Publication: Aplicación de la talidomida en mieloma múltiple
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2015-06
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Abstract
La talidomida es un medicamento vinculado a una de las mayores catástrofes de la farmacología a causa de su poder teratógeno y que significó el punto de partida de la farmacovigilancia. Presenta numerosas indicaciones; pero la recogida en ficha técnica, y en la que nos centramos, es su empleo en mieloma múltiple. Este fármaco es inhibidor de la angiogénesis, aunque en esta neoplasia su acción se debe a su efecto como antiinflamatorio, inmunomodulador y antineoplásico. Muestra beneficios en combinación con prednisona, bortezomib y melfalán, aunque también es empleado en distintas combinaciones con estos. La talidomida continúa teniendo el efecto teratógeno que causó tal desastre, a pesar de que se han conseguido aislar los dos enantiómeros que forman la muestra racémica, en el organismo se metaboliza generando los dos enantiómeros. Sin embargo, debido al seguimiento exhaustivo de protocolos indicados desde la EMA y el laboratorio que la comercializa, Celgene, la teratogenicidad se encuentra minimizada al máximo. Estos protocolos son muy rigurosos y cuentan con un plan de prevención de embarazo y distintas medidas ajustadas a las condiciones de cualquier persona que pudiera necesitar la talidomida como tratamiento.
Thalidomide is a foreign drug linked to one of the greatest disasters of the pharmacology because of its teratogenic power, which marked the beginning of pharmacovigilance. It presents numerous indications, but the the only one which is recognized in the summary of product characteristics and in which we focus is in multiple myeloma. This drug is inhibitor of angiogenesis, but in multiple myeloma the action is due to its effects as antiinflammatory, immunomodulatory and antineoplastic. Thalidomide shows benefits in combination with prednisone, bortezomib and melphalan, though it is also used in different combinations. The teratogenic effect that caused such a disaster continues existing, because it has not modified its structure and although it has been possible to isolate the two enantiomers which form the racemic mixture, it is metabolized in the body generating the two enantiomers. However, due to the strict monitoring protocols indicated from the EMA and the laboratory that marketed, Celgene, teratogenicity is minimized to the maximum. These protocols are rigorous and have a pregnancy prevention plan and other measures adjusted to the conditions of anyone who might need thalidomide as a treatment.
Thalidomide is a foreign drug linked to one of the greatest disasters of the pharmacology because of its teratogenic power, which marked the beginning of pharmacovigilance. It presents numerous indications, but the the only one which is recognized in the summary of product characteristics and in which we focus is in multiple myeloma. This drug is inhibitor of angiogenesis, but in multiple myeloma the action is due to its effects as antiinflammatory, immunomodulatory and antineoplastic. Thalidomide shows benefits in combination with prednisone, bortezomib and melphalan, though it is also used in different combinations. The teratogenic effect that caused such a disaster continues existing, because it has not modified its structure and although it has been possible to isolate the two enantiomers which form the racemic mixture, it is metabolized in the body generating the two enantiomers. However, due to the strict monitoring protocols indicated from the EMA and the laboratory that marketed, Celgene, teratogenicity is minimized to the maximum. These protocols are rigorous and have a pregnancy prevention plan and other measures adjusted to the conditions of anyone who might need thalidomide as a treatment.