GREAT BRITAIN AND NORTHERN IRELAND

Refer to Summary of Product Characteristics (SmPC) before prescribing, and for full prescribing information.
JYSELECA®▼filgotinib 100 mg or 200 mg film-coated tablets.
Indication: 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).
Dosage: Adults: Taken orally with/without food. It is recommended that tablets are swallowed whole.
Rheumatoid arthritis: 200mg once daily. In adults at increased risk of VTE, MACE and malignancy (see SmPC), 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.
Laboratory Monitoring: Refer to the SmPC for information regarding laboratory monitoring and dose initiation or interruption.
Special Populations
Elderly: In patients with rheumatoid arthritis aged 65 years of age and older, the recommended dose is 100mg once daily and may be escalated to 200mg once daily in case of insufficient disease control (see SmPC). For long term treatment, the lowest effective dose should be used.
Renal impairment: No dose adjustment required in patients with estimated 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). Not recommended in patients with CrCl < 15 mL/min.
Hepatic impairment: Mild/moderate hepatic impairment: no dose adjustment required. Severe hepatic impairment: not recommended.
Children (< 18years): Safety and efficacy not yet established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Active tuberculosis (TB) or active serious infections. Pregnancy.
Warnings/Precautions: See SmPC for full information.
Filgotinib should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
Immunosuppression: Combination use, with immunosuppressants e.g., ciclosporin, tacrolimus, biologics or other Janus kinase (JAK) inhibitors is not recommended as a risk of additive immunosuppression cannot be excluded.
Infections: Infections, including serious infections such as pneumonia and opportunistic infections e.g. tuberculosis (TB), oesophageal candidiasis, and cryptococcosis have been reported. Risk benefit should be assessed prior to initiating in patients with risk factors for infections (see SmPC). Patients should be closely monitored for the development of signs and symptoms of infections during and after filgotinib treatment. Treatment should be interrupted if the patient is not responding to antimicrobial therapy, until infection is controlled. As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients 65 years of age and older, filgotinib should only be used if no suitable treatment alternatives are available (see SmPC).
Tuberculosis: Patients should be screened for TB before initiating filgotinib, and filgotinib should not be administered to patients with active TB.
Viral reactivation: Cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies (see SmPC). In rheumatoid arthritis clinical studies, the risk of herpes zoster appeared to be higher in female patients, Asian patients, patients ≥ 50 years of age, patients with a medical history of herpes zoster, patients with a medical history of chronic lung disease and patients treated with filgotinib 200 mg once daily. If a patient develops herpes zoster, filgotinib treatment should be temporarily interrupted until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed.
Malignancy: Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including filgotinib.
In patients 65 years of age and older, patients who are current or past long-time smokers, or with other malignancy risk factors (e.g. current malignancy or history of malignancy), filgotinib should only be used if no suitable treatment alternatives are available.
Haematological abnormalities: Do not start therapy, or temporarily stop, if Absolute Neutrophil Count (ANC) <1 × 109 cells/L, ALC <0.5 × 109 cells/L or haemoglobin <8 g/dL. Temporarily stop therapy if these values are observed during routine patient management.
Vaccinations: Use of live vaccines during, or immediately prior to, filgotinib treatment is not recommended. It is recommended that immunisations, including prophylactic zoster vaccinations, be updated in agreement with current immunisation guidelines prior to initiating filgotinib treatment.
Lipids: Treatment with filgotinib was associated with dose dependent increases in lipid parameters, including total cholesterol, and high-density lipoprotein (HDL) levels, while low density lipoprotein (LDL) levels were slightly increased (see SmPC).
MACE: Events of MACE have been observed in patients taking filgotinib. In patients 65 years of age and older, patients who are current or past long-time smokers, and patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, filgotinib should only be used if no suitable treatment alternatives are available.
Venous thromboembolism (VTE): Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including filgotinib. In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, filgotinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder. Patients should be re-evaluated periodically during filgotinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue filgotinib in patients with suspected VTE, regardless of dose.
Use in patients 65 years of age and older
Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomised study of tofacitinib (another JAK inhibitor), filgotinib should only be used in these patients if no suitable treatment alternatives are available.
Lactose content: Contains lactose; patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take filgotinib.
Pregnancy/Lactation: Filgotinib is contraindicated in pregnancy. Filgotinib should not be used during breast-feeding. Women of childbearing potential must use effective contraception during and for at least 1 week after cessation of treatment.
Driving/Using machinery: No or negligible influence, however dizziness has been reported.
Side effects: See SmPC for full information.
Common (≥1/100 to <1/10): nausea, upper respiratory tract infection, urinary tract infection, dizziness and lymphopenia.
Uncommon (≥1/1000 to <1/100): herpes zoster, pneumonia, sepsis, neutropenia, hypercholesterolaemia and blood creatine phosphokinase increase.
See SmPC for full information on laboratory changes, and selected adverse reactions, including infections and experience from long term extension studies.
Legal category: POM Pack: 30 film-coated tablets/bottle Price: UK Basic NHS cost: £863.10 Marketing authorisation number(s): Great Britain Jyseleca 100mg film-coated tablets PLGB 42147/0001 Jyseleca 200mg film-coated tablets PLGB 42147/0002
Northern Ireland Jyseleca 100mg film-coated tablets EU/1/20/1480/001 EU/1/20/1480/002 Jyseleca 200mg film-coated tablets EU/1/20/1480/003 EU/1/20/1480/004
Further information: Galapagos UK, Belmont House, 148 Belmont Road, Uxbridge UB8 1QS, United Kingdom medicalinfo@glpg.com
Jyseleca® is a trademark.
Date of Preparation: March 2023 GB-RA-FIL-202301-00004 
 ▼Additional monitoring required
Adverse events should be reported.
For Great Britain and Northern Ireland, reporting forms and information can be found at yellowcard.mhra.gov.uk or via the Yellow Card app (download from the Apple App Store or Google Play Store).
Adverse events should also be reported to Galapagos via email to DrugSafety.UK.Ireland@glpg.com or 08000 727 878
References:
1. JYSELECA SmPC. Available at: www.medicines.org.uk / www.medicines.ie Last accessed: August 2023.
2. Combe B, et al. Ann Rheum Dis 2021;80(7):848–858.
3. Data on file — Galapagos - GB-RA-JY-202302-00009.
4. Genovese MC, et al. JAMA 2019;322(4):315–325.
5. Taylor P, et al. Arthritis Rheumatol 2020;72(suppl 10).
6. Combe B, et al. Ann Rheum Dis 2021;80(7):848–858 (Supplementary material).

 

August 2023 GB-RA-JY-202307-00005 V1