Infliximab-abda (in-FLIX-i-mab - abda)

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

Brand Name(s):

Renflexis

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for at least 2 hours.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

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

• Some medicines may affect how infliximab-abda works. Tell your doctor if you are using any of the following:
  • Abatacept, anakinra, cyclosporine, etanercept, theophylline, tocilizumab
  • Blood thinner (including warfarin)
  • Medicine that weakens the immune system (including methotrexate, steroid)
• Tell your doctor if you have had light treatment for psoriasis.
• You should not receive a vaccine without your doctor's approval. A live virus vaccine could cause an infection. Children should be current on all vaccines before they start treatment with this medicine. If you received infliximab-abda while pregnant, tell the baby's doctor.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart disease, COPD, a bleeding disorder, blood or bone marrow problems, or cancer. Tell your doctor if you have a history of seizures, multiple sclerosis, Guillain-Barré syndrome, or a similar nervous system disease.
• This medicine may cause the following problems:
  • Increased risk of cancer (including lymphoma, cervical or skin cancer)
  • Liver problems
  • New or worsening heart failure
  • Infusion reactions, including heart attack, stroke, low or high blood pressure, heart rhythm problems, or eye or vision problems during or after the infusion
  • Lupus-like syndrome
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine increases your risk of infection, which could result in serious or life-threatening illness. Tell your doctor if you have a history of frequent or serious infections, including tuberculosis or hepatitis B. Make sure your doctor knows if you have cuts or sores in your body, an infection, or already have trouble with your immune system. This risk may be higher in people who are older than 65 years or have diabetes. Avoid sick people, and wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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, red skin rash
• Chest pain, coughing up blood, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Joint or muscle pain or swelling, trouble swallowing, rash on the cheeks or arms that gets worse in the sun
• Lightheadedness, dizziness, or fainting
• Numbness or weakness in your arm or leg, or on one side of your body
• Seizures, numbness, tingling, problems with vision, speech, or walking
• Sudden or severe headache
• Unusual bleeding, bruising, tiredness, or weakness
• Warm, red, swollen, or painful skin, blisters, skin sores

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

• Diarrhea, heartburn
• 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