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

and vinorelbine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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
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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

            Y-site (partial list): buprenorphine, cisplatin, cyclophosphamide, diphenhydramine, gemcitabine, fluconazole, granisetron, hydromorphone, imipenem-cilastatin, lorazepam, meperidine, morphine, ondansetron, KCl, vancomycin, zidovudine

            IV Preparation

            May be diluted in syringe or bag

            Syringe: Dilute to 1.5-3 mg/mL in 0.9% NaCl or D5W

            IV Bag: 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 IV use only; fatal if given intrathecally

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

            Then flush with 75-125 mL of one of the IV 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

            Store intact vials under refrigeration protected from light

            Diluted solution may be stored in polypropylene syringes for 24 hr under normal light at 5-30°C

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            Formulary

            FormularyPatient Discounts

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            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.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.