Reference: 1. Feagan BG, Danese S, Loftus EV Jr, et al. Lancet 2021;397:2372–2384.
aJYSELECA has not been studied in these populations; no data are available.
CrCl, creatinine clearance; CV, cardiovascular; CVD, cardiovascular disease; MACE, major adverse cardiovascular event; VTE, venous thromboembolism.
GB-IBD-FIL-202301-00012 | Date of preparation: October 2023
Many drugs are affected by CYP450 (enzyme) when co-administered with drugs that have overlapping enzyme metabolism and can lead to:1
JYSELECA is the only JAK inhibitor that is not metabolised through CYP4503,4
CES2, carboxylesterase 2; CYP450, cytochrome P450; DDI, drug-drug interaction; HMG-CoA, hydroxymethlyglutaryl-coenzyme A; JAK, Janus kinase.
References: 1. Ogu CC and Maxa JL. Proc (Bayl Univ Med Cent) 2000;13:421–423; 2. Watanabe K, Peyrin-Biroulet L, Danese S, et al. UEGW 2022. P0428; 3. XELJANZ (tofacitinib). Summary of Product Characteristics 2023; 4. RINVOQ (upadacitinib). Summary of Product Characteristics 2023.
Vaccinations
It is recommended that immunisation, including prophylactic zoster vaccinations, be updated in agreement with current immunisation guidelines prior to initiating JYSELECA therapy
Infections
Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before initiating and during JYSELECA therapy
Blood tests
Lymphocytes, neutrophils, haemoglobin
Lipid parameters
Monitor before treatment initiation and thereafter according to routine patient management
Monitor 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
Patients should be managed according to international clinical guidelines for hyperlipidaemia
TB screening
JYSELECA should not be administered to patients with active TB
Patients should be screened for TB before starting JYSELECA therapy and monitored for signs and symptoms of TB
Therapeutic drug monitoring
Not required
ALC, absolute lymphocyte count; ANC, absolute neutrophil count; Hb, haemoglobin; TB, tuberculosis.
Adverse events should be reported.
For Great Britain, 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 0800 072 7878.
Adverse events should be reported.
For 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 0800 072 7878.
Adverse events should be reported.
For the Republic of Ireland, reporting forms and information can be found at www.hpra.ie and can be reported to HPRA on +353 1 6764971.
Adverse events should also be reported to Galapagos via email to DrugSafety.UK.Ireland@glpg.com or 00800 7878 1345.
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
GB-IBD-FIL-202211-00008
Date of preparation: November 2023
Contact Us
Galapagos Biotech Ltd
148 Belmont Rd, Uxbridge UB8 1QS
medicalinfo@glpg.com
Jyseleca, Galapagos and the Galapagos logo are registered trademarks of Galapagos NV.
GB-IBD-FIL-202211-00008
Date of preparation: November 2023
Contact Us
Galapagos Biotech Ltd
148 Belmont Rd, Uxbridge UB8 1QS
medicalinfo@glpg.com
© 2023 Galapagos NV. All rights reserved.
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