Hetero Labs


Concise Prescribing Info
Locally advanced or metastatic adenocarcinoma of the pancreas. Combination w/ cisplatin: Locally advanced or metastatic bladder cancer & non-small cell lung cancer. Combination w/ carboplatin: Epithelial ovarian carcinoma. Combination w/ paclitaxel: Unresectable, locally recurrent or metastatic breast cancer.
Dosage/Direction for Use
Combination therapy for bladder cancer 1,000 mg/m2 by 30-min infusion given on days 1, 8 & 15 of each 28 day cycle. Cisplatin: 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28 day-cycle. Repeated for 4-wk cycle. Pancreatic cancer 1,000 mg/m2 by 30-min IV infusion once wkly for up to 7 wk followed by a week of rest. Monotherapy for non-small cell cancer 1,000 mg/m2 by 30-min IV infusion, repeated once wkly for 3 wk followed by 1-wk rest period. Repeated for 4-wk cycle. Combination therapy for non-small cell lung cancer 1,250 mg/m2 by 30-min IV infusion on days 1 & 8 (21-day cycle) + Cisplatin: 75-100 mg/m2 once every 3 wk. Combination therapy for breast cancer Paclitaxel: 175 mg/m2 on day 1 approx 3-hr IV infusion followed by gemcitabine 1,250 mg/m2 30-min IV infusion on days 1 & 8 of each 21-day cycle. Combination therapy for ovarian cancer 1,000 mg/m2 on days 1 & 8 of each 21-day cycle as 30-min IV infusion + Carboplatin on day 1 consistent w/ a target AUC of 4 mg/mL·min.
Special Precautions
Haematologic toxicity. Hepatic insufficiency. Concomitant radiotherapy. Yellow fever vaccine or other live attenuated vaccines. Risk of cardiac &/or vascular disorders. Pulmonary effects. Discontinue if renal failure occurs. Controlled Na diet. May impair ability to drive or operate machinery. Pregnancy.
Adverse Reactions
Nausea w/ or w/o vomiting, raised liver transaminases (AST/ALT) & alkaline phosphatase; proteinuria & haematuria; dyspnoea; allergic skin rashes.
Drug Interactions
Radiation injury in association w/ both concurrent & non-concurrent use. Risk of systemic, possibly fatal, disease w/ Yellow fever & other live attenuated vaccines particularly in immunosuppressed patients.
ATC Classification
L01BC05 - gemcitabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Gemtero powd for soln for IV inj 1 g
10 × 1's
Gemtero powd for soln for IV inj 200 mg
12 × 1's
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