ACTEMRA is not FDA-approved for use in severe COVID-19 pneumonia and the safety and efficacy has not been established in these patients.

Interleukin 6 (IL-6) is a cytokine that plays an important role in immune responses. ACTEMRA is a monoclonal antibody against the interleukin-6 receptor (IL-6R), an immunosuppressive therapy.

Currently, there is no guidance from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), or from professional societies that endorse Actemra for COVID-19 pneumonia.

At present, there are no well-controlled studies and limited published evidence exists on the safety or efficacy of ACTEMRA in the treatment of patients with COVID-19 pneumonia. Several independent clinical trials have begun globally to explore the efficacy and safety of ACTEMRA for the treatment of patients with COVID-19 pneumonia.

To better understand what role ACTEMRA may play in treating COVID-19 patients, Genentech, a member of the Roche group, has initiated a Phase 3, randomized, double-blinded, placebo-controlled study to assess the safety and efficacy of intravenous ACTEMRA compared with placebo in combination with Standard of Care in approximately 330 hospitalized adults patients with severe COVID-19 pneumonia.

It is too early to draw any conclusions on potential use of ACTEMRA for patients with COVID-19 pneumonia. However, Genentech continues to receive a surge of questions from healthcare providers across the globe. The website is intended to make available, in a transparent manner, the information we have on the use of ACTEMRA for COVID-19 pneumonia to enable physicians to make informed individual patient treatment decisions.

The following ACTEMRA updates and resources for COVID-19 are available.

Genentech Medical Resources

Roche-Sponsored Clinical Trial in COVID-19: COVACTA

Health Authority Information Regarding COVID-19

Contact Information

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Additional Information HERE

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Indication

ACTEMRA is indicated for the treatment of:

  • Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
  • Adult patients with giant cell arteritis (GCA)
  • Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) in patients
  • Patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)
  • Adults and pediatric patients 2 years of age and older with chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome.

Important Safety Information

Boxed Warning: Risk of Serious Infections

Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA. If a serious infection develops, interrupt ACTEMRA until the infection is controlled. Perform test for latent TB; if positive, start treatment for TB prior to starting ACTEMRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

 

The Prescribing Information is the primary source of information for the FDA approved indications and the known and potential risks, including boxed warning, of ACTEMRA for its approved uses.

 

The information included on this site is intended for use only for the duration of the COVID-19 pandemic.