Generic drug of the therapeutic class: Oncology and Hematology
active ingredients: Amsacrine
laboratory: Prostrakan Pharma
Powder for IV infusion solution
Box of 5 bottles of 75 mg powder
Induction and maintenance treatment of acute lymphoblastic and myeloblastic leukemias.
AMSALYO is mainly indicated in case of relapse or failure to conventional treatments.
Dosage AMSALYO 75 mg Powder for solution for infusion IV Box of 5 vials of 75 mg powder
The dosage remains at the discretion of the practitioner, depending on the indication, age and condition of the patient and especially the information provided by the hematological and clinical monitoring of monotherapy or multidrug therapy.
Doses can be decreased depending on the association with one or more cytostatics or cytolytics.
The average doses are as follows:
- Induction treatment:
. Myeloblastic leukemias : the usual dose is 90 to 150 mg / m² per day for 5 consecutive days.
. lymphoblastic leukemia : 150 to 200 mg / m² per day, for 5 consecutive days.
- Maintenance treatment:
. Dose 150 to 250 mg / m², in a single infusion or spread over 3 consecutive days.
. To be repeated every 3 weeks.
Administration mode :
- After having introduced 50 ml of water for injection into the vial containing the lyophilisate, it is essential to shake the bottle moderately, without shaking, and let it rest about 15 minutes. If necessary, repeat until you obtain a clear solution and an intense orange color. For the stability of the reconstituted solution see section shelf life.
- The solution thus prepared should only be injected IV, in the form of an infusion. To prepare the infusion, remove 50 ml of the 500 ml isotonic glucose solution bag and replace with the reconstituted amsacrine solution.
- It is not necessary to use isotonic saline (risk of precipitation of amsacrine).
- The administration is exclusively in the form of intravenous infusion in 60 minutes minimum, to prevent any local irritation (risk of phlebitis).
- In the case of daily or continuous infusion over 24 hours, central catheterization is recommended to prevent the risk of venitis.
- In case of extravasation, the administration will be interrupted immediately.
- Modalities of manipulation:
. The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel, with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of materials suitable for handling, including long-sleeved gowns, face masks, hood, goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. of waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxic drugs. Any broken container must be treated with the same precautions and considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose .
. These provisions may be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of 24 March 1998) in collaboration with any suitable and qualified structure.
Those of any antimitotic therapy.
In particular, AMSALYO should not be administered to pregnant or lactating women and, unless the practitioner decides otherwise, should not be given to patients who have had bone marrow suppression.
Adverse effects Amsalyo
- Those of any antimitotic therapy, in particular:
. digestive disorders (nausea, vomiting, diarrhea),
. complications of myelosuppression (infection, hemorrhage),
. some cases of supraventricular fibrillation and tachycardia (these cases followed high doses of anthracyclines).
- AMSALYO generally causes a more or less prolonged deficit of the hematopoietic function of the bone marrow and consequently, changes in the blood count: thrombocytopenia, granulopenia.
- Given the main toxic effects that are myelosuppression and pancytopenia, it is important that the practitioner has the necessary means to treat these disturbances and their possible complications.
- Neurosensory manifestations, including epileptic seizures, have been reported, particularly when AMSALYO was associated with cytosine arabinoside.