Full Prescribing Information
Medication Guide
ACTEMRA REMS Dear Healthcare Provider Letter (June 2011)
ACTEMRA REMS Dear Pharmacist Letter (June 2011)

ACTEMRA is a prescription medication called an interleukin-6 (IL-6) receptor inhibitor. ACTEMRA is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well. Actemra is used to treat people with active systemic juvenile idiopathic arthritis (SJIA) ages 2 and above.

Important Safety Information

• Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.
• Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems.
• Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA, even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients.
• Common side effects with ACTEMRA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).
• Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.
• Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555.
• For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit www.actemra.com or call 1-800-ACTEMRA (228-3672).

For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit www.actemra.com or call 1-800-ACTEMRA (228-3672).