El medicamento PEMETREXED SUN 5 MG/ML SOLUCION PARA PERFUSION con los principios activos PEMETREXED DISODIO HEPTAHIDRATO tiene la siguiente información en la sección 4.8
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**Resumen del perfil de seguridad**![](data:image/jpg;base64,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Las reacciones adversas notificadas con mayor frecuencia en relación al tratamiento con pemetrexed, tanto si se utiliza en monoterapia como en combinación, son la supresión de médula ósea que se manifiesta como anemia, neutropenia, leucopenia, trombocitopenia y toxicidad gastrointestinal que se manifiesta como anorexia, náuseas, vómitos, diarrea, estreñimiento, faringitis, mucositis y estomatitis. Otras reacciones adversas incluyen toxicidad renal, aumento de aminotransferasas, alopecia, fatiga, deshidratación, exantema, infección/sepsis y neuropatía. Rara vez se han visto efectos como el síndrome de Stevens-Johnson y necrolisis epidérmica tóxica.

Lista tabulada de reacciones adversas

La tabla 4 enumera las reacciones adversas del medicamento, independientemente de la causalidad asociada a pemetrexed utilizado como tratamiento en monoterapia o en combinación con cisplatino, de los estudios de registro pivotales (JMCH, JMEI, JMBD, JMEN y PARAMOUNT) y del período posterior a la comercialización.

Se listan las reacciones adversas a medicamentos (RAM) según el sistema de clasificación de órganos de MedDRA. La siguiente convención ha sido utilizada para clasificar la frecuencia: Muy frecuentes (≥ 1/10), Frecuentes (≥ 1/100 a < 1/10), Poco frecuentes (≥ 1/1.000 a < 1/100), Raras (≥ 1/10.000 a < 1/1.000), Muy raras (< 1/10.000) y de frecuencia no conocida (no puede estimarse a partir de los datos disponibles).

Tabla 4. Frecuencias de todos los grados de efectos adversos del medicamento, independientemente de la causalidad de los estudios de registro pivotales: JMEI (pemetrexed vs docetaxel), JMDB (pemetrexed con  cisplatino versus gemcitabina con cisplatino), JMCH (pemetrexed con cisplatino frente a cisplatino), JMEN y PARAMOUNT (pemetrexed con los mejores cuidados de soporte frente a placebo con los mejores cuidados de soporte) y desde el período posterior a la comercialización.

 **Sistema de clasificación de**

          **Órganos (MedDRA)**  **Muy frecuentes**  **Frecuentes**  **Poco frecuent es**  **Raras**  **Muy raras**  **Frecuenc ia no conocida** 
              
 Infecciones e infestaciones  Infección a

          Faringitis  Sepsis b      Dermo- hipoderm itis   
 Trastornos de la

          sangre y del sistema linfático  Neutropenia Leucopenia Disminució n de hemoglobin a  Neutropenia febril Reducción del recuento de plaquetas  Pancitopeni a  Anemia hemolític a autoinmu ne     
 Trastornos del sistema inmunológico    Hipersensibilid ad    Shock anafilácti co     
 Trastornos del metabolismo y de la

          nutrición    Deshidratación         
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del sistema nervioso    Trastornos del gusto Neuropatía motora periférica Neuropatía Sensorial periférica Mareos  Accidente cerebrovasc ular Accidente cerebrovasc ular isquémico Hemorragia intracraneal       
 Trastornos    Conjuntivitis         
 oculares  Sequedad

          ocular 
   Aumento del 
   lagrimeo 
   Queratoconjun 
   tivitis seca 
   Edema 
   palpebral 
   Enfermedad de 
   la superficie 
   ocular 
 Trastornos    Insuficiencia  Angina       
 cardíacos  cardiaca

          Arritmia  Infarto de

          Miocardio 
     Arteriopatí 
     a coronaria 
     Arritmia 
     supraventri 
     cular 
 Trastornos vasculares      Isquemia periférica       
 Trastornos      Embolia       
 respiratorios,  pulmonar 
 torácicos y  Neumonitis 
 mediastínicos  intersticialb

          d 
 Trastornos gastrointestin ales  Estomatitis Anorexia Vómitos Diarrea Náuseas  Dispepsia Estreñimiento Dolor abdominal  Hemorragia rectal Hemorragia gastrointest inal Perforación intestinal Esofagitis Colitis e       

  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 Trastornos hepatobiliares    Elevación de alanina aminotransfera sa

          Elevación de aspartato aminotransfera sa    Hepatitis     
              
 Trastornos de  Exantema  Hiperpigmenta    Eritema  Síndrome de   
 la piel y del  Exfoliación  ción    Stevens- 
 tejido subcutáneo  de la piel  Prurito

          Eritema multiforme    Johnsonb

          Necrolisis epidérmica 
     Alopecia    tóxicab 
     Urticaria    Penfigoide 
         Dermatitis 
         bullosa 
         Epidermólisi 
         s ampollosa 
         adquirida 
         Edema 
         eritematosof 
         Pseudoceluli 
         tis 
         Dermatitis 
         Eczema 
         Prurigo 
 Trastornos renales y urinarios  Descenso del aclaramient o de creatinina  Fallo renal Disminución de la tasa de filtración

          glomerular        Diabetes insípida nefrogéni ca Necrosi

          s tubular renal 
   Aumento   
   de   
   creatinina   
   en sangre e   
 Trastornos  Astenia  Pirexia         
 generales y    Dolor 
 alteraciones    Edema 
 en el lugar de

          administración    Dolor torácico

          Inflamación de las mucosas 
 Exploracione    Elevación de         
 s  Gamma- 
 complementa  glutamiltransfe 
 rias  rasa 

  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 Lesiones traumáticas, intoxicacione s y complicacion es de procedimient os terapéuticos      Esofagitis por irradiación Neumonitis por irradiación  Fenómen o de recuerdo     
              

a con y sin neutropenia

b en algunos casos mortal

c en ocasiones, derivando en necrosis en las extremidades

d con insuficiencia respiratoria

e visto solo en combinación con cisplatino

f principalmente de las extremidades inferiores

Notificación de sospechas de reacciones adversas:

Es importante notificar sospechas de reacciones adversas al medicamento tras su autorización. Ello permite una supervisión continuada de la relación beneficio/riesgo del medicamento. Se invita a los profesionales sanitarios a notificar las sospechas de reacciones adversas a través del Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://[www.notificaram.es.](http://www.notificaram.es/)