Infliximab Solution for injection

What is this medicine?

INFLIXIMAB (in FLIX i mab) is used to treat Crohn's disease and ulcerative colitis. It is also used to treat ankylosing spondylitis, psoriasis, and some forms of arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• exposure to tuberculosis

• heart failure

• hepatitis or liver disease

• immune system problems

• infection

• lung or breathing disease, like COPD

• multiple sclerosis

• current or past resident of Ohio or Mississippi river valleys

• seizure disorder

• an unusual or allergic reaction to infliximab, mouse proteins, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• anakinra

• rilonacept

This medicine may also interact with the following medications:

• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. This medicine may decrease your body's ability to fight infections. Before beginning therapy, your doctor may do a test to see if you have been exposed to tuberculosis.

This medicine may make the symptoms of heart failure worse in some patients. If you notice symptoms such as increased shortness of breath or swelling of the ankles or legs, contact your health care provider right away.

If you are going to have surgery or dental work, tell your health care professional or dentist that you have received this medicine.

If you take this medicine for plaque psoriasis, stay out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• chest pain

• fever or chills, usually related to the infusion

• muscle or joint pain

• red, scaly patches or raised bumps on the skin

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• swollen lymph nodes in the neck, underarm, or groin areas

• unexplained weight loss

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache

• heartburn or stomach pain

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.