INDICATIONS AND USAGE（适应症）

Rheumatoid Arthritis

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.

Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Psoriatic Arthritis

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Ulcerative Colitis

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or who are intolerant to TNF blockers.

Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

Polyarticular Course Juvenile Idiopathic Arthritis

XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.

Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

DOSAGE（服用剂量）

Take XELJANZ/XELJANZ XR/XELJANZ Oral Solution exactly as your healthcare provider tells you to take it.

Take XELJANZ/XELJANZ Oral Solution 2 times a day with or without food.

Take XELJANZ XR 1 time a day with or without food.

Swallow XELJANZ XR tablets whole and intact. Do not crush, split, or chew.

When you take XELJANZ XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

If you take too much XELJANZ/XELJANZ XR/XELJANZ Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.

For the treatment of psoriatic arthritis, take XELJANZ/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.

XELJANZ XR should not be used instead of XELJANZ Oral Solution.

ADVERSE REACTIONS（不良反应）

Serious Infections

Mortality

Malignancy and Lymphoproliferative Disorders

Thrombosis

Gastrointestinal Perforations

Hypersensitivity

Laboratory Abnormalities

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/68e3d6b2-7838-4d2d-a417-09d919b43e13/spl-doc?hl=tofacitinib

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