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

FDA From the archive Source published February 23, 2016 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider Xeljanz XR for adults with RA, PsA, AS, or UC after TNF blocker failure; avoid combining with biologic DMARDs or potent immunosuppressants.

The FDA has approved Xeljanz XR (tofacitinib), a Janus kinase (JAK) inhibitor, for the treatment of several inflammatory conditions in adults and children. For adults, the extended-release tablets are indicated for moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis, all after an inadequate response or intolerance to one or more TNF blockers. Additionally, the immediate-release formulations (tablets and oral solution) are approved for pediatric patients aged 2 years and older with active psoriatic arthritis or active polyarticular course juvenile idiopathic arthritis. The approval provides an alternative for patients who have failed TNF inhibitor therapy. The label emphasizes that Xeljanx XR should not be used in combination with biologic DMARDs or potent immunosuppressants like azathioprine and cyclosporine. Dosing varies by indication, with a maximum induction period of 16 weeks for ulcerative colitis. Clinicians should note that Xeljanz XR is not substitutable with the immediate-release formulations.

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

Mechanism of Action

XELJANZ (tofacitinib) is a Janus kinase (JAK) inhibitor. The exact mechanism of action is not fully described in the label.

Indication & Patient Population

XELJANZ XR (extended-release tablets) 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 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 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 XR 11 mg once daily. For adult UC induction: XELJANZ XR 22 mg once daily for 8 weeks; may continue for up to 16 weeks if needed. For UC maintenance: XELJANZ XR 11 mg once daily. For patients with loss of response during maintenance, XELJANZ XR 22 mg once daily may be considered for the shortest duration. For pediatric PsA or pcJIA: XELJANZ tablets or oral solution 5 mg twice daily for those ≥40 kg or weight-based equivalent for those <40 kg. Prior to initiation, evaluate for active and 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. XELJANZ XR is not substitutable with XELJANZ tablets or oral solution.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

XELJANZ XR is indicated for adult patients with RA, PsA, AS, or UC who have had an inadequate response or intolerance to one or more TNF blockers. Use in combination with biologic DMARDs or potent immunosuppressants (e.g., azathioprine, cyclosporine) is not recommended. For UC, use in combination with biological therapies for UC or potent immunosuppressants is not recommended.

The FDA has approved a new drug called Xeljanz XR (tofacitinib) for several inflammatory conditions. It is an extended-release tablet for adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis. These are conditions where the body's immune system attacks its own joints or digestive tract. The approval is for patients who have tried a type of medicine called a TNF blocker and it did not work well enough or caused side effects.

For children aged 2 years and older, the immediate-release forms (tablets and oral solution) are approved for active psoriatic arthritis and active polyarticular course juvenile idiopathic arthritis. This gives younger patients a new treatment option as well.

Xeljanz XR works by blocking certain enzymes (JAKs) that play a role in inflammation. It should not be used with other strong immune-suppressing drugs like biologic DMARDs, azathioprine, or cyclosporine. The dosing depends on the condition being treated, and for ulcerative colitis, the treatment period is limited to 16 weeks.

This approval means more choices for people with these conditions. However, it is important to remember that Xeljanz XR is not the same as the immediate-release versions and cannot be swapped directly. If you or your child have one of these conditions and are considering this medicine, talk to your doctor. They can help you understand if Xeljanz XR is right for you based on your health history and other treatments.

What this means for you:

Xeljanz XR is a new option for adults and children with certain inflammatory diseases after other treatments fail.

Study Details

Study typeFda approval

PublishedFeb 2016

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 XR (tofacitinib) for Multiple Inflammatory ConditionsFDA approved new arthritis and colitis drug Xeljanz XR for adults and children.

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.

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

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.

Related in Rheumatology

From Other Specialties