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Actemra

side effects drug center actemra (tocilizumab injection) drug - patient side effects and images

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    PROFESSIONAL

    CONSUMER

    SIDE EFFECTS

    Actemra Patient Information Including Side Effects

    Brand Names: Actemra, Actemra ACTPen

    Generic Name: tocilizumab

    What is tocilizumab (Actemra, Actemra ACTPen)?

    Tocilizumab is used to treat moderate to severe rheumatoid arthritis in adults after at least one other medication did not work or has stopped working.

    Tocilizumab is also used in adults to treat giant cell arteritis, or inflammation of the lining of your arteries (blood vessels that carry blood from your heart to other parts of your body).

    Tocilizumab is used to treat polyarticular juvenile idiopathic arthritis in adults and children ages 2 and older.

    Tocilizumab is also used to treat systemic juvenile idiopathic arthritis (or "Still disease") in adults and children ages 2 and older.

    Tocilizumab is also used to treat severe or life-threatening cytokine release syndrome (CRS) caused by an overactive immune response to certain types of blood cell treatments for cancer. Tocilizumab is used for CRS in adults and children ages 2 and older.

    Tocilizumab is sometimes given together with other medications as part of your complete treatment.

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

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

    Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

    Call your doctor at once if you have:

    • severe stomach cramps, bloating, diarrhea or constipation;
    • unusual bleeding--nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop, blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;
    • liver problems--loss of appetite, right-sided stomach pain, vomiting, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
    • signs of infection--fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, burning when you urinate; or
    • signs of perforation (a hole or tear) in your stomach or intestines--fever, ongoing stomach pain, change in bowel habits.

    Common side effects may include:

    • runny or stuffy nose, sinus pain, sore throat;
    • headache;
    • increased blood pressure;
    • abnormal liver function tests; or
    • pain, swelling, burning, or irritation where an injection was given.

    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, Actemra ACTPen)?

    Tocilizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate.

    Tocilizumab may also cause a perforation (a hole or tear) in your stomach or intestines. Tell your doctor if you have a fever and stomach pain with a change in your bowel habits.

    Tocilizumab may also cause liver problems. Tell your doctor right away if you have right-sided stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or yellowing of your skin or eyes.

    Actemra Patient Information including How Should I Take

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

    You should not use tocilizumab if you are allergic to it.

    Tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

    Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

    Tell your doctor if you have ever had:

    Using tocilizumab may increase your risk of developing certain types of cancer. Ask your doctor about this risk.

    It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

    If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tocilizumab on the baby.

    You should not breast-feed while using tocilizumab.

    How is tocilizumab given (Actemra, Actemra ACTPen)?

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

    Tocilizumab is given as an infusion into a vein. A healthcare provider will give you this type of injection.

    Tocilizumab is sometimes injected under the skin. A healthcare provider may teach you how to properly use this type of injection by yourself.

    Read and carefully follow any Instructions for Use provided with your medicine. Do not use tocilizumab if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

    Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

    Tocilizumab is usually given every 1 to 4 weeks. Follow your doctor's instructions.

    Use all your medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

    Tocilizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

    If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

    You will need frequent medical tests. If you've ever had hepatitis B, using tocilizumab may cause this virus to become active or get worse. You may need liver function tests while using this medicine and for several months after you stop.

    Store the prefilled syringes in their original container in a refrigerator. Protect from moisture and light. Do not freeze. Throw away any prefilled syringes not used before the expiration date on the medicine label.

    Each single-use prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

    Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

    Tocilizumab can have long-lasting effects on your body. You may need certain medical tests every 6 months after you stop using this medication.

    Actemra Patient Information including If I Miss a Dose

    What happens if I miss a dose (Actemra, Actemra ACTPen)?

    Call your doctor for instructions if you miss a dose.

    What happens if I overdose (Actemra, Actemra ACTPen)?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    What should I avoid while receiving tocilizumab (Actemra, Actemra ACTPen)?

    While using this medicine: Do not receive a "live" vaccine or you could develop a serious infection. The vaccine may not work as well and may not fully protect you from disease.

    Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

    What other drugs will affect tocilizumab (Actemra, Actemra ACTPen)?

    Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

    Tell your doctor about all your other medicines, especially other medicines to treat rheumatoid arthritis, such as:

    • abatacept, etanercept;
    • anakinra; or
    • adalimumab, certolizumab, golimumab, infliximab, or rituximab.

    This list is not complete and many other drugs may affect tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Where can I get more information (Actemra, Actemra ACTPen)?

    Your doctor or pharmacist can provide more information about tocilizumab.

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
    Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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