Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Galapagos NV, Generaal De Wittelaan L11 A3, 2800 Mechelen, Belgium
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).
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.
Treatment with filgotinib should be initiated by a physician experienced in the treatment of rheumatoid arthritis.
The recommended dose of filgotinib for adult patients is 200 mg once daily.
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 (see section 5.1). Patients who have not shown any therapeutic benefit after 22 weeks of treatment should discontinue filgotinib.
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).
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 |
Rheumatoid arthritis:
A starting dose of 100 mg once daily is recommended for patients with rheumatoid arthritis aged 75 years and older as clinical experience is limited.
Ulcerative colitis:
No dose adjustment is recommended for patients with ulcerative colitis up to 75 years of age. Filgotinib is not recommended in patients aged 75 years and older as there is no data in this population.
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).
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).
The safety and efficacy of filgotinib in children under the age of 18 years have not yet been established. No data are available.
Oral use.
Jyseleca can be taken with or without food (see section 5.2). It has not been studied if tablets can be split, crushed, or chewed, and it is recommended that tablets are swallowed whole.
Filgotinib has been administered in clinical studies following single and once daily administration up to 450 mg without dose-limiting toxicity. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetic data following a single dose of 100 mg filgotinib in healthy subjects indicate that approximately 50% of the administered dose is eliminated within 24 hours of dosing and 90% of the dose is eliminated within 72 hours. In case of an overdose, it is recommended that a patient be monitored for signs and symptoms of adverse reactions. Treatment of overdose with filgotinib consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. It is unknown whether filgotinib can be removed by dialysis.
3 years.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
White, high-density polyethylene (HDPE) bottles, enclosed with a child-resistant polypropylene (PP) screw cap lined with an induction-sealed aluminium foil liner. Each bottle contains either a canister or sachet containing silica gel desiccant and polyester coil.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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