Severe Bone Marrow Suppression, Hypersensitivity, and Leukemogenicity
- Melphalan should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agent
- Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous (IV) to oral melphalan have shown more myelosuppression with the IV formulation.
- Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the IV formulation.
- Melphalan is leukemogenic in humans.
- Melphalan produces chromosomal aberrations in vitro and in vivo and, therefore, should be considered potentially mutagenic in humans.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Perform platelet count, hemoglobin, WBC and differential at baseline, during therapy and prior to each dose.
Patient Counseling Information
Updated January 2018