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Please read the Medication Guide for REMICADE® and discuss with your doctor.

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Most women with Crohn’s disease are able to conceive and deliver healthy babies. It is important that you speak to your gastroenterologist if you are pregnant or planning to be pregnant. Still, you may have questions about the impact that Crohn’s will have on a pregnancy.

Conception

While women with Crohn’s disease that is in remission are able to conceive, women with active Crohn’s may have more difficulty becoming pregnant. Men with Crohn’s who are taking sulfasalazine, a drug commonly used to treat Crohn’s, may be temporarily infertile because the drug decreases sperm count. A man can talk to his gastroenterologist about switching to a 5-ASA medication, which can treat Crohn’s without affecting fertility.

Pregnancy

Most women with Crohn’s can and do carry a full-term pregnancy and deliver a healthy baby. But women with active Crohn’s should be especially careful. Crohn’s causes malnourishment, anemia, and inflammation. Such conditions can interfere with the growth of the fetus, thus putting the woman at two to three times more risk of miscarriage, premature delivery, or stillbirth. Therefore, it is of the utmost importance to stay in close contact with both your gastroenterologist and your obstetrician throughout your pregnancy.

Nutrition and pregnancy

As a pregnant woman, it is important to maintain a healthy, well-balanced diet. As a pregnant woman with Crohn’s disease, your obstetrician and gastroenterologist may recommend special foods, vitamins, and minerals in conjunction with your regular diet.

Women with Crohn’s disease who are pregnant or who plan to become pregnant should speak to their gastroenterologist or obstetrician. And remember, every pregnancy is unique. If you do experience difficulties during one pregnancy, that doesn’t mean future pregnancies will be difficult.

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
Lived in a region where certain fungal infections such as histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, have diabetes or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (such as multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while REMICADE^®.

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.

You should tell your doctor right away if you have any of the signs listed below:

Infections (such as TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss it with your doctor.
(Requires Adobe^® Reader^®. Click here to download.)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Last Updated: January 19, 2009