JYSELECA FILM-COATED TABLET 100MG [SIN16980P]

Product Info

JYSELECA FILM-COATED TABLET 100MG

[SIN16980P]

4.1 Therapeutic indications

Rheumatoid arthritis

Jyseleca 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). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX).

Ulcerative colitis

Jyseleca 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.

4.2 Posology and method of administration

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), 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 section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), 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 1. Treatment should be interrupted if a patient develops a serious infection until the infection is controlled (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It has not been studied if tablets can be split, crushed, or chewed, and it is recommended that tablets are swallowed whole.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Active tuberculosis (TB) or active serious infections (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pregnancy (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).