5 mg/kg given as an intravenous infusion followed by an additional 5 mg/kg infusion 2 weeks after the first infusion. If a patient does not respond after 2 doses, no additional treatment with Flixabi™ should be given. Available data do not support further Flixabi™ treatment, in patients not responding within 6 weeks of the initial infusion.
In responding patients, the alternative strategies for continued treatment are:
- Maintenance: Additional infusion of 5 mg/kg at 6 weeks after the initial dose, followed by infusions every 8 weeks or
- Re‑administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re‑administration’ below and section 4.4 of the Summary of Product Characteristics).
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1 of the Summary of Product Characteristics). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Fistulising, active Crohn’s disease
5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusions at 2 and 6 weeks after the first infusion. If a patient does not respond after 3 doses, no additional treatment with Flixabi™ should be given.
In responding patients, the alternative strategies for continued treatment are:
- Maintenance: Additional infusions of 5 mg/kg every 8 weeks or
- Re‑administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur followed by infusions of 5 mg/kg every 8 weeks (see ‘Re‑administration’ below and section 4.4 of the Summary of Product Characteristics).
Although comparative data are lacking, limited data in patients who initially responded to 5 mg/kg but who lost response indicate that some patients may regain response with dose escalation (see section 5.1 of the Summary of Product Characteristics). Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
In Crohn’s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/risk of the alternative strategies for continued treatment are lacking.
Re‑administration
If the signs and symptoms of disease recur, Flixabi™ can be re-administered within 16 weeks following the last infusion. In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after Flixabi™-free intervals of less than 1 year (see sections 4.4 and 4.8 of the Summary of Product Characteristics). The safety and efficacy of re-administration after Flixabi™-free interval of more than 16 weeks has not been established.