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Vinorelbine Tartrate

Pronunciation: (vih-NORE-ell-bean)
Class: Vinca alkaloid

Trade Names:
Navelbine
- Solution for Injection 10 mg/mL

Pharmacology

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Vinorelbine interferes with microtubule assembly primarily by inhibiting mitosis at metaphase through its interaction with tubulin.

Pharmacokinetics

Distribution

Vd is 25 to 40.1 L/kg.

Metabolism

One metabolite, deacetylvinorelbine, has been shown to possess antitumor activity.

Elimination

T _½ is 28 to 44 h. Mean plasma clearance is about 1 to 1.26 L/h/kg. Substantial hepatic elimination in humans, with large amounts recovered in feces after IV administration.

Special Populations

Hepatic Function Impairment

Based on experience with other anticancer vinca alkaloids, dosage adjustments are recommended for patients with impaired hepatic function taking vinorelbine.

Indications and Usage

Unresectable, advanced non-small cell lung cancer.

Unlabeled Uses

Breast cancer, cisplatin-resistant ovarian cancer, Hodgkin lymphoma.

Contraindications

Pretreatment granulocyte counts less than 1,000 cells/mm ³ .

Dosage and Administration

Unresectable, Advanced Non-Small Cell Lung Cancer
Adults

IV 30 mg/m ² once weekly until either disease progression or dose-limiting toxicity occur.

Dosage Adjustment for Hematologic Toxicity

Granulocyte counts should be at least 1,000 cells/mm ³ prior to the administration of vinorelbine. Base dosage adjustments on granulocyte counts. See manufacturer's recommendations.

Dosage Adjustment in Hepatic Dysfunction
Adults

IV Reduce dose 50% if total bilirubin is 2.1 to 3 mg/dL. Reduce dose 25% if total bilirubin is more than 3 mg/dL.

General Advice

Vinorelbine must be further diluted prior to administration.
Administer by IV infusion
Infuse IV over 6 to 10 min into the side port of a freely flowing IV line closest to the IV bag. Follow injection with at least 75 to 125 mL dextrose 5% or sodium chloride 0.9%.

Storage/Stability

Refrigerate but do not freeze. Protect from light. Unopened vials may be stored at room temperature up to 25°C (77°F) for up to 72 h. Diluted solutions may be stored at room temperature or under refrigeration for up to 24 h in polypropylene syringes or PVC bags. Solutions are preservative-free and should be discarded within 24 h of preparation.

Drug Interactions

Cisplatin

Incidence of granulocytopenia increases when vinorelbine is used in combination with cisplatin.

CYP-450 3A enzyme inhibitors (eg ketoconazole, itraconazole, macrolides)

May increase vinorelbine serum levels and toxicity.

Mitomycin

Acute pulmonary reactions were noted when vinca alkaloids were given with mitomycin.

Paclitaxel

Monitor for signs and symptoms of neuropathy with concomitant use of vinorelbine and paclitaxel.

Radiation

Radiation recall reactions may occur.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Chest pain.

CNS

Fatigue; mild to moderate peripheral neuropathy.

Dermatologic

Mild alopecia; rash and injection site reactions; pain at injection site.

GI

Transient elevations in LFTs; constipation; paralytic ileus; mild stomatitis; anorexia; diarrhea.

Hematologic

Dose-limiting granulocytopenia occurs with a nadir of 7 to 10 days.

Hypersensitivity

Anaphylaxis; angioedema; pruritus.

Musculoskeletal

Jaw pain; myalgia; arthralgia.

Respiratory

Dyspnea.

Precautions

Warnings

IV use only

Intrathecal use of other vinca alkaloids has been fatal. Label syringe “Warning - For IV Use Only; fatal if given intrathecally.”

Granulocytopenia

May be severe and predispose to infection. Do not administer to patients with granulocyte counts less than 1,000 cells/mm ³ .

Avoid extravasation

Proper placement of needle/catheter prior to administration. Extravasation can cause severe local necrosis.

Pregnancy

Category D .

Lactation

Undetermined.

Children

Safety and efficacy in children have not been established.

Hepatic Function

Administer with caution to patients with hepatic insufficiency.

GI

May cause severe constipation, paralytic ileus, intestinal obstruction, necrosis, and perforation.

Interstitial pulmonary changes

Cases of interstitial pulmonary changes and ARDS, most of which were fatal, occurred in patients.

Overdosage

Symptoms

Paralytic ileus, stomatitis, esophagitis, bone marrow aplasia, sepsis, paresis.

Patient Information

Advise patients to report fever or chills immediately.
Advise women of childbearing potential to avoid pregnancy during treatment.
Advise patients to contact the health care provider if experiencing increased shortness of breath, cough, or other new pulmonary symptoms, or if experiencing symptoms of abdominal pain or constipation.