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Xeljanz Dosage

Generic name: TOFACITINIB CITRATE 5mg
Dosage form: tablet, film coated

Medically reviewed on August 27, 2018.

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 (5.4), 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.

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 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
XELJANZ XELJANZ 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 patients 5 mg twice daily 11 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 daily Switch to XELJANZ 5 mg once daily
Patients with: 5 mg once daily Switch to XELJANZ 5 mg once daily
Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing 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 ANC less than 500 cells/mm3 Discontinue dosing.
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 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.

Recommended Dosage in Ulcerative Colitis

Table 2 displays the recommended adult daily dosage of XELJANZ and dosage adjustments for patients receiving CYP2C19 and/or CYP3A4 inhibitors, with moderate or severe renal impairment or moderate hepatic impairment, with lymphopenia, neutropenia or anemia.

Table 2: Recommended Dosage of XELJANZ in Patients with UC
Ulcerative Colitis XELJANZ
*
Use in patients with severe hepatic impairment is not recommended.
Adult patients 10 mg twice daily for at least 8 weeks; followed by 5 or 10 mg twice daily, depending on therapeutic response [see Clinical Studies (14.3)].
Use the lowest effective dose to maintain response [see Warnings and Precautions (5.1, 5.2, 5.4)].
Discontinue XELJANZ after 16 weeks of treatment with 10 mg twice daily, if adequate therapeutic benefit is not achieved.
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.
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.
Patients with lymphocyte count less than 500 cells/mm3, confirmed by repeat testing Discontinue dosing.
Patients with ANC 500 to 1000 cells/mm3 If 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.
Patients with ANC less than 500 cells/mm3 Discontinue dosing.
Patients with hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL Interrupt dosing until hemoglobin values have normalized.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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