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Xeljanz XR is the brand name for tofacitinib and is available as an extended-release oral tablet.

Xeljanz XR is available as an 11 mg and 22 mg extended-release oral tablet.

Xeljanz XR is a Janus kinase (JAK) inhibitor that is used to treat:

• Moderate-to-severe rheumatoid arthritis (RA) in adults
• Psoriatic arthritis (PsA) in adults
• Ankylosing spondylitis (AS) in adults
• Moderate-to-severe ulcerative colitis (UC) in adults
• Moderate-to-severe polyarticular juvenile idiopathic arthritis (pJIA) in children ages 2 years and older – immediate-release tablets and liquid only

Xeljanz XR is a Janus kinase (JAK) inhibitor. It blocks a protein in the body called JAK. This protein plays a role in causing inflammation. By blocking and stopping JAK from working, Xeljanz XR lowers inflammation in the body.

Xeljanz XR is dosed as follows:

• Rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
• IR (immediate-release) tablets: The typical dose is 5 mg by mouth twice daily
• XR (extended-release) tablets: The typical dose is 11 mg by mouth once daily

Ulcerative colitis

• IR tablets: The typical dose is 10 mg by mouth twice daily for at least 8 weeks, then 5 mg by mouth twice daily
• XR tablets: The typical dose is 22 mg by mouth once daily for at least 8 weeks, then 11 mg by mouth once daily
• Polyarticular course juvenile idiopathic arthritis
• IR tablets and liquid: The dose is based on your body weight. The typical dose ranges from 3.2 mg to 5 mg by mouth twice daily

Xeljanz XR is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Xeljanz XR:

• Arthritis:
• Upper respiratory tract infection
• Nose and throat infection
• Diarrhea
• Headache

Ulcerative colitis:

• Nose and throat infection
• High cholesterol
• Headache
• Upper respiratory tract infection
• Muscle damage
• Rash
• Diarrhea
• Stomach infection
• Anemia

Serious side effects are rare with Xeljanz XR. Contact your healthcare provider immediately if you experience any of the following.

• Serious infections: fever, weakness, chills, difficulty breathing, cough, diarrhea, stomach pain, burning when you urinate, urinating more or less often
• Stroke: sudden weakness on one side of your body, trouble speaking, confusion
• Blood clot near or in the heart: chest pain; short of breath; pain in the jaw, neck, or back; feeling weak or lightheaded
• Blood clot in the lung (pulmonary embolism): cough, chest pain, trouble breathing, racing heart
• Blood clot in the leg (deep vein thrombosis): leg cramp, swelling or pain in the leg, muscle tightness
• Stomach tear: stomach pain, bloating, change in bowel movements, bleeding
• Liver damage: nausea, stomach pain, yellowing of the skin or whites of the eyes
• Severe allergic reaction: rash, trouble breathing, feeling faint, swelling of the face or throat
• Cancer

The following medications may interact with Xeljanz XR:

• Strong CP3A4 Inhibitors (e.g., ketoconazole): Dosage adjustment of XELJANZ/Xeljanz XR/XELJANZ Oral Solution is recommended
• Moderate CYP3A4 Inhibitors Coadministered with Strong CYP2C19 Inhibitors (e.g., fluconazole): Dosage adjustment of XELJANZ/Xeljanz XR/XELJANZ Oral Solution is recommended
• Strong CYP3A4 Inducers (e.g., rifampin): Coadministration with XELJANZ/Xeljanz XR/XELJANZ Oral Solution is not recommended
• Immunosuppressive Drugs (e.g., azathioprine, tacrolimus, cyclosporine): Risk of added immunosuppression; coadministration with biologic DMARDs or potent immunosuppressants has not been studied in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, UC, or pcJIA

Pfizer

XELJANZ/Xeljanz XR/XELJANZ Oral Solution may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/Xeljanz XR/XELJANZ Oral Solution. It is not known if XELJANZ/Xeljanz XR/XELJANZ Oral Solution will harm an unborn baby. Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/Xeljanz XR/XELJANZ Oral Solution. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ/Xeljanz XR/XELJANZ Oral Solution, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

• Tofacitinib