ETOPOSIDE INJECTION 100 mg/5 ml

4.1 Therapeutic indications

• Small cell carcinoma of the lung.
• Acute monocytic and myelomonocytic leukaemia.
• Hodgkin’s disease.
• Non-Hodgkin’s lymphoma.

4.3 Contraindications

• Severe hepatic dysfunction.
• Hypersensitivity to any of the injection ingredients.
• Severe bone marrow failure (WBC less than 2.0 x 109/L or platelet count less than 75.0 x 109/L) not due to malignant disease.
• Acute infections.
• Pregnancy.
• Lactation.

4.2 Dose and method of administration

Dosage

The usual dose of etoposide must be based on the clinical and haematological response and tolerance of the patient. A repeat course of etoposide should not be administered until the patient’s haematological function is within acceptable limits (see section 4.4 Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adult

The dosage for Etoposide Injection is 50–60 mg/m2/day intravenously for 5 consecutive days followed by a treatment free interval of 2–3 weeks. Total dose should not usually exceed 400 mg/m2 per course. In any case, repeat courses should not be given until the haematological parameters have been checked for evidence of myelosuppression and found to be satisfactory.

Method of administration

Plastic devices made of acrylic or ABS (a polymer of acrylonitrile, butadiene and styrene) have been reported to crack or leak when used with undiluted Etoposide injection.

Etoposide should only be given by slow intravenous infusion (see section 4.4 Special warnings and precautions for use, section 4.8 Adverse effects (undesirable effects) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Etoposide should not be administered by intrapleural or intraperitoneal injection.

Etoposide must be diluted before administration. Resultant concentrations should not be greater than 0.4 mg/mL since precipitation can occur. Usually etoposide is added to 250 mL of 0.9% sodium chloride or 5% glucose. The infusion should be administered over a period of 30–60 minutes.

Contact with buffered aqueous solutions with pH above 8 should be avoided. Concentrations of etoposide of 0.4 mg/mL in 5% glucose or 0.9% sodium chloride are chemically stable for 24 hours when stored at room temperature. However, to reduce microbiological hazard, admixtured solutions should be used as soon as practicable after preparation. If storage is required hold at 2–8°C for no more than 24 hours. Contains no antimicrobial preservative, use once only and discard any residue.

The use of a Pharmacy Bulk Pack should be restricted to suitably qualified pharmacists operating in suitably equipped hospital pharmacies or compounding centres. The Pharmacy Bulk Pack is intended for multiple dispensing into sterile solutions for subsequent infusion in individual patients in one treatment session. The Pharmacy Bulk Pack should be spiked only once.

Dosage Adjustment

Hepatic impairment

Etoposide is contraindicated in severe hepatic dysfunction, and it should be used with caution in patients with mild to moderate hepatic impairment.

Renal impairment

Since some etoposide (approximately 30%) is excreted unchanged in the urine, dosage adjustment may be needed in patients with impaired renal function.