Remicade is a brand-name intravenous (IV) infusion prescribed for certain autoimmune conditions. It contains the active drug infliximab. Remicade treatment may be safe during pregnancy and breastfeeding.

FDA warning: Risk of serious infection and cancer

This drug has a boxed warning about the following risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Serious infections. People who receive Remicade have an increased risk of serious infections that may lead to a hospital stay or death. These include tuberculosis (TB), fungal infections throughout the body, and other bacterial and viral infections. Before you start Remicade treatment, your doctor will test you for TB and monitor you for it during your treatment. If you develop a serious infection while receiving Remicade, your doctor will have you stop the treatment.

Cancers. Certain cancers have been reported in people who received Remicade or other medications called tumor necrosis factor (TNF) blockers. The cancers included lymphoma, which is a cancer of the lymphatic system, and skin cancer. Remicade itself is a TNF blocker. Some of the cases that occurred in children and teenagers were fatal.

One specific type of lymphoma was hepatosplenic T-cell lymphoma. Most of the people who developed it were teenage or young adult males* who had ulcerative colitis or Crohn’s disease. Nearly all of them were also taking a TNF blocker with the drugs azathioprine or 6-mercaptopurine.

Your doctor will screen you regularly for cancer during and after Remicade treatment.

If you have questions about these boxed warnings, talk with your doctor.

Note: Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

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If you can become pregnant, it’s important to consider whether Remicade is a safe choice for you.

It’s not known whether Remicade treatment is safe during pregnancy. In animal studies, there was no harm to the fetus when pregnant animals were given Remicade. However, animal studies don’t always predict what will occur in humans.

You should only receive Remicade during pregnancy if the benefits are greater than the risks.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether Remicade is safe for you.

If Remicade is given during pregnancy, the newborn may have an increased risk for infection after birth. The infant should not get live vaccines for at least 6 months to avoid serious infections.* A live vaccine contains a weakened form of a germ or virus. To learn more, see the “Remicade interactions” section in this article.

* Remicade has a boxed warning for serious infections. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more information, see the boxed warning at the top of this article.

If you’re breastfeeding or planning to do so, it’s important to consider how Remicade may affect you and your child.

Remicade is known to be present in breast milk in small amounts. A small study found that infants exposed to Remicade through breast milk did not develop side effects. It’s not known whether Remicade affects the ability to produce breast milk.

If you’re breastfeeding and considering Remicade treatment, talk with your doctor. While the treatment appears safe during breastfeeding, your doctor can review the risks and benefits specific to you and your child.

It’s not known whether Remicade treatment is safe during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during Remicade treatment.

Besides learning about how Remicade may affect your reproductive health, you may want more information about Remicade. These additional articles might be helpful:

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.