Patients should be informed of the need for regular monitoring of white blood cell (lymphocyte) counts during therapy and that AMEVIVE® must be administered under the supervision of a physician. Patients should also be informed that AMEVIVE® reduces lymphocyte counts, which could increase their chances of developing an infection or a malignancy. Patients should be advised to inform their physician promptly if they develop any signs of an infection or malignancy while undergoing a course of treatment with AMEVIVE®.

Female patients should also be advised to notify their physicians if they become pregnant while taking AMEVIVE® (or within 8 weeks of discontinuing AMEVIVE®) and be advised of the existence of and encouraged to enroll in the Pregnancy Registry. Call 1-866-AMEVIVE (1-866-263-8483) to enroll into the Registry (see PRECAUTIONS, Pregnancy).

Patients should be advised that serious liver injury has been reported in patients receiving AMEVIVE® . Patients should be advised to report to their physician persistent nausea, anorexia, fatigue, vomiting, abdominal pain, jaundice, easy bruising, dark urine or pale stools.

CD4+ T lymphocyte counts should be monitored weekly during the 12-week dosing period and used to guide dosing. Patients should have normal CD4+ T lymphocyte counts prior to an initial or a subsequent course of treatment with AMEVIVE®. Dosing should be withheld if CD4+ T lymphocyte counts are below 250 cells/µL. AMEVIVE® should be discontinued if CD4+ T lymphocyte counts remain below 250 cells/µL for one month.

Please also refer to the WARNINGS and PRECAUTIONS sections.

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