Opdivo

Țară: Uniunea Europeană

Limbă: franceză

Sursă: EMA (European Medicines Agency)

Cumpara asta acum

Prospect Prospect (PIL)
04-04-2024

Ingredient activ:

nivolumab

Disponibil de la:

Bristol-Myers Squibb Pharma EEIG

Codul ATC:

L01FF01

INN (nume internaţional):

nivolumab

Grupul Terapeutică:

Agents antinéoplasiques

Zonă Terapeutică:

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

Indicații terapeutice:

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.

Rezumat produs:

Revision: 56

Statutul autorizaţiei:

Autorisé

Data de autorizare:

2015-06-19

Prospect

                                139
_ _
B. NOTICE
140
_ _
NOTICE: INFORMATION DE L’UTILISATEUR
OPDIVO 10 MG/ML, SOLUTION À DILUER POUR PERFUSION
nivolumab
VEUILLEZ LIRE ATTENTIVEMENT CETTE NOTICE AVANT D’UTILISER CE
MÉDICAMENT CAR ELLE CONTIENT DES
INFORMATIONS IMPORTANTES POUR VOUS.
-
Gardez cette notice. Vous pourriez avoir besoin de la relire.
-
Il est important que vous conserviez la carte d'alerte patient sur
vous pendant votre traitement.
-
Si vous avez d’autres questions, interrogez votre médecin.
-
Si vous ressentez un quelconque effet indésirable, parlez-en à votre
médecin. Ceci s’applique
aussi à tout effet indésirable qui ne serait pas mentionné dans
cette notice. Voir rubrique 4.
QUE CONTIENT CETTE NOTICE?:
1.
Qu’est-ce qu'OPDIVO et dans quel cas est-il utilisé
2.
Quelles sont les informations à connaître avant d’utiliser OPDIVO
3.
Comment utiliser OPDIVO
4.
Quels sont les effets indésirables éventuels ?
5.
Comment conserver OPDIVO
6.
Contenu de l’emballage et autres informations
1.
QU’EST-CE QU'OPDIVO ET DANS QUEL CAS EST-IL UTILISÉ
OPDIVO est un médicament utilisé pour traiter :

des patients adultes et adolescents âgés de 12 ans et plus atteints
de mélanome avancé (un type
de cancer de la peau)

des patients adultes et adolescents âgés de 12 ans et plus atteints
de mélanome après une
résection complète (un traitement suivant une intervention
chirurgicale est appelé un traitement
adjuvant)

des patients adultes atteints de cancer bronchique non à petites
cellules (un type de cancer du
poumon) à un stade avancé

des patients adultes atteints de cancer bronchique non à petites
cellules (un type de cancer du
poumon) avant une résection (un traitement suivi avant la chirurgie
est appelé traitement
néoadjuvant)

des patients adultes atteints de mésothéliome pleural malin (un type
de cancer qui affecte la
paroi du poumon)

des patients adultes atteints de carcinome à cellules rénales
avancé (cancer du rein avancé)

des patients adultes atteints de lymphome de 
                                
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Caracteristicilor produsului

                                1
_ _
ANNEXE I
RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT
2
_ _
1.
DÉNOMINATION DU MÉDICAMENT
OPDIVO 10 mg/mL, solution à diluer pour perfusion
2.
COMPOSITION QUALITATIVE ET QUANTITATIVE
Chaque mL de solution à diluer pour perfusion contient 10 mg de
nivolumab.
Un flacon de 4 mL contient 40 mg de nivolumab.
Un flacon de 10 mL contient 100 mg de nivolumab.
Un flacon de 12 mL contient 120 mg de nivolumab.
Un flacon de 24 mL contient 240 mg de nivolumab.
Nivolumab est produit sur des cellules ovariennes de hamster chinois,
par la technologie de l'ADN
recombinant.
Excipient à effet notoire :
Chaque mL de solution à diluer contient 0,1 mmol (ou 2,5 mg) de
sodium.
Pour la liste complète des excipients, voir rubrique 6.1.
3.
FORME PHARMACEUTIQUE
Solution à diluer pour perfusion (solution à diluer stérile).
Solution claire à opalescente, incolore à jaune pâle, pouvant
contenir quelques particules légères. Le
pH de la solution est approximativement de 6,0 et l'osmolarité
approximativement de 340 mOsm/kg.
4.
INFORMATIONS CLINIQUES
4.1
INDICATIONS THÉRAPEUTIQUES
Mélanome
OPDIVO est indiqué en monothérapie ou en association à
l’ipilimumab dans le traitement des patients
adultes et adolescents âgés de 12 ans et plus atteints d'un
mélanome avancé (non résécable ou
métastatique).
Par rapport à nivolumab en monothérapie, une augmentation de la
survie sans progression (SSP) et de
la survie globale (SG) a été établie pour l’association de
nivolumab à l’ipilimumab seulement chez les
patients avec une expression tumorale faible de PD-L1 (voir rubriques
4.4 et 5.1).
Traitement adjuvant du mélanome
OPDIVO est indiqué en monothérapie dans le traitement adjuvant des
patients adultes et adolescents
âgés de 12 ans et plus atteints d’un mélanome de stade IIB ou
IIC, ou avec atteinte des ganglions
lymphatiques ou une maladie métastatique, et ayant subi une
résection complète (voir rubrique 5.1).
Cancer bronchique non à petites cellules (CBNPC)
OPDIVO est indiqué en association à l’ipili
                                
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