Xeljanz

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.

• •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 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.
  )
• •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 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.
  )

• •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 Recommended Evaluations and Immunization Prior to Treatment Initiation

  Prior to initiating XELJANZ (tablets and oral solution) or XELJANZ XR (extended-release tablets), consider performing the following:

  • •Active and latent tuberculosis (TB) infection evaluation: If the patient has latent TB, treat for TB prior to XELJANZ/XELJANZ XR treatment
    [see Warnings and Precautions (5.1)]
    .
  • •Viral hepatitis screening in accordance with clinical guidelines
    [see Warnings and Precautions (5.1)]
    .
  • •A complete blood count: Avoid initiation of XELJANZ/XELJANZ XR treatment in patients with a lymphocyte count less than 500 cells/mm³, absolute neutrophil count less than 1000 cells/mm³, or hemoglobin level less than 9 g/dL
    [see Warnings and Precautions (5.8)]
    .
  • •Baseline hepatic function evaluation: XELJANZ/XELJANZ XR is not recommended for patients with severe hepatic impairment
    [see Use in Specific Populations (8.7)and Clinical Pharmacology (12.3)]
    .
  • •Update immunizations according to current immunization guidelines. The interval between live vaccinations and initiation of XELJANZ/XELJANZ XR should be in accordance with current vaccination guidelines regarding immunosuppressive agents
    [see Warnings and Precautions (5.9)]
    .
  )

• •XELJANZ XR (extended-release tablets) is not substitutable with XELJANZ (tablets and oral solution). (
  2.2 Important Administration Instructions

  • •XELJANZ XR (extended-release tablets) is not substitutable with XELJANZ (tablets and oral solution). Switching between XELJANZ and XELJANZ XR should be made by the healthcare provider.
  • •Dose interruption is recommended for management of lymphopenia, neutropenia, and anemia
    [see Warnings and Precautions (5.8)and Adverse Reactions (6.1)]
    .
  • •Interrupt use of XELJANZ/XELJANZ XR if a patient develops a serious infection until the infection is controlled
    [see Warnings and Precautions (5.1)]
    .
  • •Take XELJANZ/XELJANZ XR with or without food
    [see Clinical Pharmacology (12.3)]
    .
  • •Swallow XELJANZ XR whole and intact. Do not crush, split, or chew the extended-release tablets
    [see Clinical Pharmacology (12.3)]
    .
• •Switching between XELJANZ and XELJANZ XR should be made by the healthcare provider. (
  2.2 Important Administration Instructions

  • •XELJANZ XR (extended-release tablets) is not substitutable with XELJANZ (tablets and oral solution). Switching between XELJANZ and XELJANZ XR should be made by the healthcare provider.
  • •Dose interruption is recommended for management of lymphopenia, neutropenia, and anemia
    [see Warnings and Precautions (5.8)and Adverse Reactions (6.1)]
    .
  • •Interrupt use of XELJANZ/XELJANZ XR if a patient develops a serious infection until the infection is controlled
    [see Warnings and Precautions (5.1)]
    .
  • •Take XELJANZ/XELJANZ XR with or without food
    [see Clinical Pharmacology (12.3)]
    .
  • •Swallow XELJANZ XR whole and intact. Do not crush, split, or chew the extended-release tablets
    [see Clinical Pharmacology (12.3)]
    .
  )

• •XELJANZ tablets 5 mg twice daily or XELJANZ XR (extended-release tablets) 11 mg once daily. (
  2.3 Recommended Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

  Table 1 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) for adults with RA, PsA, and AS

  [see Indication and Usage (1.1, 1.2, 1.3)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also displays the recommended dosage modifications for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 1: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	5 mg twice daily	11 mg once daily
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	5 mg twice daily	11 mg once daily
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe RI (CLcr <30 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	5 mg twice daily	11 mg once daily
  Moderate HI (Child-Pugh B)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	5 mg twice daily	11 mg once daily
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.	Interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets 5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  )

• •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 Recommended Dosage in Pediatric Patients 2 Years of Age and Older with Psoriatic Arthritis or Polyarticular Course Juvenile Idiopathic Arthritis

  Table 2 displays the recommended body weight-based dosages for XELJANZ tablets and XELJANZ oral solution in pediatric patients 2 years of age and older with PsA or pcJIA

  [see Indication and Usage (1.2, 1.4)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also includes recommended dosage modification for pediatric patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and pediatric patients with lymphopenia, neutropenia, or anemia.

  Administer XELJANZ oral solution using the included press-in bottle adapter and oral dosing syringe

  [see Instructions for Use]

  .

  10 kg ≤ body weight <20 kg: 3.2 mg (3.2 mL oral solution) twice daily

  20 kg ≤ body weight <40 kg: 4 mg (4 mL oral solution) twice daily

  Body weight ≥40 kg: 5 mg (one 5 mg tablet or 5 mL oral solution) twice dailyPatients treated with XELJANZ oral solution 5 mL may be switched to XELJANZ tablets 5 mg.10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  Table 2: Recommended Dosage of XELJANZ Tablets and XELJANZ Oral Solution in Pediatric Patients 2 Years of Age and Older with PsA or pcJIA

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  Pediatric Patients 2 Years of Age and Older	XELJANZ tablets and XELJANZ oral solution
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ (tablets and oral solution) with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.
  Recommended Dosage in Patients with Renal Impairment (RI)
  Mild RI	Same as patients with normal renal function.
  Moderate RI
  Severe RI
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI	Same as patients with normal hepatic function.
  Moderate HI
  Severe HI	Use of XELJANZ tablets/XELJANZ oral solution is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing until ANC is greater than 1000 cells/mm3.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.
  )

• •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 Recommended Dosage in Adults with Ulcerative Colitis

  Table 3 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) in adult patients with ulcerative colitis (UC)

  [see Indications and Usage (1.5)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . Table 4 displays the recommended dosage modification for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 3: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Ulcerative Colitis With and Without Renal Impairment or Hepatic Impairment

  Adults	XELJANZ tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic FunctionExcludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	Induction: 10 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 10 mg twice daily for a maximum of 16 weeks. Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 22 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 22 mg once daily for a maximum of 16 weeks. Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg twice daily. For patients with loss of response during maintenance treatment, may consider a dosage of 10 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: 11 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 22 mg once daily (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.
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); CLcr >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	Same as patients with normal renal function.
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Severe RI (CLcr <30 mL/min)	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate or Severe RI. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	Same as patients with normal hepatic function.
  Moderate HI (Child-Pugh B)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate HI.
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.

  10 mg twice daily, reduce to 5 mg twice daily. When ANC is greater than 1000, increase to 10 mg twice daily based on clinical response.

  5 mg twice daily, interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.22 mg once daily, reduce to 11 mg once daily. When ANC is greater than 1000, increase to 22 mg once daily based on clinical response.

  11 mg once daily, interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.

  Table 4: Dosage Modifications of XELJANZ Tablets and XELJANZ XR Due to Drug Interactions and for Lymphopenia, Neutropenia or Anemia in Adults with Ulcerative Colitis

  •

  •

  •

  •

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Strong CYP3A4 inhibitor(s)
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. see Maintenance Dosage for XELJANZ tablets for Strong CYP3A4 inhibitors.
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  ANC less than 500 cells/mm3	Discontinue dosing.
  ANC 500 to 1000 cells/mm3	If taking:
  If taking:
  Hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets:

  • •5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  • •10 mg twice daily may be switched to XELJANZ XR extended-release tablets 22 mg once daily the day following the last dose of XELJANZ tablets 10 mg.
  )
• •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 Recommended Dosage in Adults with Ulcerative Colitis

  Table 3 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) in adult patients with ulcerative colitis (UC)

  [see Indications and Usage (1.5)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . Table 4 displays the recommended dosage modification for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 3: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Ulcerative Colitis With and Without Renal Impairment or Hepatic Impairment

  Adults	XELJANZ tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic FunctionExcludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	Induction: 10 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 10 mg twice daily for a maximum of 16 weeks. Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 22 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 22 mg once daily for a maximum of 16 weeks. Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg twice daily. For patients with loss of response during maintenance treatment, may consider a dosage of 10 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: 11 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 22 mg once daily (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.
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); CLcr >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	Same as patients with normal renal function.
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Severe RI (CLcr <30 mL/min)	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate or Severe RI. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	Same as patients with normal hepatic function.
  Moderate HI (Child-Pugh B)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate HI.
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.

  10 mg twice daily, reduce to 5 mg twice daily. When ANC is greater than 1000, increase to 10 mg twice daily based on clinical response.

  5 mg twice daily, interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.22 mg once daily, reduce to 11 mg once daily. When ANC is greater than 1000, increase to 22 mg once daily based on clinical response.

  11 mg once daily, interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.

  Table 4: Dosage Modifications of XELJANZ Tablets and XELJANZ XR Due to Drug Interactions and for Lymphopenia, Neutropenia or Anemia in Adults with Ulcerative Colitis

  •

  •

  •

  •

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Strong CYP3A4 inhibitor(s)
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. see Maintenance Dosage for XELJANZ tablets for Strong CYP3A4 inhibitors.
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  ANC less than 500 cells/mm3	Discontinue dosing.
  ANC 500 to 1000 cells/mm3	If taking:
  If taking:
  Hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets:

  • •5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  • •10 mg twice daily may be switched to XELJANZ XR extended-release tablets 22 mg once daily the day following the last dose of XELJANZ tablets 10 mg.
  )

• •Use of XELJANZ (tablets and oral solution) or XELJANZ XR in patients with severe HI is not recommended. (
  2.3 Recommended Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

  Table 1 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) for adults with RA, PsA, and AS

  [see Indication and Usage (1.1, 1.2, 1.3)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also displays the recommended dosage modifications for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 1: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	5 mg twice daily	11 mg once daily
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	5 mg twice daily	11 mg once daily
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe RI (CLcr <30 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	5 mg twice daily	11 mg once daily
  Moderate HI (Child-Pugh B)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	5 mg twice daily	11 mg once daily
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.	Interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets 5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  ,
  2.4 Recommended Dosage in Pediatric Patients 2 Years of Age and Older with Psoriatic Arthritis or Polyarticular Course Juvenile Idiopathic Arthritis

  Table 2 displays the recommended body weight-based dosages for XELJANZ tablets and XELJANZ oral solution in pediatric patients 2 years of age and older with PsA or pcJIA

  [see Indication and Usage (1.2, 1.4)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also includes recommended dosage modification for pediatric patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and pediatric patients with lymphopenia, neutropenia, or anemia.

  Administer XELJANZ oral solution using the included press-in bottle adapter and oral dosing syringe

  [see Instructions for Use]

  .

  10 kg ≤ body weight <20 kg: 3.2 mg (3.2 mL oral solution) twice daily

  20 kg ≤ body weight <40 kg: 4 mg (4 mL oral solution) twice daily

  Body weight ≥40 kg: 5 mg (one 5 mg tablet or 5 mL oral solution) twice dailyPatients treated with XELJANZ oral solution 5 mL may be switched to XELJANZ tablets 5 mg.10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  Table 2: Recommended Dosage of XELJANZ Tablets and XELJANZ Oral Solution in Pediatric Patients 2 Years of Age and Older with PsA or pcJIA

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  Pediatric Patients 2 Years of Age and Older	XELJANZ tablets and XELJANZ oral solution
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ (tablets and oral solution) with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.
  Recommended Dosage in Patients with Renal Impairment (RI)
  Mild RI	Same as patients with normal renal function.
  Moderate RI
  Severe RI
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI	Same as patients with normal hepatic function.
  Moderate HI
  Severe HI	Use of XELJANZ tablets/XELJANZ oral solution is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing until ANC is greater than 1000 cells/mm3.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.
  ,
  2.5 Recommended Dosage in Adults with Ulcerative Colitis

  Table 3 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) in adult patients with ulcerative colitis (UC)

  [see Indications and Usage (1.5)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . Table 4 displays the recommended dosage modification for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 3: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Ulcerative Colitis With and Without Renal Impairment or Hepatic Impairment

  Adults	XELJANZ tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic FunctionExcludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	Induction: 10 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 10 mg twice daily for a maximum of 16 weeks. Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 22 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 22 mg once daily for a maximum of 16 weeks. Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg twice daily. For patients with loss of response during maintenance treatment, may consider a dosage of 10 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: 11 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 22 mg once daily (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.
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); CLcr >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	Same as patients with normal renal function.
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Severe RI (CLcr <30 mL/min)	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate or Severe RI. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	Same as patients with normal hepatic function.
  Moderate HI (Child-Pugh B)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate HI.
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.

  10 mg twice daily, reduce to 5 mg twice daily. When ANC is greater than 1000, increase to 10 mg twice daily based on clinical response.

  5 mg twice daily, interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.22 mg once daily, reduce to 11 mg once daily. When ANC is greater than 1000, increase to 22 mg once daily based on clinical response.

  11 mg once daily, interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.

  Table 4: Dosage Modifications of XELJANZ Tablets and XELJANZ XR Due to Drug Interactions and for Lymphopenia, Neutropenia or Anemia in Adults with Ulcerative Colitis

  •

  •

  •

  •

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Strong CYP3A4 inhibitor(s)
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. see Maintenance Dosage for XELJANZ tablets for Strong CYP3A4 inhibitors.
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  ANC less than 500 cells/mm3	Discontinue dosing.
  ANC 500 to 1000 cells/mm3	If taking:
  If taking:
  Hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets:

  • •5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  • •10 mg twice daily may be switched to XELJANZ XR extended-release tablets 22 mg once daily the day following the last dose of XELJANZ tablets 10 mg.
  ,
  8.7 Hepatic Impairment

  Severe Hepatic Impairment

  XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) has not been studied in patients with severe hepatic impairment (HI) (Child-Pugh C); therefore, use of XELJANZ/XELJANZ XR in patients with severe HI is not recommended.

  Moderate Hepatic Impairment

  XELJANZ-treated patients with moderate hepatic impairment (Child-Pugh B) had greater tofacitinib blood concentration than XELJANZ-treated patients with normal hepatic function

  [see Clinical Pharmacology (12.3)]

  . Higher blood concentrations may increase the risk of some adverse reactions. The recommended XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) dosage in patients with moderate HI is lower than the recommended dosage in patients with normal hepatic function

  [see Dosage and Administration (2.3, 2.4, 2.5)]

  .

  Mild Hepatic Impairment

  The recommended dosage of XELJANZ/XELJANZ XR in patients with mild hepatic impairment (Child-Pugh A) is the same as patients with normal hepatic function.

  Hepatitis B or C Serology

  The safety and efficacy of XELJANZ/XELJANZ XR have not been studied in patients with positive hepatitis B virus or hepatitis C virus serology.
  )
• •See full prescribing information (FPI) for recommended dosage in patients with moderate or severe RI or moderate HI. (
  2.3 Recommended Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

  Table 1 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) for adults with RA, PsA, and AS

  [see Indication and Usage (1.1, 1.2, 1.3)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also displays the recommended dosage modifications for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 1: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	5 mg twice daily	11 mg once daily
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	5 mg twice daily	11 mg once daily
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe RI (CLcr <30 mL/min)	5 mg once daily	XELJANZ tablets 5 mg once daily
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	5 mg twice daily	11 mg once daily
  Moderate HI (Child-Pugh B)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	5 mg twice daily	11 mg once daily
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	5 mg once daily	XELJANZ tablets 5 mg once daily
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.	Interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets 5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  ,
  2.4 Recommended Dosage in Pediatric Patients 2 Years of Age and Older with Psoriatic Arthritis or Polyarticular Course Juvenile Idiopathic Arthritis

  Table 2 displays the recommended body weight-based dosages for XELJANZ tablets and XELJANZ oral solution in pediatric patients 2 years of age and older with PsA or pcJIA

  [see Indication and Usage (1.2, 1.4)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . The table also includes recommended dosage modification for pediatric patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and pediatric patients with lymphopenia, neutropenia, or anemia.

  Administer XELJANZ oral solution using the included press-in bottle adapter and oral dosing syringe

  [see Instructions for Use]

  .

  10 kg ≤ body weight <20 kg: 3.2 mg (3.2 mL oral solution) twice daily

  20 kg ≤ body weight <40 kg: 4 mg (4 mL oral solution) twice daily

  Body weight ≥40 kg: 5 mg (one 5 mg tablet or 5 mL oral solution) twice dailyPatients treated with XELJANZ oral solution 5 mL may be switched to XELJANZ tablets 5 mg.10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  10 kg ≤ body weight <20 kg: 3.2 mg once daily

  20 kg ≤ body weight <40 kg: 4 mg once daily

  Body weight ≥40 kg: 5 mg once daily

  Table 2: Recommended Dosage of XELJANZ Tablets and XELJANZ Oral Solution in Pediatric Patients 2 Years of Age and Older with PsA or pcJIA

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  •

  Pediatric Patients 2 Years of Age and Older	XELJANZ tablets and XELJANZ oral solution
  Patients with Normal Renal and Hepatic Function Excludes patients who concomitantly use XELJANZ (tablets and oral solution) with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.
  Recommended Dosage in Patients with Renal Impairment (RI)
  Mild RI	Same as patients with normal renal function.
  Moderate RI
  Severe RI
  	For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI	Same as patients with normal hepatic function.
  Moderate HI
  Severe HI	Use of XELJANZ tablets/XELJANZ oral solution is not recommended.
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)
  Strong CYP3A4 inhibitor(s)
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  Patients with ANC less than 500 cells/mm3	Discontinue dosing.
  Patients with ANC 500 to 1000 cells/mm3	Interrupt dosing until ANC is greater than 1000 cells/mm3.
  Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.
  ,
  2.5 Recommended Dosage in Adults with Ulcerative Colitis

  Table 3 displays the recommended dosage of XELJANZ tablets and XELJANZ XR (extended-release tablets) in adult patients with ulcerative colitis (UC)

  [see Indications and Usage (1.5)]

  with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment

  [see Use in Specific Populations (8.6, 8.7)]

  . Table 4 displays the recommended dosage modification for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors

  [see Drug Interactions (7)and Clinical Pharmacology (12.3)]

  , and patients with lymphopenia, neutropenia, or anemia.

  Table 3: Recommended Dosage of XELJANZ Tablets and XELJANZ XR in Adults with Ulcerative Colitis With and Without Renal Impairment or Hepatic Impairment

  Adults	XELJANZ tablets	XELJANZ XR (extended-release tablets)
  Patients with Normal Renal and Hepatic FunctionExcludes patients who concomitantly use XELJANZ tablets/XELJANZ XR with strong CYP3A4 inhibitor(s) or moderate CYP3A4 inhibitor(s) and strong CYP2C19 inhibitor(s), as well as patients with lymphocyte count less than 500 cells/mm3, ANC <1000 cells/mm3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL.	Induction: 10 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 10 mg twice daily for a maximum of 16 weeks. Discontinue 10 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 22 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 22 mg once daily for a maximum of 16 weeks. Discontinue 22 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg twice daily. For patients with loss of response during maintenance treatment, may consider a dosage of 10 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: 11 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 22 mg once daily (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.
  Recommended Dosage in Patients with Renal Impairment (RI) Tofacitinib PK was evaluated in subjects with varying degrees of renal impairment, where the severity of renal impairment was defined based on creatinine clearance (CLcr) estimated using the Cockcroft‑Gault equation: CLcr >80 mL/min (normal renal function); CLcr >50 and ≤80 mL/min (mild renal impairment); ≥30 and ≤50 mL/min (moderate renal impairment); <30 mL/min (severe renal impairment).
  Mild RI (CLcr >50 and ≤80 mL/min)	Same as patients with normal renal function.
  Moderate RI (CLcr ≥30 and ≤50 mL/min)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Severe RI (CLcr <30 mL/min)	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate or Severe RI. For patients undergoing hemodialysis, administer the dose after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended after dialysis.
  Recommended Dosage in Patients with Hepatic Impairment (HI)
  Mild HI (Child-Pugh A)	Same as patients with normal hepatic function.
  Moderate HI (Child-Pugh B)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. See Maintenance Dosage for XELJANZ tablets for Moderate HI.
  Severe HI (Child-Pugh C)	Use of XELJANZ tablets/XELJANZ XR is not recommended.

  10 mg twice daily, reduce to 5 mg twice daily. When ANC is greater than 1000, increase to 10 mg twice daily based on clinical response.

  5 mg twice daily, interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.22 mg once daily, reduce to 11 mg once daily. When ANC is greater than 1000, increase to 22 mg once daily based on clinical response.

  11 mg once daily, interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.

  Table 4: Dosage Modifications of XELJANZ Tablets and XELJANZ XR Due to Drug Interactions and for Lymphopenia, Neutropenia or Anemia in Adults with Ulcerative Colitis

  •

  •

  •

  •

  Adults	XELJANZ Tablets	XELJANZ XR (extended-release tablets)
  Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s)
  Strong CYP2C19 inhibitor(s)	No dosage modification is recommended.
  Moderate CYP2C19 inhibitor(s)
  Moderate CYP3A4 inhibitor(s)
  Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole)	Induction: 5 mg twice daily for at least 8 weeks [see Clinical Studies (14.5)] ; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 5 mg twice daily for a maximum of 16 weeks. Discontinue 5 mg twice daily after 16 weeks if adequate therapeutic response is not achieved.	Induction: 11 mg once daily for at least 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed continue 11 mg once daily for a maximum of 16 weeks. Discontinue 11 mg once daily after 16 weeks if adequate therapeutic response is not achieved.
  Strong CYP3A4 inhibitor(s)
  	Maintenance: 5 mg once daily. For patients with loss of response during maintenance treatment, may consider a dosage of 5 mg twice daily (limited to the shortest duration), with careful consideration of the benefits and risks for the individual patient. Use the lowest effective dosage needed to maintain response.	Maintenance: XELJANZ XR is not recommended. see Maintenance Dosage for XELJANZ tablets for Strong CYP3A4 inhibitors.
  Dosage Modifications for Lymphopenia, Neutropenia, or Anemia
  Lymphocyte count less than 500 cells/mm3, confirmed by repeat testing	Discontinue dosing.
  ANC less than 500 cells/mm3	Discontinue dosing.
  ANC 500 to 1000 cells/mm3	If taking:
  If taking:
  Hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL	Interrupt dosing until hemoglobin values have normalized.

  Switching from XELJANZ Tablets to XELJANZ XR Extended-Release Tablets

  Patients treated with XELJANZ tablets:

  • •5 mg twice daily may be switched to XELJANZ XR extended-release tablets 11 mg once daily the day following the last dose of XELJANZ tablets 5 mg.
  • •10 mg twice daily may be switched to XELJANZ XR extended-release tablets 22 mg once daily the day following the last dose of XELJANZ tablets 10 mg.
  ,
  8.6 Renal Impairment

  Moderate and Severe Renal Impairment

  XELJANZ-treated patients with moderate renal impairment (RI) (CLcr ≥30 and ≤50 mL/minute) or severe RI (<30 mL/minute) had greater tofacitinib blood concentrations than XELJANZ-treated patients with normal renal function (CLcr >80 mL/minute). The recommended dosage of XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) in patients with moderate or severe RI (including those with severe RI who are undergoing hemodialysis) is lower than the recommended dosage in patients with normal renal function

  [see Dosage and Administration (2.3, 2.4, 2.5)]

  .

  Mild Renal Impairment

  The recommended dosage in patients with mild RI (CLcr >50 and ≤80 mL/minute) is the same as patients with normal renal function.
  ,
  8.7 Hepatic Impairment

  Severe Hepatic Impairment

  XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) has not been studied in patients with severe hepatic impairment (HI) (Child-Pugh C); therefore, use of XELJANZ/XELJANZ XR in patients with severe HI is not recommended.

  Moderate Hepatic Impairment

  XELJANZ-treated patients with moderate hepatic impairment (Child-Pugh B) had greater tofacitinib blood concentration than XELJANZ-treated patients with normal hepatic function

  [see Clinical Pharmacology (12.3)]

  . Higher blood concentrations may increase the risk of some adverse reactions. The recommended XELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) dosage in patients with moderate HI is lower than the recommended dosage in patients with normal hepatic function

  [see Dosage and Administration (2.3, 2.4, 2.5)]

  .

  Mild Hepatic Impairment

  The recommended dosage of XELJANZ/XELJANZ XR in patients with mild hepatic impairment (Child-Pugh A) is the same as patients with normal hepatic function.

  Hepatitis B or C Serology

  The safety and efficacy of XELJANZ/XELJANZ XR have not been studied in patients with positive hepatitis B virus or hepatitis C virus serology.
  )

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. (

• •XELJANZ tablets: 5 mg, 10 mg (
  3 DOSAGE FORMS AND STRENGTHS

  • •XELJANZ tablets: 5 mg, 10 mg
  • •XELJANZ XR extended-release tablets: 11 mg, 22 mg
  • •XELJANZ oral solution: 1 mg/mL

  XELJANZ tablets:

  • o5 mg of tofacitinib: White, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 5” on the other side.
  • o10 mg of tofacitinib: Blue, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 10” on the other side.

  XELJANZ XR extended-release tablets:

  • o11 mg of tofacitinib: Pink, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
  • o22 mg of tofacitinib: Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 22” printed on one side of the tablet.

  XELJANZ oral solution:

  1 mg/mL of tofacitinib: Clear, colorless oral solution.
  )
• •XELJANZ XR extended-release tablets: 11 mg, 22 mg (
  3 DOSAGE FORMS AND STRENGTHS

  • •XELJANZ tablets: 5 mg, 10 mg
  • •XELJANZ XR extended-release tablets: 11 mg, 22 mg
  • •XELJANZ oral solution: 1 mg/mL

  XELJANZ tablets:

  • o5 mg of tofacitinib: White, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 5” on the other side.
  • o10 mg of tofacitinib: Blue, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 10” on the other side.

  XELJANZ XR extended-release tablets:

  • o11 mg of tofacitinib: Pink, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
  • o22 mg of tofacitinib: Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 22” printed on one side of the tablet.

  XELJANZ oral solution:

  1 mg/mL of tofacitinib: Clear, colorless oral solution.
  )
• •XELJANZ oral solution: 1 mg/mL (
  3 DOSAGE FORMS AND STRENGTHS

  • •XELJANZ tablets: 5 mg, 10 mg
  • •XELJANZ XR extended-release tablets: 11 mg, 22 mg
  • •XELJANZ oral solution: 1 mg/mL

  XELJANZ tablets:

  • o5 mg of tofacitinib: White, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 5” on the other side.
  • o10 mg of tofacitinib: Blue, round, immediate-release film-coated tablets, debossed with “Pfizer” on one side, and “JKI 10” on the other side.

  XELJANZ XR extended-release tablets:

  • o11 mg of tofacitinib: Pink, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
  • o22 mg of tofacitinib: Beige, oval, extended-release film-coated tablets with a drilled hole at one end of the tablet band and “JKI 22” printed on one side of the tablet.

  XELJANZ oral solution:

  1 mg/mL of tofacitinib: Clear, colorless oral solution.
  )