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Precautions and Warnings With Tofacitinib

Tofacitinib has been reported to increase the risk for certain types of cancers and potentially dangerous infections. To help minimize your risk of problems, make sure your healthcare provider has your complete medical history, as well as a current list of all medications you are taking. Other warnings and precautions associated with tofacitinib apply to people who have certain allergies.


What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider before taking tofacitinib (Xeljanz®) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure, or if you are on dialysis
  • An infection of any kind
  • Ever had tuberculosis or hepatitis
  • Low blood cell counts, including low platelets, white blood cells, or red blood cells (anemia)
  • Diverticulitis
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Tofacitinib Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Tofacitinib can make it harder for your body to fight an infection. As a result, you could develop potentially serious bacterial, viral, or fungal infections. You could also get a painful skin rash caused by the herpes zoster virus (shingles). Let your healthcare provider know if you develop any sign of an infection, such as:
    • Fever
    • Body aches and pains
    • Cough
    • Chills
    • Painful skin blisters or a rash.
  • Because tofacitinib diminishes the body's ability to fight infections, infections that would normally be mild may become quite dangerous. Uncommon infections that are not usually seen in healthy individuals may also occur. These risks must be carefully considered before you start taking this drug.
  • You should be tested for tuberculosis (typically using a skin test) before starting tofacitinib. If there is evidence that you have tuberculosis (or if you have had it in the past), you will need to be treated before you can start taking tofacitinib.
  • Because of its effects on the immune system, tofacitinib may allow inactive viruses to become active in the body. This can cause shingles (when the chickenpox virus becomes reactivated) or can cause a reactivation of hepatitis B or C.
  • As is possible with many medications that suppress the immune system, tofacitinib may increase the risk for certain cancers. Discuss this risk with your healthcare provider, especially if you have a history of any type of cancer.
  • During studies, there were a few cases of gastrointestinal perforation (tears in the stomach or intestines) in people taking tofacitinib, although it is not entirely clear if the drug played any specific role in these cases. Nonetheless, make sure to report any symptoms of a perforation such as new, unexplained digestive pain or an unexplained change in bowel habits right away. People with a history of diverticulitis may have a higher risk for this problem.  
  • Tofacitinib can cause low red blood cells, white blood cells, and platelet counts. This can increase your risk for anemia, infections, and bleeding. Your healthcare provider will monitor your blood cell counts, using a simple blood test, before you start treatment and routinely during treatment.

    If your blood cells counts drop too low, you may need to temporarily stop taking tofacitinib or take a lower dose. Tell your healthcare provider if you experience unusual bleeding or bruising, extreme tiredness or fatigue, or shortness of breath.
  • It is unknown how tofacitinib may interact with vaccines. You should not receive any "live" vaccines while taking this drug. It is important for your healthcare provider to double check that you are caught up with all your vaccines before starting treatment.
  • Tofacitinib can cause increases in cholesterol (including both good and bad cholesterol) and liver enzymes. Your healthcare provider should monitor your cholesterol and liver enzymes while you are taking this medication.
  • Tofacitinib is a pregnancy Category C medication, which means it may not be safe for use in pregnancy, although the full risks are currently unknown (see Xeljanz and Pregnancy).
  • It is unknown whether tofacitinib passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Xeljanz and Breastfeeding).
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