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How Well Has ACTEMRA Been Proven to Work?

ACTEMRA, given as a subcutaneous (SC) injection, was studied in people with giant cell arteritis (GCA) in a yearlong clinical trial

149 people received ACTEMRA + 6-month steroid taper

*Some people received ACTEMRA every week. Other people received ACTEMRA every other week.

The goal of the trial was to find out if ACTEMRA could control GCA in people while getting them off of steroids.

56% of people achieved lasting remission at 1 year after being tapered off steroids
14% of people achieved lasting remission at 1 year after being tapered off steroids

Remission means a decrease or disappearance in signs and symptoms.

Most people who took ACTEMRA were completely steroid free after 6 months.

ACTEMRA could help you reduce your current steroid dose

People taking ACTEMRA + steroid taper took substantially fewer steroids over 1 year than people receiving a steroid taper alone.

  • The total dose that patients from the ACTEMRA groups received was approximately 2000 mg, whereas the total dose that patients who received steroids alone was approximately 3800 mg

ACTEMRA Intravenous (IV) Was Studied in People With GCA in a Separate 20-Week Clinical Trial

*This was an open-label study and all patients received ACTEMRA IV.

ACTEMRA may not work for everyone

When looking at clinical trial results, keep in mind that individual results may vary. Some people respond to ACTEMRA more quickly than others. Taking ACTEMRA in the way it is prescribed by your healthcare professional may help you get the most out of treatment.

The experience of ACTEMRA icon

The Experience of ACTEMRA

ACTEMRA has been studied in 2 clinical trials for GCA. However, ACTEMRA has also been studied in over 20 clinical trials for other conditions in the past 10+ years.

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Financial
Support

You may qualify for help paying for ACTEMRA. Learn more about your options.


Next Page: How Will You Take ACTEMRA?

  • A biologic is a type of medicine developed using processes that are similar to what happens in your body naturally. Biologics can be used to interact with certain parts of your body, like your immune system. They can also fight inflammation in certain diseases, like GCA.

  • An inflammation of the blood vessels. The cause is often unknown.

  • When a part of the body becomes swollen and painful.

  • A flare is a sudden worsening of your disease. It can happen after you haven’t experienced symptoms for a long time. It’s also known as a relapse.

  • A chemical messenger that tells the immune system to attack harmful bacteria and viruses. When your body produces too much IL-6, it causes the immune system to attack healthy cells.

  • A decrease or disappearance in signs and symptoms.

  • Under the skin.

  • A sample of cells taken from the body in order to examine them more closely. A healthcare professional will recommend a biopsy when a test suggests an area of tissue in the body isn’t normal.

  • A genetic predisposition means that a person may be more likely to develop a disease based on their genes. However, they may not see any symptoms unless something in the environment triggers the disease.

  • Steroids, including cortisone and prednisone, are a type of medicine used temporarily to reduce inflammation.

  • Biologics, a type of DMARD, are a class of arthritis treatments designed to target your immune system.

  • The immune system is a complex network of organs and cells that protects the body from foreign substances such as bacteria, fungi, and viruses.

Important Safety Information

INDICATIONS

What does ACTEMRA treat?

ACTEMRA is a prescription medicine called an interleukin-6 (IL-6) receptor antagonist.

ACTEMRA is 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 patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older 
  • To treat patients 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 serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting, during and after 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 States where there is an increased chance of getting fungal infections. These parts include the Ohio and Mississippi River valleys 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.

Who should not take 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 who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you see any of these side effects: fever, new onset 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
  • weakness
  • nausea and vomiting
  • confusion
  • dark “tea-colored” urine

Changes in Blood Test Results

Your healthcare provider should do blood tests before you start receiving ACTEMRA. If you have rheumatoid arthritis (RA) or giant cell arteritis (GCA), or systemic sclerosis-interstitial lung disease (SSc-ILD) your healthcare provider should do blood tests 4 to 8 weeks after you start receiving ACTEMRA for the first 6 months and then every 3 months after that. If you have polyarticular juvenile idiopathic arthritis (PJIA) you will have blood tests done every 4 to 8 weeks during treatment. If you have systemic juvenile idiopathic arthritis (SJIA) you will have blood tests done every 2 to 4 weeks during treatment. 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 to 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.

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. Tell your healthcare provider if you have any signs of these symptoms:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fevers
  • chills
  • 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. Stop taking ACTEMRA, contact your healthcare provider, and get emergency help right away if you have any of the following signs of a serious allergic reaction:

  • swelling of the face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rash, hives, redness, or swelling outside of the injection site area
  • dizziness or fainting
  • fast heartbeat or pounding in your chest (tachycardia)
  • sweating

Nervous System Problems

While rare, Multiple Sclerosis has been diagnosed in people who take ACTEMRA. It is not known what effect ACTEMRA may have on some nervous system disorders.

What should I tell my healthcare provider before receiving ACTEMRA?

ACTEMRA may not be right for you. Before receiving ACTEMRA, tell your healthcare provider if you:

  • have an infection 
  • have liver problems 
  • have any stomach-area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines 
  • have had a reaction to tocilizumab or any of the ingredients in ACTEMRA before 
  • have or had a condition that affects your nervous system, such as multiple sclerosis 
  • have recently received or are scheduled to receive a vaccine 
  • plan to have surgery or a medical procedure 
  • have any other medical conditions 
  • plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm your unborn baby. 
  • 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. 
  • are taking any medications, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of ACTEMRA include:

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

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of ACTEMRA.

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.

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.