• The recommended dose is 10 mg given orally twice daily for induction for 8 weeks.
• 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 induction therapy should be discontinued in any patient who shows no evidence of theraputic benefit by week 16.

• The recommended dose for maintenance treatment is XELJANZ 5 mg given twice daily.
• XELJANZ 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known venous thromboembolism (VTE), major adverse cardiovascular events (MACE) and malignancy risk factors, unless there is no suitable alternative treatment available (see section 4.4 and 4.8 of the XELJANZ Summary of Product Characteristics).
• For patients with UC who are not at increased risk for VTE, MACE and malignancy (see section 4.4 of the XELJANZ Summary of Product Characteristics), XELJANZ 10 mg orally twice daily may be considered if the patient experiences a decrease in response on XELJANZ 5 mg twice daily and failed to respond to alternative treatment options for ulcerative colitis such as tumour necrosis factor inhibitor (TNF inhibitor) treatment.
• XELJANZ 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used.
• In patients who have responded to treatment with XELJANZ, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

• If therapy is interrupted, restarting treatment with XELJANZ can be considered. If there has been a loss of response, reinduction with XELJANZ 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 (see section 5.1 of the XELJANZ Summary of Product Characteristics).

• XELJANZ 5 mg and 10 mg tablets can be given with or without food.
• For patients who have difficulties swallowing, XELJANZ 5 mg and 10 mg tablets may be crushed and taken with water.
• Terminal half-life is approximately 3 hours.
• This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

• No dose adjustment is required in mild-to-moderate renal impairment.
• In patients with severe renal impairment (creatinine clearance <30 mL/min), where the indicated dose in the presence of normal renal function is 5 mg BID, reduce to 5 mg once daily; where the indicated dose in the presence of normal renal function is 10 mg BID, reduce to 5 mg BID.
• Patients with severe renal impairment should remain on a reduced dose even after haemodialysis.

• In patients with moderate hepatic impairment (Child Pugh B), where the indicated dose in the presence of normal hepatic function is 5 mg BID, reduce to 5 mg once daily; where the indicated dose in the presence of normal hepatic function is 10 mg BID, reduce to 5 mg BID.
• 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).

• 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