Generic Name: tocilizumab (TOE-si-LIZ-ue-mab)
Brand Name: Actemra
Patients who use tocilizumab 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 tocilizumab. Patients who test positive for TB should begin treatment for TB before starting tocilizumab. All patients should also be monitored for signs of TB while using tocilizumab 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).
Tocilizumab is used for:
Treating moderate to severe rheumatoid arthritis (RA) in certain patients. It is also used to treat juvenile idiopathic arthritis in children 2 years old 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.
Tocilizumab 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 tocilizumab if:
- you are allergic to any ingredient in tocilizumab
- you have a severe infection (eg, sepsis) or any other active infection
- you have liver problems
- you are using abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, golimumab, infliximab, rilonacept, rituximab, or tofacitinib
Contact your doctor or health care provider right away if any of these apply to you.
Before using tocilizumab:
Some medical conditions may interact with tocilizumab. 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 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-BarrÃ© 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 low blood platelet or neutrophil levels, HIV, or 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 tocilizumab. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abatacept, adalimumab, anakinra, canakinumab, certolizumab, corticosteroids (eg, prednisone), etanercept, golimumab, infliximab, methotrexate, rilonacept, rituximab, or tofacitinib 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 or bowel 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 tocilizumab
This may not be a complete list of all interactions that may occur. Ask your health care provider if tocilizumab 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 tocilizumab:
Use tocilizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tocilizumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get tocilizumab refilled.
- Tocilizumab is usually given as an injection at your doctor's office, hospital, or clinic.
- Do not use tocilizumab 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 away from 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 tocilizumab, contact your doctor.
Ask your health care provider any questions you may have about how to use tocilizumab.
Important safety information:
- Tocilizumab may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use tocilizumab 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.
- Tocilizumab 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 tocilizumab. The risk may be increased if you have a certain bowel problem (diverticulitis) or stomach or bowel ulcers. Tell your doctor if you develop persistent stomach pain, blood in your stool or vomit, fever, or a change in your bowel habits.
- Tocilizumab may increase the risk of developing cancer by changing the way your immune system works. Discuss any questions or concerns with your doctor.
- Tell your doctor or dentist that you take tocilizumab before you receive any medical or dental care, emergency care, or surgery.
- Serious and sometimes fatal allergic reactions have occurred in patients while receiving tocilizumab. These reactions may occur with any infusion of tocilizumab, even if it did not occur with a previous dose. Symptoms may include shortness of breath or trouble breathing; skin rash; swelling of the lips, tongue, or face; chest pain; dizziness; or fainting. Tell your doctor right away if you experience any of these symptoms or other unusual effects during or after an infusion.
- Tocilizumab 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 tocilizumab, 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 tocilizumab. 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 tocilizumab. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Tocilizumab may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using tocilizumab.
- Lab tests, including TB, liver function, cholesterol and lipid levels, and complete blood cell counts, may be performed while you use tocilizumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use tocilizumab with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.
- Tocilizumab should be used with extreme caution in CHILDREN younger than 2 years old when used for systemic juvenile idiopathic arthritis and in children younger than 18 years old 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 tocilizumab while you are pregnant. It is not known if tocilizumab is found in breast milk. Do not breast-feed while using tocilizumab.
Possible side effects of tocilizumab:
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:
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); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; nausea; loss of appetite); 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.
If OVERDOSE is suspected:
Tocilizumab is usually handled and stored by a health care provider. Keep tocilizumab out of the reach of children and away from pets.
- If you have any questions about tocilizumab, please talk with your doctor, pharmacist, or other health care provider.
- Tocilizumab 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 should not be used to decide whether or not to take tocilizumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about tocilizumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to tocilizumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using tocilizumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.