Getanosan

Gemcitabine

NSCLC, pancreatic, bladder, breast, ovarian cancer.

Adult NSCLC Combination therapy: 1,250 mg/m² on days 1 & 8 of a 21-day cycle or 1,000 mg/m² on days 1, 8 & 15 of a 28-day cycle + cisplatin 75-100 mg/m² after gemcitabine on day 1 of a 21- or 28-day cycle. Monotherapy: 1,000 mg/m² once wkly for 3 wk followed by a 1-wk rest period. Pancreatic cancer 1,000 mg/m² once wkly for up to 7 wk followed by a wk of rest. Subsequent cycles given once wkly for 3 wk out of every 4 wk. Bladder cancer Combination therapy: 1,000 mg/m² on days 1, 8 & 15 of each 28-day cycle + cisplatin 70 mg/m² after gemcitabine on day 1 or day 2 of a 28-day cycle. Breast cancer Combination therapy: Paclitaxel 175 mg/m² on day 1 as a 3-hr IV infusion followed by gemcitabine 1,250 mg/m² on days 1 & 8 of each 21-day cycle. Ovarian cancer Monotherapy: 800-1,250 mg/m² on days 1, 8 & 15 of a 28-day cycle. Combination therapy: 1,000 mg/m² on days 1 & 8 of a 21-day cycle + carboplatin after gemcitabine on day 1 to achieve AUC of 4 mg/mL·min. Gemcitabine is administered as a 30-min IV infusion for all indications.

Hypersensitivity.

Bone marrow function suppression eg, leucopenia, thrombocytopenia & anaemia; monitor platelet, leucocyte & granulocyte count. Discontinue in case of signs of microangiopathic haemolytic anaemia. Renal &/or hepatic failure; hepatitis, alcoholism, liver cirrhosis. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn.

Leucopenia, thrombocytopenia; nausea, vomiting; mild proteinuria, haematuria, renal failure; anaphylaxis; bronchospasm, dyspnoea; hypotension; rash, pruritus; influenza-like symptoms, cough, rhinitis, malaise, sweating & insomnia, oedema/peripheral oedema. Alopecia, somnolence, diarrhoea, oral soreness & erythema, constipation.

Radiotherapy.

Cytotoxic Chemotherapy

L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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