Country: Израел
Језик: Енглески
Извор: Ministry of Health
NIVOLUMAB
BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL
L01XC17
CONCENTRATE FOR SOLUTION FOR INFUSION
NIVOLUMAB 10 MG/ML
I.V
Required
BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA
NIVOLUMAB
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).
2020-02-29
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 Прочитајте комплетан документ
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 Прочитајте комплетан документ