Infliximab (Injection)

Introduction

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.
• This medicine needs to be given slowly. The needle will need to be 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.

• Tell your doctor if you also use abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®), rituximab (Rituxan®), or tocilizumab (Actemra®).
• Make sure your doctor knows if you use 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 if you also use cyclosporine (Gengraf®, Neoral®, Sandimmune®), theophylline (Theo-Dur®), or a blood thinner (such as warfarin, Coumadin®).
• Tell your doctor if you have had phototherapy or light therapy.
• Patients who use infliximab should not have any immunizations (vaccines) without a doctor's approval. Make sure your doctor knows if you received infliximab while you were pregnant. Your infant may need to wait before he or she receives a live vaccine. Your child's vaccinations need to be current before he or she begins using infliximab. Be sure to ask your child's doctor if you have any questions about this.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or if you have liver disease, heart problems, lung disease (such as COPD), 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 have signs of an infection, such as such as cough, fever, chills, body aches, night sweats, trouble breathing, or unusual tiredness or weakness. Tell your doctor if you have been in close contact with someone who is ill.
• 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 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. These could be symptoms of an infusion reaction.
• Check with your doctor right away if you have a rash, unusual tiredness or weakness, joint or muscle pain, nausea and vomiting, or stomach pain. This medicine may rarely cause other problems with your immune system.
• A small number of people who have used this medicine have developed cancer. Talk to your doctor about your personal risk for cancer. Tell 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 when you receive infliximab. Call your doctor right away if you have trouble breathing, swelling in the face, ankles, or 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
• Change in how much or how often you urinate
• Dark-colored urine or pale stools
• Fast, slow, or pounding heartbeat or chest pain
• Fever, rash, headache, sore throat, chills, or body aches
• Joint or muscle pain
• 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
• Problems with vision, speech, or walking
• Seizures
• Swollen face, hands, ankles, or feet
• Swollen glands
• Trouble breathing or swallowing
• Unexplained weight loss or night sweats
• Unusual bleeding, bruising, tiredness, 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 headache
• Mild skin rash or itching
• Mild stomach pain or upset stomach
• 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