

              • erythromycin base

                erythromycin base will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ethotoin

                vinorelbine decreases levels of ethotoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                vinorelbine decreases levels of ethotoin by increasing metabolism. Use Caution/Monitor.

              • fedratinib

                fedratinib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

              • finerenone

                vinorelbine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • fingolimod

                vinorelbine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • flibanserin

                vinorelbine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • fosphenytoin

                vinorelbine decreases levels of fosphenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                vinorelbine decreases levels of fosphenytoin by increasing metabolism. Use Caution/Monitor.

              • hydroxyurea

                vinorelbine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • iloperidone

                iloperidone increases levels of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

              • influenza A (H5N1) vaccine

                vinorelbine decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • influenza virus vaccine (H5N1), adjuvanted

                vinorelbine decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.

              • isoniazid

                isoniazid will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • istradefylline

                istradefylline will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

              • itraconazole

                itraconazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ketoconazole

                ketoconazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • lemborexant

                vinorelbine will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • lomitapide

                vinorelbine increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • lopinavir

                lopinavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • meningococcal group B vaccine

                vinorelbine decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • midazolam intranasal

                vinorelbine will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • mifepristone

                mifepristone will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • mitomycin

                mitomycin, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Acute shortness of breath and severe bronchospasm have occurred following use of vinca alkaloids in patients who had previously or simultaneously received mitomycin. .

              • mitotane

                mitotane decreases levels of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

              • ofatumumab SC

                ofatumumab SC, vinorelbine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                vinorelbine and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • phenytoin

                vinorelbine decreases levels of phenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

                vinorelbine decreases levels of phenytoin by increasing metabolism. Use Caution/Monitor.

              • ribociclib

                ribociclib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

                rifampin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rucaparib

                rucaparib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • saquinavir

                saquinavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • siponimod

                siponimod and vinorelbine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                vinorelbine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • St John's Wort

                St John's Wort will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tazemetostat

                tazemetostat will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

                vinorelbine will increase the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tecovirimat

                tecovirimat will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

              • tinidazole

                vinorelbine will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tipranavir

                tipranavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • tobramycin inhaled

                tobramycin inhaled and vinorelbine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity

              • trastuzumab

                trastuzumab, vinorelbine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, vinorelbine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

              Minor (55)

              • amobarbital

                amobarbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • aprepitant

                aprepitant will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • armodafinil

                armodafinil will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • artemether/lumefantrine

                artemether/lumefantrine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • atazanavir

                atazanavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • bosentan

                bosentan will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • butabarbital

                butabarbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • butalbital

                butalbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • cisplatin

                cisplatin, vinorelbine. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown.

              • conivaptan

                conivaptan will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • darifenacin

                darifenacin will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • darunavir

                darunavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dasatinib

                dasatinib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dexamethasone

                dexamethasone will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • DHEA, herbal

                DHEA, herbal will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • dronedarone

                dronedarone will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • efavirenz

                efavirenz will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • etravirine

                etravirine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fluconazole

                fluconazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fosamprenavir

                fosamprenavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • fosphenytoin

                fosphenytoin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • grapefruit

                grapefruit will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • griseofulvin

                griseofulvin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • hydrocortisone

                hydrocortisone will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • indinavir

                indinavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lapatinib

                lapatinib will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • lumefantrine

                lumefantrine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • maitake

                maitake increases effects of vinorelbine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).

              • marijuana

                marijuana will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • metronidazole

                metronidazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • miconazole vaginal

                miconazole vaginal will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • modafinil

                modafinil will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nafcillin

                nafcillin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nelfinavir

                nelfinavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • nevirapine

                nevirapine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • oxcarbazepine

                oxcarbazepine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • pentobarbital

                pentobarbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • phenobarbital

                phenobarbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • phenytoin

                phenytoin will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • posaconazole

                posaconazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • prednisone

                prednisone will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • primidone

                primidone will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • quinupristin/dalfopristin

                quinupristin/dalfopristin will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • rifapentine

                rifapentine will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ritonavir

                ritonavir will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • rufinamide

                rufinamide will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • ruxolitinib

                vinorelbine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • secobarbital

                secobarbital will decrease the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • taurine

                vinorelbine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.

              • verapamil

                verapamil will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • vitamin A

                vitamin A, vinorelbine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • vitamin E

                vitamin E, vinorelbine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

              • voriconazole

                voriconazole will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

              • zafirlukast

                zafirlukast will increase the level or effect of vinorelbine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              Adverse Effects

              >10%

              Leukopenia (92%)

              Granulocytopenia (90%)

              Anemia (83%)

              Elev AST (67%)

              Nausea (44%)

              Asthenia (36%)

              Constipation (35%)

              Fatigue (27%)

              Peripheral neuropathy (25%)

              Vomiting (20%)

              Anorexia (20%)

              Stomatitis (20%)

              Alopecia (12%)

              1-10%

              Dyspnea (7%)

              Chest pain (5%)

              Rash (5%)

              SOB (3%)

              Hemorrhagic cystitis (1%)

              SIADH (1%)

              Postmarketing Reports

              Palmar-plantar erythrodysesthesia syndrome

              Hepatic toxicity

              Bowel obstruction

              Pulmonary toxicity

              Respiratory failure

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              Warnings

              Black Box Warnings

              Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death can occur

              Decrease and/or withhold dose in accord with recommended dose modifications

              Contraindications

              None

              Cautions

              Myelosuppression, manifested by neutropenia, anemia, and thrombocytopenia reported; neutropenia is the major dose-limiting toxicity; monitor complete blood counts before each dose

              Risk of extravasation and tissue injury

              Sensory and motor neuropathies reported

              Can cause fetal harm if administered to pregnant women based on findings from animal studies and mechanism of action

              Hepatic toxicity

              • Drug-induced liver injury manifested by elevated aspartate aminotransferase (AST) and bilirubin occur in patients receiving drug as single agent and in combination with cytotoxic agents
              • Assess hepatic function prior to initiation of therapy and periodically during treatment
              • Reduce dose for patients who develop elevations in total bilirubin greater than or equal to 2 times upper limit of normal

              Gastrointestinal effects

              • Severe and fatal paralytic ileus, constipation, intestinal obstruction, necrosis, and perforation reported
              • Institute a prophylactic bowel regimen to mitigate potential constipation, bowel obstruction and/or paralytic ileus
              • Consider adequate dietary fiber intake, hydration and routine use of stool softeners

              Pulmonary toxicity

              • Pulmonary toxicity, including severe acute bronchospasm, interstitial pneumonitis, acute respiratory distress syndrome (ARDS) occur in patients receiving therapy
              • Interrupt therapy in patients who develop unexplained dyspnea or have any evidence of pulmonary toxicity
              • Permanently discontinue therapy for confirmed interstitial pneumonitis or ARDS

              Preparation in IV infusion bag only

              • On January 15, 2021, FDA alerted that vinca alkaloids should be prepared in IV infusion bags only
              • Intrathecal (IT) administration will result in severe neurological injury and/or death
              • Label update is to reduce the potential for unintended IT administration
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              Pregnancy & Lactation

              Pregnancy

              Based on animal findings, can cause fetal harm when administered to pregnant women

              Verify pregnancy status in females of reproductive potential before initiating

              Animal studies

              • In animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with vinorelbine doses ~0.33 and 0.18 times the human therapeutic dose, respectively

              Contraception

              • Females: Use effective contraception during treatment and for 6 months after final dose
              • Males: May damage spermatozoa; advise males with female sexual partners of reproductive potential to use effective contraception during treatment and for 3 months after final dose

              Infertility

              • Males: Based on animal findings, may impair fertility

              Lactation

              Data are not available regarding drug in human milk or effects on breastfed infant or milk production

              Because of potential harm; advise women not to breastfeed during treatment and for 9 days after final dose

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Semi-synthetic vinca alkaloid; inhibits mitosis at metaphase by depolymerizing microtubules; specific for S ans M phases; may also inhibit nucleic acid and protein synthesis by blocking glutamic acid use

              Pharmacokinetics

              Half-Life: 28-44 hr

              Peak Plasma: 234-1160 ng/mL

              Plasma clearance: 0.97-1.26 L/hr/kg

              Protein Bound: 80-92%

              Vd: 25-40 L/kg

              Metabolism: CYP3A isoenzymes

              Metabolites: vinorelbine N-oxide, deacetylvinorelbine

              Clearance: 0.97-1.26 L/hr/kg

              Excretion: Feces (46%); urine (18%)

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              Administration

              IV Incompatibilities

              Y-site: acyclovir, allopurinol, aminophylline, amphotericin B, ampho B cholesteryl sulfate, ampicillin, cefazolin, cefoperazone, cefotetan, ceftriaxone, cefuroxime, co-trimoxazole, fluorouracil, furosemide, ganciclovir, methylprednisolone sodium succinate, mitomycin, piperacillin, sodium bicarbonate, thiotepa

              IV Compatibilities

              Solution

              • D5W
              • 0.9% NaCl
              • 0.45% NaCl
              • D5W 0.45% NaCl
              • Lactated Ringer (LR)
              • Ringer’s

              Y-site (partial list)

              • Buprenorphine, cisplatin, cyclophosphamide, diphenhydramine, gemcitabine, fluconazole, granisetron, hydromorphone, imipenem-cilastatin, lorazepam, meperidine, morphine, ondansetron, KCl, vancomycin, zidovudine

              IV Preparation

              Prepare in infusion bag only

              Dilute to 0.5-2 mg/mL in 0.9% NaCl, 0.45% NaCl, D5W, D5/0.45% NaCl, LR or Ringer's

              IV Administration

              Vesicant

              For IVPB use only; fatal if given intrathecally

              Always properly position IV needle or catheter before any infusion

              Infuse over 6-10 min through sidearm of free-flowing IV closest to IV bag

              Flush with 75-125 mL of one of the IV compatible fluids

              Extravasation Management

              Mix 250 U hyaluronidase with 6 mL NS

              Inject hyaluronidase solution subcutaneously through 6 clockwise injections into infiltrated area using a 25-gauge needle

              Change needle with each new injection

              Elevate extremities

              Apply heat immediately for 1 hr

              Give QID for 3-5 days

              Application of cold or hydrocortisone is contraindicated

              Storage

              Unopened vials: Refrigerate; protected from light

              Diluted solution: Store for 24 hr under normal light at 5-30ºC

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              vinorelbine intravenous
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              10 mg/mL vial
              vinorelbine intravenous
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              50 mg/5 mL vial
              vinorelbine intravenous
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              10 mg/mL vial
              vinorelbine intravenous
              -
              50 mg/5 mL vial
              vinorelbine intravenous
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              50 mg/5 mL vial
              vinorelbine intravenous
              -
              10 mg/mL vial
              Navelbine intravenous
              -
              50 mg/5 mL vial
              Navelbine intravenous
              -
              10 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              vinorelbine intravenous

              VINORELBINE - INJECTION

              (vye-nor-ELL-bean)

              COMMON BRAND NAME(S): Navelbine

              WARNING: This medication must be given only by injection into a vein (intravenously-IV) by a trained healthcare professional. Deaths have occurred with medications similar to vinorelbine that were injected into the spine.Vinorelbine can lower your blood cell counts (bone marrow suppression) and lower your ability to fight an infection. Your doctor will follow your blood counts closely. Tell your doctor right away if you develop any signs of an infection such as fever, chills, or persistent sore throat.If this medication accidentally leaks out of your vein into surrounding tissue, the skin and/or muscle may be severely damaged. Tell your doctor right away if you have pain, redness, swelling, or discoloration at the injection site.

              USES: Vinorelbine is used to treat various types of cancer. It is a chemotherapy drug that works by slowing or stopping cancer cell growth.

              HOW TO USE: Vinorelbine is given by injection only into a vein by a healthcare professional. It is usually given over 6-10 minutes, once a week, or as directed by your doctor. The dosage is based on your medical condition, response to therapy, and body size.If this medication comes into contact with your skin, wash your skin right away and completely with soap and water. If vinorelbine gets into your eyes, flush them right away and completely with water, and contact the doctor.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, fatigue, constipation, diarrhea, dizziness, muscle aches, joint pain, or irritation at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.To prevent constipation, eat dietary fiber, drink enough water, and exercise. Your doctor may prescribe a laxative (such as a stool softener) to help prevent constipation. Ask your doctor or pharmacist which type of laxative is right for you.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling/pain in the hands or feet, decreased reflexes, mouth sores, easy bruising/bleeding, weakness, new or increased trouble breathing, cough, severe constipation, blood in the urine, mental/mood changes.Get medical help right away if this rare but very serious side effect occurs: chest pain.A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using vinorelbine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: decreased bone marrow function/blood cell disorders (e.g., anemia, leukopenia, thrombocytopenia).Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, numbness/tingling of the hands or feet, blockage of the stomach/intestines (e.g., obstruction, paralytic ileus), heart disease.Vinorelbine can sometimes cause a serious skin reaction that looks likes a severe sunburn when given after radiation treatment (radiation recall). The reaction usually develops on the skin area previously treated with radiation within days to months after vinorelbine treatment. Throat problems can also be part of radiation recall with vinorelbine. Tell your doctor right away if you develop skin redness/tenderness/swelling/peeling/blisters or painful/difficult swallowing. Your doctor may prescribe medication to treat your symptoms. If you develop a skin reaction, avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.Do not have immunizations/vaccinations without the consent of your doctor and avoid contact with people who have recently received oral polio vaccine.Use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports to lower the chance of getting cut, bruised or injured.Wash your hands well to prevent the spread of infections.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication can affect fertility in males. Ask your doctor for more details.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vinorelbine. Vinorelbine may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Men with female partners should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 9 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: mitomycin.Other medications can affect the removal of vinorelbine from your body, which may affect how vinorelbine works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine), among others.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Laboratory and/or medical tests (e.g., complete blood counts, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.