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High risk and intermediate-2 risk myelofibrosis Clinical criteria: Treatment Phase: Initial treatment The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report, AND The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition. Details of the following must be documented in the patient's medical records: (a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and (b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.
Intermediate-1 risk myelofibrosis Clinical criteria: Treatment Phase: Initial treatment The condition must be either: (i) primary myelofibrosis, (ii) post-polycythaemia vera myelofibrosis, (iii) post-essential thrombocythaemia myelofibrosis, confirmed through a bone marrow biopsy report, AND Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy; OR Patient must have intolerance to prior treatment with a JAK inhibitor for this condition, AND The treatment must be the sole PBS-subsidised JAK inhibitor therapy for this condition. Details of the following must be documented in the patient's medical records: (a) the bone marrow biopsy report confirming diagnosis of myelofibrosis (date, unique identifying number/code or provider number); and (b) a classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.
“Fedratinib is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). Fedratinib is a JAK2-selective inhibitor with higher inhibitory activity for JAK2 over family members JAK1, JAK3, and TYK2.”
“Fedratinib pharmacokinetics is characterised by a biphasic disposition with an effective half-life of 41 hours, a terminal half-life of approximately 114 hours, and apparent clearance (CL/F) (%CV) of 13 L/hr (51%) in patients with myelofibrosis.”
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Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Fedratinib is chiefly metabolised by CYP3A4, with a lesser contribution from CYP2C19 and flavin- containing monooxygenases 3 (FMO3).”