Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: NordMedica A/S, Jaegersborg, Alle 164, DK-2820, Gentofte, Denmark
Amsidine is indicated for the induction and maintenance of remission in acute leukaemia of adults. It is effective in patients refractory to the anthracycline antibiotics used singly or in combination with other chemotherapeutic agents, and in patients who were formerly treated with maximum cumulative doses of these antibiotics.
Amsidine must be diluted in 500ml 5% Dextrose Injection BP and infused over 60 to 90 minutes. Phlebitis or pain at the injection site may occur at doses greater than 70 mg/m². (NOTE: DO NOT USE OTHER DILUENTS. AMSIDINE IS INCOMPATIBLE WITH SALINE). Care must be taken that no extravasation occurs which might produce severe irritation or necrosis. Caution in the handling and preparation of the solution should be exercised, and the use of polyethylene gloves is recommended. If the solution of Amsidine contacts the skin or mucosae, immediately wash thoroughly with soap and water.
The usual dosage of Amsidine in the induction phase is 90mg/m² every day for five consecutive days (total dose 450 mg/m² per course of treatment). If bone marrow biopsy performed on day six displays over 50% cellularity and the blasts count is over 30%, the treatment may be extended for an additional three days, bringing the total dose per course of treatment to 720 mg/m².
More than one course of treatment may be required to achieve induction. Depending on the effectiveness of the first course in producing myelosuppression, the subsequent courses are given at two-week (if not effective) to four-week (if effective) intervals. In cases where a hypocellular marrow has not been achieved after the first course of treatment, the daily dose of Amsidine may be escalated to 120 mg/m² per day for the subsequent courses, provided that this is not contra-indicated for reasons of non-myelosuppressive toxicity.
For patients with impaired liver function or impaired renal function, the dose of Amsidine should be decreased by 20-30% (to 60-75 mg/m² per day).
The maintenance dose is about one third the induction dose, given either as a single IV infusion or divided in three daily doses e.g. 150 mg/m² given once every 3-4 weeks or 50 mg/m² per day for three consecutive days, repeated every 3-4 weeks.
Each maintenance course should bring down the granulocyte count to 1,000-1,500/µl and Platelet count to 50,000-100,000/µl. The granulocyte and platelet counts should be allowed to recover between the courses to over 1,500/µl abd 100,000/µl respectively; otherwise the subsequent course should be delayed.
Elimination may be slower in this group. This should be considered when designing dose schedules for the elderly.
Not recommended.
No specific antidote is known in case of overdosage. Treatment should be symptomatic and supportive.
Hemorrhage and infection, resulting from bone marrow hypoplasia or aplasia, may require intensive supportive treatment with red cell, granulocyte or platelet transfusions and appropriate antibiotics.
Vigourous symptomatic treatment may be necessary for severe mucositis, vomiting or diarrhea.
Unopened: Amsacrine concentrate vial: 12 months.
Unopened: Solvent vial: 12 months.
Once opened and diluted with Amsidine solvent: Chemical and physical in-use stability of the reconstituted and diluted drug has been demonstrated for 8 hours when stored below 25°C and protected from sunlight. Unused solution should be discarded.
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately after first opening or following reconstitution. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not store above 25°C.
Store in the original pack in order to protect from light and moisture
Concentrate vial: 2ml clear Type I, Ph. Eur. neutral glass vial containing 1.5ml amsacrine solution.
Solvent vial: 20ml clear Type I, Ph. Eur. neutral glass vial contains 13.5ml of 0.0353M L-lactic acid.
Each carton contains 6 vials of concentrate and 6 vials of solvent.
Amsidine should be handled in accordance with local hospital guidelines for handling cytotoxic drugs. Any unused product or waste material should be disposed of in accordance with local requirements.
Preparation of the medicinal product: 1.5ml of the drug solution is withdrawn from the concentrate vial and added to the solvent vial. The diluted concentrate is further diluted with 500ml of 5% Dextrose Injection BP solution. The concentration when diluted with 500ml of 5% Dextrose solution is 0.146mg Amsacrine per ml.
Use immediately once diluted further with 500ml of 5% Dextrose Injection BP.
Appearance of the diluted solution: The diluted solution is clear deep orange red solution.
Dextrose 5% Injection BP must be used for dilution of Amsidine. Other diluents should not be used.
Caution in handling and preparation of the solution should be excercised, and the use of polyethylene gloves is recommended (see patient information leaflet). If the solution of Amsidine contacts the skin or mucosae, immediately wash thoroughly with soap and water.
Glass syringes must be used as Amsidine in solution reacts with plastic syringes.
Do not use the solution if the contents are discoloured in any way or contains particles in it.
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