Gemcitabine

Introduction: Gemcitabine is used in the treatment of non-small cell lung cancer, breast cancer, pancreatic cancer, urinary bladder cancer, and ovarian cancer. It is given as an injection by a qualified medical professional.

How it works: Gemcitabine interferes with the growth of DNA and RNA of the cancer cells by substituting their building blocks. It prevents the cancer cells from growing and multiplying.

Important Information: Continue treatment as advised by your doctor. Regular blood tests are required (monitor blood cells, liver, heart and uric acid). Avoid during pregnancy and lactation.

• Non-Small Cell Lung Cancer - first-line treatment in combination with Cisplatin
• Pancreatic Cancer - locally advanced or metastatic adenocarcinoma
• Bladder Cancer - advanced bladder cancer (with Cisplatin)
• Breast Cancer - metastatic breast cancer with Paclitaxel
• Ovarian Cancer - recurrent epithelial ovarian carcinoma with Carboplatin

Cytotoxic Chemotherapy

Pyrimidine Analog

Gemcitabine (dFdC) is metabolised intracellularly by nucleoside kinases to the active diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. The cytotoxic action of Gemcitabine appears to be due to inhibition of DNA synthesis by two actions of dFdCDP and dFdCTP. dFdCDP inhibits ribonucleotide reductase which is responsible for catalysing the reactions that generate the deoxynucleoside triphosphates for DNA synthesis. dFdCTP competes with dCTP for incorporation into DNA. A small amount of Gemcitabine may also be incorporated into RNA.

Gemcitabine inhibits DNA synthesis and induces apoptosis (programmed cell death) to destroy cancer cells.

Dosage for Various Cancers (IV Infusion):

• Non-Small Cell Lung Cancer (with Cisplatin): 1250 mg/m² (Days 1 & 8, 21-day cycle) or 1000 mg/m² (Days 1,8 & 15, 28-day cycle)
• Pancreatic Cancer: 1000 mg/m² (weekly x 7 weeks, 1 week rest, then Days 1,8 & 15 of 28-day cycle)
• Breast Cancer (with Paclitaxel): 1250 mg/m² (Days 1 & 8, 21-day cycle)
• Ovarian Cancer (with Carboplatin): 1000 mg/m² (Days 1 & 8, 21-day cycle)

* Use as directed by the registered physician

Intravenous (IV) infusion (30 minutes). Your doctor or nurse will give you this medicine. Do not self-administer.

If you miss a dose, consult your doctor.

Common Side Effects:

• Nausea and vomiting
• Loss of appetite
• Hair loss
• Decreased blood platelets
• Anemia
• Leukopenia
• Fever, flu-like symptoms
• Dyspnea
• Skin rash
• Blood in urine

Precautions:

• Myelosuppression - regular blood tests required.
• Pulmonary Toxicity - caution if dyspnea occurs.
• Hepatic Toxicity - monitor liver enzymes.
• Hemolytic Uremic Syndrome - rare but serious.
• Caution with radiation therapy.

Contraindications:

• Hypersensitivity to Gemcitabine or any components
• Pregnancy and lactation

Drug Interactions:

• May increase the anticoagulant effect of warfarin.
• May increase myelosuppression with cisplatin.

Food Interactions:

• Alcohol may cause excessive drowsiness.

Use in Pregnancy: Unsafe during pregnancy. There is definite evidence of risk to the developing baby.

Use in Lactation: Unsafe during breastfeeding. Data suggests the drug may cause toxicity to the baby.

Pediatric Use: Safety and efficacy in children have not been established.

Geriatric Use: Well tolerated in patients over 65. No dose adjustment needed.

Renal Impairment: Use with caution in renal impairment. GFR 30-80 mL/min has no significant effect.

Hepatic Impairment: Use with caution in hepatic insufficiency.

Overdose: No specific antidote. Myelosuppression, paresthesias and severe rash may occur. Supportive therapy.

Storage: Store in original carton at 20-25°C, away from light. Do not refrigerate (crystallization may occur). Keep out of reach of children.

Gemcitabine Injection