Amsacrine parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of amsacrine
Drugs List
Therapeutic Indications
Uses
Leukaemia - acute
For the induction and maintenance of remission in acute leukaemia of adults.
Effective in patients refractory to anthracycline monotherapy or in combination, and in patients who were formerly treated with maximum cumulative doses of anthracyclines.
Dosage
Adults
Induction of remission phase:
The recommended dose is 90 mg/square metre body surface area every day for 5 consecutive days (total dose 450 mg/square metre). The course may be extended for an additional 3 days if a bone marrow biopsy performed on day 6 displays over 50% cellularity and the blast count is over 30%.
Subsequent courses are given at 2 to 4 week intervals depending on the effectiveness of first cycle at producing myelosuppression. If a hypocellular marrow has not been achieved after the first course, the daily dose may be increased to 120 mg/square metre, provided this is not contraindicated by non-myelosuppressive toxicity.
Maintenance Phase:
Maintenance dose is approximately one third of the total induction dose, (i.e. 150 mg/square metre) given either as a single intravenous infusion or divided (i.e. of 50 mg/square metre per day) over 3 consecutive days.
This should be repeated every 3 to 4 weeks.
Each maintenance course should bring the granulocyte count to 1,000 to 1,500 per microlitre and the platelet count to 50,000 to 100,000 per microlitre. If this is not achieved, the maintenance dose may be increased by 20% every second course. The granulocyte and platelet counts should be allowed to recover between the courses to over 1,500 per microlitre and 100,000 per microlitre respectively.
The leucopenia nadir usually occurs after 5 to 12 days, with recovery usually following by the 25th day.
Patients with Renal Impairment
Decrease the dose by 20 to 30% (to 60 to 75 mg/square metre) in patients with GFR below 50 ml/minute.
Patients with Hepatic Impairment
Decrease the dose by 20 to 30% (to 60 to 75 mg/square metre) in patients with hepatic impairment.
Administration
For intravenous infusion (after dilution)
Contraindications
Children under 12 years
Breastfeeding
Myelosuppression secondary to chemotherapy
Myelosuppression secondary to radiotherapy
Pregnancy
Precautions and Warnings
Elderly
Cardiac disorder
Hepatic impairment
Hypokalaemia
Renal impairment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Consider premedication with hypouricaemic agent
Treatment to be initiated and supervised by a specialist
Accidental contact of soln with skin/mucous membranes-rinse well with water
Consult local policy on the safe use of anti-cancer drugs
If extravasation occurs follow local policy & seek expert help immediately
Incompatible with plastic
Staff: Not to be handled by pregnant staff
Correct serum potassium levels before commencing treatment
Monitor serum electrolytes before and during treatment
Monitor cardiac function
Monitor hepatic function
Monitor patients for signs of tumour lysis syndrome
Monitor renal function
Monitor uric acid levels
Perform regular white blood cell and platelet counts
May cause tissue irritation
Suspend / reduce dose if excessive drop in WBC / bone marrow occurs
Suspend treatment if granulocyte count is less than 1500 per cubic mm
Suspend treatment if platelet count is less than 100,000 per cubic mm
May cause impaired fertility
Female: Contraception required during and for 3 months after treatment
Male: Contraception required during and for 6 months after treatment
Complete blood counts should be performed frequently as the drug may cause severe bone marrow depression. If an exceedingly large fall in white cell count and excessive depression of bone marrow occurs it may be necessary to suspend treatment or reduce dose. Appropriate transfusions should be available.
Pregnancy and Lactation
Pregnancy
Amsacrine is contraindicated during pregnancy.
The manufacturer discourages the use of amsacrine during pregnancy, especially during the first trimester. There are no data on the use of amsacrine in pregnant women, however, animal studies have indicated that amsacrine is teratogenic and has shown reproductive toxicity.
Lactation
Amsacrine is contraindicated during breastfeeding.
The manufacturer recommends that breastfeeding is contraindicated during amsacrine treatment. It is unclear whether amsacrine is excreted in the mother's milk.
Side Effects
Abdominal pain
Acute renal insufficiency
Alopecia
Anaemia
Anaphylactic reaction
Anuria
Arrhythmias
Atrial fibrillation
Blood urea increased
Bradycardia
Cardiomyopathy
Cardiotoxicity
Confusion
Congestive cardiac failure
Decreased ejection fraction
Diarrhoea
Dizziness
Dyspnoea
ECG changes
Grand mal seizure
Granulocytopenia
Haematuria
Haemorrhage
Headache
Hepatic impairment
Hepatitis
Hypersensitivity reactions
Hyperuricaemia
Hypoesthesia
Hypokalaemia
Hypotension
Increase in alkaline phosphatase
Increases in hepatic enzymes
Infections
Irritation (injection site)
Jaundice
Lability of affect
Lethargy
Leukopenia
Nausea
Necrosis (injection site)
Oedema
Pancytopenia
Peripheral neuropathy
Phlebitis (injection site)
Proteinuria
Purpura
Pyrexia
Rash
Serum bilirubin increased
Serum creatinine increased
Sinus tachycardia
Skin inflammation
Stomatitis
Thrombocytopenia
Urticaria
Ventricular arrhythmias
Ventricular fibrillation
Visual disturbances
Vomiting
Weight gain
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2022
Reference Sources
Summary of Product Characteristics: Amsidine 75mg/1.5ml concentrate and solvent for solution for infusion. Eurocept International BV. Revised March 2020.
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