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tocilizumab

Pronunciation: TOE si LIZ oo mab

Brand: Actemra

What is the most important information I should know about tocilizumab?

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Serious and sometimes fatal infections may occur during treatment with tocilizumab. Contact your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

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

Tell your doctor if you have an active or recent infection, liver disease or hepatitis B, diabetes, diverticulitis, stomach ulcer or bleeding, high cholesterol, multiple sclerosis, HIV/AIDS, a weak immune system, or a history of cancer.

Tocilizumab can lower the blood cells that help your body fight infections. Avoid being near people who are sick or have infections.

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Do not receive a "live" vaccine while you are being treated with tocilizumab.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

What is tocilizumab?

Tocilizumab reduces the effects of a substance in the body that can cause inflammation.

Tocilizumab is used to treat moderate to severe rheumatoid arthritis in adults. It is sometimes given together with other arthritis medications.

Tocilizumab is also used to treat systemic juvenile idiopathic arthrits (or "Still disease") in children who are at least 2 years old. It is sometimes given together with methotrexate (Rheumatrex, Trexall).

Tocilizumab is usually given after other medications have been tried without successful treatment of symptoms.

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

What should I discuss with my healthcare provider before I receive tocilizumab?

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Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure you can safely use tocilizumab, tell your doctor if you have any of these other conditions:

  • an active or recent infection (such as herpes, pneumonia, or yeast infection);
  • signs of infection such as fever, chills, cough, body aches, diarrhea, weight loss, painful urination, or coughing up blood;
  • open sores or skin wounds;
  • liver disease;
  • diverticulitis, stomach ulcer, or a history of stomach or intestinal bleeding;
  • diabetes;
  • a weak immune system;
  • high cholesterol;
  • hepatitis B (or if you are a carrier of the virus);
  • a nerve-muscle disease such as multiple sclerosis;
  • HIV or AIDS;
  • a history of cancer; or
  • if you are scheduled to receive any vaccines.
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FDA pregnancy category C. It is not known whether tocilizumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tocilizumab on the baby.

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It is not known whether tocilizumab passes into breast milk. You should not breast-feed while you are using tocilizumab.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

How is tocilizumab given?

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

Tocilizumab is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Tocilizumab must be given slowly, and the IV infusion can take 1 hour to complete.

This medication is usually given every 4 weeks.

Tocilizumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood need to be tested often. Visit your doctor regularly.

Contact your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

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Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

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If you need to have surgery, tell the surgeon ahead of time that you are using tocilizumab.

You may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your tocilizumab injection.

What happens if I overdose?

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

What should I avoid while receiving tocilizumab?

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Do not receive a "live" vaccine while using tocilizumab, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Avoid being near people who are sick or have infections.

What are the possible side effects of tocilizumab?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Serious and sometimes fatal infections may occur during treatment with tocilizumab. Call your doctor right away if you have signs of infection such as:

  • fever, flu symptoms, mouth and throat ulcers, weight loss, feeling very tired;
  • sores in your mouth and throat or on your skin;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
  • purple or red pinpoint spots under your skin;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • pain or burning when you urinate.
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Call your doctor at once if you have any of these other serious side effects:

  • severe stomach pain with constipation;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • painful blistering skin rash with burning, itching, or tingly feeling; or
  • upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • runny or stuffy nose, sinus pain, sore throat;
  • headache, dizziness;
  • itching; or
  • mild stomach cramps.

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 other drugs will affect tocilizumab?

Tell your doctor about all other medications you use, especially:

  • birth control pills;
  • a blood thinner such as warfarin (Coumadin);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • omeprazole (Prilosec);
  • sirolimus (Rapamune) or tacrolimus (Prograf);
  • theophylline (Elixophyllin, Theo-24, Uniphyl);
  • abatacept (Orencia), adalimumab (Humira), anakinra (Kineret) certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), or rituximab (Rituxan);
  • atorvastatin (Lipitor), lovastatin (Mevacor) and other cholesterol-lowering medications;
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene);
  • a heart rhythm medication such as disopyramide (Norpace), procainamide (Pronestyl), or quinidine (Quin-G);
  • other drugs that weaken your immune system (such as cancer medicine or steroids); or
  • any other pain or arthritis medications (both prescription and over-the-counter) including methotrexate (Rheumatrex), aspirin, or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others.
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This list is not complete and many other drugs may interact with tocilizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

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.

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