See related Navelbine information |
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Manufacturer |
Pierre Fabre Medicament |
Distributor |
Zuellig |
Contents |
Vinorelbine tartrate |
Indications |
Treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination. 1st-line treatment of advanced non-small cell lung cancer, as a single agent or in combination. |
Dosage |
Softcap As single agent: 1st 3 administrations of 60 mg/m2 BSA once a wk as a single administration. Beyond the 3rd administration, increase to 80 mg/m2 once a wk in a single administration. In combination: Adapted to treatment protocol. Max total dose: 120 mg/wk (60 mg/m2 dose) or 160 mg/wk (80 mg/m2 dose). Inj 25-30 mg/m2 wkly as single agent. In combination chemotherapy, the dose may be the same & the frequency of administration reduced ie day 1 & 8 or day 1 & 5 every 3 wk. |
Administration |
Should be taken with food (Take after a meal or snack. Swallow whole, do not chew/suck.). |
Contraindications |
Severe hepatic insufficiency. Pregnancy, lactation. Softcap GI disorder significantly affecting absorption, history of extensive surgical resection of the stomach or small intestine, neutrophil count <1,500/mm3 or current/recent severe infection (w/in last 2 wk), in combination w/ yellow fever vaccine. Inj Neutrophil count <1,000/mm3. |
Special Precautions |
Monitor for myelosuppression during & after therapy. Patients whose bone marrow reserve is compromised. Do not give concomitantly w/ radiotherapy if treatment field includes the liver. Severe hepatic injury or impairment, renal impairment, heart disease. Fructose intolerance (softcap). Childn. |
Adverse Drug Reactions |
Neutropenia, constipation, mild to moderate neuropathy, nausea & vomiting, alopecia, fatigue; heart disorders or breathing difficulties, pain esp in the joints (jaw), muscles, chest & at the tumour site. Softcap Thrombocytopenia, diarrhoea, mucitis, loss of appetite. Inj Pain at inj site, vein discoloration, erythema, transient elevation of liver enzymes.
View ADR Monitoring Form |
Drug Interactions |
Softcap Live attenuated vaccine, phenytoin, mitomycin C & itraconazole.
View more drug interactions with Navelbine |
Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
Presentation/Packing |
Form |
Packing |
Photo |
Navelbine soft capsule |
Navelbine 20 mg x 1's |
Navelbine 30 mg x 1's |
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Navelbine injection |
Navelbine 10 mg/1 mL x 1's |
Navelbine 50 mg/5 mL x 1's |
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Manufacturer: |
Pierre Fabre Medicament |
Distributor: |
Zuellig |
Marketer: |
Baxter Healthcare |
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