Cytopenias

• Serious, including fatal pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia and autoimmune hemolytic anemia can occur with this drug.
• Single doses > 30 mg or cumulative doses > 90 mg/week increased the incidence of pancytopenia.

Infusion Reactions

• Administration of this drug can result in serious,including fatal, infusion reactions.
• Carefully monitor patients during infusions and withhold the drug for Grade 3 or 4 infusion reactions.
• Gradually escalate the drug to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days. (See Dosage and Administration, and Warnings and Precautions)

Infections

• Serious, including fatal bacterial, viral, fungal, and protozoan infections have been reported with this drug.
• Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTION

FDA and Industry Communications

FDA Safety Information Alemtuzumab

Patient Counseling Information

• Campath

Package Inserts

Alemtuzumab