|20/06/2017||Human medicines European public assessment report (EPAR):Yondelis,|
Revision: 21, Authorised
La EMA Tan solo recomienda que se modifique el Manual de uso del Yondelis al encontrarse un efecto secundario ( Capillary leak syndrome (CLS) ) para que los oncologos lo sepan y lo tengan en cuenta ... por lo demas todo sigue igual con respecto a su Comercialización y uso Clinico .
Hay que tener en cuenta que TODOS los Farmacos tienen Efectos secundarios y más aún los Oncologicos ... lo bueno es saberlo para tenerlo en cuenta y poder actuar al respecto correctamente .
Scientific conclusions :
Taking into account the PRAC Assessment Report on the PSUR(s) for trabectedin, the scientific conclusions of CHMP are as follows:
Capillary leak syndrome (CLS) is a rare entity characterized by recurrent and unpredictable attacks of capillary leakage of plasma fluid and proteins throughout the endothelium. Capillary leak syndrome (CLS) is usually characterized by peripheral oedema, hypotension which is relatively well tolerated, oliguria with acute pre-renal failure. In some patients, a compartment syndrome can occur.
CLS can be idiopathic (Clarkson’s disease) or secondary to various conditions and treatments. Secondary CLSs are mostly due to malignant hematological diseases, viral infections, and treatments such as chemotherapies and therapeutic growth factors.
Based on a cumulative review of suspected CLS cases, there is evidence to suggest a casual association between CLS and the use of trabectedin. A cumulative review of the 102 suspected CLS cases performed by an independent experts committee concluded that CLS was considered as possible in 48 cases (defined as more information needed to exclude or confirm that diagnostic
criteria were met); CLS was considered probable (defined as a very strong clinical suspicion) in 14 cases (all from clinical trial or solicited sources). Causality was assessed as doubtful in 3 of these cases and at least possible in the remaining 11 cases.
Therefore, in view of the data presented in the reviewed PSUR, the PRAC considered that changes to the product information of medicinal products containing trabectedin were warranted.
The CHMP agrees with the scientific conclusions made by the PRAC.
Grounds for the variation to the terms of the marketing authorisation(s)
On the basis of the scientific conclusions for trabectedin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing trabectedin is unchanged subject to the proposed changes to the product information
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.