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 given.

One medicine, two ways to treat polyarticular juvenile idiopathic arthritis (PJIA)

Intravenous (IV) infusion:

  • This medicine is a liquid solution placed into a vein with a needle 
  • It is given at a doctor’s office or an infusion center every 4 weeks 
  • A trained healthcare professional is there to help you and your child through treatment and watch for any reactions 

Subcutaneous (SC) injection:

Please review the full Instructions for Use to learn more about the right way to prepare and inject ACTEMRA before using the ACTEMRA prefilled syringe. The first injection should be done under the supervision of a qualified healthcare professional.

  • This medicine comes in a prefilled syringe for injection under the skin 
  • If your doctor decides that you or another caregiver can give injections at home, you or the caregiver should receive training on the right way to prepare and inject ACTEMRA. Do not try to inject ACTEMRA until you have been shown the right way to give the injections by your doctor
  • PJIA patients may self-inject with ACTEMRA if both the doctor and parent/legal guardian find it appropriate.

 Click here to see the most important things you should know about ACTEMRA.

What to know about ACTEMRA IV infusions

Where to receive infusions: IV infusions are given to your child once every 4 weeks at a doctor’s office or at an infusion center.

How dosing is managed: Your child’s doctor may change your child’s dose depending on their response to treatment, or a change in body weight.

How your child will receive the infusion: Your child will sit in a comfortable chair or lie down on a cot or bed.

How long the infusion will take: Your child’s IV infusion will last about 1 hour.

How infusions are given: ACTEMRA IV is given by needle directly into your child’s vein.

Look out for side effects: Irritation or other injection site reactions from the infusion may occur. A doctor or nurse will be there to monitor your child.

ACTEMRA IV Dosing

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

What to know about ACTEMRA SC injections

This is not a complete list of all the things to know before using the ACTEMRA prefilled syringe. Please refer to the full Instructions for Use for more information.

Learning how to inject: You’ll be trained by your child’s doctor or nurse–they’ll make sure you feel comfortable giving your child his or her medicine. PJIA patients will be trained on self-injection with ACTEMRA if both you and the doctor find it appropriate.

Where to inject: ACTEMRA is injected into areas such as the belly or upper thigh, directly under the skin, but no deeper.

What to expect: Total injection time is about 35 minutes; during that time, you will PREPAREINJECT, and DISPOSE of the syringe.

  • PREPARE: After removing from the refrigerator, the syringe needs to sit out at room temperature, out of the reach of children, for about 30 minutes 
  • INJECT: Remember, please read and follow the Instructions for Use before each injection 
  • DISPOSAL: Use a sharps container for safe disposal of ACTEMRA syringes and needles. To get a free sharps container, call 1-800-ACTEMRA

When to inject: Your child’s doctor will tell you if an injection should be given once every 2 weeks or once every 3 weeks. This is based on weight, but it may change depending on how your child responds to treatment.

Look out for side effects: Serious allergic reactions may occur. Please seek immediate medical attention if your child starts to experience any serious allergic reaction, including:

  • Shortness of breath or trouble breathing 
  • Swelling of lips, tongue, or face 
  • Chest pain 
  • Feeling dizzy or faint 
  • Moderate or severe stomach pain or vomiting

ACTEMRA SC Dosing

How often your child is given ACTEMRA is based on weight, so your child will be weighed at every office visit. If your child’s weight changes, you and your child’s doctor may decide if a change in dosing schedule is necessary.

 

Important Side Effect Information | Serious infections

Before starting ACTEMRA, tell your child’s healthcare provider if your child thinks he or she has an infection or has symptoms of an infection, with or without fever, such as sweating or chills, shortness of breath, warm, red or painful skin or sores on his or her body, feels very tired, muscle aches, blood in phlegm, diarrhea or stomach pain, cough, weight loss, burning when he or she urinates or urinating more often than normal; is being treated for an infection; gets a lot of infections or has infections that keep coming back; has diabetes, HIV, or a weak immune system; has TB or has been in close contact with someone with TB; lived in or currently lives in parts of the United States, such as the Ohio or Mississippi River Valleys and the Southwest, where there is an increased chance of getting certain kinds of fungal infections; or has or has had hepatitis B.

After starting ACTEMRA, call your child's healthcare provider right away if your child has any symptoms of an infection.

Patients should not take ACTEMRA if they are allergic to any of its ingredients.

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

Look out for side effects

Remember to keep an eye out for any side effects during and after your child’s infusion or injection. Allergic reactions may happen even if they have not happened before.

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.

Order your free sharps container

To order a free sharps container for safe disposal of ACTEMRA syringes and needles, call 1-800-ACTEMRA.

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.