Navelbine

Navelbine

vinorelbine tartrate

Manufacturer:

Pierre Fabre Medicament

Distributor:

Zuellig Pharma

Marketer:

Baxter Healthcare
Concise Prescribing Info
Contents
Vinorelbine tartrate
Indications/Uses
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/Direction for Use
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 Reactions
Neutropenia, constipation, mild to moderate neuropathy, nausea & vomiting, alopecia, fatigue; heart disorders or breathing difficulties, pain especially 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.
Drug Interactions
Softcap: Live attenuated vaccine, phenytoin, mitomycin C & itraconazole.
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.
Presentation/Packing
Form
Navelbine inj 10 mg/mL
Packing/Price
1's
Form
Navelbine inj 50 mg/5 mL
Packing/Price
1's
Form
Navelbine softcap 20 mg
Packing/Price
1's
Form
Navelbine softcap 30 mg
Packing/Price
1's
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