Tofacitinibdosage

Recommended Evaluations and Immunization Prior to Treatment Initiation Prior to initiating tofacitinib extended-release tablets, consider performing an active and latent TB evaluation, viral hepatitis screening, a complete blood count, and updating immunizations. Avoid tofacitinib extended-release tablets initiation if absolute lymphocyte count <500 cells/mm 3, an absolute neutrophil count (ANC) <1,000 cells/mm 3 or hemoglobin <9 g/dL. Important Administration Instructions Tofacitinib extended-release tablets are not substitutable with XELJANZ (tablets and oral solution). Switching between tofacitinib tablets and tofacitinib extended-release tablets should be made by the healthcare provider. Recommended Dosage Adult Patients with RA, PsA or AS Tofacitinib extended-release tablets 11 mg once daily. Dosage in Patients with Renal Impairment or Hepatic Impairment Use of tofacitinib extended-release tablets in patients with severe HI is not recommended. See full prescribing information (FPI) for recommended dosage in patients with moderate or severe RI or moderate HI. 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.

2.1 Recommended

Evaluations and Immunization Prior to Treatment Initiation Prior to initiating tofacitinib 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 tofacitinib extended-release tablets treatment. Viral hepatitis screening in accordance with clinical guidelines.

A complete blood count: Avoid initiation of tofacitinib extended-release tablets treatment in patients with a lymphocyte count less than 500 cells/mm 3, absolute neutrophil count less than 1,000 cells/mm 3, or hemoglobin level less than 9 g/dL.

Baseline hepatic function evaluation: tofacitinib extended-release tablets are not recommended for patients with severe hepatic impairment. Update immunizations according to current immunization guidelines. The interval between live vaccinations and initiation of tofacitinib extended-release tablets should be in accordance with current vaccination guidelines regarding immunosuppressive agents.

2.2 Important

Administration Instruction Tofacitinib extended-release tablets is not substitutable with XELJANZ (tablets and oral solution). Switching between XELJANZ and tofacitinib extended-release tablets should be made by the healthcare provider. Dose interruption is recommended for management of lymphopenia, neutropenia, and anemia. Interrupt use of tofacitinib extended-release tablets if a patient develops a serious infection until the infection is controlled. Take tofacitinib extended-release tablets with or without food. Swallow tofacitinib extended-release tablets whole and intact. Do not crush, split, or chew the extended-release tablets.

2.3 Recommended

Dosage in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis Table 1 displays the recommended dosage of tofacitinib extended-release tablets for adults with RA, PsA, and AS with and without renal impairment (including those who are undergoing hemodialysis) or hepatic impairment. The table also displays the recommended dosage modifications for patients concomitantly using CYP2C19 and/or CYP3A4 inhibitors, and patients with lymphopenia, neutropenia, or anemia.

Table 1: Recommended Dosage of Tofacitinib Extended-Release Tablets in Adults with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis a Excludes patients who concomitantly use XELJANZ tablets/tofacitinib extended-release tablets 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/mm 3, ANC <1,000 cells/mm 3, or hemoglobin less than 8 g/dL or a decrease of more than 2 g/dL. b 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). Adults Tofacitinib extended-release tablets Patients with Normal Renal and Hepatic Function a 11 mg once daily Recommended Dosage in Patients with Renal Impairment (RI) b Mild RI (CLcr >50 and ≤80 mL/min) 11 mg once daily Moderate RI (CLcr ≥30 and ≤50 mL/min) XELJANZ tablets 5 mg once daily Severe RI (CLcr <30 mL/min) 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) 11 mg once daily Moderate HI (Child-Pugh B) XELJANZ tablets 5 mg once daily Severe HI (Child-Pugh C) Use of XELJANZ tablets/tofacitinib extended-release tablets are not recommended. Dosage Modifications with Concomitant Use of CYP3A4 and/or CYP2C19 Inhibitor(s) Strong CYP2C19 inhibitor(s) 11 mg once daily Moderate CYP2C19 inhibitor(s) Moderate CYP3A4 inhibitor(s) Moderate CYP3A4 inhibitor(s) with strong CYP2C19 inhibitor(s) (e.g., fluconazole) 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/mm 3, confirmed by repeat testing Discontinue dosing. Patients with ANC less than 500 cells/mm 3 Discontinue dosing. Patients with ANC 500 cells/mm 3 to 1,000 cells/mm 3 Interrupt dosing. When ANC is greater than 1,000, 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 Tofacitinib Tablets to Tofacitinib Extended-Release Tablets Patients treated with tofacitinib tablets 5 mg twice daily may be switched to tofacitinib extended-release tablets 11 mg once daily the day following the last dose of tofacitinib tablets 5 mg.