Navelbineg soln for IV inj（Vinorelbine Tartrate）
NAVELBINE Rx
Generic Name and Formulations:
Vinorelbine (as tartrate) 10mg/mL; soln for IV inj after dilution; preservative-free.
Company:
Pierre Fabre Pharmaceuticals, Inc.

Select therapeutic use: Respiratory and thoracic cancers
Indications for NAVELBINE:
First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with cisplatin. As a single agent, for the treatment of patients with metastatic NSCLC.

Adult:
See full labeling. Give by IV inj over 6–10mins. Monotherapy: 30mg/m2 once weekly. Combination therapy: 25mg/m2 on Days 1, 8, 15, and 21 of a 28-day cycle with cisplatin given on Day 1 of each 28-day cycle; or 30mg/m2 once weekly with cisplatin given on Days 1 and 29, then every 6 weeks. Dose adjustment for toxicities, hepatic impairment: see full labeling.

Children:
Not recommended.

Contraindications:
Pretreatment granulocyte counts <1000 cells/mm3.

Warnings/Precautions:
Risk of myelosuppression. Monitor for infection, and/or fever; obtain CBCs with differentials prior to each dose. Discontinue if neurotoxicity ≥grade 2. Pre-existing pulmonary dysfunction or neuropathy. Hepatic injury or impairment: assess hepatic function prior to and during treatment. Cardiovascular disease. Avoid extravasation. Embryo-fetal toxicity. Females of reproductive potential should use highly effective contraception during therapy. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:
May be potentiated by CYP3A inhibitors. Increased risk of granulocytopenia with cisplatin.

Pharmacological Class:
Antimicrotubule agent.

Adverse Reactions:
Neutropenia, anemia, elevated liver enzymes, nausea, vomiting, asthenia, constipation, inj site reaction, peripheral neuropathy; hepatotoxicity, bowel obstruction, paralytic ileus.

How Supplied:
Single-use vial (1mL, 5mL)—1