Swissmedic Vigilance-News Edition 30 – Mai 2023

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Tabelle 1: Zusammenfassung der Risikokommunikation zu JAKi, die in dieser Übersichtsarbeit behandelt werden FDA EMA SMC Label update of Warnings and Precautions Boxed warning in label (Last line treatment in patients with risk factors) Limiting indication to post-TNFi - - (Further measures are under evaluation) Update of dose recommendations in patients with increased risk for thrombosis, MACE and malignancies - - (Further measures are under evaluation) DSC / DHPC Link Link Link Swissmedic Vigilance-News | Edition 30 – Mai 2023 24
Abkürzungen AESI BID DHPC DSC EMA FDA HAQ-DI IL JAK JAKi MACE MAH MTX NMSC PE RA SDAI SmPC STAT TNFi VTE Literatur adverse event of special interest twice a day direct healthcare professional communication drug safety communication European Medicines Agency Food and Drug Administration (USA) Health Assessment Questionnaire–Disability Index interleukin Janus kinase Janus kinase inhibitor major adverse cardiovascular events marketing authorisation holder methotrexate non-melanoma skin cancers pulmonary embolism rheumatoid arthritis Simplified Disease Activity Index Summary of Product Characteristic signal transducer and activator of transcription tumour necrosis factor inhibitor venous thromboembolism (1) U.S. Food and Drug Administration. Center for Drug Evaluation and Research: NDA 203214 Tofacitinib for Rheumatoid Arthritis - Approval Letter. 2012; Available from: https://www.accessdata.fda.gov/ drugsatfda_docs/nda/2012/203214Orig1s000Approv.pdf. (2) FDA Drug Safety Communication - FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. 2021; Available from: https://www.fda.gov/ media/151936/download. (5) Clark, J.D., M.E. Flanagan, and J.B. Telliez, Discovery and development of Janus kinase (JAK) inhibitors for inflammatory diseases. J Med Chem, 2014. 57(12): p. 5023-38. (6) Dowty, M.E., et al., Janus kinase inhibitors for the treatment of rheumatoid arthritis demonstrate similar profiles of in vitro cytokine receptor inhibition. Pharmacol Res Perspect, 2019. 7(6): p. e00537. (7) McInnes, I.B., et al., Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations. Arthritis Res Ther, 2019. 21(1): p. 183. (8) Ytterberg, S.R., et al., Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med, 2022. 386(4): p. 316-326. (9) Palleria, C., et al., Limitations and obstacles of the spontaneous adverse drugs reactions reporting: Two "challenging" case reports. J Pharmacol Pharmacother, 2013. 4(Suppl 1): p. S66-72. (10) EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. 2023; Available from: https:// www.ema.europa.eu/en/documents/referral/ janus-kinase-inhibitors-jaki-article-20-procedure-ema-confirms-measures-minimise-risk-serious-side_en.pdf. (11) Swissmedic DHPC - JAK-Inhibitoren - Cibinqo ® (Abrocitinib), Olumiant ® (Baricitinib), Rinvoq ® (Upadacitinib) und Xeljanz ® (Tofacitinib) - Erhöhtes Risiko für Malignome, schwerwiegende kardiovaskuläre Ereignisse (MACE), schwerwiegende Infektionen, Thrombosen und Gesamtmortalität. 2023; Available from: https://www.swissmedic.ch/swissmedic/en/home/ humanarzneimittel/market-surveillance/healthprofessional-communication--hpc-/dhpc-januskinase-jak-inhibitoren.html. (3) Shalabi, M.M.K., et al., Janus Kinase and Tyrosine Kinase Inhibitors in Dermatology: A Review of Their Utilization, Safety Profile and Future Applications. Skin Therapy Lett, 2022. 27(1): p. 4-9. (4) McLornan, D.P., et al., Current and future status of JAK inhibitors. Lancet, 2021. 398(10302): p. 803-816. Swissmedic Vigilance-News | Edition 30 – Mai 2023 25
Page 1 and 2: Vigilance-News Edition 30 - Mai 202
Page 3 and 4: In dieser Ausgabe 4 Editorial 5 Arz
Page 5 and 6: Arzneimittelsicherheit und Fallberi
Page 7 and 8: aufgenommen. 65 Fallberichte (63,1
Page 9 and 10: Literatur (1) Beenen, A.C.; Sauerer
Page 11 and 12: im Normbereich. Die zytologische Un
Page 13 and 14: Sicherheitsprofil von Remdesivir be
Page 15 and 16: Referenzen (1) Humeniuk R, Mathias
Page 17 and 18: Tabelle 1: Pharmakologische Beschre
Page 19 and 20: optimalen Dosis zwischen diesen Pat
Page 21 and 22: sche Dermatitis. Die zugelassenen I
Page 23: (Patienten- bzw. Fachinformation) h
Page 27 and 28: Literatur (1) DHPC - mRNA Impfstoff
Page 29 and 30: Verdachtsmeldungen unerwünschter W
Page 31 and 32: Diskussion Die bisher eingegangenen
Page 33 and 34: SHOT (Serious Hazards of Transfusio
Page 35 and 36: 6 1 18 13 SRNM 18 13 HSE 6 1 ADU 3
Page 37 and 38: Healthcare Professional Communicati
Page 39 and 40: 03.03.2023 Zulassungen von Kompleme
Page 42: Schweizerisches Heilmittelinstitut

Swissmedic Vigilance-News Edition 30 – Mai 2023

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