Adult: Including patients with cerebral metastases: Induction: 100 mg/m2 once weekly for 3 weeks as monotherapy or 100 mg/m2 once weekly for 2 weeks in combination with other anticancer agents. Maintenance: 100 mg/m2 once weekly every 3 weeks, given 4-5 weeks after last induction dose. Doses are given via IV infusion over 1 hour or via intra-arterial infusion over 4 hours. Dosage may be reduced or withheld according to haematological status (refer to detailed product guideline).
Reconstitute with 4 mL of supplied diluent to a final concentration of 200 mg/4 mL. Further dilute with 250-400 mL of 5% dextrose in water.
Women of child-bearing potential, children and adolescents. Pregnancy and lactation. Concomitant use with yellow fever vaccine.
Not recommended for initiation within 4 weeks of receiving previous chemotherapy or 6 weeks of previous treatment with nitrosourea. Elderly. Renal and hepatic impairment.
Significant: Extravasation, bone marrow suppression (e.g. thrombocytopenia, leucopenia, anaemia), haematologic toxicity, gastrointestinal toxicity (e.g. nausea, vomiting); increased transaminases, bilirubin, and alkaline phosphatase. Blood and lymphatic system disorders: Pancytopenia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain. General disorders and administration site conditions: Fever, injection site reactions (e.g. phlebitis, swelling pain, redness of the vein).
Patient Counseling Information
This medicine may cause impaired physical or mental abilities, if affected, do not drive or operate machinery.
Monitor CBC with differential (at baseline and before every treatment), LFT and renal function. Monitor infusion site.
May decrease the serum concentration of phenytoin. Increased risk of excessive immunosuppression and lymphoproliferation with immunosuppressants. Increased risk of pulmonary toxicity with dacarbazine. Potentially Fatal: Increased risk of vaccine-related disease with yellow fever vaccine.
Description: Fotemustine is a nitrosourea derivative and alkylating agent. It has a potent cytostatic activity on cells in cycle, thereby causing an accumulation of cells in G2M phase. Pharmacokinetics: Distribution: Crosses the blood brain barrier. Plasma protein binding: 25-30% to acid alpha-1 glycoprotein and albumin. Excretion: Via urine (approx 50-60%); faeces (5%); CO2 (<0.2%).
Store between 2-8°C. Reconstituted solutions must be protected from light. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.