Our Commitment to Providing Ongoing ACTEMRA Information During the COVID-19 Pandemic
Genentech takes the health and safety of patients very seriously. This website is intended to provide information on ACTEMRA during the COVID-19 outbreak to enable physicians to make patient treatment decisions.
ACTEMRA is not FDA-approved for use in severe COVID-19
ACTEMRA is a monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin-6 (IL-6) is a cytokine that plays an important role in immune responses.
Genentech, a member of the Roche group, initiated three Phase 3 and one Phase 2 clinical trials to evaluate ACTEMRA in COVID-19 associated pneumonia. Information on these trials may be found in the “COVID-19 Clinical Trials” section of this website or by accessing www.clinicaltrials.gov.
UPDATE: On July 28, Genentech announced that the Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter COVACTA study did not meet its primary endpoint of showing improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. The study also failed to meet key secondary endpoints, including reduced patient mortality.
This 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 ultimate decision to use ACTEMRA for COVID-19 pneumonia patients remains with the treating physician.
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COVID-19 Clinical Trials
Roche-Sponsored Clinical Trials in COVID-19
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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.
Apr 2020 - Shipping short-dated ACTEMRA (tocilizumab) 400 mg/20 mL vial for IV with dark blue cap