Xeljanz (tofacitinib) is a prescription medication indicated to treat moderate to severe rheumatoid arthritis in adults who have tried methotrexate without success. Xeljanz is also being studied as a possible treatment for psoriasis, inflammatory bowel disease and other immune disease, as well as organ transplant rejection. Xeljanz was approved by the U.S. Food & Drug Administration (FDA) in 2012, and was developed by Pfizer, Inc. and the National Institutes of Health.

How Does Xeljanz Work?

xeljanz lawyerRheumatoid arthritis, also known as RA, is a progressive, chronic condition in which the body’s immune system attacks its own tissues, specifically a thin membrane around the joints called the synovium. This results in inflammation, stiffness, and swelling in the joints. For most people, the swelling, stiffness and joint damage associated with RA will worsen over time.

Xeljanz is a janus kinase (JAK) inhibitor. JAKs are enzymes that work within the immune system and other cells to transmit signals that influence their function. By inhibiting JAK in immune cells, the drug interferes with the processes that cause RA.

While other RA treatments are administered via injection or infusion, Xeljanz is available in tablet form. The recommended dosage is 5mg, twice daily. Xeljanz can be used on its own or with methotrexate.

Xeljanz Safety Concerns

Because it impacts the immune system, the most serious Xeljanz side effect is an increased risk of serious infections. People who have an active infection should not take Xeljanz, and those who develop symptoms of an infection while using the drug should contact their doctors immediately.

The Xeljanz label includes a Black Box Warning regarding its association with serious infections, including tuberculosis. Among other things, the warning recommends that patients be tested for tuberculosis before starting treatment with the medication. In addition to tuberculosis, bacterial, invasive fungal, viral, and other opportunistic infections leading to hospitalizations and death have occurred in patients receiving Xeljanz. In addition, the Black Box Warning notes that some Xeljanz patients have developed lymphoma and other malignancies. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in kidney transplant patients treated with Xeljanz and concomitant immunosuppressive medications.

Other potential Xeljanz side effects include:

  • Allergic reactions. Xeljanz patients should seek emergency help if the experience hives; difficulty breathing; or swelling of the face, lips, tongue, or throat.
  • Severe liver symptoms. Patients should contact their doctor if they experience low fever, itching, tiredness; upper stomach pain, loss of appetite; dark urine, clay colored stools; or jaundice (yellowing of the skin or eyes)
  • Headache
  • Diarrhea
  • Cold symptoms such as stuffy nose, sneezing, sore throat.

Xeljanz can interact with a wide range of prescription, over-the-counter and herbal medications. Patients should inform their doctors of any other drugs they are taking before beginning treatment with Xeljanz.

This medication should not be used by patients who suffer from severe liver disease. Xeljanz patients should not receive a “live” vaccination during treatment, and they should avoid contact with anyone who has recently received such a vaccine.

Xeljanz is a pregnancy category C drug, which means there have been no well-controlled studies of its effects in pregnant women. However, animal studies did suggest that Xeljanz may cause birth defects in a developing fetus. There fore, it should only be used in pregnant women if the potential benefits justify the risk. It is unknown whether Xeljanz is excreted into human milk, so nursing mothers should either stop taking the medication or discontinue nursing while using the drug.

  1. Pfizer, Inc. (June 2015) “Xeljanz Prescribing Information” http://labeling.pfizer.com/ShowLabeling.aspx?id=959
  2. Johns Hopkins Medicine (September 2013) “RA Pathophysiology” http://www.hopkinsarthritis.org/arthritis-info/rheumatoid-arthritis/ra-pathophysiology-2/
  3. Johns Hopkins Medicine (January 2013) “Tofacitinib: A novel Janus kinase inhibitor is FDA approved as the first oral biologic treatment for rheumatoid arthritis.” http://www.hopkinsarthritis.org/arthritis-news/tofacitinib-fda-approved-oral-biologic-for-rheumatoid-arthritis/
Last Modified: November 13, 2015

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