Label Changes for:
Isentress (raltegravir potassium) 400 mg tablets
November 2009
Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009
ADVERSE REACTIONS
Postmarketing Experience
- Blood and Lymphatic System Disorders: thrombocytopenia
PATIENT PACKAGE INSERT
What are the possible side effects of Isentress?
- Other: low blood platelet count
