FDA Approves Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized Adults
– Actemra is the first FDA-approved monoclonal antibody to treat COVID-19 –
– Since the beginning of the pandemic, more than one million people hospitalized with COVID-19 have been treated with Actemra worldwide –
– Actemra is approved for this use in more than 30 countries for the treatment of COVID-19 –
“With new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19,” said
Four randomized, controlled studies evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. Altogether, the results of these four studies (the
The FDA approval follows the FDA’s Emergency Use Authorization (EUA) for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in
More than one million people hospitalized with COVID-19 have been treated with Actemra worldwide since the beginning of the pandemic. Around the world, Actemra is approved for use in more than 30 countries for patients hospitalized with severe COVID-19. In the
About Actemra in COVID-19
Actemra is approved for use in multiple territories including
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA)
Actemra is intended for use under the guidance of a healthcare practitioner.
IMPORTANT SAFETY INFORMATION ABOUT ACTEMRA FOR COVID-19
ACTEMRA can cause serious side effects
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).
Before starting ACTEMRA, tell your healthcare provider if you have:
- an infection, think you may have an infection, are being treated for an infection, or get a lot of infections that return. Symptoms of an infection, with or without a fever, include sweating or chills; shortness of breath; warm, red or painful skin or sores on your body; feeling very tired; muscle aches; blood in phlegm; diarrhea or stomach pain; cough; weight loss; burning when you urinate or urinating more than normal
- any of the following conditions that may give you a higher chance of getting infections: diabetes, HIV, or a weak immune system
- tuberculosis (TB), or have been in close contact with someone with TB
- live or have lived, or have traveled to certain parts of
the United Stateswhere there is an increased chance of getting fungal infections. These parts include the Ohioand Mississippi Rivervalleys and the Southwest
- hepatitis B or have had hepatitis B
If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA.
Do not take ACTEMRA if you are allergic to tocilizumab, or any of the ingredients in ACTEMRA.
Be sure to talk to your healthcare provider if you see any signs of these serious side effects:
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). This happens most often in people
Tell your healthcare provider right away if you see any of these side effects: fever, stomach-area pain that does not go away, or if you see a change in your bowel habits.
Liver problems (Hepatotoxicity)
Some people have experienced serious life-threatening liver problems, which required 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. Tell your healthcare provider right away if you have any of the following symptoms:
- feeling tired (fatigue)
- lack of appetite for several days or longer (anorexia)
- yellowing of your skin or the whites of your eyes (jaundice)
- abdominal swelling and pain on the right side of the stomach-area
- light colored stools
- nausea and vomiting
- dark “tea-colored” urine
Changes in Blood Test Results
Your healthcare provider should do blood tests before you start receiving ACTEMRA. These blood tests are to check for the following side effects of ACTEMRA:
- Low neutrophil count: neutrophils are white blood cells that help the body fight infection
- Low platelet count: platelets are blood cells that help with clotting, which stops bleeding
- Increase in liver function test levels
- Increase in blood cholesterol levels: your cholesterol levels should be checked 4-8 weeks after you start receiving ACTEMRA.
Your healthcare provider will determine how often you will have follow-up blood tests. Make sure you get all your follow-up blood tests done as ordered by your healthcare provider.
You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. Changes in blood test results may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose.
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. Tell your healthcare provider if you have any signs of these symptoms:
- feel very tired
- skin or eyes look yellow
- little or no appetite
- clay-colored bowel movements
- stomach discomfort
- muscle aches
- dark urine
- skin rash
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. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.
Contact 911 immediately, as well as your healthcare provider if you experience any of these reactions:
- shortness of breath or trouble breathing
- swelling of the lips, tongue, or face
- chest pain
- feeling dizzy or faint
- moderate or severe abdominal pain or vomiting
Nervous System Problems
While rare, Multiple Sclerosis has been diagnosed in people
The most common side effects of ACTEMRA include:
- upper respiratory tract infections (common cold, sinus infections)
- 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. You and your healthcare provider should decide if you will take ACTEMRA or breast-feed. You should not do both. If you are pregnant and taking ACTEMRA, join the pregnancy registry. The purpose of this registry is to check the health of the pregnant mother and her baby. 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
About Genentech’s response to the COVID-19 pandemic
As a leading healthcare company, we are doing all we can to support countries in their fight against COVID-19 and minimizing its impact. That is why we are working with governments, policy makers, healthcare professionals and others to help contain the COVID-19 pandemic and make sure patients continue to receive the tests, treatment and care they need.
The pandemic has profoundly raised awareness of the role diagnostics play in COVID-19 diagnosis, treatment development and disease management.
Our utmost goal remains to be a trusted partner
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the
Founded more than 40 years ago,