Jyseleca Dosage/Direction for Use

Treatment with filgotinib should be initiated by a physician experienced in the treatment of rheumatoid arthritis or ulcerative colitis.
Posology: Rheumatoid arthritis: The recommended dose of filgotinib for adult patients is 200 mg once daily.
In adults at increased risk of VTE, MACE and malignancy (see Precautions), the recommended dose is 100 mg once daily and may be escalated to 200 mg once daily in case of insufficient disease control. For long term treatment, the lowest effective dose should be used.
Ulcerative colitis: Induction treatment: The recommended dose for induction 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 (see Pharmacology: Pharmacodynamics under Actions). Patients who have not shown any therapeutic benefit after 22 weeks of treatment should discontinue filgotinib.
Maintenance treatment: The recommended dose for maintenance treatment is 200 mg once daily.
In adults at higher risk of VTE, MACE and malignancy (see Precautions), the recommended dose for maintenance treatment is 100 mg once daily. In case of flare of the disease, the dose may be escalated to 200 mg once daily. For long term treatment, the lowest effective dose should be used.
Laboratory monitoring, and dose initiation or interruption: Guidance for laboratory monitoring, and dose initiation or interruption is provided in Table 9. Treatment should be interrupted if a patient develops a serious infection until the infection is controlled (see Precautions). (See Table 9.)

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Special populations: Elderly: Rheumatoid arthritis: In patients with rheumatoid arthritis aged 65 years of age and older, the recommended dose is 100 mg once daily and may be escalated to 200 mg once daily in case of insufficient disease control (see Precautions). For long term treatment, the lowest effective dose should be used.
Ulcerative colitis: In patients with ulcerative colitis aged 65 years of age and older, the recommended dose is 200 mg once daily for the induction treatment and 100 mg once daily for maintenance treatment (see Precautions). In case of flare of the disease, the dose may be escalated to 200 mg once daily. For long term treatment, the lowest effective dose should be used. Filgotinib is not recommended in patients aged 75 years and older as there is no data in this population.
Renal impairment: No dose adjustment is required in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 mL/min). A dose of 100 mg of filgotinib once daily is recommended for patients with moderate or severe renal impairment (CrCl 15 to <60 mL/min). Filgotinib has not been studied in patients with end stage renal disease (CrCl <15 mL/min) and is therefore not recommended for use in these patients (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh A or B). Filgotinib has not been studied in patients with severe hepatic impairment (Child-Pugh C) and is therefore not recommended for use in these patients (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of filgotinib in children under the age of 18 years have not yet been established. No data are available.
Method of administration: Oral use.
Jyseleca can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions). It has not been studied if tablets can be split, crushed, or chewed, and it is recommended that tablets are swallowed whole.