Opdivo
Maa: Euroopan unioni
Kieli: malta
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
04-04-2024
Valmisteyhteenveto
(SPC)
04-04-2024
Julkisesta arviointikertomuksesta
(PAR)
08-09-2023
Aktiivinen ainesosa:
nivolumab
Saatavilla:
Bristol-Myers Squibb Pharma EEIG
ATC-koodi:
L01FF01
INN (Kansainvälinen yleisnimi):
nivolumab
Terapeuttinen ryhmä:
Aġenti antineoplastiċi
Terapeuttinen alue:
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
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 56
Valtuutuksen tilan:
Awtorizzat
Valtuutus päivämäärä:
2015-06-19
Pakkausseloste
132
_ _
B. FULJETT TA’ TAGĦRIF
133
_ _
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
OPDIVO 10 MG/ML KONĊENTRAT GĦAL SOLUZZJONI GĦALL-INFUŻJONI
nivolumab
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Huwa importanti li żżomm il-kard ta’ twissija miegħek matul
il-trattament.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib tiegħek. Dan
jinkludi xi effett sekondarju
possibbli li mhuwiex elenkat f’dan il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu OPDIVO u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża OPDIVO
3.
Kif għandek tuża OPDIVO
4.
Effetti sekondarji possibbli
5.
Kif taħżen OPDIVO
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU OPDIVO U GĦALXIEX JINTUŻA
OPDIVO hu mediċina li jintuża għat-trattament ta’:
melanoma avvanzata (tip ta’ kanċer tal-ġilda) fl-adulti u
fl-adolexxenti minn 12-il sena ’l fuq
melanoma wara risezzjoni kompleta fl-adulti u fl-adolexxenti minn
12-il sena ’l fuq (trattament
wara kirurġija hija msejħa terapija aġġuvanti)
kanċer avvanzat tal-pulmun mhux b’ċelloli żgħar (tip ta’
kanċer tal-pulmun) fl-adulti
kanċer tal-pulmun mhux b’ċelloli żgħar (tip ta’ kanċer
tal-pulmun) qabel it-tneħħija f’adulti (it-
trattament qabel il-kirurġija jissejjaħ terapija neoaġġuvanti)
mesoteljoma plewrali malinna (tip ta’ kanċer li jaffettwa l-kisja
tal-pulmun) fl-adulti
karċinoma taċ-ċelloli tal-kliewi avvanzata (kanċer tal-kliewi
avvanzat) fl-adulti
limfoma ta’ Hodgkin klassika li reġgħet tfaċċat wara jew li ma
rrispondietx għat-terapiji minn
qabel, inkluż trapjant awtologu ta’ ċelluli staminali (trapjant
taċ-ċelluli li jipproduċu d-demm
tiegħek stess) fl-adulti
kanċer avvanzat tar-ras u tal-għonq fl-adulti
karċinoma tal-apparat tal-awrina avvanzata (
Lue koko asiakirja
Valmisteyhteenveto
1
_ _
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
_ _
1.
ISEM IL-PRODOTT MEDIĊINALI
OPDIVO 10 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull mL konċentrat għal soluzzjoni għall-infużjoni fih 10 mg
nivolumab.
Kunjett tal-4 mL fih 40 mg nivolumab.
Kunjett tal-10 mL fih 100 mg nivolumab.
Kunjett tat-12-il mL fih 120 mg nivolumab.
Kunjett tal-24 mL fih 240 mg nivolumab.
Nivolumab huwa prodott fiċ-ċelloli tal-ovarji tal-ħamster Ċiniż
b’teknoloġija rikombinanti tad-DNA.
Eċċipjent(i) b’effett magħruf
Kull mL tal-konċentrat fih 0.1 mmol (jew 2.5 mg) sodium.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Konċentrat għal soluzzjoni għall-infużjoni (konċentrat sterili).
Likwidu trasparenti sa opalexxenti, bla kulur sa isfar mitfi li
jista’ jkun fih ftit frak ħfief. Is-soluzzjoni
għandha pH ta’ madwar 6.0 u osmolalità ta’ madwar 340 mOsm/kg.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Melanoma
OPDIVO bħala monoterapija jew f’taħlita ma’ ipilimumab huwa
indikat għal trattament ta’ melanoma
avvanzata (metastatika jew li ma tistax titneħħa bil-kirurġija)
fl-adulti u fl-adolexxenti minn 12-il sena
’l fuq.
Relattiva għall-monoterapija ta’ nivolumab, żieda fis-sopravivenza
mingħajr progressjoni
(
_progression-free survival_
, PFS) u fis-sopravivenza globali (overall survival, OS)
għall-kombinazzjoni
ta’ nivolumab ma’ ipilimumab hija stabbilita biss f’pazjenti
b’espressjoni baxxa ta’ PD-L1 tat-tumur
(ara sezzjonijiet 4.4 u 5.1).
Trattament aġġuvanti għal melanoma
OPDIVO bħala monoterapija huwa indikat għal trattament aġġuvanti
ta’ adulti u adolexxenti minn 12-
il sena ’l fuq b’melanoma ta’ Stadju IIB jew IIC, jew melanoma
bl-involviment ta’ nodi limfatiċi jew
b’marda metastatika li jkunu għaddew minn risezzjoni kompleta (ara
sezzjoni 5.1).
Kanċer tal-pulmun mhux b’ċelloli żgħar (NSCLC)
OPDIVO flimkien ma’ ipilimumab u 2 ċikli ta’ kim
Lue koko asiakirja
