Opdivo
Land: Europäische Union
Sprache: Kroatisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
04-04-2024
Fachinformation
(SPC)
04-04-2024
Öffentlichen Beurteilungsberichts
(PAR)
08-09-2023
Wirkstoff:
nivolumab
Verfügbar ab:
Bristol-Myers Squibb Pharma EEIG
ATC-Code:
L01FF01
INN (Internationale Bezeichnung):
nivolumab
Therapiegruppe:
Antineoplastična sredstva
Therapiebereich:
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
Anwendungsgebiete:
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.
Produktbesonderheiten:
Revision: 56
Berechtigungsstatus:
odobren
Berechtigungsdatum:
2015-06-19
Gebrauchsinformation
133
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B. UPUTA O LIJEKU
134
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UPUTA O LIJEKU: INFORMACIJE ZA KORISNIKA
OPDIVO 10 MG/ML KONCENTRAT ZA OTOPINU ZA INFUZIJU
nivolumab
PAŽLJIVO PROČITAJTE CIJELU UPUTU PRIJE NEGO POČNETE PRIMJENJIVATI
OVAJ LIJEK JER SADRŽI VAMA
VAŽNE PODATKE.
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Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.
-
Važno je da tijekom liječenja sa sobom nosite karticu s
upozorenjima.
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Ako imate dodatnih pitanja, obratite se liječniku.
-
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti
liječnika. To uključuje i svaku
moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.
ŠTO SE NALAZI U OVOJ UPUTI
1.
Što je OPDIVO i za što se koristi
2.
Što morate znati prije nego počnete primati OPDIVO
3.
Kako primjenjivati OPDIVO
4.
Moguće nuspojave
5.
Kako čuvati OPDIVO
6.
Sadržaj pakiranja i druge informacije
1.
ŠTO JE OPDIVO I ZA ŠTO SE KORISTI
OPDIVO je lijek koji se koristi za liječenje:
uznapredovalog melanoma (jedne vrste raka kože) u odraslih i
adolescenata u dobi od 12 godina
i starijih
melanoma nakon potpunog kirurškog odstranjivanja tumora u odraslih i
adolescenata u dobi od
12 godina i starijih (liječenje nakon kirurškog zahvata naziva se
adjuvantnom terapijom)
uznapredovalog raka pluća nemalih stanica (jedne vrste raka pluća) u
odraslih
raka pluća nemalih stanica (vrsta raka pluća) prije resekcije u
odraslih (liječenje prije operacije
naziva se neoadjuvantno liječenje)
malignog pleuralnog mezotelioma (jedne vrste raka koji zahvaća
plućnu ovojnicu) u odraslih
uznapredovalog karcinoma bubrežnih stanica (uznapredovalog raka
bubrega) u odraslih
klasičnog Hodgkinovog limfoma koji se vratio nakon prethodnih
terapija ili nije odgovorio na
prethodne terapije, uključujući autologno presađivanje matičnih
stanica (presađivanje vlastitih
krvotvornih stanica) u odraslih
uznapredovalog raka glave i vrata u odraslih
uznapredovalog karcinoma urotela (raka mokraćnog mjehura i mokraćnih
putova) u odraslih
karcinoma urotela nakon
Lesen Sie das vollständige Dokument
Fachinformation
1
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PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
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1.
NAZIV LIJEKA
OPDIVO 10 mg/ml koncentrat za otopinu za infuziju.
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
Jedan ml koncentrata za otopinu za infuziju sadrži 10 mg nivolumaba.
Jedna bočica od 4 ml sadrži 40 mg nivolumaba.
Jedna bočica od 10 ml sadrži 100 mg nivolumaba.
Jedna bočica od 12 ml sadrži 120 mg nivolumaba.
Jedna bočica od 24 ml sadrži 240 mg nivolumaba.
Nivolumab se proizvodi u stanicama jajnika kineskog hrčka
tehnologijom rekombinantne DNA.
Pomoćna tvar s poznatim učinkom
Jedan ml koncentrata sadrži 0,1 mmol (ili 2,5 mg) natrija.
Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
3.
FARMACEUTSKI OBLIK
Koncentrat za otopinu za infuziju (sterilni koncentrat).
Bistra do opalescentna, bezbojna do blijedožuta tekućina koja može
sadržavati malu količinu sitnih
čestica. Otopina ima pH od približno 6,0 i osmolalnost od približno
340 mOsm/kg.
4.
KLINIČKI PODACI
4.1
TERAPIJSKE INDIKACIJE
Melanom
OPDIVO je u monoterapiji ili u kombinaciji s ipilimumabom indiciran za
liječenje uznapredovalog
(neresektabilnog ili metastatskog) melanoma u odraslih bolesnika i
adolescenata u dobi od 12 godina i
starijih.
U odnosu na monoterapiju nivolumabom, produljenje preživljenja bez
progresije bolesti (engl.
_progression-free survival_
, PFS) i ukupnog preživljenja (engl.
_overall survival_
, OS) uz liječenje
kombinacijom nivolumaba i ipilimumaba ustanovljeno je samo u bolesnika
s niskom razinom
tumorske ekspresije PD-L1 (vidjeti dijelove 4.4 i 5.1).
Adjuvantno liječenje melanoma
OPDIVO je u monoterapiji indiciran za adjuvantno liječenje odraslih
bolesnika i adolescenata u dobi
od 12 godina i starijih s melanomom stadija IIB ili IIC, ili melanomom
koji je zahvatio limfne čvorove
ili metastazirao, a koji su bili podvrgnuti potpunoj resekciji
(vidjeti dio 5.1).
Rak pluća nemalih stanica
OPDIVO je u kombinaciji s ipilimumabom i 2 ciklusa kemoterapije na
bazi platine indiciran za prvu
liniju liječenja metastatskog raka pluća nemalih stanica (engl.
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Lesen Sie das vollständige Dokument
