Infliximab Treatment Report

Precautions

Instructions

Side Effects

Interactions

You should not use this medication if you are allergic to infliximab, if you have severe heart failure, or if you are also being treated with anakinra (Kineret).

Before using infliximab, 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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using infliximab, tell your doctor if you have:

• an active or recent infection;
• open sores or skin wounds;
• hepatitis B;
• congestive heart failure;
• epilepsy or other seizure disorder;
• chronic obstructive pulmonary disease (COPD);
• a history of cancer;
• a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome;
• if you have recently been vaccinated with BCG (Bacille Calmette-Guerin); or
• if you are scheduled to receive any vaccines.

FDA pregnancy category B. Infliximab is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether infliximab passes into breast milk. Do not use infliximab without first talking to your doctor if you are breast-feeding a baby.

Infliximab is not for use in children younger than 6 years old.

Treatment with infliximab may increase your risk of certain types of cancer, such as breast, colon, skin cancer, or lymphoma (cancer of the lymph nodes). This risk may be greater in children and young adults. You may also develop an autoimmune disorder (such as a lupus-like syndrome). Talk with your doctor about your specific risk.

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

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

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Contact your doctor if you miss a dose of infliximab.

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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.

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

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat;
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• chest pain, ongoing cough, coughing up blood;
• shortness of breath with swelling of your ankles or feet;
• numbness or tingling;
• weak feeling in your arms or legs;
• problems with vision;
• seizure (convulsions);
• pain or burning when you urinate;
• easy bruising or bleeding, pale skin, unusual weakness;
• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• stuffy nose, sinus pain;
• mild stomach pain;
• mild skin rash; or
• headache.

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. You may report side effects to FDA at 1-800-FDA-1088.

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There may be other drugs that can interact with infliximab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Remicade and infliximab

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