Gemzen 200 mg/vial (IV Infusion)

Indications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Bladder Cancer
• Breast Cancer
• Ovarian Cancer

Dosage & Administration

• Recommended dose of Gemcitabine: 1000 mg/m2
• Given by 30-minute intravenous infusion
• Dose reduction based on toxicity experienced by the patient

Pharmacology

• Metabolized intracellularly by nucleoside kinases
• Active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides
• Cytotoxic action due to inhibition of DNA synthesis
• Inhibition of ribonucleotide reductase by dFdCDP
• dFdCTP competes with dCTP for incorporation into DNA
• Also incorporated into RNA
• Induces programmed cellular death process known as apoptosis

Interaction

• No confirmed interactions reported
• No specific drug interaction studies conducted

Contraindications

• Contraindicated in patients with known hypersensitivity to Gemcitabine

Side Effects

• Haematological Toxicity
• Hepatic Toxicity
• Gastrointestinal effects
• Genito-Urinary Toxicity
• Pulmonary Toxicity
• Allergic Toxicity
• Neurotoxicity
• Alopecia

Pregnancy & Lactation

• Pregnancy Category D
• Use during pregnancy
• Excretion in human breast milk unknown

Precautions & Warnings

• Caution in patients with risk of Schedule-dependent Toxicity
• Myelosuppression
• Pulmonary Toxicity and Respiratory Failure
• Hemolytic Uremic Syndrome
• Hepatic Toxicity
• Embryofetal Toxicity
• Radiation Therapy Toxicity and Impairment of Fertility

Use in Special Populations

• Elderly Patients
• Renal and Hepatic Impairment
• Children

Overdose Effects

• No known antidote for overdoses of Gemzen
• Myelosuppression, paresthesias and severe rash seen in overdose cases
• Monitor patient with appropriate blood counts
• Supportive therapy as necessary

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store the vial in original carton at 20°C to 25°C
• Away from light
• Do not refrigerate as crystallisation may occur
• Keep out of the reach of children

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