Active Ingredient: Filgotinib
Filgotinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
200 - 200 mg
From 200 To 200 mg once every day
The recommended dose for induction and maintenance treatment is 200 mg once daily.
For patients with ulcerative colitis who do not show an adequate therapeutic benefit during the initial 10 weeks of treatment, 12 additional weeks of induction treatment with filgotinib 200 mg once daily may provide additional relief of symptoms. Patients who have not shown any therapeutic benefit after 22 weeks of treatment should discontinue filgotinib.
Table 1. Laboratory measures and monitoring guidance:
| Laboratory measure | Action | Monitoring guidance |
|---|---|---|
| Absolute neutrophil count (ANC) | Treatment should not be initiated, or should be interrupted, if ANC is <1 × 109 cells/L. Treatment may be restarted once ANC returns above this value. | Before treatment initiation and thereafter according to routine patient management |
| Absolute lymphocyte count (ALC) | Treatment should not be initiated, or should be interrupted, if ALC is <0.5 × 109 cells/L. Treatment may be restarted once ALC returns above this value | |
| Haemoglobin (Hb) | Treatment should not be initiated, or should be interrupted, if Hb is <8 g/dL. Treatment may be restarted once Hb returns above this value. | |
| Lipid parameters | Patients should be managed according to international clinical guidelines for hyperlipidaemia | 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia |
Filgotinib can be taken with or without food.
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