Xeljanz (tofacitinib)

Reviewed by: HU Medical Review Board | Last reviewed: August 2023

Tofacitinib is a drug used to treat some adults with moderate or severe ulcerative colitis (UC). In the United States, tofacitinib is sold under the brand name Xeljanz® and Xeljanz XR®.1,2

UC is a type of inflammatory bowel disease (IBD). It causes inflammation and sores in the digestive tract. UC can be difficult to live with. In some cases, it can cause life-threatening complications. It has no known cure, but treatments are designed to reduce symptoms and complications.1,3

Tofacitinib is recommended for adults who have not responded to 1 or more tumor necrosis factor (TNF) blockers or have had an intolerance to TNF blockers. TNF blockers are a different kind of drug that is used to treat UC.1,2

Tofacitinib is also approved to treat other conditions, such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is also approved to treat children with polyarticular juvenile arthritis. However, for UC, tofacitinib is approved to treat only adults.2

What are the ingredients in tofacitinib?

The active ingredient is tofacitinib citrate.2

How does tofacitinib work?

Tofacitinib is a type of drug called a Janus kinase (JAK) inhibitor. JAK inhibitors treat many conditions. They work by targeting specific proteins that cells use for several functions.1,2

Tofacitinib works by targeting the JAK protein. This protein plays a role in signaling the body’s inflammation response. By targeting this protein, tofacitinib interrupts the signal. This can reduce the inflammation caused by conditions like UC.1,3

What are the possible side effects?

The most common side effects of tofacitinib are:2

  • Common cold
  • Higher cholesterol levels
  • Headache
  • Upper respiratory tract infections
  • Increased creatine phosphokinase (an enzyme in the blood)
  • Rash
  • Diarrhea
  • Herpes zoster (shingles) infection

Tofacitinib has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because taking tofacitinib can increase your risk of severe and life-threatening side effects, including:2

  • Serious infections such as tuberculosis
  • Heart failure, heart attack, or stroke
  • Certain types of cancer, including lymphoma and lung cancer
  • Blood clots

Other serious side effects may include:2

  • Tears in the intestinal lining
  • Allergic reaction
  • Changes in certain blood test results

These are not all the possible side effects of tofacitinib. Talk to your doctor about what to expect when taking tofacitinib. Call your doctor if you have any changes that concern you when taking tofacitinib.2

Other things to know

Tofacitinib affects the immune system, so it can make people more likely to get infections. Call your doctor right away if you have any signs of infections while taking tofacitinib, such as:1,2

  • Fever or chills
  • Shortness of breath
  • Unusual tiredness
  • Cough
  • Muscle aches

While taking tofacitinib, you cannot receive live vaccines. You will also be tested for tuberculosis before starting treatment.2

Tofacitinib can affect a person's ability to become pregnant. You also should not breastfeed while taking tofacitinib. Talk to your doctor if you are taking tofacitinib and want to become pregnant or breastfeed.2

Before beginning treatment for IBD, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. You may have side effects if you take tofacitinib along with other drugs, including medicines that:2

  • Treat fungal or bacterial infections
  • Treat neurological disorders
  • Suppress your immune system

Because of the risk of blood clots, heart attack, and stroke, also tell your doctor if you have a history of:2

  • Diabetes
  • High blood pressure
  • Obesity
  • Stroke

For more information, read the full prescribing information of tofacitinib.

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