Medicinal Products

ALKERAN 2 mg

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

Coated tablet
Box of 1 bottle of 50
All forms

Indication

- Multiple myeloma.
- Ovarian adenocarcinoma, in advanced stages.
- Carcinoma of the breast, in the advanced stages or in addition to a surgical treatment.

Dosage ALKERAN 2 mg Film-coated tablet Box of 1 vial of 50

The dosage depends on the therapeutic protocol applied to the patient and takes into account the indication and any associated therapies. The daily dosage should be divided into several doses.
There is no evidence that continuous treatment is more or less effective than discontinuous treatment. - Multiple myeloma: In combination with 40 mg per day of prednisone: 0.15 to 0.25 mg / kg / day for 4 to 7 days in divided doses. The treatment is repeated every 4 to 6 weeks.
Extending treatment beyond one year in the responder does not improve the results. - Ovarian adenocarcinoma: Cures of 0.2 mg / kg / day for 5 days, renewed every 4 and 8 weeks, depending on the blood count. - Advanced stage of breast carcinoma: 0.15 mg / kg of body weight per day or 6 mg / m² of body surface area for 4 to 6 days to be renewed every 6 weeks. The dosage will be decreased if myelotoxicity develops.
- In patients with renal insufficiency :
The clearance of ALKERAN, although variable, is decreased in renal failure. The available pharmacokinetic data do not warrant a dose reduction in these patients. Nevertheless, as a precaution, a decrease in the initial dosage may be considered until tolerance to treatment is established.

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.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
- Due to the presence of sucrose, this drug is contraindicated in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
NOT RECOMMENDED :
- Breastfeeding is not recommended during treatment.
- Associations not recommended : ciclosporin, tacrolimus.

Alkeran side effects

- Hematological effects:
. The incidence of acute leukemias is increased in long-term subjects with alkylating agents such as ALKERAN.
. 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:
Digestive disorders such as nausea, vomiting, more rarely diarrhea and stomatitis.
- Allergic reactions:
. Rare cases of allergic reactions (urticaria, edema, rash and anaphylactic shock) have been reported in long-term treated patients.
. In two 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, but rarely at usual dosages.
- Possible modification of ovarian function in premenopausal women with possible induction of amenorrhea.

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