Dosing

An alternative way to treat patients with UC

Dosing and administration of XELJANZ ¹

​​​​Please refer to the full XELJANZ SmPC for details on dosing and administration of XELJANZ

Please note tablets depicted in table above are not true to size

*If there has been a loss of response, reinduction with XELJANZ 10 mg BID 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 BID therapy. ¹

• XELJANZ induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16. In patients who have responded to treatment with XELJANZ, corticosteroids may be reduced and/or discontinued in accordance with standard of care. ¹
• XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled. ^{​​​​​​​1}
  
• XELJANZ 10 mg twice daily for maintenance treatment is not recommended in patients with UC who have known venous thromboembolism (VTE) risk factors, unless there is no suitable alternative treatment available.¹
• For patients with UC who are not at increased risk for VTE, 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.¹
• 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.     

Packs and tablets shown not true to size.

Contraindications and special populations¹

Contraindications for use:

• Hypersensitivity to the active substance of XELJANZ or to any of its excipients*
• Active TB, serious infections such as sepsis, or opportunistic infections
• Severe hepatic impairment
• Pregnancy and lactation

Special populations:

Renal Impairment

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

Hepatic impairment

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

Dose adjustment for drug-drug interactions ¹

Please note tablets depicted in table above are not true to size

• 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​​​​​​​.