Opdivo

Quốc gia: Liên Minh Châu Âu

Ngôn ngữ: Tiếng Tây Ban Nha

Nguồn: EMA (European Medicines Agency)

Thành phần hoạt chất:

nivolumab

Sẵn có từ:

Bristol-Myers Squibb Pharma EEIG

Mã ATC:

L01FF01

INN (Tên quốc tế):

nivolumab

Nhóm trị liệu:

Agentes antineoplásicos

Khu trị liệu:

Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms

Chỉ dẫn điều trị:

MelanomaOpdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Relative to nivolumab monotherapy, an increase in progression free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression. Adjuvant treatment of melanomaOpdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Non-small cell lung cancer (NSCLC)Opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Malignant pleural mesothelioma (MPM)Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Neoadjuvant treatment of NSCLCOPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. Renal cell carcinoma (RCC)Opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. Opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. Classical Hodgkin lymphoma (cHL)Opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. Squamous cell cancer of the head and neck (SCCHN)Opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. Urothelial carcinomaOpdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. Adjuvant treatment of urothelial carcinomaOPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC)Opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. Oesophageal squamous cell carcinoma (OSCC)OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%. Opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. Adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (OC or GEJC)Opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. Gastric, gastro‑oesophageal junction (GEJ) or oesophageal adenocarcinomaOPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.

Tóm tắt sản phẩm:

Revision: 56

Tình trạng ủy quyền:

Autorizado

Ngày ủy quyền:

2015-06-19

Tờ rơi thông tin

135
_ _
B. PROSPECTO
136
_ _
PROSPECTO: INFORMACIÓN PARA EL USUARIO
OPDIVO 10 MG/ML CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
nivolumab
LEA TODO EL PROSPECTO DETENIDAMENTE ANTES DE EMPEZAR A USAR ESTE
MEDICAMENTO, PORQUE
CONTIENE INFORMACIÓN IMPORTANTE PARA USTED.
-
Conserve este prospecto, ya que puede tener que volver a leerlo.
-
Es importante que tenga siempre con usted, la "Tarjeta de información
para el paciente" durante
el tratamiento.
-
Si tiene alguna duda, consulte a su médico.
-
Si experimenta efectos adversos, consulte a su médico, incluso si se
trata de efectos adversos
que no aparecen en este prospecto. Ver sección 4.
CONTENIDO DEL PROSPECTO
1.
Qué es OPDIVO y para qué se utiliza
2.
Qué necesita saber antes de empezar a usar OPDIVO
3.
Cómo usar OPDIVO
4.
Posibles efectos adversos
5.
Conservación de OPDIVO
6.
Contenido del envase e información adicional
1.
QUÉ ES OPDIVO Y PARA QUÉ SE UTILIZA
OPDIVO es un medicamento que se utiliza para tratar:

melanoma avanzado (un tipo de cáncer de piel) en adultos y
adolescentes a partir de 12 años

melanoma tras resección completa en adultos y adolescentes a partir
de 12 años (el tratamiento
después de la cirugía se denomina terapia adyuvante)

cáncer de pulmón no microcítico avanzado (un tipo de cáncer de
pulmón) en adultos

cáncer de pulmón no microcítico (un tipo de cáncer de pulmón)
antes de la resección en adultos
(el tratamiento previo a la cirugía se denomina tratamiento
neoadyuvante)

mesotelioma pleural maligno (un tipo de cáncer que afecta al
revestimiento de los pulmones) en
adultos

carcinoma de células renales avanzado (cáncer de riñón avanzado)
en adultos

linfoma de Hodgkin clásico que ha reaparecido o que no ha respondido
a tratamientos previos,
incluyendo un trasplante autólogo de progenitores hematopoyéticos
(un trasplante de sus
propias células productoras de sangre) en adultos

cáncer de cabeza y cuello avanzado en adultos

carcinoma urotelial avanzado (cáncer de vejiga y de

Đặc tính sản phẩm

1
_ _
ANEXO I
FICHA TÉCNICA O RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO
2
_ _
1.
NOMBRE DEL MEDICAMENTO
OPDIVO 10 mg/ml concentrado para solución para perfusión.
2.
COMPOSICIÓN CUALITATIVA Y CUANTITATIVA
Cada ml de concentrado para solución para perfusión contiene 10 mg
de nivolumab.
Un vial de 4 ml contiene 40 mg de nivolumab.
Un vial de 10 ml contiene 100 mg de nivolumab.
Un vial de 12 ml contiene 120 mg de nivolumab.
Un vial de 24 ml contiene 240 mg de nivolumab.
Nivolumab se produce en células de ovario de hámster chino mediante
tecnología de ADN
recombinante.
Excipiente con efecto conocido
Cada ml de este concentrado contiene 0,1 mmol (o 2,5 mg) de sodio.
Para consultar la lista completa de excipientes, ver sección 6.1.
3.
FORMA FARMACÉUTICA
Concentrado para solución para perfusión (concentrado estéril).
Líquido, de incoloro a amarillo pálido, de transparente a
opalescente que puede contener algunas
(pocas) partículas. La solución tiene un pH de aproximadamente 6,0 y
una osmolalidad de
aproximadamente 340 mOsm/kg.
4.
DATOS CLÍNICOS
4.1
INDICACIONES TERAPÉUTICAS
Melanoma
OPDIVO en monoterapia o en combinación con ipilimumab está indicado
para el tratamiento del
melanoma avanzado (irresecable o metastásico) en adultos y
adolescentes a partir de 12 años.
En comparación con nivolumab en monoterapia se ha establecido un
aumento de la supervivencia libre
de progresión (SLP) y supervivencia global (SG) para la combinación
de nivolumab con ipilimumab,
solamente en los pacientes con baja expresión de PD-L1 en el tumor
(ver las secciones 4.4 y 5.1).
Tratamiento adyuvante del melanoma
OPDIVO en monoterapia está indicado para el tratamiento adyuvante en
adultos y adolescentes a
partir de 12 años con melanoma en estadio IIB o IIC o melanoma con
afectación de los ganglios
linfáticos o enfermedad metastásica que hayan sido sometidos a
resección completa (ver sección 5.1).
Cáncer de pulmón no microcítico (CPNM)
OPDIVO en combinación con ipilimumab y 2 ciclos de quimioterapia
basada