Tocilizumab

Listing ID #6434711

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 (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Trexall, others), sirolimus (Rapamune), and tacrolimus (Prograf); oral steroids such as dexamethasone, methylprednisolone, and prednisone (Rayos); 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 before and during your treatment to check your body's response to tocilizumab injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tocilizumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of using tocilizumab injection.