gemcitabine hydrochloride: clinical use

Prescribing considerations

• Prescribing should be supervised by a clinician experienced in anticancer chemotherapy.
• Assess marrow reserve, performance status, previous treatment, infection and cumulative toxicity from combination therapy.
• Use caution with renal or hepatic impairment, pre-existing liver disease, previous cardiovascular events or concurrent radiotherapy.
• Discuss pregnancy prevention and possible fertility preservation before treatment.

Contraindications and cautions

• Hypersensitivity to gemcitabine or an excipient.
• Breastfeeding.

Monitoring

• Full blood count, including granulocytes and platelets, before each administration.
• Periodic renal and hepatic function assessment; consider virological testing where clinically indicated.
• Monitor for infection, bleeding, pulmonary toxicity, severe skin reactions, haemolytic uraemic syndrome, capillary leak syndrome and posterior reversible encephalopathy syndrome.
• Observe the intravenous site and stop administration promptly if extravasation occurs.

Clinical pharmacology

Gemcitabine is activated intracellularly to diphosphate and triphosphate metabolites. It inhibits ribonucleotide reductase and is incorporated into DNA, producing masked chain termination and apoptosis. It is rapidly deaminated; its inactive principal metabolite is predominantly eliminated in urine.

Formulation and product differences

• The selected product is a liquid concentrate requiring aseptic dilution, not a ready-to-administer infusion.
• It is a clear, colourless to light straw-coloured, single-use vial presentation that is essentially sodium-free.
• Use the specified preservative-free sodium chloride diluent; inspect for particles or discolouration and handle as a cytotoxic preparation.

Solution for infusion

Route: Intravenous

Strengths: 10 mg/mL, 38 mg/mL, 200 mg, 1000 mg