Generic Medicine Info
Indications and Dosage
Intra-arterial, Intravenous
Disseminated malignant melanoma
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.
Special Precautions
Not recommended for initiation within 4 weeks of receiving previous chemotherapy or 6 weeks of previous treatment with nitrosourea. Elderly. Renal and hepatic impairment.
Adverse Reactions
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.
Monitoring Parameters
Monitor CBC with differential (at baseline and before every treatment), LFT and renal function. Monitor infusion site.
Drug Interactions
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.
Mechanism of Action: 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.
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%).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 104799, Fotemustine. Accessed Feb. 22, 2021.

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.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AD05 - fotemustine ; Belongs to the class of alkylating agents, nitrosoureas. Used in the treatment of cancer.
Anon. Fotemustine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 19/01/2020.

Buckingham R (ed). Fotemustine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 19/01/2020.

Disclaimer: This information is independently developed by MIMS based on Fotemustine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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