Actemra

Pronunciation: TOE-si-LIZ-oo-mab
Generic Name: Tocilizumab
Brand Name: Actemra

Patients who use Actemra have an increased risk of developing serious and sometimes fatal infections, including tuberculosis (TB), fungal infection, and other types of infection. Most patients who developed these infections were also taking medicine that suppressed their immune system (eg, corticosteroids, methotrexate).

Patients should receive a TB skin test before using Actemra. Patients who test positive for TB should begin treatment for TB before starting Actemra. All patients should also be monitored for signs of TB while using Actemra even if their TB test is negative.

Contact your doctor immediately if you develop signs of TB or any other type of infection (eg, persistent cough; muscle weakness; unexplained weight loss; fever, chills, or persistent sore throat; shortness of breath; unusual tiredness; warm, red, or painful skin or sores; increased or painful urination; severe or persistent diarrhea; blood in the mucus).

Actemra is used for:

Treating moderate to severe rheumatoid arthritis (RA) in certain patients. It is also used to treat systemic juvenile idiopathic arthritis (SJIA) in children 2 years and older. It may be used alone or in combination with other medicine. It may also be used for other conditions as determined by your doctor.

Actemra is an interleukin-6 (IL-6) receptor blocker. It works by blocking a substance (IL-6) in the body that contributes to inflammation.

Do NOT use Actemra if:

• you are allergic to any ingredient in Actemra


• you have a severe infection (eg, sepsis) or any other active infection


• you have active liver problems


• you are using abatacept, anakinra, an anti-CD20 monoclonal antibody (eg, rituximab), or a tumor necrosis factor (TNF) blocker (eg, adalimumab)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Actemra:

Some medical conditions may interact with Actemra. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have low blood platelet or neutrophil levels; a history of hepatitis B infection or other liver problems; stomach or bowel problems (eg, diverticulitis, pain, bleeding, perforation, inflammation, ulcer); high cholesterol; high blood pressure; diabetes; kidney problems; cancer; or numbness, tingling, or other nervous system problems (eg, multiple sclerosis [MS], Guillain-Barré syndrome)


• if you have an infection, open cuts or sores on your body, flu-like symptoms or other signs of infection (eg, fever; chills; cough; warm, red, or painful skin), shingles, or are using medicine to treat an infection


• if you have a history of an infection that keeps coming back, TB infection, or a positive TB skin test


• if you have ever lived in or traveled to an area where TB is common, or if you have come into close contact with a person with active TB


• if you have ever lived or traveled to certain parts of the country (eg, Ohio or Mississippi river valleys, the Southwest) where certain types of fungal infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common. Check with your doctor if you are not sure if you have lived in an area where these infections are common


• if you have HIV, a weakened immune system, or you take medicine that may weaken your immune system (eg, cyclosporine)


• if you have recently received or are scheduled to receive a vaccine, or are using another medicine to treat RA


• if you will be having surgery or a medical procedure

Some MEDICINES MAY INTERACT with Actemra. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Abatacept, anakinra, an anti-CD20 monoclonal antibody (eg, rituximab), corticosteroids (eg, prednisone), methotrexate, or TNF blockers (eg, adalimumab) because the risk of serious infection may be increased


• Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of severe stomach problems may be increased


• Cyclosporine, HMG-CoA reductase inhibitors (eg, atorvastatin), oral contraceptives (birth control pills), theophylline, or warfarin because their effectiveness may be decreased by Actemra

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actemra may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Actemra:

Use Actemra as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Actemra comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actemra refilled.


• Actemra is usually given as an injection at your doctor's office, hospital, or clinic.


• Do not use Actemra if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Actemra, contact your doctor.

Ask your health care provider any questions you may have about how to use Actemra.

Important safety information:

• Actemra may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actemra with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Actemra may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Serious stomach or bowel problems have been reported with the use of Actemra. The risk may be increased if you have a certain bowel problem (diverticulitis). Tell your doctor if you develop persistent stomach pain, blood in your stool or vomit, fever, or a change in your bowel habits.


• Actemra may increase the risk of developing cancer. Discuss any questions or concerns with your doctor.


• Tell your doctor or dentist that you take Actemra before you receive any medical or dental care, emergency care, or surgery.


• Actemra may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Before you use Actemra, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.


• Do not receive a live vaccine (eg, measles, mumps) while you are taking Actemra. Talk with your doctor before you receive any vaccine.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Actemra. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Actemra may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Actemra.


• Lab tests, including TB, liver function, cholesterol and lipid levels, and complete blood cell counts, may be performed while you use Actemra. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Actemra with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.


• Actemra should be used with extreme caution in CHILDREN younger than 2 years when used for SJIA and in children younger than 18 years when used for other conditions; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Actemra while you are pregnant. It is not known if Actemra is found in breast milk. Do not breast-feed while using Actemra.

Possible side effects of Actemra:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody, dark, or tarry stools; burning, numbness, or tingling; chest pain; fainting; muscle weakness or aches; numbness, tingling, or pain in the hands or feet; persistent pain, swelling, or redness at the injection site; severe or persistent headache or dizziness; severe or persistent stomach pain; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; persistent cough; flu-like symptoms; warm, red, or painful skin or sores; increased or painful urination; severe or persistent diarrhea; unexplained weight loss; blood in the mucus); unusual bruising or bleeding; unusual skin growth or other skin changes; unusual tiredness or weakness; vision changes; vomit that contains blood or looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Actemra side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Actemra:

Actemra is usually handled and stored by a health care provider. If you are using Actemra at home, store Actemra as directed by your pharmacist or health care provider. Keep Actemra out of the reach of children and away from pets.

General information:

• If you have any questions about Actemra, please talk with your doctor, pharmacist, or other health care provider.


• Actemra is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Actemra. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Actemra resources

• Actemra Side Effects (in more detail)
• Actemra Use in Pregnancy & Breastfeeding
• Actemra Drug Interactions
• Actemra Support Group
• 0 Reviews for Actemra - Add your own review/rating

• Actemra Prescribing Information (FDA)


• Actemra Consumer Overview


• Actemra Monograph (AHFS DI)


• Actemra Advanced Consumer (Micromedex) - Includes Dosage Information


• Tocilizumab Professional Patient Advice (Wolters Kluwer)

Compare Actemra with other medications

• Juvenile Idiopathic Arthritis
• Rheumatoid Arthritis