OPDIVO

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

NIVOLUMAB

Dostupno od:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC koda:

L01XC17

Farmaceutski oblik:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sastav:

NIVOLUMAB 10 MG/ML

Administracija rute:

I.V

Tip recepta:

Required

Proizveden od:

BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA

Područje terapije:

NIVOLUMAB

Terapijske indikacije:

Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and pediatric patients 12 years and older.Adjuvant Treatment of Melanoma:OPDIVO is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, IIC, III, or IV melanoma.Metastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of adult patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:- Opdivo as a single agent is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.- Opdivo in combination with ipilimumab is indicated for the first line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).- OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced RCC.Classical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:- OPDIVO is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.- Opdivo (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who: * have disease progression during or following platinum-containing chemotherapy * have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.Hepatocellular Carcinoma:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Esophageal cancer:-OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). -OPDIVO is indicated for the treatment of adult patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.- OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal 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 esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Malignant Pleural Mesothelioma:OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma:OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.Neoadjuvant Treatment of Resectable Non-Small Cell Lung Cancer:OPDIVO, in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).

Datum autorizacije:

2020-02-29

Uputa o lijeku

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
OPDIVO
Concentrate for solution for intravenous infusion
The active ingredient and its concentration:
nivolumab 10 mg/ml
For the list of inactive ingredients and allergens, please see section
2 under
‘Important information about some of this medicine’s
ingredients’ and section 6
‘Further information’.
Read this leaflet carefully in its entirety before using the medicine.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
If the treating doctor prescribes you OPDIVO in combined treatment
with ipilimumab,
carefully read the patient leaflet that comes with ipilimumab as well.
If the treating
doctor prescribes you OPDIVO in combined treatment with cabozantinib,
carefully
read the patient leaflet that comes with cabozantinib as well.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them, even if it seems to you that
their ailment
is similar.
This leaflet does not take the place of talking with your treating
doctor about your
medical condition or your treatment.
Pocket guide and patient safety information card
In addition to the leaflet, pocket guide and patient safety
information card
are available for OPDIVO.
The pocket guide and the card contain important safety information
which you have to know before and during the treatment with OPDIVO,
and which you must follow. Review the pocket guide, the card and the
patient leaflet before you start using the medicine. Keep the card and
the
pocket guide for further review if required.
1. WHAT IS THIS MEDICINE INTENDED FOR?
OPDIVO is used to treat:
•
A type of skin cancer called melanoma
○ OPDIVO used alone or in combination with ipilimumab is indicated
for
treatment of adults with advanced (unresectable or metastatic)
melanoma.
○ OPDIVO is indicated as complementary (ad

Svojstava lijeka

1
Opdivo_NPI_Dec2023
OPDIVO (NIVOLUMAB 10 MG/ML)
CONCENTRATE FOR SOLUTION FOR INFUSION
FULL PRESCRIBING INFORMATION
PATIENT POCKET GUIDE AND PATIENT WALLET CARD
_ _
The marketing of OPDIVO is subject to a risk management plan (RMP)
including a
‘
patient
pocket guide
’
together with a
‘
patient wallet card
’
(Patient safety information card).
The Patient Pocket Guide and Wallet Card emphasize important safety
information that the
patient should be aware of before and during treatment.
Please ensure you are familiar with this important information and
explain to the patient the need
to review the pocket guide and wallet card before starting treatment.
1
INDICATIONS AND USAGE
1.1
UNRESECTABLE OR METASTATIC MELANOMA
OPDIVO, as monotherapy or in combination with ipilimumab is indicated
for the treatment of
advanced (unresectable or metastatic) melanoma in adult
and pediatric patients 12 years and older.
1.2
ADJUVANT TREATMENT OF MELANOMA
OPDIVO is indicated for the adjuvant treatment of adult and pediatric
patients 12 years and older
with completely resected Stage IIB, IIC, III, or IV melanoma.
1.3
NEOADJUVANT TREATMENT OF RESECTABLE NON-SMALL CELL LUNG CANCER
OPDIVO, in combination with platinum-doublet chemotherapy, is
indicated as neoadjuvant
treatment of adult patients with resectable
(tumors ≥4 cm
or node positive) non-small cell lung
cancer (NSCLC).
1.4
METASTATIC NON-SMALL CELL LUNG CANCER
•
OPDIVO, in combination with ipilimumab and 2 cycles of
platinum-doublet
chemotherapy, is indicated for the first-line treatment of adult
patients with metastatic or
recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK
genomic tumor
aberrations
.
•
OPDIVO is indicated for the treatment of adult patients with
metastatic non-small cell lung
cancer (NSCLC) with progression on or after platinum-based
chemotherapy.
1.5
MALIGNANT PLEURAL MESOTHELIOMA
OPDIVO, in combination with ipilimumab, is indicated for the
first-line treatment of adult patients
with unresectable malignant pleural mesothelioma.
2
Opdi