Active Ingredient: Filgotinib
Filgotinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX).
For this indication, competent medicine agencies globally authorize below treatments:
Oral
100 - 200 mg
From 100 To 200 mg once every day
100 mg
A starting dose of 100 mg once daily is recommended for patients aged 75 years and older as clinical experience is limited.
Laboratory monitoring, and dose initiation or interruption Guidance for laboratory monitoring, and dose initiation or interruption is provided in Table 1. Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
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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