Dosing in RA
Dosing
XELJANZ 5 mg BID and 11 mg prolonged release QD are the only approved dosages for the treatment of RA. XELJANZ prolonged release 11 mg QD is pharmacokinetically equivalent to XELJANZ 5 mg BID.
Another treatment option for Rheumatoid Arthritis (RA) patients1
Always refer to the full Prescribing Information before prescribing XELJANZ.
Tablets shown not true to size.
​​​​​​​Note: the dose should not be exceeded
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  • Can be given with or without food.
  • XELJANZ 5mg tablets may be crushed and taken with water.
  • XELJANZ 11 mg prolonged release tablets must be taken whole in order to ensure the entire dose is delivered correctly. They must not be crushed, split or chewed.
  • No dose adjustment required when used in combination with MTX.
  • XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
  • Terminal half-life of approximately 3 hours for XELJANZ 5 mg tablets and approximately 6 hours for XELJANZ 11 mg prolonged release tablets.
  • XELJANZ is available in a 28-day treatment pack.
  • XELJANZ contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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​​​​​​​Packs and tablets shown not true to size.
Contraindications and special populations1
Contraindications for use:
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  • Hypersensitivity to the active substance or to any of the excipients*.
  • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections.
  • Severe hepatic impairment.
  • Pregnancy and lactation.
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Special populations:
Renal Impairment
  • XELJANZ dose should be reduced to 5 mg once daily in patients with severe renal impairment (creatinine clearance <30 mL/min).
  • Patients with severe renal impairment should remain on a reduced dose of 5 mg once daily even after haemodialysis.
Hepatic impairment
  • XELJANZ dose should be reduced to 5 mg once daily in patients with moderate hepatic impairment (Child Pugh B).
  • XELJANZ should not be used in patients with severe hepatic impairment (Child Pugh C).
Elderly
  • No dose adjustment is required in patients aged ≥65 years based on age alone (see other special populations). There are limited data in patients aged 75 years and older.
  • The elderly population in general has an increased risk of infections; caution should be used when treating the elderly. In patients over 65 years of age XELJANZ should only be considered if no suitable alternative treatment is available.​​​​​​​
Other
  • XELJANZ should only be used in patients over 65 years of age, In patients who are current or past smokers, patients with other cardiovascular risk factors, and patients with other malignancy risk factors if no suitable treatment alternatives are available.
Drug-drug interactions
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  • XELJANZ dose should be reduced to 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole).
  • XELJANZ dose should also be reduced to 5 mg once daily in patients receiving one or more concomitant medicines that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g. fluconazole).
  • Co-administration of XELJANZ with potent CYP inducers (e.g. rifampicin) may result in a loss of, or reduced, clinical response.
  • Co-administration of potent inducers of CYP3A4 with XELJANZ is not recommended.
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* XELJANZ contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

MTX - methotrexate; BID - twice daily; QD - once daily; TB - tuberculosis; RA - rheumatoid arthritis; PsA - psoriatic arthritis.
References
  1. ​​​​​​​​​​​​​​XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
PP-XEL-GBR-3109. August 2021
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

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