Clinical Trial Results

THE TENDER STUDY

In a clinical trial called the TENDER study, ACTEMRA IV was tested over a 5-year period in a number of children living with systemic JIA (SJIA). This study showed that for many children:

ACTEMRA works fast

Nearly 9 out of 10 children saw at least a 30% improvement in the signs and symptoms of their SJIA, also called a JIA ACR30 response, and saw no signs of fever at 12 weeks of treatment.* "No signs of fever" was defined as no temperature at or above 99.5º F (37.5º C) in the preceding 7 days.

*After 12 weeks, 85% of patients taking ACTEMRA showed an ACR30 response with an absence of fever compared to just 24% of patients receiving placebo alone.

ACTEMRA may lessen the need for steroids

Nearly 25% of children taking ACTEMRA IV and steroids were able to REDUCE their steroid dose at 12 weeks of treatment, compared to just 3% in patients treated with a placebo. After 44 weeks of treatment, 4 in 10 patients were able to completely stop taking steroids.

ACTEMRA helps control fever

Out of the children who had fevers at the start of the study, 85% taking ACTEMRA showed no sign of fever at 12 weeks, compared to just 21% taking placebo alone.

In the study, controlled fever was defined as no temperature at or above 99.5º F (37.5º C) in the preceding 14 days

Some children in the study also saw noticeable reductions in:

Rash
Number of joints affected
Number of joints with limited movement

Important Side Effect Information | Changes in Blood Test Results

Your healthcare provider should do blood tests before you start receiving ACTEMRA. 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.

Please see Important Safety and Side Effect Information. For additional Important Safety Information, please see full Prescribing Information, including BOXED WARNING and Medication Guide.

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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.

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.