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Tocilizumab (Injection) (Injectable)

(ACTEMRA)
Tocilizumab (By injection)
Tocilizumab (toe-si-LIZ-oo-mab)Treats moderate to severe rheumatoid arthritis. Also treats polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (SJIA).
Actemra

When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to tocilizumab or if you have an active infection.

How to Use This Medicine:
Injectable

  • Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle will remain in place for at least 1 hour.
  • A nurse or other health provider will give you this medicine.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Make sure your doctor knows if you use cyclosporine (Gengraf®, Neoral®, Sandimmune®), methotrexate (Trexall®), omeprazole (Prilosec®), theophylline (Theo-Dur®), medicine to lower cholesterol (such as atorvastatin, lovastatin, simvastatin, Lipitor®, Vytorin®), an NSAID pain or arthritis medicine (such as aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), a blood thinner (such as warfarin, Coumadin®, Jantoven®), or birth control pills. Tell your doctor if you use medicines that weaken your immune system, such as cancer medicines or steroids (such as hydrocortisone, methylprednisolone, prednisolone, prednisone).
  • Make sure your doctor knows if you also use other medicines to treat rheumatoid arthritis (such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, Cimzia®, Enbrel®, Humira®, Kineret®, Orencia®, Remicade®, Rituxan®, Simponi®).
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Your child's vaccines need to be current before he or she begins using tocilizumab. Ask your child's doctor if you have questions about this.

Warnings While Using This Medicine:

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have diabetes, HIV or AIDS, an infection, high cholesterol, liver disease (including hepatitis B), multiple sclerosis, stomach or bowel problems (such as diverticulosis, perforations, ulcers), or an immune system problem. Tell your doctor if you have tuberculosis (TB), a history of TB, or have been in close contact with someone who has active TB.
  • You will need to have a skin test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
  • This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
  • This medicine may increase your risk of cancer. Talk to your doctor if you have concerns about this risk.
  • You may get infections more easily while you use this medicine. Call your doctor right away if you have symptoms of an infection, such as fever, chills, or a cough.
  • This medicine may cause serious stomach and bowel problems, especially if you have a history of ulcers or diverticulosis. Check with your doctor right away if you have severe stomach cramps or pain, black, tarry stools, diarrhea, fever, or vomiting while being treated with this medicine.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Bloody, black, or tarry stools
  • Change in how much or how often you urinate
  • Chest pain
  • Fast, slow, or pounding heartbeat
  • Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
  • Severe stomach pain
  • Trouble breathing
  • Vomiting of material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

  • Headache
  • Pain, itching, burning, swelling, bleeding, or a lump under your skin where the needle was placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088