FDA Approves Expanded Indication for Actemra in RA

October 12th, 2012

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).

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.

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

ACTEMRA can cause serious side effects. ACTEMRA changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some patients have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some patients taking ACTEMRA have died from these infections.

ACTEMRA can cause other serious side effects. These include:

  • Stomach tears
  • Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels
  • An increased risk of certain cancers by changing the way a patient’s immune system works
  • Hepatitis b infection in people who carry the virus in their blood
  • Serious allergic reactions, including death. These may happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If a patient has had hives, a rash, or experienced flushing after injecting, the patient should tell their doctor or nurse before their next injection
  • Nervous system problems

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

Most common side effects in patients treated with ACTEMRA:

Patients must tell their doctor if they have these or any other side effect that bothers them or does not go away:

  • Upper respiratory tract infections (like common cold and sinus infections)
  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions (for subcutaneous use only)

ACTEMRA & pregnancy:

Patients must tell their doctor if they are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. The patient and their doctor should decide if the patient will take ACTEMRA or breast-feed. Patients should not do both. If a patient is pregnant and taking ACTEMRA, they must join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients must tell their doctor right away if they are experiencing any side effects.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Call Genentech at 1-888-835-2555.

Please see the full Prescribing Information, including BOXED WARNING and Medication Guide, for additional Important Safety Information.