HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR.
XELJANZ® (tofacitinib) tablets, for oral use
XELJANZ® (tofacitinib) oral solution
XELJANZ® XR (tofacitinib) extended-release tablets, for oral use
Initial U.S. Approval: 2012 WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSISSee full prescribing information for complete boxed warning.- •
- Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death. Interrupt XELJANZ/XELJANZ XR treatment if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. (5.1)
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- Higher rate of all-cause mortality, including sudden cardiovascular (CV) death with XELJANZ vs. TNF blockers in rheumatoid arthritis (RA) patients. (5.2)
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- Malignancies have occurred in patients treated with XELJANZ. Higher rate of lymphomas and lung cancers with XELJANZ vs. TNF blockers in RA patients. (5.3)
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- Higher rate of major adverse CV events (defined as CV death, myocardial infarction, and stroke) with XELJANZ vs. TNF blockers in RA patients. (5.4)
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- Thrombosis has occurred in patients treated with XELJANZ. Increased incidence of pulmonary embolism, venous and arterial thrombosis with XELJANZ vs. TNF blockers in RA patients. (5.5)
RECENT MAJOR CHANGES Boxed Warning | 10/2025 | Indications and Usage, Psoriatic Arthritis (1.2) | 10/2025 | Dosage and Administration, Recommended Dosage in Pediatric Patients 2 Years of Age and Older with Psoriatic Arthritis or Polyarticular Course Juvenile Idiopathic Arthritis (2.4) | 10/2025 |
INDICATIONS AND USAGEXELJANZ (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.
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- Active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
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- Active ankylosing spondylitis (AS), who have had an inadequate response or intolerance to one or more TNF blockers.
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- 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.
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- 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)
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- 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)
DOSAGE AND ADMINISTRATIONRecommended Evaluations and Immunization Prior to Treatment Initiation - •
- Prior to initiating XELJANZ/XELJANZ XR, consider performing an active and latent TB evaluation, viral hepatitis screening, a complete blood count, and updating immunizations. Avoid XELJANZ or XELJANZ XR initiation if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL. (2.1)
Important Administration Instructions - •
- XELJANZ XR (extended-release tablets) is not substitutable with XELJANZ (tablets and oral solution). (2.2)
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- Switching between XELJANZ and XELJANZ XR should be made by the healthcare provider. (2.2)
Recommended Dosage Adult Patients with RA, PsA or AS - •
- XELJANZ tablets 5 mg twice daily or XELJANZ XR (extended-release tablets) 11 mg once daily. (2.3)
Pediatric Patients 2 Years of Age and Older with PsA or pcJIA Who Weigh At Least 10 kg - •
- XELJANZ (tablets or oral solution) 5 mg twice daily for those ≥40 kg or weight-based equivalent twice daily for those <40 kg. (2.4)
Adult Patients with UC - •
- Induction: XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily for a maximum of 16 weeks. Discontinue XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved. (2.5)
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- Maintenance: XELJANZ tablets 5 mg twice daily or XELJANZ XR 11 mg once daily. For patients with loss of response during maintenance treatment, XELJANZ tablets 10 mg twice daily or XELJANZ XR 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dose needed to maintain response. (2.5)
Dosage in Patients with Renal Impairment or Hepatic Impairment - •
- Use of XELJANZ (tablets and oral solution) or XELJANZ XR in patients with severe HI is not recommended. (2.3, 2.4, 2.5, 8.7)
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- See full prescribing information (FPI) for recommended dosage in patients with moderate or severe RI or moderate HI. (2.3, 2.4, 2.5, 8.6, 8.7)
Dosage Modification See the full prescribing information for dosage modification by indication for patients who concomitantly use CYP2C19 and/or CYP3A4 inhibitors and patients with lymphopenia, neutropenia, or anemia. (2.3, 2.4, 2.5, 7) DOSAGE FORMS AND STRENGTHS- •
- XELJANZ tablets: 5 mg, 10 mg (3)
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- XELJANZ XR extended-release tablets: 11 mg, 22 mg (3)
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- XELJANZ oral solution: 1 mg/mL (3)
WARNINGS AND PRECAUTIONS- •
- Serious Infections: Avoid use of XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) during an active serious infection, including localized infections. (5.1)
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- Gastrointestinal Perforations: Promptly evaluate patients at increased risk for gastrointestinal perforation who present with new onset abdominal symptoms. (5.6)
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- Laboratory Monitoring: Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. (5.8)
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- Vaccinations: Avoid use of live vaccines concurrently with XELJANZ or XELJANZ XR. (5.9)
ADVERSE REACTIONSMost common adverse reactions are: - •
- RA, PsA, and AS: Reported in ≥2% of adult patients treated with XELJANZ tablets monotherapy or in combination with DMARDs: upper respiratory tract infection (URI), nasopharyngitis, diarrhea, and headache. (6.1)
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- PcJIA: Consistent with common adverse reactions reported in adult patients with RA. (6.1)
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- UC: Reported in ≥ 5% of adult patients treated with either XELJANZ tablets and ≥1% greater than reported in patients treated with placebo: nasopharyngitis, elevated cholesterol levels, headache, URI, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee FPI for clinically significant drug interactions. (2, 7) USE IN SPECIFIC POPULATIONSLactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 10/2025 |