Brand Name(s):

• Actemra®

IMPORTANT WARNING

Using tocilizumab injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection that may spread through the body. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and ongoing infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV), or any condition that affects your immune system, and if you live, have ever lived, or traveled to areas such as the Ohio and Mississippi River valleys and the Southwest where severe fungal infections are more common. Ask your doctor if you do not know if these infections are common in your area. Also tell your doctor if you are taking: abatacept (Orencia); adalimumab (Humira); anakinra (Kineret); certolizumab (Cimzia); etanercept (Enbrel); golimumab (Simponi); infliximab (Remicade); medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Rheumatrex, Trexall), sirolimus (Rapamune), and tacrolimus (Prograf); oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred); or rituximab (Rituxan). If you experience any of the following symptoms, call your doctor immediately: fever; chills; sweating; difficulty breathing; sore throat; cough; weight loss; diarrhea; stomach pain; blood in phlegm; extreme tiredness; muscle aches; warm, red, or painful skin; sores on the skin or in the mouth; burning when you urinate; frequent urination; or other signs of infection.

You may be infected with tuberculosis (TB; a type of lung infection) or hepatitis B (a type of liver disease) but not have any symptoms of the disease. In this case, tocilizumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using tocilizumab injection. Tell your doctor if you have or have ever had TB or hepatitis B, if you have visited any country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, chest pain, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea, vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Keep all appointments with your doctor and the laboratory. Your doctor will monitor your health carefully to be sure you do not develop a serious infection. Your doctor will order certain lab tests to check your body's response to tocilizumab injection.

WHY is this medicine prescribed?

Tocilizumab injection is used alone or in combination with other medications to relieve the symptoms of rheumatoid arthritis (a condition in which the body attacks its own joints causing pain, swelling, and loss of function) in patients who have not been helped by other medications called tumor necrosis factor (TNF) inhibitors. Tocilizumab injection is in a class of medications called interleukin-6 (IL-6) receptor inhibitors. It works by blocking the activity of interleukin-6, a substance in the body that causes inflammation.

HOW should this medicine be used?

Tocilizumab injection comes as a solution (liquid) to be injected intravenously (into a vein) in your arm by a doctor or nurse in a medical office or hospital outpatient clinic. It is usually given once every 4 weeks. It will take about 1 hour for you to receive your dose of tocilizumab injection.

Tocilizumab injection may help control your symptoms, but it will not cure your condition. Your doctor will watch you carefully to see how well tocilizumab injection works for you. Your doctor may adjust your dose or delay your treatment if you have certain changes in your laboratory results. It is important to tell your doctor how you are feeling during your treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving tocilizumab injection,

• tell your doctor and pharmacist if you are allergic to tocilizumab, any other medications, or any of the ingredients in tocilizumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev, Mevacor, in Advicor), and simvastatin (Zocor, in Vytorin); oral contraceptives (birth control pills); or theophylline (Elixophyllin, Theo-24, Uniphyl, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with tocilizumab injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had cancer; diverticulitis (small pouches in the lining of the large intestine that can become inflamed); ulcers in your stomach or intestines; any condition that affects the nervous system such as multiple sclerosis (MS; a disease in which the nerves do not function properly and patients may experience weakness, numbness, loss of muscle coordination and problems with vision, speech, and bladder control) or chronic inflammatory demyelinating polyneuropathy (CIDP; a disorder of the immune and nervous systems); or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving tocilizumab injection, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving tocilizumab injection.
• ask your doctor whether you should receive any vaccinations before you begin your treatment with tocilizumab injection. Do not have any vaccinations during your treatment without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about tocilizumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 1, 2011.