Opdivo

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

Active ingredient:

nivolumab

Available from:

Bristol-Myers Squibb Pharma EEIG

ATC code:

L01FF01

INN (International Name):

nivolumab

Therapeutic group:

Antineoplastiske midler

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 indications:

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.

Product summary:

Revision: 56

Authorization status:

autoriseret

Authorization date:

2015-06-19

Patient Information leaflet

131
_ _
B. INDLÆGSSEDDEL
132
_ _
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
OPDIVO 10 MG/ML KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
nivolumab
LÆS DENNE INDLÆGSSEDDEL GRUNDIGT, INDEN DU BEGYNDER AT BRUGE DETTE
LÆGEMIDDEL, DA DEN
INDEHOLDER VIGTIGE OPLYSNINGER.
-
Gem indlægssedlen. Du kan få brug for at læse den igen.
-
Det er vigtigt, at du altid har patient-informationskortet på dig,
så længe du er i behandling med
OPDIVO.
-
Spørg lægen, hvis der er mere, du vil vide.
-
Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger, som
ikke er nævnt i denne
indlægsseddel. Se afsnit 4.
Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
OVERSIGT OVER INDLÆGSSEDLEN
1.
Virkning og anvendelse
2.
Det skal du vide, før du begynder at bruge OPDIVO
3.
Sådan skal du bruge OPDIVO
4.
Bivirkninger
5.
Opbevaring
6.
Pakningsstørrelser og yderligere oplysninger
1.
VIRKNING OG ANVENDELSE
OPDIVO er en medicin, der anvendes til behandling af:

fremskredent melanom (en bestemt type hudkræft, modermærkekræft)
hos voksne og unge på
12 år og derover

melanom efter komplet resektion hos voksne og unge på 12 år og
derover (behandling efter en
operation kaldes adjuverende behandling)

fremskreden ikke små-cellet lungekræft (en bestemt type lungekræft)
hos voksne

ikke-småcellet lungekræft (en bestemt type lungekræft) før
fjernelse ved operation hos voksne
(behandling forud for operation kaldes neoadjuverende behandling)

malignt pleura mesotheliom (en bestemt type kræft der påvirker
hinderne i lungen,
lungehindekræft) hos voksne

fremskredent renalcellekarcinom (fremskreden nyrekræft) hos voksne

klassisk Hodgkins lymfom, som er vendt tilbage, eller som ikke har
reageret på tidligere
behandlinger, herunder autolog stamcelletransplantation
(transplantation af dine egne
bloddannende celler) hos voksne

fremskreden hoved-halskræft hos voksne

fremskredent urotelialt karcinom (blære- og urinvejskræft) hos
voksne

urotelialt karcinom efter komplet fjernelse af et or

Summary of Product characteristics

1
_ _
BILAG I
PRODUKTRESUMÉ
2
_ _
1.
LÆGEMIDLETS NAVN
OPDIVO 10 mg/ml koncentrat til infusionsvæske, opløsning.
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
Hver ml koncentrat til infusionsvæske, opløsning, indeholder 10 mg
nivolumab.
Et 4 ml hætteglas indeholder 40 mg nivolumab.
Et 10 ml hætteglas indeholder 100 mg nivolumab.
Et 12 ml hætteglas indeholdende 120 mg nivolumab.
Et 24 ml hætteglas indeholder 240 mg nivolumab.
Nivolumab fremstilles ved rekombinant DNA-teknologi i ovarieceller fra
kinesiske hamstere.
Hjælpestof, som behandleren skal være opmærksom på
En ml koncentrat indeholder 0,1 mmol (eller 2,5 mg) natrium.
Alle hjælpestoffer er anført under pkt. 6.1.
3.
LÆGEMIDDELFORM
Koncentrat til infusionsvæske, opløsning (sterilt koncentrat).
Klar til opaliserende, farveløs til lysegul væske, der kan indeholde
få lyse partikler. Koncentratet har
en pH på ca. 6,0 og en osmolaritet på ca. 340 mOsm/kg.
4.
KLINISKE OPLYSNINGER
4.1
TERAPEUTISKE INDIKATIONER
Melanom
OPDIVO som monoterapi eller i kombination med ipilimumab er indiceret
til behandling af
fremskredent (inoperabelt eller metastatisk) melanom hos voksne og
unge på 12 år og derover.
I forhold til nivolumab-monoterapi er forbedring af progressionsfri
overlevelse (PFS) og samlet
overlevelse (OS) med kombinationen nivolumab og ipilimumab udelukkende
dokumenteret hos
patienter med lav PD-L1-tumorekspression (se pkt. 4.4 og 5.1).
Adjuverende behandling af melanom
OPDIVO som monoterapi er indiceret til adjuverende behandling af
voksne og unge på 12 år og
derover med stadie IIB eller IIC melanom eller melanom med involvering
af lymfeknuder eller
metastatisk sygdom, som har fået foretaget komplet resektion (se pkt.
5.1).
Ikke-småcellet lungecancer (NSCLC)
OPDIVO i kombination med ipilimumab og 2 cyklusser af platinbaseret
kemoterapi er indiceret til
førstelinjebehandling af voksne med metastatisk ikke-småcellet
lungecancer uden sensibiliserende
EGFR-mutation eller ALK-translokation.
OPDIVO som monoterapi er indiceret til behandling