Indications 

Xeljanz (tofacitinib) is classified as a Janus kinase (JAK) inhibitor medication that reduces the activity of the immune system. 

Xeljanz is indicated to treat the following conditions in adults who are either intolerant or unresponsive to one or more TNF inhibitor medication(s) or methotrexate: 

• Moderate to severe rheumatoid arthritis, a condition characterized by joint pain, swelling, and loss of function caused by the body’s immune system attacking its own joints. 
• Psoriatic arthritis, a condition that causes joint pain, swelling, and skin scales. 
• Moderate to severe ulcerative colitis, a condition characterized by inflammation and sores in the colon and rectum. 

Xeljanz is used to treat polyarticular juvenile idiopathic arthritis in children aged two years and older, who are either intolerant or unresponsive to one or more TNF inhibitor medication(s). 

Uses and Dosage 

Prior to taking tofacitinib, read the Medication Guide provided by your pharmacist carefully.  

Take this medication by mouth with or without food, once or twice daily, as prescribed by your doctor. 

The dosage of this medication is based on your medical condition, response to treatment, lab tests, and other medications you may be using.  

Inform your doctor and pharmacist about all the products you use, including prescription drugs, nonprescription drugs, and herbal products.  

The dosage for children is based on their weight. Do not increase your dose or take this medication more often or for a longer duration than recommended. Doing so will not accelerate your recovery, and may increase the likelihood of serious side effects. 

To obtain the best benefit from this medication, it should be taken regularly. You should remember to take it at the same time(s) every day. 

Side Effects 

Allergic Reaction

Signs of an allergic reaction to Xeljanz: 

• Hives 
• Difficult breathing 
• Swelling of your face, lips, tongue, or throat 

Severe Side Effects

Stop taking Xeljanz and seek emergency medical attention if you experience: 

• Sudden shortness of breath 
• Chest pain or pressure that may spread to your jaw, shoulder, arms, or back 
• Nausea, vomiting, cold sweat 
• A light-headed feeling, like you might pass out 
• Weakness on one side of your body 
• Slurred speech, drooping on one side of your mouth 
• Pain, swelling, or redness in an arm or leg 

Serious side effects that require immediate medical attention: 

• Fever, chills, night sweats, constant tiredness 
• Wheezing, trouble breathing, severe or worsening cough 
• Increased urination, pain or burning when you urinate 
• Unexplained weight loss 
• Lumps in your neck, armpits, or groin 
• Signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body 
• A hole (perforation) in your digestive tract – fever, severe stomach pain, diarrhea or changes in bowel habits 
• Signs of hepatitis – loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes) 

Common Side Effects

Common Xeljanz side effects may include: 

• Skin rash, shingles 
• Increased blood pressure 
• Abnormal blood tests 
• Fever 
• Headache 
• Nausea, vomiting, diarrhea 
• Cold symptoms such as stuffy nose, sneezing, sore throat 

Cautions 

Xeljanz use may pose a risk of severe medical conditions that could be life-threatening, such as serious infections, digestive tract perforation, heart attack, stroke, blood clots, or cancer. Inform your doctor about your medical history before starting Xeljanz treatment. 

If you have a weak immune system, diabetes, chronic lung disease, or infections such as hepatitis, tuberculosis, shingles, or HIV, or if you have ever had diverticulitis, an ulcer in your stomach or intestines, cancer, a kidney transplant, heart problems, or a history of smoking, heart attack, stroke, or blood clots, be sure to inform your doctor.