ALKERAN
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Package(a):
TABLETS: 25 x 2 mg.
Dosage(a):
2-35 mg daily up to total of 150-200 mg. Children: Not more than 0.06 mg/kg body weight daily.
Prescribing Restrictions:
Package(b):
AMPOULES: 1.8 ml of acid alcohol solvent, 9 ml of diluent x 50 mg/10 ml.
Dosage(b):
I.V: 1 mg/kg body weight. Repeat in 8 weeks according to response.
Prescribing Restrictions:
Indications:
Tablets: For the palliative treatment of and for the palliation of non-epithelial carcinoma of the ovary, multiple myeloma.
Ampoules: For the palliative treatment of multiple myeloma and the palliation of non-rejectable epithelial cancer of the ovary.
Contra-Indications:
Neutrophil count of less than 1,500/ml, concurrent radio or chemotherapy, low platelet count. Hypersensitivity reaction to melphalan.
Special Precautions:
Alkeran is an active cytotoxic agent for use under the direction of physicians experienced in the administration of such agents. Careful attention should be paid to the monitoring of blood counts to avoid the possibility of excessive myelosuppression. Patients who have undergone recent radiotherapy or chemotherapy. Clearance may be reduced in patients with renal impairment, who may also have uraemic bone marrow suppression. Dosage reduction may therefore be necessary and these patients should be closely observed. Adequate contraceptive precautions should be practised when either partner is receiving Alkeran. Whenever possible during pregnancy, the potential hazard to the fetus must be balanced against the expected benefit to the mother. Mothers receiving Alkeran should not breast-feed.
Side Effects:
Bone marrow suppression, leading to leucopenia and thrombocytopenia. Nausea and vomiting in up to 30% of patients. Stomatitis occurs rarely. Urticaria, edema, skin rashes and anaphylactic shock have been reported uncommonly. Maculopapular rashes and pruritis. Reports of fatal pulmonary fibrosis and hemolytic anemia after treatment. See prescribing information for full details.
Drug Interactions:
Nalidixic acid together with high-dose I.V. melphalan has caused deaths in children due to hemorrhagic enterocolitis. Impaired renal function has been described in bone marrow transplant patients who were conditioned with high-dose I.V. melphalan and who subsequently received cyclosporin to prevent graft-versus-host disease.
