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FDA Approves Expanded Indication for Actemra in RA

The expanded indication in rheumatoid arthritis further supports the safety and efficacy profile of Actemra.

On October 12, the FDA expanded the use of Actemra® (tocilizumab) so it can now be used to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).

Full Prescribing Information

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News in brief

• Earlier treatment with a biologic medicine may prevent irreversible joint damage in RA patients who experience rapid disease progression.
• Actemra, a biologic, can be used both alone as a single-agent therapy and in combination with methotrexate (MTX) or other DMARDs.

Read the press release

About Rheumatoid Arthritis

RA is a chronic inflammatory form of arthritis and an autoimmune disease. RA can affect many tissues and organs in the body, but it primarily attacks the joints, sometimes leading to permanent disability.

Learn more

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 (including low white blood cell count, low platelet count, increase in certain liver function tests, and increase in blood cholesterol levels), hepatitis B infection becoming an active infection again, and nervous system problems.

ACTEMRA affects the immune system and may increase a patient’s risk of certain cancers.

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 in patients with RA include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension).

Common side effects with ACTEMRA in patients with PJIA or SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.

Patients must tell their healthcare provider 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.

Report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. Patients and caregivers may also report side effects to Genentech at 1-888-835-2555.

Please visit www.actemra.com for the full Prescribing Information, includingBoxed Warningand Medication Guide, for additional Important Safety Information or call1-800-ACTEMRA (228-3672).