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Nivolumab, sold under the brand name Opdivo, is an anti-cancer medication in the class of immune checkpoint inhibitors. It selectively binds and blocks the programmed death-1 (PD-1) receptor on T cells, thereby facilitating their activation. It is used to treat certain types of cancer including melanoma, lung cancer, malignant pleural mesothelioma, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, colon cancer, esophageal squamous cell carcinoma, liver cancer, gastric cancer, and esophageal or gastroesophageal junction cancer. It is administered intravenously.
Read the full article on WikipediaStage IIIB, IIIC, IIID or Stage IV malignant melanoma Clinical criteria: Treatment Phase: Initial treatment The treatment must be in addition to complete surgical resection, AND Patient must have a WHO performance status of 1 or less, AND Patient must not have received prior PBS-subsidised treatment for this condition, AND The treatment must commence within 12 weeks of complete resection, AND Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy. When nivolumab is initially prescribed as a 3-weekly dosing regimen, patients must only receive a maximum of 240 mg every 3 weeks for 2 cycles (i.e., 1 repeat). When prescribed as a weight based or flat dose adjuvant regimen, patients must only receive a maximum of 240 mg every 2 weeks or 480 mg every 4 weeks for a maximum of 12 months of adjuvant treatment.
Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer Clinical criteria: The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records, AND The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy, AND The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug, AND The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records, AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, AND The treatment must be the sole PBS-subsidised therapy for this condition. Treatment criteria: Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information, AND Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
Urothelial carcinoma Clinical criteria: The treatment must be for each of: (i) adjuvant therapy that is/was initiated within 6 months of radical surgical resection, (ii) muscle invasive type disease, (iii) disease considered to be at high risk of recurrence based on pathologic staging of radical surgery tissue (ypT2-ypT4a or ypN+), but yet to recur, (iv) use as the sole PBS-subsidised anti-cancer treatment for this condition, AND Patient must have received prior platinum containing neoadjuvant chemotherapy, AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition, AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1. Treatment criteria: Patient must be undergoing treatment with a dosing regimen as set out in the drug's Therapeutic Goods Administration (TGA) approved Product Information, AND Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. An increase in repeat prescriptions, up to a value of 11, may only be sought where the prescribed dosing is 240 mg administered fortnightly.
Resectable non-small cell lung cancer (NSCLC) Clinical criteria: The condition must be at least one of: (i) node positive, (ii) at least 4 cm in size, AND The treatment must be for neoadjuvant use in a patient preparing for surgical resection, AND Patient must have a WHO performance status of 0 or 1, AND The treatment must be in combination with platinum-based chemotherapy. Treatment criteria: Patient must not be undergoing treatment with more than 3 PBS-subsidised doses of this drug per lifetime for this indication. In non-squamous type NSCLC where any of the following is known to be present, this drug must not be a PBS benefit: (i) activating epidermal growth factor receptor (EGFR) gene mutation, (ii) anaplastic lymphoma kinase (ALK) gene rearrangement.
Immunotherapy sensitive advanced or metastatic cancer Clinical criteria: Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for. Patients must only receive a maximum of 240 mg every two weeks, 360 mg every three weeks, or 480 mg every four weeks under a weight based or flat dosing regimen.
“Nivolumab's mechanism of action is based on its role as a monoclonal antibody that selectively binds to the programmed death-1 (PD-1) receptor on the surface of T cells, a type of white blood cell that plays a crucial role in the immune system's ability to combat malignancies. Normally, certain cancer cells exploit the PD-1 pathway to shield themselves from the immune response by expressing programmed death-ligand 1 (PD-L1), which interacts with the PD-1 receptor and inhibits T-cell activation and proliferation. Nivolumab interrupts this interaction by binding to the PD-1 receptor, thereby blocking tumor cells from evading immune detection. This blockade enhances T-cell response, boosts the immune system's anti-tumor activity, and ultimately contributes to the destruction of cancer cells.”
“27 days”
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