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Sunitinib, sold under the brand name Sutent, is an anti-cancer medication. It is a small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor that was approved by the FDA for the treatment of renal cell carcinoma (RCC) and imatinib-resistant gastrointestinal stromal tumor (GIST) in January 2006. Sunitinib was the first cancer drug simultaneously approved for two different indications.
Read the full article on WikipediaMetastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET) Clinical criteria: Treatment Phase: Initial treatment Patient must be symptomatic (despite somatostatin analogues); OR Patient must have disease progression, AND The treatment must be as monotherapy. Disease progression must be documented in the patient's medical records. Patients who have developed progressive disease with any of: (i) everolimus; (ii) cabozantinib are not eligible to receive PBS-subsidised treatment with sunitinib for this condition. Patients who have developed intolerance with any of: (i) everolimus; (ii) cabozantinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.
Stage IV clear cell variant renal cell carcinoma (RCC) Clinical criteria: Treatment Phase: Continuing treatment beyond 3 months Patient must have received an initial authority prescription for this drug for this condition, AND Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST), AND The treatment must be the sole PBS-subsidised tyrosine kinase inhibitor therapy for this condition. Treatment criteria: Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. PBS-subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib.
Metastatic or unresectable malignant gastrointestinal stromal tumour Clinical criteria: Treatment Phase: Initial treatment The condition must not be resectable, AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition, AND Patient must have a WHO performance status of 2 or less, AND Patient must have previously failed or be intolerant to imatinib mesilate. Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib.
“Sunitinib inhibits cellular signalling by targeting multiple receptor tyrosine kinases (RTKs).”
“40 to 60 hours (sunitinib)80 to 110 hours (metabolite)”
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