vinorelbine (Rx)

Brand and Other Names:Navelbine
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 10mg/mL
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Non-small Cell Lung Carcinoma

Monotherapy

  • 30 mg/m² IV over 6-10 minutes qWeek 

Combo Therapy

  • 25 mg/m² IV qWeek with IV cisplatin 100 mg/m² q4Weeks OR
  • 30 mg/m² IV qWeek with cisplatin 120 mg/m² on Days 1 & 29 & then q6Weeks

Dosage Modifications

Hematologic toxicity (granulocyte count)

  • >1500 cells/mm³: 100 % of dose
  • 1000-1499 cells/mm³: Decrease dose 50%
  • <1000 cells/mm³: Do not administer

Neurotoxicity

  • Grade >2: Discontinue

Renal impairment

  • Dose adjustment not necessary

Hepatic impairment

  • 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%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to diagnose and manage complications

            Severe granulocytopenia may occur

            The needle should be properly positioned in the vein before this product is injected. Leakage to surrounding tissue during IV administration may cause considerable irritation. Immediately discontinue the injection, and introduce any remaining portion of the dose into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage will help disperse the drug and may minimize the discomfort and possibility of cellulitis.

            Intrathecal use may be fatal

            Contraindications

            Hypersensitivity

            Acute bacterial infection, ANC <1000/mm³, intrathecal (IT) administration, intestinal obstruction, paralytic ileus, pregnancy, lactation

            Cautions

            Vesicant: Moderate

            Likely fatal if given intrathecally

            Bone marrow depression, neuropathy, myopathy, neuromuscular disease, neurotoxic agents, ototoxic agents, pulmonary disease, hepatic impairment

            Avoid extravasation

            Avoid pregnancy

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk; do not nurse

            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

            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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