Infliximab-abda (By injection)

Renflexis

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

• Some foods and 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 immune system (including methotrexate or a 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.

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine needs to be given slowly. The needle will remain 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.

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

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

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

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
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Joint or muscle pain or swelling, trouble swallowing
• Headache, lightheadedness, trouble breathing, rash
• Seizures, numbness, tingling, problems with vision, speech, or walking
• 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:

• Redness, pain, or swelling where the needle is placed

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart failure, COPD, liver disease, a bleeding disorder, blood or bone marrow problems, cancer, or heart disease. 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:
  • Higher risk of lymphoma or other cancers (including skin cancer)
  • Liver damage
  • Infusion reaction during or after the infusion, or if you start using the medicine again after not receiving it for a long time
  • 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 have an infection or already have trouble with your immune system. This risk may be higher in people who are older than 65 years or who have diabetes. Avoid sick people, and wash your hands often.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.