FDA approved Xeljanz (tofacitinib) for Multiple Inflammatory ConditionsFDA approved new oral drug Xeljanz for arthritis and colitis.

FDA From the archive Source published November 6, 2012 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Xeljanz for adults with RA, PsA, AS, or UC and children with PsA or pcJIA after TNF blocker failure.

The FDA has approved Xeljanz (tofacitinib), a Janus kinase (JAK) inhibitor, for the treatment of several inflammatory conditions in adults and children. In adults, Xeljanz tablets and Xeljanz XR are indicated for moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and moderately to severely active ulcerative colitis (UC), all in patients who have had an inadequate response or intolerance to one or more TNF blockers. For pediatric patients 2 years of age and older, Xeljanz tablets and oral solution are approved for active PsA and active polyarticular course juvenile idiopathic arthritis (pcJIA), also after TNF blocker failure. The approval provides an oral treatment option for patients who have not responded adequately to biologic therapies. Limitations of use include avoiding combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

XELJANZ (tofacitinib) is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes involved in signaling pathways that mediate inflammation and immune responses.

Indication & Patient Population

XELJANZ tablets and XELJANZ XR are indicated for adult patients with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ tablets and oral solution are indicated for pediatric patients 2 years of age and older with active PsA or active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers.

Dosing & Administration

For adult RA, PsA, or AS: XELJANZ tablets 5 mg twice daily or XELJANZ XR 11 mg once daily. For pediatric PsA or pcJIA (≥2 years, ≥10 kg): XELJANZ 5 mg twice daily (≥40 kg) or weight-based equivalent twice daily (<40 kg). For adult UC induction: XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily for 8 weeks (up to 16 weeks if needed); discontinue if no adequate response after 16 weeks. For UC maintenance: XELJANZ tablets 5 mg twice daily or XELJANZ XR 11 mg once daily; if loss of response, may consider 10 mg twice daily or 22 mg once daily for shortest duration. Prior to initiation, evaluate for active/latent TB, viral hepatitis, complete blood count, and update immunizations. Avoid initiation if absolute lymphocyte count <500 cells/mm³, ANC <1000 cells/mm³, or hemoglobin <9 g/dL.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Use of XELJANZ/XELJANZ XR for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Use for UC in combination with biological therapies or potent immunosuppressants is not recommended.

Place in Therapy

XELJANZ is indicated for patients who have had an inadequate response or intolerance to one or more TNF blockers. It is an oral JAK inhibitor option for these conditions, with limitations on use in combination with other immunosuppressive therapies.

The FDA has approved Xeljanz (tofacitinib), a pill that works by blocking certain enzymes in the body that cause inflammation. It is for adults with moderate to severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, or moderate to severe ulcerative colitis. It is also approved for children ages 2 and older with active psoriatic arthritis or polyarticular course juvenile idiopathic arthritis. In all cases, Xeljanz is for patients who have tried a TNF blocker and it did not work well enough or caused side effects.

Xeljanz is taken by mouth, either as a tablet or an oral solution for children. This approval gives patients a new treatment option that does not require injections or infusions. However, it is not meant to be used with other biologic drugs or strong immune suppressants like azathioprine or cyclosporine.

This approval is based on studies showing that Xeljanz can reduce symptoms and improve physical function in these conditions. Like all medicines, it has risks and benefits. Patients should talk to their doctor to see if Xeljanz is a good choice for their specific situation. It is important to discuss your medical history and any other medicines you take.

What this means for you:

Xeljanz is a new oral option for certain inflammatory conditions after TNF blockers fail.

Study Details

Study typeFda approval

PublishedNov 2012

View Original Abstract ↓

1 INDICATIONS AND USAGE XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with: • Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. • Moderately to severely active ulcerative colitis (UC), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with: • Active PsA, who have had an inadequate response or intolerance to one or more TNF blockers. • Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use : • Use of XELJANZ/XELJANZ XR for RA, AS, PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.1 , 1.2 , 1.3 , 1.4 ) • Use of XELJANZ tablets and XELJANZ XR for UC in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.5 ) 1.1 Rheumatoid Arthritis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic disease-modifying antirheumatic drugs (DMARDs) or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.2 Psoriatic Arthritis XELJANZ (tablets and oral solution) is indicated for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers. XELJANZ XR (extended-release tablets) is indicated for the treatment of adults with active PsA who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ or XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.3 Ankylosing Spondylitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.4 Polyarticular Course Juvenile Idiopathic Arthritis XELJANZ (tablets and oral solution) are indicated for the treatment of pediatric patients 2 years of age and older with of active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 1.5 Ulcerative Colitis XELJANZ tablets and XELJANZ XR (extended-release tablets) are indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers. Limitations of Use Use of XELJANZ tablets or XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

FDA approved Xeljanz (tofacitinib) for Multiple Inflammatory ConditionsFDA approved new oral drug Xeljanz for arthritis and colitis.

Study Details

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FDA approved Xeljanz (tofacitinib) for Multiple Inflammatory ConditionsFDA approved new oral drug Xeljanz for arthritis and colitis.

Study Details

Evaluating the Efficacy of Traditional Chinese Medicine Decoctions for Rheumatoid Arthritis Management

Traditional Chinese medicine decoctions may improve rheumatoid arthritis symptoms

Clinical research that matters. Delivered to your inbox.

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