Medicinal Products

ALKERAN 50 mg / 10 mL Lyophilisate and solution for parenteral use (IV) Box of 1 vial of lyophilisate + 10 ml solvent bottle

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Lyophilisate:, Melphalan
laboratory: Aspen Pharma Trading Ltd

Lyophilisate and solution for parenteral use (IV)
All forms

Indication

Therapeutic intensification used alone or in combination with other cytotoxic agents and / or extensive or total body irradiation in the treatment of:
- multiple myeloma,
- malignant lymphomas (Hodgkin's disease, non-Hodgkin's lymphoma),
- acute lymphoblastic and myeloblastic leukemias,
- neuroblastoma of the child,
- ovarian adenocarcinoma,
- mammary adenocarcinoma.

Dosage ALKERAN 50 mg / 10 mL Lyophilisate and solution for parenteral use (IV) Box of 1 bottle of lyophilisate + 10 ml solvent bottle

Dosage:
- Multiple myeloma, malignant lymphomas (Hodgkin's disease, non-Hodgkin lymphoma), acute lymphoblastic and myeloblastic leukemias, mammary adenocarcinoma, ovarian adenocarcinoma in therapeutic intensification:
The dosing regimen is as follows: a dose of 100 to 200 mg / m 2 body surface area (about 2.5 to 5.0 mg / kg body weight). The dose can be spread over two or three consecutive days. Autologous stem cell transplantation is essential from a dose of approximately 140 mg / m².
- Treatment of child neuroblastoma:
To consolidate a response obtained with conventional treatment, at a dose of between 100 and 240 mg / m 2 of body surface area (sometimes divided into 3 consecutive days) with medullary autograft, the infusion is used either alone or in combination with radiotherapy. and / or other cytostatic products.
- In the elderly subject :
There is no dosage recommendation for the use of ALKERAN.
- In patients with moderate or severe renal impairment :
The dosage should in all cases be reduced by half (see precautions for use).
Method of administration: ALKERAN should be administered only intravenously.
A risk of extravasation is possible with peripheral intravenous administration of ALKERAN.
The administration will be interrupted immediately, in case of extravasation.
It is recommended to inject the ALKERAN solution slowly, usually in a central venous route.
For the administration of high doses, direct injection by central route is recommended.
The ALKERAN solution can also be administered diluted in an infusion bag if direct administration is not possible.
The solution should be diluted with sodium chloride 0.9% (w / v) only and should be completed within 1 hour 30 minutes of reconstitution.
It is recommended to put the infusion at an ambient temperature of 25 ° C.
If there is a visible cloudiness or crystallization in the diluted solution, the preparation should be discarded.
The ALKERAN solution has reduced stability when diluted in an infusion solution and the rate of degradation increases rapidly with increasing temperature. How to handle:
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 equipment suitable for handling, including long-sleeved gowns, face masks, hood, safety goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. 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.

Against indications

CONTRAINDICATED:
- Hypersensitivity to melphalan or to any of the constituents.
- Pregnant or breastfeeding woman: as with all cytotoxic chemotherapy, adequate contraceptive precautions should be advised during treatment with ALKERAN. The use of ALKERAN should be avoided as much as possible during pregnancy, especially during the first trimester. The benefit of treatment should in each case be evaluated according to the potential risk to the fetus.
NOT RECOMMENDED :
- Breast-feeding: Breastfeeding is not recommended during treatment.
- Associations not recommended : ciclosporin, tacrolimus.

Alkeran side effects

- Hematological effects:
. The most common side effect is bone marrow hypoplasia with leukopenia and thrombocytopenia.
. Few cases of haemolytic anemia after treatment with ALKERAN have been reported.
- Gastrointestinal effects:
The most common effects are nausea, vomiting, diarrhea and stomatitis, the incidence of which increases in patients receiving high intravenous doses of ALKERAN.
Pretreatment with cyclophosphamide has been shown to reduce the severity of digestive disorders.
- Allergic reactions:
Rare cases of allergic reactions (urticaria, edema, rash and anaphylactic shock) have been reported in long-term treated patients. In 2 patients, these reactions were associated with the occurrence of a favorable cardiac arrest.
Maculopapular rashes and pruritus have been noted occasionally.
- Hepatic disorders ranging from liver test abnormalities to clinical manifestations including jaundice have been described.
- Isolated cases of interstitial pneumonitis and pulmonary fibrosis, the course of which may be fatal, have also been described.
- In patients with renal insufficiency at the beginning of treatment for myeloma, a transient deterioration of the renal functions could be observed (see posology and method of administration).
- Cases of reversible alopecia have been reported.
- A subjective and transient sensation of heat and / or tingling has been reported in about 2/3 of patients with severe hematologic disorders receiving high doses of centrally administered ALKERAN.
Possible modification of ovarian function in premenopausal women with possible induction of amenorrhea in a significant number of patients.

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