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XELJANZ / XELJANZ XR (tofacitinib) Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Do not initiate XELJANZ/XELJANZ XR in patients with an absolute lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or who have hemoglobin levels less than 9 g/dL.
  • Dose interruption is recommended for management of lymphopenia, neutropenia, and anemia [see Warnings and Precautions (5.7), 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 tablets whole and intact. Do not crush, split, or chew.

2.2 Recommended Dosage in Rheumatoid Arthritis and Psoriatic Arthritis

Table 1 displays the recommended adult daily dosage of XELJANZ and XELJANZ XR and dosage adjustments for patients receiving CYP2C19 and/or CYP3A4 inhibitors, in patients with moderate or severe renal impairment (including but not limited to those with severe insufficiency who are undergoing hemodialysis) or moderate hepatic impairment, with lymphopenia, neutropenia, or anemia.

Table 1: Recommended Dosage of XELJANZ and XELJANZ XR in Patients with Rheumatoid Arthritis* and Psoriatic Arthritis
XELJANZXELJANZ XR
*
XELJANZ/XELJANZ XR may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis.
XELJANZ/XELJANZ XR is used in combination with nonbiologic disease modifying antirheumatic drugs (DMARDs) in psoriatic arthritis. The efficacy of XELJANZ/XELJANZ XR as a monotherapy has not been studied in psoriatic arthritis.
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
Adult patients5 mg twice daily11 mg once daily
Patients receiving:
  • Strong CYP3A4 inhibitors (e.g., ketoconazole), or
  • a moderate CYP3A4 inhibitor(s) with a strong CYP2C19 inhibitor(s) (e.g., fluconazole)
[see Drug Interactions (7)]
5 mg once dailyReduce to XELJANZ 5 mg once daily
Patients with: 5 mg once dailyReduce to XELJANZ 5 mg once daily
For patients undergoing hemodialysis, dose should be administered after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended in patients after dialysis.
Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testingDiscontinue dosing.
Patients with ANC 500 to 1000 cells/mm3Interrupt 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 ANC less than 500 cells/mm3Discontinue dosing.
Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dLInterrupt dosing until hemoglobin values have normalized.

Switching from XELJANZ Tablets to XELJANZ XR Tablets

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

2.3 Recommended Dosage in Ulcerative Colitis

Table 2 displays the recommended adult daily dosage of XELJANZ/XELJANZ XR and dosage adjustments for patients receiving CYP2C19 and/or CYP3A4 inhibitors, with moderate or severe renal impairment (including but not limited to those with severe insufficiency who are undergoing hemodialysis) or moderate hepatic impairment, with lymphopenia, neutropenia or anemia.

Table 2: Recommended Dosage of XELJANZ/XELJANZ XR in Patients with UC
XELJANZXELJANZ XR
*
Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended.
Adult patientsInduction: 10 mg twice daily for at least 8 weeks [see Clinical Studies (14.3)]; 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.
Maintenance: 5 mg twice daily.
For patients with loss of response during maintenance treatment, a dosage of 10 mg twice 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.
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: 11 mg once daily.
For patients with loss of response during maintenance treatment, a dosage of 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.
Patients receiving:
  • Strong CYP3A4 inhibitors (e.g., ketoconazole), or
  • a moderate CYP3A4 inhibitor(s) with a strong CYP2C19 inhibitor(s) (e.g., fluconazole)
[see Drug Interactions (7)]
If taking 10 mg twice daily, reduce to 5 mg twice daily.
If taking 5 mg twice daily, reduce to 5 mg once daily.
If taking 22 mg once daily, reduce to 11 mg once daily.
If taking 11 mg once daily, reduce to XELJANZ 5 mg once daily
Patients with: If taking 10 mg twice daily, reduce to 5 mg twice daily.
If taking 5 mg twice daily, reduce to 5 mg once daily.
If taking 22 mg once daily, reduce to 11 mg once daily.
If taking 11 mg once daily, reduce to XELJANZ 5 mg once daily.
For patients undergoing hemodialysis, dose should be administered after the dialysis session on dialysis days. If a dose was taken before the dialysis procedure, supplemental doses are not recommended in patients after dialysis.
Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testingDiscontinue dosing.
Patients with ANC 500 to 1000 cells/mm3If taking 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.
If taking 5 mg twice daily, interrupt dosing. When ANC is greater than 1000, resume 5 mg twice daily.
If taking 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.
If taking 11 mg once daily, interrupt dosing. When ANC is greater than 1000, resume 11 mg once daily.
Patients with ANC less than 500 cells/mm3Discontinue dosing.
Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dLInterrupt dosing until hemoglobin values have normalized.

Switching from XELJANZ Tablets to XELJANZ XR Tablets

Patients treated with XELJANZ 5 mg twice daily may be switched to XELJANZ XR 11 mg once daily the day following the last dose of XELJANZ 5 mg. Patients treated with XELJANZ 10 mg twice daily may be switched to XELJANZ XR 22 mg once daily the day following the last dose of XELJANZ 10 mg.

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