vinorelbine tartrate


OEP Phils


Concise Prescribing Info
Vinorelbine tartrate
Monotherapy & in combination chemotherapy of non-small cell lung cancer & metastatic breast cancer.
Dosage/Direction for Use
Monotherapy 1st 3 administrations: 60 mg/m2 once wkly, subsequently beyond the 3rd administrations, increase the dose to 80 mg/m2 once wkly except in patients for whom the neutrophil count dropped once <500/mm3 or more than once between 500 & 1,000/mm3 during the 1st 3 administrations at 60 mg/m2. Dose modification: For any administration planned to be given at 80 mg/m2, if the neutrophil count is <500/mm3 or between 500 & 1,000 mm3more than once, the administration should be delayed until recovery & the dose reduced from 80-60 mg/m2/wk during the 3 following administrations. Increase the dose from 60-80 mg/m2/wk if the neutrophil count did not drop <500/mm3 or more than once between 500 & 1,000/mm3 during the last 3 administrations given at 60 mg/m2 according to the rules previously defined for the 1st 3 administrations. Combination chemotherapy Dose & treatment regimen should be adjusted according to treatment protocol. BSA of ≥2 m2 Total dose must not exceed 120 mg/wk (60 mg/m2 dosage) or 160 mg/wk (80 mg/m2). Patient w/ mild liver impairment (bilirubin <1.5 x ULN & AST &/or ALT 1.5-2.5 x ULN) 60 mg/m2/wk. Patient w/ moderate liver impairment (bilirubin from 1.5-3 x ULN regardless of the ALT & AST) 50 mg/m2/wk.
Should be taken with food: Take at the end of a meal. Swallow whole w/ water, do not chew/suck.
Hypersensitivity to vinorelbine or other vinca alkaloids. Disease significantly affecting absorption, previous significant surgical resection of stomach or small bowel. severe hepatic insufficiency, 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, concomitant use w/ yellow fever vaccine. Lactation.
Special Precautions
If the cap was accidentally chewed or sucked by the patient, rinse the mouth w/ water or preferably a normal saline soln. Cap content is an irritant & may damage skin, mucosa or eyes if in contact. Fructose intolerance. Close haematological monitoring must be undertaken during the treatment. Prompt investigation should be carried out if patients present signs or symptoms suggestive of infection. Do not co-administer w/ phenytoin, fosphenytoin, itraconazole, ketoconazole or posaconazole. History of ischaemic heart disease. Poor performance status. Should not be given concomitantly w/ radiotherapy if the treatment field includes the liver. Not recommended for patients w/ impaired kidney function. Women of childbearing potential must use effective contraception during & 3 mth after treatment. Irreversible fertility in men. May affect ability to drive or operate machinery. Pregnancy. Childn.
Adverse Reactions
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 resulting from bone marrow depression &/or immune system compromise; 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 pain at the tumour site; wt gain.
Drug Interactions
Increase risk of fatal generalised vaccine disease w/ live attenuated vaccines (for yellow fever vaccine). Increased hepatic metabolism by phenytoin or fosphenytoin. Increased thrombotic & haemorrhagic risk in case of tumoral diseases w/ vit K antagonists. Risk of increased toxicity w/ macrolides eg, clarithromycin, erythromycin, telithromycin. Increased neurotoxicity w/ cobicistat. Excessive immunodepression w/ risk of lymphoproliferation w/ cyclosporine, tacrolimus, everolimus, sirolimus. Increased neurotoxicity w/ itraconazole, posaconazole, ketoconazole. Decreased hepatic metabolism by PIs. Risk of bronchospasms & dyspnoea w/ mitomycin C. Exacerbation of myelosuppressive adverse effects when combined w/ other drugs w/ known bone marrow toxicity.
ATC Classification
L01CA04 - vinorelbine ; Belongs to the class of plant alkaloids and other natural products, vinca alkaloids and analogues. Used in the treatment of cancer.
Navelbine softgel cap 30 mg
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