General In all instances where the use of ALKERAN is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse events. ALKERAN should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from previous cytotoxic therapy. If the leukocyte count falls below 3,000 cells/mcL, or the platelet count below 100,000 cells/mcL, ALKERAN should be discontinued until the peripheral blood cell counts have recovered. A recommendation as to whether or not dosage reduction should be made routinely in patients with renal insufficiency cannot be made because:
- There is considerable inherent patient-to-patient variability in the systemic availability of melphalan in patients with normal renal function.
- Only a small amount of the administered dose appears as parent drug in the urine of patients with normal renal function.
Patients with azotemia should be closely observed, however, in order to make dosage reductions, if required, at the earliest possible time. Administration of live vaccines to immunocompromised patients should be avoided. Laboratory Tests Periodic complete blood counts with differentials should be performed during the course of treatment with ALKERAN. At least one determination should be obtained prior to each treatment course. Patients should be observed closely for consequences of bone marrow suppression, which include severe infections, bleeding, and symptomatic anemia (see WARNINGS). Carcinogenesis, Mutagenesis, Impairment of Fertility See WARNINGS section. Pregnancy Teratogenic Effects Pregnancy Category D: See WARNINGS section. Nursing Mothers It is not known whether this drug is excreted in human milk. ALKERAN should not be given to nursing mothers. Pediatric Use The safety and effectiveness of ALKERAN in pediatric patients have not been established. Geriatric Use Clinical studies of ALKERAN Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Last reviewed on RxList: 6/8/2011
This monograph has been modified to include the generic and brand name in many instances.