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 or ACTPen® autoinjector. Remember to download the How to Use Your Prefilled Syringe brochure or the How to Use Your ACTPen brochure for more information.

Before the injection

Make sure to check:

  • The expiration date on the ACTEMRA prefilled syringe or ACTPen autoinjector. 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 or ACTPen. 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 4-8 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. Refer to the How to Use Your Prefilled Syringe brochure or the How to Use Your ACTPen brochure 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 4-8 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 countsliver 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.

For blood tests, you will need to schedule an appointment with your child's doctor every 4 to 8 weeks after starting treatment. Your child's doctor should discuss the Medication Guide in the ACTEMRA Prescribing Information with you as well.

Learn how to inject

Read a step-by-step guide to get you comfortable with the process of injecting ACTEMRA.

How to Use Your Prefilled Syringe brochure

How to Use Your ACTPen brochure

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
  • Adults with giant cell arteritis (GCA)
  • Patients with active polyarticular juvenile idiopathic arthritis (PJIA) 2 years of age and older 
  • Patients with active systemic juvenile idiopathic arthritis (SJIA) 2 years of age and older

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 test you for TB before starting and during treatment with ACTEMRA.

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

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, 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) 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. Tell your healthcare provider before your next dose if you had hives, rash or flushing after your injection.

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

  • shortness of breath or trouble breathing 
  • swelling of the 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 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

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.

Tell your healthcare provider if you have any side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

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