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Von Hippel-Lindau (VHL) disease Clinical criteria: Treatment Phase: Initiating or recommencing treatment The condition must have been diagnosed by at least one of: (i) a germline VHL alteration; (ii) at least two manifestations highly characteristic of VHL disease; (iii) at least one manifestation highly characteristic of VHL disease with a documented family history of VHL, AND The condition must be at least one of: (i) VHL-associated non-metastatic renal cell carcinoma (RCC); (ii) VHL-associated central nervous system (CNS) haemangioblastoma; (iii) VHL-associated non-metastatic pancreatic neuroendocrine tumour (pNET), AND Patient must not have tumour(s) that require immediate surgery as assessed by the treating clinician, AND Patient must be untreated with this drug for this condition; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition for a different tumour type; OR Patient must have previously received PBS-subsidised treatment with this drug for this condition and ceased previous treatment for family planning purposes, AND Patient must have WHO performance status no higher than 1; OR The condition must be VHL-associated brainstem tumour(s), or brain herniation, which temporarily affected the patient's WHO performance status to be higher than 1, AND The treatment must be the sole PBS-subsidised therapy for VHL disease associated tumours. Treatment criteria: Must be treated by a physician with expertise in the management of VHL disease associated tumours. Patients who cease therapy for reasons other than, clinical disease progression or metastasis, may re-initiate PBS-subsidised treatment through the initiating or recommencing treatment phase. For the purpose of administering this restriction, the highly characteristic manifestations of VHL disease include but not limited to: (i) retinal, spinal, or cerebellar haemangioblastoma; (ii) adrenal or extra-adrenal phaeochromocytoma; (iii) renal cell carcinoma; (iv) multiple renal and pancreatic cysts; (v) endolymphatic sac tumours, papillary cystadenomas of the epididymis or broad ligament, or pancreatic neuroendocrine tumours.
“Belzutifan is an inhibitor of hypoxia-inducible factor 2 alpha (HIF- 2α) .”
“Based on the population PK analysis, the mean (CV%) clearance is 5.89 L/hr (60.6%) and the mean elimination half-life is approximately 14 hrs.”
“Belzutifan is primarily metabolised by UGT2B17 and CYP2C19 and to a lesser extent by CYP3A4.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.