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

What does ACTEMRA treat?

ACTEMRA is a prescription medicine used:

• To treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well
• To treat adults with giant cell arteritis (GCA)
• To treat people with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older
• To treat people with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older
• To treat people with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older
• For slowing the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
• To treat hospitalized adults with coronavirus disease 2019 (COVID-19) receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation.
• ACTEMRA is not approved for subcutaneous use in people with COVID-19.

It is not known if ACTEMRA is safe and effective in children with PJIA or SJIA under 2 years of age or in children with conditions other than PJIA or SJIA.

ACTEMRA can cause serious side effects

Serious Infections

ACTEMRA changes the way your immune system works. This can make you more likely to get infections or make any current infection worse. Some people have died from these infections. Your healthcare provider should assess you for TB before starting and during treatment with ACTEMRA (except if you have COVID-19).

Do not take ACTEMRA if you are allergic to tocilizumab, or any of the ingredients in ACTEMRA.

ACTEMRA can cause other serious side effects. These include:

Tears (perforation) of the Stomach or Intestines

If you have diverticulitis (inflammation in parts of the large intestine), talk to your healthcare provider before taking ACTEMRA. Some people taking ACTEMRA may develop a hole in the wall of their stomach or intestines (also known as a perforation).

Liver problems (Hepatotoxicity)

Some people have experienced serious life-threatening liver problems, which required a liver transplant or led to death. Your healthcare provider may tell you to stop taking ACTEMRA if you develop new or worsening liver problems during treatment with ACTEMRA.

Changes in Blood Test Results

Your healthcare provider should do blood tests before and after you start receiving ACTEMRA. You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. These may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose.

Cancer

ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B Infection

If you have or are a carrier of the hepatitis B virus (a virus that affects the liver), the virus may become active while you use ACTEMRA. Your healthcare provider may do blood tests before you start treatment with ACTEMRA and while you are using ACTEMRA.

Serious Allergic Reactions

Serious allergic reactions, including death, can happen with ACTEMRA. These reactions can happen with any infusion or injection of ACTEMRA, even if they did not occur with an earlier infusion or injection.

Nervous System Problems

While rare, Multiple Sclerosis has been diagnosed in people who take ACTEMRA.

The most common side effects of ACTEMRA include:

• upper respiratory tract infections (common cold, sinus infections)
• headache
• increased blood pressure (hypertension)
• injection site reactions

ACTEMRA & Pregnancy

Tell your healthcare provider if you are planning to become pregnant, are pregnant, plan to breast-feed, or are breast-feeding. If you are pregnant and taking ACTEMRA, join the pregnancy registry. To learn more, call 1-877-311-8972 or talk to your healthcare provider to register.

Tell your healthcare provider if you have any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.