Gemcitabine
Cytostatic · Antimetabolite
Indications
Palliative treatment in patients with locally advanced or metastatic non-small cell lung cancer.
Dosage
Adults & Elderly: Refer to individual protocols. Note: Prolongation of the infusion time >60 min has been shown to increase toxicity. Pancreatic Cancer: IV: 1000 mg/m2 over 30 min once wkly for 7 wk followed by 1 wk rest; then once wkly for 3 wks out of every 4 wk. Non-small cell lung cancer in combination with Cisplatin(unlabelled use): IV: 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.
Administration
Gemcitabine HCl is administered weekly by IV inf over 30 min. It may be administered as reconstituted or diluted further in additional NS to a conc as low as 0.1 mg/mL. Stability: Store unopened vials at 20°C-25°C (68°F-77°F). 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% NaCl or D5W are chemically stable for up to 35 days at room temperature or under refrigeration when stored in polyvinyl chloride bags. Because these solutions contain no preservative, they should be used within 24 hours of preparation.
Adverse Effects
Fatigue, fever, lethargy, somnolence, alopecia, rash, GI upset, stomatitis, myelo suppression, LFTs increases, proteinuria, hematuria, dyspnoea, pruritus, rash, sweating, blood dyscrasias, anorexia, headache, insomnia, cough, rhinitis, flu-like syndrome, hypospermatogenesis, posterior reversible encephalopathy syndrome, capillary leak syndrome.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Contraindicated or not recommended. Precautions: Renal and hepatic impairment. Monitor platelet, granulocyte and leucocyte counts closely. Impaired bone marrow function, hepatic or renal impairment, concomitant radiotherapy, history of cardiovascular events.
Interactions
Live vaccines.
Advice to Patient
This medication is administered by infusion. Contact prescriber if there is severe GI disturbance, unusual bruising or bleeding, increased fatigue, fever, chills, sore throat, swelling of extremities, unusual weight gain, difficulty in breathing, vaginal discharge, colour change of urine or stool, yellowing of skin or eyes, muscle pain, bone pain, weakness. Do not take alcohol during therapy. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Take small, frequent meals to maintain good nutritional status. Avoid highly crowded places to prevent infection. Do not get vaccinated without consulting prescriber. Using soft toothbrush, cotton swabs, regular mouth care may help to prevent mouth sores.
Pharmacokinetics
Metabolism: Metabolized intracellularly by nucleoside kinase to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleoside metabolites. Half-life elimination: Gemcitabine: Infusion time =70 minutes: 42 to 94 minutes; infusion time 3 to 4 hours: 4 to 10.5 hours (affected by age and gender). Metabolite (gemcitabine triphosphate), terminal phase: 1.7 to 19.4 hours. Time to peak, plasma: 30 minutes after completion of infusion. Excretion: Urine (92% to 98%; primarily as inactive uracil metabolite); feces (<1%).
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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