Abatacept (Orencia): Plattenepithelkarzinome, Hautpapillome, Lymphome und maligne Neoplasmen der Lunge

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20. Oktober 2017 – In Abstimmung mit Swissmedic, dem Schweizerischen Heilmittelinstitut, informiert die Zulassungsinhaberin von Abatacept (Orencia) in der Schweiz, die Bristol-Myers Squibb SA, über Änderungen in der Schweizer Arzneimittelinformation zu Abatacept (Orencia) in der Form einer Direct Healthcare Professional Communication (DHPC).

Plattenepithelkarzinom

Gemäss der Mitteilung wurden nach der Markteinführung (Postmarketing) von Abatacept (Orencia) bei Patienten mit rheumatoider Arthritis, die Abatacept (Orencia) (Abatacept) verwendeten, spontane Fälle von Plattenepithelkarzinomen, Hautpapillomen, Lymphomen und malignen Neoplasmen der Lunge beobachtet. Diese gravierenden unerwünschten Ereignisse werden neu in die Abschnitte “Unerwünschte Wirkungen” und “Warnhinweise und Vorsichtsmassnahmen” der Schweizer Arzneimittelinformation zu Abatacept (Orencia) aufgenommen. Nach Einschätzung von Swissmedic und der Zulassungsinhaberin bleibt das sogenannte Nutzen-Risiko-Profil von Abatacept (Orencia) unverändert. Allen Patienten werden jedoch regelmässige Hautuntersuchungen empfohlen, insbesondere wenn weitere Risikofaktoren für Hautkrebs vorliegen sollten.

Seit der ursprünglichen Markteinführung von Abatacept (Orencia) wurden in der Schweizer Arzneimittelinformation von Abatacept (Orencia) Malignitäten unter “Warnhinweise und Vorsichtsmassnahmen” sowie unter “Unerwünschte Wirkungen” schon beschrieben. Dabei wurde darauf hingewiesen, dass Arzneimittel, die wie Abatacept (Orencia) unterdrückend auf das Immunsystem einwirken, die Immunabwehr gegen Malignitäten insgesamt schwächen können.

Seit der Einführung von sogenannten Checkpoint-Inhibitoren wie Pembrolizumab (Keytruda), Ipilimumab (Yervoy), Nivolumab (Opdivo), und anderen in der erfolgreichen Behandlung von gewissen Tumoren durch eine gezielte Stärkung des lokalen Immunsystems, ist es denkbar, dass eine Schwächung des Immunsystems als Auslöser für das Entstehen gewisser Tumore verantwortlich sein kann. Dies ist der wahrscheinliche Mechanismus des mit Abatacept (Orencia) beobachteten Auftretens der hier beschriebenen Malignitäten, obwohl die Zulassungsinhaberin schreibt, dass trotz umfangreicher präklinischer und klinischer Programme, Beobachtungsstudien, permanenter Überprüfung der medizinischen Literatur und kontinuierlicher Überwachung der Postmarketingberichte es immer noch keine ausreichende Evidenz für einen kausalen Zusammenhang zwischen der Anwendung von Abatacept (Orencia) und dem Auftreten von Malignitäten im Allgemeinen oder speziellen Krebsarten gebe.  Der Zusammenhang könnte jedoch sehr wohl kausal sein; immerhin kennt man von einigen immunosupressiven Arzneimitteln das Auftreten von Plattenepithelkarzinoma als schwerwiegende unerwünschte Nebenwirkung schon lange.

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About the Author
thassodotcom Professor in Pharmakologie und Toxikologie. Experte in theragenomischer und personalisierter Medizin und individualisierter Arzneimittelsicherheit. Experte in Pharmako- und Toxiko-Genetik. Experte in der klinischen Sicherheit von Arzneimitteln, Chemikalien, Umweltschadstoffen und Nahrungsinhaltsstoffen.

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