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Five years' clinical use of GnRH antagonists: evaluation of safety and allergic potential
J B Engel1, A Schultze-Mosgau, K Diedrich
1University of Schleswig-Holstein, Department of Gynecology and Obstetrics, University Clinic Hospital, Campus Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany. joergbengel@hotmail.com
Abstract:
Three antagonists of gonadotrophin-releasing hormone are currently clinically available. Cetrorelix (Cetrotide) and ganirelix (Orgalutran/Antagon) have been safely used in assisted reproduction since 1999 and 2000 respectively. The structurally similar abarelix (Plenaxis) has been approved for the therapy of advanced androgen sensitive prostate cancer. However, due to the occurrence of allergic reactions, its use is restricted to only a subgroup of patients. These allergic side effects may not be due to abarelix, as the drug itself does not have a strong histamine liberating potential in vitro, but could be attributed to carboxymethylcellulose (CMC), which only Plenaxis, but not Cetrotide or Orgalutran/Antagon contain. CMC is used to obtain the sustained-release characteristics of Plenaxis. Since 1973, numerous case reports and studies have been published regarding allergic reactions and specific immunoglobulin E antibodies against CMC. Thus, the allergic side effects of Plenaxis could be rather due to CMC than to abarelix.
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