• Can be given with or without food.
• XELJANZ 5mg tablets may be crushed and taken with water.
• XELJANZ 11 mg prolonged-release once daily 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.
• Terminal half-life of approximately 3 hours for XELJANZ 5 mg tablets and approximately 6 hours for XELJANZ 11 mg prolonged-release once daily tablets.
• XELJANZ is available in a 28-day treatment pack.
• XELJANZ 5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. For the full list of excipients, please see section 6.1 of the XELJANZ Summary of Product Characteristics.

XELJANZ 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. See tables in section 4.2 of the XELJANZ Summary of Product Characteristics for recommendations for temporary dose interruption or permanent discontinuation of treatment according to the severity of laboratory abnormalities.

• 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

• 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)

• No dose adjustment is required in patients 65 years of age and older. There are limited data in patients aged 75 years and older.
• Considering the increased risk of serious infections, myocardial infarction, malignancies and all cause mortality with tofacitinib in patients 65 years of age and older, XELJANZ should only be used in these patients if no suitable treatment alternatives are available (see section 4.4 of the Summary of Product Characteristics for further details).

• 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
• Co-administration of XELJANZ did not have an effect on the pharmacokinetics of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers

Please refer to the XELJANZ Summary of Product Characteristics for full prescribing information