Infliximab (in-FLIX-i-mab)

Treats rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, plaque psoriasis, and ulcerative colitis.

Brand Name(s):

Remicade

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
• This medicine needs to be given slowly. The needle will need to remain in place for at least 2 hours. You may also receive medicines to help with side effects.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine should not be taken together with abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), rituximab (Rituxan®), or tocilizumab (Actemra®).
• Make sure your doctor knows if you are using medicines that weaken your immune system. These include methotrexate (Folex®, Rheumatrex®) or a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®). Tell your doctor knows if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), theophylline (Theo-Dur®), or a blood thinner (such as warfarin, Coumadin®).
• Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Also make sure your doctor knows if you have liver disease, heart problems, a history of cancer, or a bleeding disorder. Tell your doctor if you have a history of seizures, multiple sclerosis, Guillain-Barré syndrome, or a similar nervous system disease.
• This medicine increases your risk of infection. Make sure your doctor knows if you have an infection, chronic infections, or a weak immune system. Tell your doctor if you have traveled recently or have ever had tuberculosis or hepatitis B. Call your doctor right away if you start to have signs of an infection, such as such as cough, fever, chills, weight loss, night sweats, trouble breathing, unusual tiredness or weakness, or flu-like symptoms. Tell your doctor if you are exposed to any illness.
• You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.
• Check with your doctor or nurse right away if you have fever, chills, rash, dizziness, lightheadedness, headache, body aches, trouble breathing, nausea, or swelling of the face, tongue, and throat. You might be having an infusion reaction.
• This medicine may increase your risk of a lupus-like syndrome or autoimmune hepatitis. Check with your doctor right away if you have dark brown-colored urine, fever or chills, unusual tiredness or weakness, joint pain, light-colored stools, nausea and vomiting, a rash on the cheeks or arms that is worse in the sun, pain in your right side, or yellow eyes and skin.
• A small number of people who have used this medicine have developed cancer. You need to talk to your doctor about your personal risk, because it depends on your personal health history. Talk with your doctor if you have swollen lymph nodes, unexplained weight loss, or unusual bleeding, bruising, or weakness.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• It is important to have your heart checked closely if you receive infliximab. Call your doctor right away if you have shortness of breath, swelling in the ankles and feet, or a sudden weight gain.
• If your symptoms do not improve or if they get worse, call your doctor.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bone pain
• Change in how much or how often you urinate
• Cold or flu symptoms such as runny or stuffy nose, sore throat, fever, chills, or body aches
• Joint pain or swelling
• Lightheadedness, dizziness, or fainting
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Pain in your lower leg (calf)
• Pain when urinating, or dark-colored urine or pale stools
• Skin rash, headache, sore throat, muscle pain, trouble swallowing
• Sores or white patches on your lips, mouth, or throat
• Stiff neck or seizures
• Sudden or severe headache, or problems with vision, speech, or walking
• Sudden numbness or weakness
• Swollen hands, ankles, or feet
• Swollen lymph nodes
• Trouble breathing, chest pain, cough
• Unexplained weight loss, night sweats
• Unusual bleeding, bruising, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Feeling of warmth or redness
• Mild skin rash or itching
• Redness, pain, or swelling where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088