Relubin

Relubin

vinorelbine

Manufacturer:

Sanbe

Marketer:

Sanbe
Concise Prescribing Info
Contents
Vinorelbine
Indications/Uses
NSCLC; advanced breast cancer in combination w/ standard chemotherapy.
Dosage/Direction for Use
IV infusion Infuse 6-10 min after dilution in 20-50 mL NSS or 5% dextrose soln. Hematologic toxicity ≥1,500 cells/mm3 30 mg/m2, <1,500 cells/mm3 Do not administer. Repeat granulocyte count in 1 wk. >3 mg/dL total bilirubin 7.5 mg/m2, 2.1-3 mg/dL total bilirubin 15 mg/m2, ≤2 mg/dL total bilirubin 30 mg/m2. Monotherapy 25-30 mg/m2 once wkly. Combination therapy 25-30 mg/m2 at day 1 & day 5 every 3 wk or day 1 & day 8 every 3 wk according to treatment protocol.
Contraindications
Hypersensitivity to vinorelbine tartrate or other vinca alkaloids. Neutrophil count <1,500 cells/mm3. Current or recent severe infection (w/in 2 wk). Pregnancy & lactation.
Special Precautions
For IV use only. Granulocyte counts should be ≥1,500 cells/mm3. Discontinue use if extravasations occur. Close haematological monitoring should be undertaken. Delay treatment if neutrophil count is <1,500/mm3 &/or platelet count is <75,000/mm3. Not to be given concomitantly w/ radiotherapy if the treatment field includes the liver. Avoid contact w/ the eyes. History of ischemic cardiac disease. Investigation should be carried out if patient presents signs or symptoms suggestive of infection. Frequently monitor myelosuppression during & post-therapy. Promptly evaluate patients w/ alterations in baseline pulmonary symptoms or new onset of dyspnoea, cough, hypoxia. May cause severe constipation eg, paralytic ileus. Compromised bone marrow reserve prior to irradiation/chemotherapy or recovering from effects of previous chemotherapy. History or preexisting neuropathy. May affect ability to drive or operate machinery. Reduce dose in patients w/ severe hepatic impairment.
Adverse Reactions
Bone marrow depression resulting to neutropenia; anemia, thrombocytopenia; paresthesia & hyperesthesia; constipation, stomatitis, diarrhea; nausea, vomiting; transient elevations of liver function tests w/o clinical symptoms; alopecia; acute shortness of breath, dyspnoea, severe bronchospasm; chest pain; local reaction.
Drug Interactions
Acute pulmonary reactions w/ mitomycin. Higher incidence of granulocytopenia w/ cisplatin. Paclitaxel may produce signs of neuropathy. Radio-sensitizing effect w/ prior or concomitant radiation therapy. Drugs metabolised by cytochrome CYP3A4.
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
Relubin inj 10 mg/mL
Packing/Price
1 mL x 1's (Rp1,100,000/boks)
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