Pronunciation: TOE si LIZ oo mab

Brand: Actemra

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

Serious and sometimes fatal infections may occur during treatment with tocilizumab. Stop using this medicine and call 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. While using tocilizumab, you may need frequent medical tests.

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 medicines.

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

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 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?

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

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 certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

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.

To make sure tocilizumab is safe for you, tell your doctor if you have ever had:

  • an infection such as herpes, pneumonia, or yeast infection;
  • liver disease;
  • diverticulitis, stomach ulcer, or stomach or intestinal bleeding;
  • diabetes;
  • HIV or AIDS;
  • a weak immune system;
  • hepatitis B (or if you are a carrier of the virus);
  • a nerve-muscle disease such as multiple sclerosis;
  • cancer; or
  • if you have received or are scheduled to receive any vaccines.

Treatment with tocilizumab may increase your risk of developing certain types of cancer. Talk to your doctor about your specific 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. This is to track the outcome of the pregnancy and to evaluate any effects of tocilizumab on the baby.

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

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. A healthcare provider will give you this type of injection.

Tocilizumab is sometimes injected under the skin. You may be shown how to use this type of injection at home using a prefilled syringe. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

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

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not use tocilizumab if it has changed colors or has particles in it. Call your pharmacist for new medication.

Each tocilizumab prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

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.

Tocilizumab can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Your injections may be delayed based on the results of these tests.

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.

If you have ever had hepatitis B, tocilizumab can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using tocilizumab. You may need to stop using the medicine for a short time.

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

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?

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

What should I avoid while receiving tocilizumab?

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

Do not receive a "live" vaccine while using tocilizumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What are the possible side effects of tocilizumab?

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.

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, chills, muscle pain, night sweats, mouth sores, white patches in your throat, weight loss, feeling very tired;
  • fast heart rate, rapid breathing, chest pain, wheezing, cough, shortness of breath;
  • redness or swelling under your skin, painful skin sores, blistering skin rash with burning or tingly feeling;
  • watery diarrhea, pain or burning when you urinate;
  • blurred vision, bone pain, confusion, headache, nausea, swollen glands.; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Also call your doctor at once if you have:

  • severe stomach cramps, bloating, diarrhea or constipation;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds; 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;
  • high blood pressure (blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heartbeats); or
  • pain, swelling, burning, or irritation around the IV needle or 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 other drugs will affect tocilizumab?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, or rituximab.

This list is not complete and many other drugs can interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.

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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