Country: Европска Унија
Језик: Хрватски
Извор: EMA (European Medicines Agency)
nivolumab
Bristol-Myers Squibb Pharma EEIG
L01FF01
nivolumab
Antineoplastična sredstva
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
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.
Revision: 56
odobren
2015-06-19
133 _ _ B. UPUTA O LIJEKU 134 _ _ 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. - Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati. - Važno je da tijekom liječenja sa sobom nosite karticu s upozorenjima. - 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 Прочитајте комплетан документ
1 _ _ PRILOG I. SAŽETAK OPISA SVOJSTAVA LIJEKA 2 _ _ 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. _ Прочитајте комплетан документ