Medications and Drugs

Brand Names: Actemra

Generic Name: tocilizumab (Pronunciation: TOE si LIZ oo mab)

What is tocilizumab (Actemra)?

Tocilizumab reduces the effects of a substance in the body that can cause inflammation.

Tocilizumab is used to treat moderate to severe rheumatoid arthritis in adults. It is sometimes given together with other arthritis medications.

Tocilizumab is also used to treat systemic juvenile idiopathic arthrits (or "Still disease") in children who are at least 2 years old. It is sometimes given together with methotrexate (Rheumatrex, Trexall).

Tocilizumab is usually given after other medications have been tried without successful treatment of symptoms.

Tocilizumab may also be used for purposes not listed in this medication guide.

What are the possible side effects of tocilizumab (Actemra)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with tocilizumab. Call your doctor right away if you have signs of infection such as:

fever, flu symptoms, mouth and throat ulcers, weight loss, feeling very tired;
sores in your mouth and throat or on your skin;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
purple or red pinpoint spots under your skin;
cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
pain or burning when you urinate.

Call your doctor at once if you have any of these other serious side effects:

severe stomach pain with constipation;
bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
painful blistering skin rash with burning, itching, or tingly feeling; or
upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

runny or stuffy nose, sinus pain, sore throat;
headache, dizziness;
itching; or
mild stomach cramps.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tocilizumab (Actemra)?

Serious and sometimes fatal infections may occur during treatment with tocilizumab. Contact your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

Before you start treatment with tocilizumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Tell your doctor if you have an active or recent infection, liver disease or hepatitis B, diabetes, diverticulitis, stomach ulcer or bleeding, high cholesterol, multiple sclerosis, HIV/AIDS, a weak immune system, or a history of cancer.

Tocilizumab can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections.

Do not receive a "live" vaccine while you are being treated with tocilizumab.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

What should I discuss with my healthcare provider before I receive tocilizumab (Actemra)?»

(Page 1 of 3)

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.