|FDA Approved For:
|ALKERAN Tablets are indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary.
|The safety and effectiveness of ALKERAN in pediatric patients have not been established.
|Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma have been reported in patients with cancer treated with alkylating agents (including melphalan). Some patients also received other chemotherapeutic agents or radiation therapy. Precise quantitation of the risk of acute leukemia, myeloproliferative syndrome or carcinoma is not possible. Published reports of leukemia in patients who have received melphalan (and other alkylating agents) suggest that the risk of leukemogenesis increases with chronicity of treatment and with cumulative dose.
|ALKERAN has been shown to cause chromatid or chromosome damage in humans. Intramuscular administration of ALKERAN at 6 and 60 mg/m2 produced structural aberrations of the chromatid and chromosomes in bone marrow cells of Wistar rats.
|Manufacturer and/or Distributor:
Hematologic The most common side effect is bone marrow suppression. Although bone marrow suppression frequently occurs, it is usually reversible if melphalan is withdrawn early enough. However, irreversible bone marrow failure has been reported. Gastrointestinal Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently. Hepatic toxicity has been reported rarely. Miscellaneous Other reported adverse reactions include: pulmonary fibrosis and interstitial pneumonitis, skin hypersensitivity, vasculitis, alopecia, and hemolytic anemia. Allergic reactions, including rare anaphylaxis, have occurred after multiple courses of treatment. )More Information