Navelbine Injection

Vinorelbine tartrate

Non-small cell lung cancer & advanced breast cancer in combination w/ standard chemotherapy.

IV Infusion Infuse 6-10 min after dilution in 20-50 mL NSS or 5% dextrose soln. Monotherapy 25-30 mg/m² once wkly. Combination therapy 25-30 mg/m² at day 1 & day 5 every 3 wk or day 1 & day 8 every 3 wk according to treatment protocol. >3 mg/dL total bilirubin 7.5 mg/m², 2.1-3 total bilirubin 15 mg/m², ≤2 total bilirubin 30 mg/m².

Hypersensitivity to vinorelbine or other vinca alkaloids. Current or recent (w/in 2 wk) severe infection. Neutrophil count <1,500/mm³. Platelet count <100,000/mm³. In combination w/ yellow fever vaccine. Pregnancy & lactation.

For IV use only. Not to be administered intrathecally. Discontinue use if extravasations occur; moderate or severe neurotoxicity develops. History of ischemic cardiac disease; presence or sign of infection; severe constipation eg, paralytic ileus; compromised bone marrow reserve prior to irradiation/chemotherapy or recovering from previous chemotherapy effects; prior or preexisting neuropathy. Monitor for new or worsening signs & symptoms of neuropathy during treatment. Frequently monitor myelosuppression during & after treatment. Delay treatment if neutrophil count is <1,500/mm³ &/or platelet count is <100,000/mm³. Perform CBC w/ differential. Promptly evaluate patients w/ alterations in baseline pulmonary symptoms or new onset of dyspnoea, cough, hypoxia. Close haematological monitoring should be undertaken during treatment. Avoid contact w/ eyes. Not to be given concomitantly w/ radiotherapy if treatment field includes liver; mitomycin. Not recommended w/ live attenuated vaccines, phenytoin, fosphenytoin, itraconazole or posaconazole. May affect ability to drive & use machines. Reduce dose in patients w/ hepatic insufficiency. Not recommended in childn.

Loss of deep tendon reflexes; arthralgia including jaw pain & myalgia. Mild to moderate bacterial, viral or fungal infection; anorexia; hand & feet erythema; inj site reactions. Anaphylaxis, anaphylactic shock or anaphylactoid type reaction.

Acute pulmonary reaction w/ mitomycin. Incidence of granulocytopenia w/ cisplatin. Radiosensitizing effect w/ radiotherapy. Increased blood conc w/ strong CYP3A4 inhibitors. Decreased blood conc w/ strong CYP3A4 inducers. Risk of fatal generalised vaccine disease w/ live attenuated vaccines. Decreased phenytoin digestive absorption. Increased thrombotic & haemorrhagic risk in case of tumoral diseases w/ oral anticoagulants. Excessive immunodepression w/ risk of lymphoproliferation w/ immunosuppressive medicines eg, ciclosporine, tacrolimus, everolimus, sirolimus. Increased neurotoxicity w/ itraconazole. Exacerbated myelosuppressive adverse effects w/ other drugs w/ known bone marrow toxicity.

Cytotoxic Chemotherapy

L01CA04 - vinorelbine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.

G