Navelbine Capsule

Navelbine Capsule

vinorelbine

Manufacturer:

Transfarma Medica Indah

Marketer:

A Menarini
Concise Prescribing Info
Contents
Vinorelbine tartrate
Indications/Uses
In combination w/ platinum-based therapy for inoperable or stage IIIb or IV NSCLC. Monotherapy or in combination w/ capecitabine for metastatic or relapsed breast cancer after or refractory to an anthracycline containing regimen.
Dosage/Direction for Use
Monotherapy 60-80 mg/m2 once wkly. Combination therapy 80 mg/m2 was demostrated to correspond to 30 mg/m2 of IV form & 60-25 mg/m2. Max: (even for patient w/ ≥2 m2): 120 mg/wk at 60 mg/m2 & 160 mg/wk at 80 mg/m2. Moderate hepatic impairment 50 mg/m2/wk.
Administration
Should be taken with food: Swallow whole, do not chew/crush/suck.
Contraindications
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 current or recent (w/in 2 wk) severe infection, platelet count <100,000/m3; patients requiring long-term O2 therapy. In combination w/ yellow fever vaccine. Severe hepatic insufficiency. Pregnancy & lactation.
Special Precautions
History of ischaemic heart disease, poor performance status. Higher incidence of nausea/vomiting. Carefully monitor bowel mobility; close haematologic monitoring during treatment. Carry out investigation if patient presents signs or symptoms of infection. Not to be given concomitantly w/ radiotherapy if treatment field includes liver. Not recommended in concomitant use w/ other live attenuated vaccines; CYP3A4 inducers or inhibitors, combination w/ phenytoin, itraconazole. May cause damage if in contact w/ skin, mucosa & eyes due to liqd content. Not to be taken by patients w/ rare hereditary problems w/ fructose intolerance due to sorbitol content. Contains small amounts of ethanol (<100 mg/dose). May affect ability to drive & use machines. Men should not father a child during & up to 3 mth after treatment. Women of childbearing potential should use effective contraception during & up to 3 mth after treatment. Discontinue breast feeding prior to treatment. Not recommended in childn.
Adverse Reactions
Bone marrow depression w/ neutropenia, leucopenia, anemia & thrombocytopenia, GI toxicity w/ nausea, vomiting, diarrhoea, anorexia, stomatitis & constipation. Fatigue & fever.
Drug Interactions
Increased thrombotic risk in case of tumoral diseases w/ anticoagulants. Risk of fatal generalised vaccine disease w/ yellow fever vaccine, live attenuated vaccines. Decreased phenytoin digestive absorption. Excessive immunodepression w/ risk of lymphoproliferation by ciclosporine, tacrolimus. Increased neurotoxicity w/ itraconazole. Increased risk of bronchospasms & dyspnoea w/ mitomycin C. Exacerbated myelosuppressive adverse effects w/ other drugs w/ known bone marrow toxicity. Increased blood conc w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole. Decreased blood conc w/ strong CYP3A4 inducers eg, rifampicin, phenytoin.
MIMS Class
Cytotoxic Chemotherapy
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 Capsule soft cap 20 mg
Packing/Price
1's (Rp3,134,934/boks)
Form
Navelbine Capsule soft cap 30 mg
Packing/Price
1's (Rp4,702,495/boks)
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