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Rheumatoid arthritis (RA) Rheumatoid arthritis (RA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Psoriatic arthritis (PsA) Psoriatic arthritis (PsA) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions Ulcerative colitis (UC) Ulcerative colitis (UC) Dosage and Administration Dose Adjustments and Drug Interactions Efficacy Mechanism of Action Prescribing Information Safety Special Populations and Contraindications Special Warnings and Precautions
Dosage and AdministrationDosage1

Treatment should be initiated and supervised by medical practitioners experienced in the diagnosis and treatment of conditions for which XELJANZ® (tofacitinib) is indicated.

  • The recommended dose is 10 mg given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.
  • For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. XELJANZ® (tofacitinib) induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
  • For some patients, such as those who have failed prior tumour necrosis factor (TNF) antagonist therapy, consideration should be given to continuation of the 10 mg twice daily dose for maintenance in order to maintain therapeutic benefit.
  • Patients who experience a decrease in response on XELJANZ® (tofacitinib) 5 mg twice daily maintenance therapy may benefit from an increase to XELJANZ® (tofacitinib) 10 mg administered twice daily.
  • In patients who have responded to treatment with XELJANZ® (tofacitinib), corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Dose adjustment1No dose adjustment is required when used in combination with MTX.Dose interruption and discontinuation1XELJANZ® (tofacitinib) treatment should be interrupted if a patient develops a serious infection until the infection is controlled. Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia.Retreatment in UC1If therapy is interrupted, restarting treatment with XELJANZ® (tofacitinib) can be considered. If there has been a loss of response, reinduction with XELJANZ® (tofacitinib) 10 mg twice daily may be considered. The treatment interruption period in clinical studies extended up to 1 year. Efficacy may be regained by 8 weeks of 10 mg twice daily therapy.Method of administration1 Storage Instructions1
ReferencesPfizer Laboratories (Pty) Ltd. XELJANZ® 5mg and 10mg film-coated tablets. Final Approved Package Insert - 27 October 2020.
PP-XEL-ZAF-0083

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