Composition
Inj100 mg/200 mg/500 mg/1 gm/2 gm: Gemcitabine (as HCI) 100 mg/200 mg/500 mg/1 gm/2 gm; powder in vial.
Indications & Dosage
First-line treatment for locally advanced or metastatic non-small cell lung cancer as monotherapy in elderly patients and in palliative treatment or in combination with cisplatin: BY IV INF: Adults & Elderly:1000 mg/m2 over 30 min on days 1,8 &15; repeat every 28 day or 1250 mg/m2 over 30 min on days 1,8; repeat every 21 day. Treatment of locally advanced or metastatic pancreatic cancer, advanced or metastatic bladder cancer (in combination with cisplatin), locally advanced or metastatic epithelial ovarian cancer which has relapsed (in combination with carboplatin), metastatic breast cancer which has relapsed after previous chemotherapy (in combination with paclitaxel): BY IV INF: Adults:1000 mg/m2 over 30 min wkly for 3 or 7 wk followed by 1 wk rest; repeat cycles 3 out of every 4 wk.
Administration
Gemcitabine HCI is administered weekly by IV inf over 30 min, It may be administered as reconstituted or diluted further in additional NS to a concentration as low as 0.1 mg/ ml.
Stability
Store unopened vials at 20C-25C (681F-7rF) Reconstituted gemcitabine solutions are chemically stable for up to 35 days at room temperature. However, reconstituted solutions are preservative-free and should be discarded after 24 hours. Do not refrigerate reconstituted product because crystals may form in the bag or bottle. Discard unused portion. Gemcitabine 0.1 and 10 mg/ml solutions diluted with 0.9% NaCI or D5W are chemically stable for up to 35 days at room temperature or under refrigeration when stored in polyvir1 chloride bags. Because these solutions contain no preservative, they should be used within 24 hours of preparation.
Precautions
Renal and hepatic impairment. Prolongation of the infusion time >60 min has been shown to increase TOXICITY
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Alopecia, bone-marrow suppression, extravasation, hyperuricaemia, influenza-like symptoms, microangiopathic haemolytic anaemia, musculoskeletal pain, nausea, oralmucositis, pulmonary toxicity, rash, renal impairment, thromboembolism, tumourlysis syndrome, vomiting Rare: Haemolytic uraemic syndrome