Opdivo

Country: Եվրոպական Միություն

language: սլովեներեն

source: EMA (European Medicines Agency)

active_ingredient:

nivolumab

MAH:

Bristol-Myers Squibb Pharma EEIG

ATC_code:

L01FF01

INN:

nivolumab

therapeutic_group:

Antineoplastična sredstva

therapeutic_area:

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

therapeutic_indication:

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.

leaflet_short:

Revision: 56

authorization_status:

Pooblaščeni

authorization_date:

2015-06-19

PIL

135
_ _
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v hladilniku.
Ne zamrzujte.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Irska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/15/1014/001 40 mg viala
EU/1/15/1014/002 100 mg viala
EU/1/15/1014/003 240 mg viala
EU/1/15/1014/004 120 mg viala
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
136
_ _
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA_ _
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC
SN
NN
137
_ _
PODATKI NA PRIMARNI OVOJNINI
NALEPKA VIALE
1.
IME ZDRAVILA
OPDIVO 10 mg/ml sterilni koncentrat
nivolumab
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
En ml koncentrata vsebuje 10 mg nivolumaba.
Ena viala z 12 ml vsebuje 120 mg nivolumaba.
Ena viala s 24 ml vsebuje 240 mg nivolumaba.
3.
SEZNAM POMOŽNIH SNOVI
Pomožne snovi: natrijev citrat dihidrat, natrijev klorid, manitol
(E421), pentetska kislina,
polisorbat 80 (E433), natrijev hidroksid, klorovodikova kislina in
voda za injekcije.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
sterilni koncentrat
120 mg/12 ml
240 mg/24 ml
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred uporabo preberite priloženo navodilo!
i.v. uporaba
Samo za enkratno uporabo.
6.
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
POGLEDA OTROK
Zdravilo shranjujte nedosegljivo otrokom!
7.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
8.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
138
_ _
9.
POSEBNA NAVODILA ZA SHRANJEVANJE
Shranjujte v hladilniku.
Ne zamrzujte.
Shranjujte v originaln

SPC

1
_ _
PRILOGA I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
_ _
1.
IME ZDRAVILA
OPDIVO 10 mg/ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
En ml koncentrata za raztopino za infundiranje vsebuje 10 mg
nivolumaba.
Ena viala s 4 ml vsebuje 40 mg nivolumaba.
Ena viala z 10 ml vsebuje 100 mg nivolumaba.
Ena viala z 12 ml vsebuje 120 mg nivolumaba.
Ena viala s 24 ml vsebuje 240 mg nivolumaba.
Nivolumab je pridobljen s tehnologijo rekombinantne DNA na ovarijskih
celicah kitajskega hrčka.
Pomožna snov z znanim učinkom
En ml koncentrata vsebuje 0,1 mmol (ali 2,5 mg) natrija.
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
koncentrat za raztopino za infundiranje (sterilni koncentrat)
Bistra do opalescentna, brezbarvna do svetlorumena tekočina, ki lahko
vsebuje nekaj svetlih delcev.
pH vrednost raztopine je približno 6,0, osmolalnost pa približno 340
mOsm/kg.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Melanom
Zdravilo OPDIVO je v monoterapiji ali v kombinaciji z ipilimumabom
indicirano za zdravljenje
napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih
in mladostnikih, starih 12 let
in starejših.
V primerjavi z zdravljenjem z nivolumabom v monoterapiji so pri
zdravljenju z nivolumabom v
kombinaciji z ipilimumabom podaljšanje preživetja brez napredovanja
bolezni (PFS - progression-free
survival) in celokupnega preživetja (OS - overall survival) ugotovili
le pri bolnikih z nizko ekspresijo
PD-L1 tumorja (glejte poglavji 4.4 in 5.1).
Adjuvantno zdravljenje melanoma
Zdravilo OPDIVO je v monoterapiji indicirano za adjuvantno zdravljenje
odraslih in mladostnikov,
starih 12 let in starejših, z melanomom v stadiju IIB ali IIC ali
melanomom, ki se je razširil na
bezgavke, ali z metastatsko boleznijo po popolni kirurški odstranitvi
(glejte poglavje 5.1).
Nedrobnocelični pljučni rak (NSCLC - non-small cell lung cancer)
Zdravilo OPDIVO je v kombinaciji z ipilimumabom in 2 cikloma
kemoterapije na osnovi platine
indicirano za prvo linijo zd