Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
nivolumab, Quantity: 250 mg
Bristol-Myers Squibb Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium citrate dihydrate; sodium chloride; mannitol; pentetic acid; polysorbate 80; hydrochloric acid; sodium hydroxide; water for injections
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
Melanoma,OPDIVO, as monotherapy, is indicated for the adjuvant treatment of adults and adolescent patients 12 years and older with completely resected Stage IIB, IIC, III or IV melanoma.,OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable or metastatic melanoma.,OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.,Non-Small Cell Lung Cancer (NSCLC),OPDIVO, in combination with platinum-doublet chemotherapy, is indicated for the neoadjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC).,OPDIVO, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.,OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy.,OPDIVO, as monotherapy, is indicated for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, OPDIVO should be used after progression on or after targeted therapy.,Malignant Pleural Mesothelioma (MPM),OPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.,Renal Cell Carcinoma (RCC),OPDIVO, in combination with ipilimumab, is indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.,OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.,OPDIVO, as monotherapy, is indicated for the treatment of patients with advanced clear cell renal cell carcinoma after prior anti-angiogenic therapy.,Classical Hodgkin Lymphoma (cHL),OPDIVO, as monotherapy, is indicated for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin. The approval of this indication is based on objective response rate in a single arm study.,Squamous Cell Carcinoma 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 patients progressing on or after platinum based therapy.,Urothelial Carcinoma (UC),OPDIVO, as monotherapy, is indicated for the adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC) who are at high risk of recurrence after undergoing radical resection of MIUC.,OPDIVO, as monotherapy, is indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.,Hepatocellular Carcinoma (HCC),OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.,Oesophageal Squamous Cell Carcinoma (OSCC),OPDIVO in combination with ipilimumab is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ? 1% as determined by a validated test.,OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ? 1% as determined by a validated test.,OPDIVO, as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.,Adjuvant Oesophageal Cancer (OC) or Gastro-Oesophageal Junction Cancer (GOJC),OPDIVO, as monotherapy, is indicated for the adjuvant treatment of resected oesophageal or gastro-oesophageal junction cancer in patients who have received neoadjuvant chemoradiotherapy.,Gastric Cancer (GC), Gastro-oesophageal Junction Cancer (GOJC), or Oesophageal Adenocarcinoma (OAC),OPDIVO, in combination with fluoropyrimidine- and platinum-based combination chemotherapy, is indicated for the first-line treatment of patients with HER2 negative advanced or metastatic gastric or gastro-oesophageal junction or oesophageal adenocarcinoma.
Visual Identification: Clear to opalescent, colourless to pale yellow liquid for intravenous infusion that may contain few light particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-04-09
OPDIVO ® (OP-DEE-VOH) _Nivolumab (nee-vol-u-mab)_ CONSUMER MEDICINE INFORMATION WARNINGS AND PRECAUTIONS - COMBINATION OF OPDIVO AND IPILIMUMAB Both OPDIVO and ipilimumab act on your immune system and may cause inflammation in parts of your body. Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening. These side effects are most likely to begin during treatment, howev- er, side effects can show up months after your last infusion. IT IS IMPORTANT TO TELL YOUR DOCTOR IMMEDI- ATELY IF YOU HAVE, OR DEVELOP, ANY OF THE SYMPTOMS LISTED UNDER POSSIBLE SIDE EFFECTS. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about OPDIVO. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you receiving OPDIVO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. YOU SHOULD READ THIS LEAFLET CAREFULLY AND KEEP IT IN A SAFE PLACE TO REFER TO IT LATER. WHAT IS OPDIVO USED FOR OPDIVO contains the active substance nivolumab, a protein which helps your immune system to attack and destroy cancer cells. _TREATMENT WITH OPDIVO_ OPDIVO is used to treat advanced skin cancer (unresectable or metastatic melanoma). OPDIVO is also used to treat skin cancer (melanoma) after surgical removal of the cancer. OPDIVO is used to treat a type of lung cancer (advanced squamous and non squamous non-small cell lung cancer) , a type of kidney cancer (clear cell renal cell carcinoma) , a type of head and neck cancer (squamous cell cancer of the head and neck), a type of blood cancer called classical Hodgkin lymphoma, a type of bladder cancer (urothelial carcinoma), a type of liver cancer (hepatocellular carcinoma) and a type of food pipe cancer (oesophageal cancer), if your cancer has not responded, or if it has stopped responding, to earlier treatment. _TREATMENT WITH OPDIV Leggi il documento completo
AU_PI_OPDIVO_V32.0 1 AUSTRALIAN PRODUCT INFORMATION OPDIVO ® (NIVOLUMAB) WARNING: IMMUNE-RELATED ADVERSE REACTIONS WITH OPDIVO AND IPILIMUMAB COMBINATION THERAPY IMMUNE-RELATED ADVERSE REACTIONS ARE SEEN MORE FREQUENTLY, AND ARE MORE SEVERE, WITH OPDIVO AND IPILIMUMAB COMBINATION THERAPY THAN WITH OPDIVO OR IPILIMUMAB MONOTHERAPY. IMMUNE-RELATED ADVERSE REACTIONS CAN INVOLVE ANY ORGAN SYSTEM. THE MAJORITY OF THESE INITIALLY MANIFEST DURING TREATMENT; HOWEVER, A MINORITY CAN OCCUR WEEKS TO MONTHS AFTER DISCONTINUATION. SOME IMMUNE-RELATED ADVERSE REACTIONS CAN BE PERMANENT (SUCH AS THYROID DYSFUNCTION AND DIABETES MELLITUS). LIFE-THREATENING OR FATAL IMMUNE-RELATED ADVERSE REACTIONS THAT HAVE OCCURRED INCLUDE COLITIS, INTESTINAL PERFORATION, HEPATITIS, PNEUMONITIS, HYPOPHYSITIS, ADRENAL INSUFFICIENCY, TOXIC EPIDERMAL NECROLYSIS, MYOCARDITIS, ENCEPHALITIS AND MYASTHENIA GRAVIS (SEE SECTIONS 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS). EARLY DIAGNOSIS AND APPROPRIATE MANAGEMENT ARE ESSENTIAL TO MINIMISE LIFE-THREATENING COMPLICATIONS (SEE SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION). MONITORING AT LEAST PRIOR TO EACH DOSE IS RECOMMENDED. ADVISE PATIENTS OF THE IMPORTANCE OF IMMEDIATELY REPORTING POSSIBLE SYMPTOMS. PHYSICIANS SHOULD CONSULT THE IPILIMUMAB PRODUCT INFORMATION PRIOR TO INITIATION OF OPDIVO IN COMBINATION WITH IPILIMUMAB. THE COMBINATION OF OPDIVO AND IPILIMUMAB SHOULD BE ADMINISTERED AND MONITORED UNDER THE SUPERVISION OF PHYSICIANS EXPERIENCED WITH THE USE OF IMMUNOTHERAPY IN THE TREATMENT OF CANCER. 1. NAME OF THE MEDICINE Nivolumab 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg/mL concentrate solution for infusion Each 1 mL of concentrate contains 10 mg of nivolumab. One 10 mL vial contains 40 mg of nivolumab in 4 mL. One 10 mL vial contains 100 mg of nivolumab in 10 mL . One 25 mL vial contains 240 mg of nivolumab in 24 mL. OPDIVO (nivolumab (rch)) is a fully human anti-PD-1 monoclonal antibody (IgG4) produced in mammalian (Chinese hamster ovary) cells by recombinant Leggi il documento completo