Adult: Induction of remission phase: 90 mg/m2 daily for 5 consecutive days; may extend for an additional 3 days according to clinical response. Courses may be repeated at 2- to 4-week intervals based on response and may be increased to 120 mg/m2 daily in subsequent courses if tolerated. Maintenance phase: 150 mg/m2 as a single dose or divided over 3 consecutive days. Maintenance doses are given every 3-4 weeks and adjusted as necessary according to response. All doses are given via IV infusion over 60-90 minutes. Dose reduction or dosing interruption may be required according to individual safety or tolerability (refer to detailed product guideline).
Renal Impairment
Dose reduction may be required.
Hepatic Impairment
Dose reduction may be required.
Reconstitution
IV infusion: Add the 1.5 mL concentrate solution to the inj bottle with 13.5 mL diluent provided to make a solution containing 75 mg/15 mL. Further dilute the solution in 500 mL of dextrose 5% inj.
Incompatibility
Incompatible with NaCl 0.9% inj and other chloride-containing solutions.
Contraindications
Cytostatics or radiotherapy-induced bone marrow suppression. Lactation.
Special Precautions
Patient with hypokalaemia. Avoid extravasation. Hepatic and renal impairment. Pregnancy.
Adverse Reactions
Significant: Severe bone marrow depression; hyperuricaemia (secondary to rapid lysis of neoplastic cells); cardiotoxicity or increased risk of ventricular fibrillation (especially in patients with hypokalaemia); allergic reactions (e.g. anaphylaxis, oedema); local necrosis with extravasation. Blood and lymphatic system disorders: Thrombocytopenia, pancytopenia, anaemia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain. General disorders and administration site conditions: Pyrexia, infusion site phlebitis, inj site irritation, skin inflammation. Hepatobiliary disorders: Hepatitis, jaundice, hepatic insufficiency. Investigations: Increased hepatic enzymes. Metabolism and nutrition disorders: Hypokalaemia. Nervous system disorders: Grand mal seizure, headache, hypoaesthesia, dizziness, peripheral neuropathy. Psychiatric disorders: Affect lability. Renal and urinary disorders: Haematuria. Respiratory, thoracic and mediastinal disorders: Dyspnoea. Skin and subcutaneous tissue disorders: Purpura, alopecia, urticaria, rash. Vascular disorders: Hypotension. Potentially Fatal: Infections, haemorrhage, stomatitis.
Patient Counseling Information
Women of childbearing potential must use proven birth control methods during therapy and for 3 months after stopping the treatment. Males with female partners of childbearing potential must use effective contraception during treatment and for 6 months after the last dose.
Monitoring Parameters
Correct hypokalaemia prior to initiation of therapy. Monitor serum potassium, renal function, LFTs (before and during treatment); CBC (regularly); and blood uric acid levels. Evaluate electrolyte levels before each day's treatment.
Overdosage
Symptoms: Haemorrhage, infection, severe mucositis, vomiting or diarrhoea.
Management: Symptomatic and supportive treatment. Red blood cell, granulocyte or platelet transfusions and appropriate antibiotics may be required in case of haemorrhage and infection resulting from bone marrow hypoplasia or aplasia.
Drug Interactions
May impair immune response to vaccines (e.g. influenza or pneumococcal vaccines). May potentiate adverse effects with other cytotoxic agents.
Action
Description: Overview: Amsacrine is an antineoplastic agent. Mechanism of Action: Amsacrine intercalates with DNA and inhibits nucleic acid synthesis. Its activity appears to be most pronounced against cells in the G2 and S phases of the cell cycle. Pharmacokinetics: Distribution: Plasma protein binding: Approx 98%. Metabolism: Metabolised in the liver. Excretion: Mainly via bile (as metabolites); urine (20%). Elimination half-life: 5-8 hours.
Chemical Structure
Amsacrine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2179, Amsacrine. https://pubchem.ncbi.nlm.nih.gov/compound/Amsacrine. Accessed Sept. 25, 2025.
Storage
Intact vial: Store below 25°C. Protect from light. Diluted solution for IV infusion: Store at room temperature for up to 8 hours. Protect from light. Follow applicable procedures for receiving, handling, administration, and disposal.
L01XX01 - amsacrine ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
References
Amsidine 75 mg/1.5 mL Concentrate and Solvent for Concentrate for Solution for Infusion (Eurocept International BV). MHRA. https://products.mhra.gov.uk. Accessed 11/09/2025.Brayfield A, Cadart C (eds). Amsacrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/09/2025.Joint Formulary Committee. Amsacrine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/09/2025.
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