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Generic Name: tocilizumab (TOE-si-LIZ-ue-mab)
Brand Name: Actemra
Patients who use Actemra Subcutaneous 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 Subcutaneous. Patients who test positive for TB should begin treatment for TB before starting Actemra Subcutaneous. All patients should also be monitored for signs of TB while using Actemra Subcutaneous 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 or stomach pain; blood in the mucus).
Actemra Subcutaneous is used for:
Treating moderate to severe rheumatoid arthritis (RA) in certain patients. 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 Subcutaneous 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 Subcutaneous if:
- you are allergic to any ingredient in Actemra Subcutaneous
- 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 Actemra Subcutaneous:
Some medical conditions may interact with Actemra Subcutaneous. 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-BarrÃƒÂ© 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 Actemra Subcutaneous. 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 Actemra Subcutaneous
This may not be a complete list of all interactions that may occur. Ask your health care provider if Actemra Subcutaneous 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 Subcutaneous:
Use Actemra Subcutaneous as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Actemra Subcutaneous comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actemra Subcutaneous refilled.
- Actemra Subcutaneous is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Actemra Subcutaneous at home, a health care provider will teach you how to use it. Be sure you understand how to use Actemra Subcutaneous. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
- Do not use Actemra Subcutaneous if it contains particles, is cloudy or discolored, or if the syringe 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 Actemra Subcutaneous, contact your doctor.
Ask your health care provider any questions you may have about how to use Actemra Subcutaneous.
Important safety information:
- Actemra Subcutaneous may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actemra Subcutaneous 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 Subcutaneous 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 Subcutaneous. 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.
- Actemra Subcutaneous 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 Actemra Subcutaneous before you receive any medical or dental care, emergency care, or surgery.
- Serious and sometimes fatal allergic reactions have occurred in patients while receiving Actemra Subcutaneous. These reactions may occur with any infusion of Actemra Subcutaneous, even if it did not occur with a previous dose. Symptoms may include shortness of breath or trouble breathing; skin rash; stomach pain; vomiting; 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.
- If you carry the hepatitis B virus, the virus may become active while you use Actemra Subcutaneous. Tell your doctor right away if you develop signs of liver problems, including dark urine, pale stools, severe stomach pain, nausea, vomiting, loss of appetite, unusual tiredness, or yellowing of the eyes or skin.
- Actemra Subcutaneous 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 Subcutaneous, 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 Subcutaneous. 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 Subcutaneous. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Actemra Subcutaneous may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using Actemra Subcutaneous.
- Lab tests, including TB, liver function, cholesterol and lipid levels, and complete blood cell counts, may be performed while you use Actemra Subcutaneous. 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 Subcutaneous with caution in the ELDERLY; they may be more sensitive to its side effects, especially an increased risk of infection.
- Actemra Subcutaneous should be used with extreme caution in CHILDREN younger than 18 years old; 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 Subcutaneous while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while using Actemra Subcutaneous.
Possible side effects of Actemra Subcutaneous:
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); 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Actemra Subcutaneous:
Actemra Subcutaneous is usually handled and stored by a health care provider. If you are using Actemra Subcutaneous at home, store Actemra Subcutaneous as directed by your pharmacist or health care provider. Keep Actemra Subcutaneous out of the reach of children and away from pets.
- If you have any questions about Actemra Subcutaneous, please talk with your doctor, pharmacist, or other health care provider.
- Actemra Subcutaneous 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 Actemra Subcutaneous 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 Actemra Subcutaneous. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Actemra Subcutaneous. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Actemra Subcutaneous.