Glossary

How ACTEMRA Is Given 

How your child will receive ACTEMRA

If you and your child’s doctor are deciding on treating with ACTEMRA or your child is just starting ACTEMRA, it’s important to know how ACTEMRA is taken. Some medications are given orally as a pill or liquid, but others are given by an injection or as an intravenous (IV) infusion. ACTEMRA is a biologic that is administered as an IV infusion for SJIA.

ACTEMRA is given once every 2 weeks by an IV infusion.

 

The facts about infusions: 

If you are not familiar with infusions, here are a few things to keep in mind: 

  • An infusion is a way to deliver medicine into the body
  • During an infusion, a needle distributes liquid medicine directly into a vein
  • Infusions are used to treat a variety of conditions
  • Infusions usually take place in a doctor's office or an infusion center 
  • A trained healthcare professional is there to help you and your child manage the infusion and watch for any reactions. Click here to see the most important things you should know about ACTEMRA  

Dosing

Children’s ACTEMRA doses are based on weight. So before every infusion appointment, they will be weighed. If your child’s weight changes, you and your child’s doctor may decide if a change of dose is necessary. 

 

Important Side Effect Information | Changes in certain laboratory test results

Your child’s healthcare provider should do blood tests before your child starts receiving ACTEMRA and every 2 to 4 weeks during treatment to check for changes in his or her blood test results (including low neutrophil count, low platelet count, and increase in certain liver function tests). Your child should not receive ACTEMRA if your child's neutrophil or platelet counts are too low or liver function test levels are too high. Your child’s healthcare provider may stop your child’s ACTEMRA treatment for a period of time if needed because of changes in these blood test results. Your child may also have changes in blood cholesterol levels. Your child’s healthcare provider should do blood tests to check your child’s cholesterol levels 4 to 8 weeks after your child starts receiving ACTEMRA and then every 6 months after that.

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

Look out for side effects at every infusion

Remember to keep an eye out for any side effects during or after your child’s infusion. These reactions could include shortness of breath or trouble breathing; swelling of the lips, tongue, or face; chest pain; feeling dizzy or faint; or moderate or severe abdominal pain or vomiting. Seek medical attention right away and contact a doctor if your child experiences any treatment reactions.

 

A space just for kids

Check out the Creative Corner for infusion center games and activities, and get recipes for easy-to-make after school treats.

 

SAFETY FIRST

Before reading more, please see the Important Side Effect Information for ACTEMRA

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important Side Effect Information

After reading about ACTEMRA, please talk to your healthcare provider if you have any questions.

ACTEMRA is:

  • Available by medical prescription only
  • For adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief
  • For adults with giant cell arteritis (GCA)
  • For people with active PJIA ages 2 and above
  • For people with active SJIA ages 2 and above

ACTEMRA is not approved for subcutaneous use in people with SJIA.

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 died from these infections.

Before taking 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. Infection signs, with or without a fever, include:
    • Sweating or chills
    • Shortness of breath
    • Warm, red or painful skin or sores on your body
    • Feel very tired
    • Muscle aches
    • Blood in phlegm
    • Diarrhea or stomach pain
    • Cough
    • Weight loss
    • Burning when you urinate or urinating more often than normal
  • Any of the following conditions that may give you a higher chance of getting infections. These include: diabetes, HIV, or a weak immune system
  • Tuberculosis (TB) or have been in close contact with someone who has TB. Your healthcare provider should test you for TB before starting ACTEMRA and during treatment with ACTEMRA
  • Lived in or currently live in parts of the United States known for fungal infections. These parts include the Ohio and Mississippi River Valleys and the Southwest
  • Hepatitis B or have had hepatitis B

Be sure to contact your healthcare provider or nurse if you see any signs of these side effects.

Stomach tears

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
  • Stomach-area pain that does not go away
  • Change in your bowel habits

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) your healthcare provider should do blood tests 4 to 8 weeks after you start receiving ACTEMRA 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

You should not receive ACTEMRA if your neutrophil and platelet counts are too low or your liver function test levels are too high. These may cause your healthcare provider to stop your ACTEMRA treatment for a time or change your dose. Your cholesterol levels should be checked 4 to 8 weeks after the start of your treatment, and then every 6 months after that.

Increased risk of cancer

ACTEMRA may increase your risk of certain cancers by changing the way your immune system works.

Hepatitis B infection

If you have hepatitis B, a virus that affects the liver, or are a carrier of the virus, ACTEMRA can cause the virus to become active. Your healthcare provider should test you for hepatitis B before starting treatment. Tell your healthcare provider right away if you see any signs of these symptoms:

  • Feeling very tired
  • Vomiting
  • Chills
  • Dark urine
  • Skin or eyes look yellow
  • Clay-colored bowel movements
  • Stomach discomfort
  • Skin rash
  • Little or no appetite
  • Fevers
  • Muscle aches

Serious allergic reactions

Serious allergic reactions, including death, can happen with ACTEMRA infusions or injections, even if they did not occur with an earlier infusion or injection. If you had hives, a rash, or experienced flushing after injecting, you should tell your healthcare provider or nurse before your next injection.

Contact 911 immediately, as well as your healthcare provider or nurse, if you experience any of these reactions:

  • Shortness of breath or trouble breathing
  • Swelling of 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 some people taking ACTEMRA.

Most common side effects

Tell your healthcare provider if you have these or any other side effect that bothers you or does not go away:

Upper respiratory tract infections (like common cold and sinus infections)

Headache

Increased blood pressure (also called 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.

Reporting side effects

Tell your healthcare provider right away if you are experiencing any side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch. You may also call Genentech at 1-888-835-2555.

Please see full Prescribing Information and the Medication Guide, including Serious Side Effects, for more Important Safety Information.