Vinorelbine Alvogen

Vinorelbine

Monotherapy or in combination for 1st line treatment of stage 3 or 4 NSCLC & advanced breast cancer relapsing after or refractory to an anthracycline containing regimen.

Adult Monotherapy 1st 3 administrations: 60 mg/m² once wkly. Subsequently, may increase dose to 80 mg/m² once wkly except for patient whose neutrophil count dropped once <500/mm³ or more than once between 500 & 1,000/mm³ during 1st 3 administrations at 60 mg/m². Combination 80 mg/m² PO was demonstrated to correspond to 30 mg/m² IV & 60 mg/m² to 25 mg/m². Patient w/ BSA ≥2 m² Max total dose: 120 mg wkly at 60 mg/m² & 160 mg wkly at 80 mg/m².

Should be taken with food: Swallow whole w/ water, do not chew/suck/dissolve.

Known hypersensitivity to vinorelbine or other vinca-alkaloids. Disease significantly affecting absorption. Previous significant surgical resection of stomach or small bowel. Neutrophil count <1,500/mm³ or severe infection current or recent (w/in 2 wk); platelet count <100,000/mm³. Patients requiring long-term oxygen therapy. Combination w/ yellow fever vaccine. Severe hepatic insufficiency. Pregnancy & lactation.

Not to re-administer in case of vomiting w/in few hrs after drug intake. Delay treatment if neutrophil count is <500/mm³ or more than once between 500 & 1,000/mm³ when given at 80 mg/m². Patients w/ history of ischemic heart disease; poor performance status. Fructose intolerance. Carefully monitor bowel mobility in patients receiving concomitant morphine or opioid analgesics. Closely monitor haematological during treatment (determination of Hb level & leucocyte, neutrophil & platelet counts on the day of each new administration). Prompt investigation if patients present signs or symptoms suggestive of infection. Not to be given concomitantly w/ RT. Not recommended in concomitant use w/ other live attenuated vaccines; combination w/ strong CYP3A4 inhibitors or inducers; phenytoin & itraconazole. Severe hepatic impairment. Impaired kidney function. Men should not father a child during & minimally up to 3 mth after treatment. Women of childbearing potential must use effective contraception during treatment & up to 3 mth after treatment. Serious birth effects during pregnancy. Lactation. Not recommended for childn.

Bacterial, viral or fungal infections w/o neutropenia at different sites; bone marrow depression resulting mainly in neutropenia, leucopenia, anemia, thrombocytopenia; neurosensory disorders; nausea, vomiting, diarrhoea, anorexia, stomatitis, abdominal pain, constipation, gastric disorders; alopecia; fatigue/malaise, fever; wt loss. Bacterial, viral or fungal infections, neutropenic infection; neutropenia associated w/ fever >38°C including febrile neutropenia; insomnia; neuromotor disorders, headache, dizziness, taste disorders; visual disorders; HTN, hypotension; dyspnoea, cough; oesophagitis, dysphagia; hepatic disorders; skin reactions; arthralgia including jaw pain, myalgia; dysuria, other genitourinary disorders; pain including at tumour site, chills; wt gain.

Risk of fatal generalised vaccine disease w/ yellow fever & live attenuated vaccines. Decreased phenytoin digestive absorption. Decreased hepatic metabolism w/ itraconazole. Concomitant use w/ cisplatin; mitomycin C; ciclosporin, tacrolimus; P-gp. Combination w/ other drugs known to have bone marrow toxicity. Increased blood conc w/ strong inhibitors of isoenzyme eg, ketoconazole & itraconazole. Decreased blood conc w/ strong inducers eg, rifampicin, phenytoin. Potential interaction w/ oral anticoagulants & increased coagulation variability.

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.

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