Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xeljanz (Tofacitinib).
HEALTH CANADA ADVISORY
April 6, 2021
Health Canada has issued information concerning the use of Xeljanz (Tofacitinib). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Previous advisories on Xeljanz (Tofacitinib) were issued on December 2, 2019 and March 15, 2019.
Blood Clots: Xeljanz (Tofacitinib) may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities. If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, Stroke, or clots in the deep veins of your leg. Discuss with your doctor how Xeljanz (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz (Tofacitinib), and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, get immediate medical attention.
Cancer: Although not common, Xeljanz (Tofacitinib) has been associated with several different types of cancer including skin, lung, breast, prostate, and lymphoma. Discuss any concerns that you may have with your doctor.
Gastrointestinal narrowing: The long acting formulation of Xeljanz (Tofacitinib) should be used with caution by people who have narrowing of the stomach. Because the shell around the medication does not break down, people with narrowing in the digestive system are at increased risk of experiencing a blockage.
Gastrointestinal perforation: People who take anti-inflammatory medications such as NSAIDs or corticosteroids while they are also taking Xeljanz (Tofacitinib) may be more likely to experience a tear in the lining of the stomach, which can cause serious bleeding. This can occur without abdominal pain.
If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.
Infection: Xeljanz (Tofacitinib) reduces your body's response to infection. People taking Xeljanz (Tofacitinib) are at an increased risk of developing serious infections that can be difficult to treat and may cause hospitalization or death. These infections include Tuberculosis and fungal infections as well as infections caused by bacteria and viruses. These infections are more likely to occur if you are taking another medication that reduces the activity of the immune system.
If you have been exposed to tuberculosis, have a history of serious or recurrent infections or have medical conditions that may increase the likelihood of developing infections, discuss with your doctor how Xeljanz (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz (Tofacitinib), and whether any special monitoring is needed.
If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.
Heart rate: Xeljanz (Tofacitinib) may cause decreases in heart rate. If you have a history of decreased heart rate, irregular heart rhythms, or heart disease, discuss with your doctor how Xeljanz (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz (Tofacitinib), and whether any special monitoring is needed.
Kidney function: If you have reduced kidney function or Kidney Disease, discuss with your doctor how Xeljanz (Tofacitinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xeljanz (Tofacitinib), and whether any special monitoring is needed. A lower dose of Xeljanz (Tofacitinib) may be necessary.
Liver function: People taking Xeljanz (Tofacitinib) may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Xeljanz (Tofacitinib). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Xeljanz (Tofacitinib) or stop taking it altogether.
Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred rarely for some people taking Xeljanz (Tofacitinib). This complication can be serious and sometimes fatal. If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking Xeljanz (Tofacitinib), contact your doctor immediately.
Vaccinations: People taking Xeljanz (Tofacitinib) should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to have may be used with Xeljanz (Tofacitinib).
Pregnancy: Xeljanz (Tofacitinib) should not be used during pregnancy. If you become pregnant while taking Xeljanz (Tofacitinib), contact your doctor immediately.
Women who may become pregnant should use effective birth control during treatment with Xeljanz (Tofacitinib) and for 4 to 6 weeks after the last dose.
Breast-feeding: It is not known if Xeljanz (Tofacitinib) passes into breast milk. If you are a breast-feeding mother and are taking Xeljanz (Tofacitinib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Xeljanz (Tofacitinib) have not been established for children.
Seniors: People over the age of 65 have a higher risk of developing a serious infection when taking Xeljanz (Tofacitinib). Talk to your doctor to determine whether the benefits outweigh the risks for your condition.
