JYSELECA FILM-COATED TABLET 200MG

ROTTENDORF PHARMA GMBH - GERMANYBUSHU PHARMACEUTICALS LTD. KAWAGOE FACTORY (PRIMARY PACKAGER AND SECONDARY PACKAGER) (JAPAN)🇸🇬 Health Sciences Authority

Approval Date: Mar 27, 2024
Approval ID: d7131d83069ca95d
Company: ROTTENDORF PHARMA GMBH - GERMANYBUSHU PHARMACEUTICALS LTD. KAWAGOE FACTORY (PRIMARY PACKAGER AND SECONDARY PACKAGER) (JAPAN)
Type: Therapeutic

Approval Details

Approval Id: d7131d83069ca95d
Drug Name: JYSELECA FILM-COATED TABLET 200MG
Product Name: JYSELECA FILM-COATED TABLET 200MG
Approval Number: SIN16981P
Approval Date: 2024-03-27
Registrant: EISAI (SINGAPORE) PTE. LTD.
Licence Holder: EISAI (SINGAPORE) PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 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). <img src="/TGIF/Jyseleca-Table1.png" alt="Jyseleca Dosage Table 1" /> 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.
Route Of Administration: ORAL
Indication Info: 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.
Contraindications: 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).
Atc Code: L04AA45
Atc Item Name: xl 04 aa 45
Pharma Manufacturer Name: EISAI (SINGAPORE) PTE. LTD.
Company Detail Path: /organization/eisai-singapore-pte-ltd

Active Ingredients

Filgotinib maleate eqv filgotinib

200 mg

Filgotinib maleate eqv filgotinib

200 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Mar 27, 2024

Approval ID

d7131d83069ca95d

Type

Therapeutic

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