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Direct Healthcare Professional Communication (DHPC) on Janus kinase inhibitors: Updated recommendations for risk minimisation

Active substance: Janus kinase inhibitors

Cibinqo (abrocitinib), Jyseleca (filgotinib), olumiant (Baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib)

Cibinqo (abrocitinib), Jyseleca (filgotinib), Olumiant (baricitinib), Rinvoq (upadacitinib) and Xeljanz (tofacitinib) – Updated recommendations to minimise the risks of malignancy, major adverse cardiovascular events, serious infections, venous thromboembolism and mortality with use of Janus kinase inhibitors (JAKi).

AbbVie, Galapagos, Lilly and Pfizer in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about the updated recommendations for risk minimisation regarding the Janus kinase inhibitors (JAKi) therapy. These JAKi should only be used if no suitable treatment alternatives are available in patients: 65 years of age and older; who are current or past long-time smokers; with other cardiovascular or malignancy risk factors. JAKi should be used with caution in patients with VTE risk factors other than those listed above.

Download DHPC (available in German only)

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