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.