Composition
Inj 10 mg/50 mg: Per ml: Vinorelbine 10 mg; 1 ml and 5 ml soln.
Indications & Dosage
First line treatment of stage III or IV non-small cell lung cancer alone or in combination, Treatment of stage 3 or 4 advanced breast cancer relapsing or refractory to anthracycline containing regimens: BY IV INJ: Adults & Elderly: Monotherapy: 30 mg/m2 every 7 day. Combination therapy with Cisplatin: 25 mg/m2 every 7 day (with cisplatin100 mg/m2 every 4 week). Alternatively: 30 mg/m2 in combination with cisplatin 120 mg/m2 on days 1 & 29, then every 6 wk.
Administration
Administer as a direct IVP or IV rapid bolus; over 6-10 min (up to 30 min). Longer infusions may in-crease the risk of pain and phlebitis. IV doses should be followed by 150-250 ml of NS or D5W to reduce the incidence of phlebitis and inflammation, Central line only for IVP bolus administration. Dilute in 10-50 ml D5W or NS.
Compatibility
Stable in D51/2NS, D5W, LR, VAS.
Stability
Store unopened vials under refrigeration at 2C-8C (36F-46F) in the carton. Protect from light. Do not freeze. Unopened vials are stable at temperatures up to 25C (77F) for up to 72 hours. Product should not be frozen. Diluted vinorelbine may be used for up to 24 hours under normal room light when stored in polypropylene syringes or PVC bags at 5C-30C (41F-86F),
Contraindications
Myelosuppression.
Precautions
Hepatic impairment, ischaemic heart disease, history of constipation, monitor haematology.
Interactions
Yellow fever vaccine, live vaccines, cisplatin, mi-tomycin C, anticoagulants, opiate analgesics, CYP3A4 substrates.
Pregnancy
Contraindicated.
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Alopecia, autonomic neuropathy, bone marrow suppression, extravasation, hyperuricaemia, irritant to tissues, myelosuppression, neurotoxicity, oral mucositis, peripheral neuropathy, severe bronchospasm, severe local irritation, thromboembolism, tumourlysis syndrome, vomiting