It’s not known if Xeljanz and Xeljanz XR (generic) are safe to take while pregnant or breastfeeding. Certain factors, including the risks of not treating your condition, may determine whether you should take the drug during this time.

Boxed warnings

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

Risk of serious infections. Taking Xeljanz or Xeljanz XR can increase your risk of serious bacterial, viral, and fungal infections. Examples of the most common serious infections reported include pneumonia and diverticulitis. Serious infections that happen while taking Xeljanz can require treatment in a hospital. They may even be fatal in certain cases.

Risk of blood clots. If you’re 50 years old or older and have rheumatoid arthritis and at least one risk factor for heart disease, Xeljanz can increase your risk for blood clots. This includes clots such as pulmonary embolism, arterial thrombosis, and deep venous thrombosis. In this case, Xeljanz and Xeljanz XR can also increase the risk of death.

The risk of blood clots may be greater at higher doses of Xeljanz. The risk may also be high if you have certain heart-related risk factors. These include high blood pressure, smoking, or a low activity level.

Risk of cancer and problems with your immune system. Xeljanz and Xeljanz XR can increase your risk of certain cancers including lymphoma. These drugs can also increase the risk of immune system disorders in certain people.

The risk of cancer may be greater at higher doses of Xeljanz. Also, people who smoke, have smoked in the past, or who already have cancer have an increased risk.

Risk of death in certain people. Xeljanz and Xeljanz XR may increase the risk of death in certain people. This includes people ages 50 years and older who have rheumatoid arthritis and certain risk factors.

For more information about these warnings, talk with your doctor or pharmacist.

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There isn’t enough information available to know if tofacitinib (the active drug in Xeljanz and Xeljanz XR) is safe to take during pregnancy. In animal studies, harm occurred in fetuses when pregnant animals were given the drug. However, animal studies don’t always predict what will happen in humans.

It is important to keep in mind that there are known risks to fetuses when a pregnant person has active rheumatoid arthritis (RA) or ulcerative colitis (UC), and Xeljanz and Xeljanz XR are used to treat these conditions.

If you’re pregnant or considering becoming pregnant, talk with your doctor about whether Xeljanz or Xeljanz XR is right for you. Your doctor will discuss the benefits and risks of using either drug during pregnancy. They’ll also discuss the benefits and risks of not treating your condition during pregnancy.

Pregnancy registry

If you’re taking or have taken Xeljanz or Xeljanz XR during pregnancy, you’re encouraged to enroll in the drugs’ pregnancy registry. A pregnancy registry allows healthcare professionals to collect information about the safety of using certain drugs during pregnancy. To enroll in this pregnancy registry, call 877-311-8972 or visit the registry website.

Xeljanz and fertility

Animal studies have found that tofacitinib (the active drug in Xeljanz and Xeljanz XR) affects the ability of certain animals to become pregnant. It’s not known if this effect is also seen in humans. If you can become pregnant, talk with your doctor before starting the treatment.

It’s recommended that you don’t breastfeed while taking Xeljanz. There are reports that tofacitinib (the active drug in Xeljanz and Xeljanz XR) passes into human breast milk.

People shouldn’t breastfeed while taking Xeljanz or for at least 18 hours after their last dose of Xeljanz. If you’re taking Xeljanz XR, you shouldn’t breastfeed for at least 36 hours after your last dose of the drug. This is because either drug could possibly cause serious side effects if it passes to your child.

If you’re breastfeeding and considering taking Xeljanz or Xeljanz XR, talk with your doctor about other healthy ways to feed your child.

It’s not known if Xeljanz or Xeljanz XR is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you’re using Xeljanz or Xeljanz XR.

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.