Glossary

Preparing Your Child for Treatment 

There are 2 ways to take ACTEMRA: subcutaneous administration and intravenous infusion. If you are giving your child the subcutaneous administration, your child’s doctor or nurse will train you to properly inject ACTEMRA. Also, your child's doctor or nurse will train your child to self-inject ACTEMRA, if both you and the doctor find it appropriate. Please follow the directions below.

SC Administration

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.

Before the injection

Make sure to check:

  • The expiration date on the ACTEMRA prefilled syringe. Do not use it if the expiration date has passed because it may not be safe to use.
  • The liquid in the ACTEMRA prefilled syringe. It should be clear and colorless to pale yellow. Do not inject ACTEMRA if the liquid is cloudy, discolored, or has lumps or particles in it because it may not be safe to use.

Blood test. At the start of your child's ACTEMRA treatment, his or her doctor will do blood tests every 2-4 weeks.

Reviewing safety. Before your child starts on ACTEMRA, make sure you review the ACTEMRA Medication Guide. Take note of the following sections:

  • "What is the most important information I should know about ACTEMRA?"
  • "Before you receive ACTEMRA, tell your healthcare provider about all of your medical conditions"

Choose an injection site. The front of your child’s thigh and abdomen–except for the 2-inch area around his or her navel–as well as the outer areas of the upper arms, are the recommended injection sites. Choose a different injection site for each new injection at least 1 inch from the last area injected. Be sure to see the Instructions for Use (Figure D) for more guidance.

Prepare injection site:

  • To reduce the chance of your child getting an infection, wipe the injection site with an alcohol pad in a circular motion
  • Let injection site air-dry
  • Do not touch the injection site again before giving the injection

Provide distraction. Distract your child with a favorite game or song to help reduce pain and keep your child calm.

During and after the injection

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

Please refer to the Instructions for Use for more information.

IV Administration

Before the infusion appointment

Make infusions less stressful for your child. Because ACTEMRA is given over the course of an hour, here are some tips to make the infusion appointment more comfortable for you and your child.

  • Have your child wear comfortable clothing
  • Arrive early to fill out any paperwork
    • This will keep your appointment running smoothly
  • Bring entertainment for your child
    • Music, a book, or games will make the time fly by
  • Bring up any questions you have with your child’s doctor and nurses
    • They’ll be on hand to monitor your child, so use the visit to get answers

At the infusion appointment

Blood test. At the start of your child’s ACTEMRA treatment, his or her doctor will do blood tests every 2-4 weeks.

Reviewing safety. Before your child starts on ACTEMRA, make sure you review the ACTEMRA Medication Guide. Take note of the following sections:

  • "What is the most important information I should know about ACTEMRA?"
  • "Before you receive ACTEMRA, tell your healthcare provider about all of your medical conditions"

Monitoring. While receiving treatment, a doctor or nurse will monitor your child. ACTEMRA may lead to serious allergic reactions, including death. These events may happen at any infusion, even if they have not happened before. Let your doctor or nurse know if your child is experiencing:

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

However, a doctor or nurse should always be on hand during your child’s infusion to respond to any reactions and answer any questions you may have.

After the infusion appointment

Monitoring. Pay attention to how your child is feeling during and after every infusion. Let the doctor or nurse know right away if your child is having any reactions such as shortness of breath.

Scheduling. Remember to schedule your child’s next ACTEMRA infusion appointment and lab tests.

Lab tests

Both ways of taking ACTEMRA can affect your child's laboratory test results. This may include your child's neutrophil and platelet counts, liver enzymes, and cholesterol levels. A trained doctor will perform blood tests to review these levels. After your child starts ACTEMRA, he or she will need to visit the doctor regularly for these tests. After your child's first few months on ACTEMRA, however, the monitoring may become less frequent.

 

You will need to schedule an appointment with your child's doctor every 2 to 4 weeks after starting treatment to have blood tests done. You should also schedule an appointment 4 to 8 weeks after starting treatment to check their cholesterol levels, and then every 6 months after that. Your child's doctor should discuss the Medication Guide in the ACTEMRA Prescribing Information with you as well.

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

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.