Opdivo

Country: Եվրոպական Միություն

language: բուլղարերեն

source: EMA (European Medicines Agency)

active_ingredient:

nivolumab

MAH:

Bristol-Myers Squibb Pharma EEIG

ATC_code:

L01FF01

INN:

nivolumab

therapeutic_group:

Антинеопластични средства

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:

упълномощен

authorization_date:

2015-06-19

PIL

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
OPDIVO 10 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 10 mg of
nivolumab.
One vial of 4 mL contains 40 mg of nivolumab.
One vial of 10 mL contains 100 mg of nivolumab.
One vial of 12 mL contains 120 mg of nivolumab.
One vial of 24 mL contains 240 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
Excipient with known effect
Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to pale yellow liquid that may contain
few light particles. The solution
has a pH of approximately 6.0 and an osmolality of approximately 340
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
OPDIVO 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 (see sections 4.4 and 5.1).
Adjuvant treatment of melanoma
OPDIVO as monotherapy is indicated for the adjuvant treatment of
adults and adolescents 12 years of
age and older with Stage IIB or IIC melanoma, or melanoma with
involvement of lymph nodes or
metastatic disease who have undergone complete resection (see section
5.1).
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

SPC

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
_ _
1.
NAME OF THE MEDICINAL PRODUCT
OPDIVO 10 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 10 mg of
nivolumab.
One vial of 4 mL contains 40 mg of nivolumab.
One vial of 10 mL contains 100 mg of nivolumab.
One vial of 12 mL contains 120 mg of nivolumab.
One vial of 24 mL contains 240 mg of nivolumab.
Nivolumab is produced in Chinese hamster ovary cells by recombinant
DNA technology.
Excipient with known effect
Each mL of concentrate contains 0.1 mmol (or 2.5 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to pale yellow liquid that may contain
few light particles. The solution
has a pH of approximately 6.0 and an osmolality of approximately 340
mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melanoma
OPDIVO 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 (see sections 4.4 and 5.1).
Adjuvant treatment of melanoma
OPDIVO as monotherapy is indicated for the adjuvant treatment of
adults and adolescents 12 years of
age and older with Stage IIB or IIC melanoma, or melanoma with
involvement of lymph nodes or
metastatic disease who have undergone complete resection (see section
5.1).
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