Navelbine Oral/IV

Navelbine Oral/IV

vinorelbine tartrate

Manufacturer:

Pierre Fabre Medicament

Distributor:

Orient Europharma
Concise Prescribing Info
Contents
Vinorelbine ditartrate
Indications/Uses
Non-small cell lung cancer. Metastatic breast cancer.
Dosage/Direction for Use
Oral Monotherapy: 60 mg/m2 BSA once a wk for the 1st 3 doses, may be increased to 80 mg/m2 once a wk after the 3rd dose. Combination: 60 mg/m2 days 1 & 8 cycle 1, 80 mg/m2 days 1 & 8 thereafter every 3 wk. IV Non-small cell lung cancer & advanced breast cancer Monotherapy: 25-30 mg/m2 once wkly. Combination: 25-30 mg/m2 days 1 & 8 every 3 wk.
Administration
Should be taken with food: Take at the end of a meal. Swallow whole, do not chew/suck.
Contraindications
Known hypersensitivity to vinorelbine or other vinca alkaloids. Neutrophil count <1,500/mm3 or severe infection current or recent (w/in 2 wk). Combination w/ yellow fever vaccine. Pregnancy & lactation. Oral: GI disorder, history of extensive surgical resection of stomach or small intestine, severe hepatic insufficiency, fructose intolerance.
Special Precautions
Monitor hematological parameters during treatment. Infection, ischemic cardiac disease. Delay treatment if neutrophil count is <1,500/mm3 &/or platelet count is <75,000/mm3. Oral: Renal insufficiency, radiotherapy.
Adverse Reactions
Neutropenia, anemia, thrombocytopenia, nausea & vomiting, constipation & paralytic ileus, stomatitis & diarrhea, alopecia, fatigue, fever, arthralgia including jaw pain, myalgia, pain at tumor site. Oral: Anorexia, esophagitis, ataxia, neuromotor disorders. Rarely, ischemic heart disease, cutaneous reactions. Transient hepatic enzyme elevation. IV: Loss of tendon reflexes, weakness of lower extremities, dyspnea & bronchospasm, erythema, burning pain, vein discoloration & local phlebitis, pain at different locations.
Drug Interactions
Oral anticoagulants. Oral: Contraindicated w/ yellow fever vaccine. Phenytoin, fosphenytoin, live attenuated vaccine, ciclosporin, tacrolimus, itraconazole, mitomycin. IV: CYP3A4 inducers or inhibitors.
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 Oral softcap 30 mg
Packing/Price
1's
Form
Navelbine IV inj 10 mg/mL
Packing/Price
1 mL x 10 × 1's
Form
Navelbine IV inj 50 mg/5 mL
Packing/Price
5 mL x 10 × 1's
Form
Navelbine Oral softcap 20 mg
Packing/Price
1's
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