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Givosiran, sold under the brand name Givlaari, is a medication used for the treatment of adults with acute hepatic porphyria. Givosiran is a small interfering RNA (siRNA) directed towards delta-aminolevulinate synthase 1 (ALAS1), an important enzyme in the production of heme.
Read the full article on WikipediaChronic treatment of Acute Hepatic Porphyria (AHP) Clinical criteria: Treatment Phase: Initial treatment Patient must have a confirmed diagnosis of AHP based on clinical features, AND Patient must have a previous result that showed a 4 times greater than the upper limit of normal (ULN) on one of the following tests: (i) urinary porphobilinogen, (ii) plasma porphobilinogen, (iii) delta-aminolevulinic acid, AND Patient must have had at least 2 porphyria attacks (requiring hospitalisation, presentation at an emergency department, or medical intervention via a porphyria clinic) within the 6 months prior to: (i) commencement of this drug; or (ii) prophylactic treatment with gonadotropin-releasing hormone analogues or hemin, AND Patient must not have previously undergone a liver transplant, AND The treatment must be initiated under the supervision of a healthcare professional experienced in the management of porphyria. Population criteria: Patient must be at least 12 years of age. For the purposes of administering this restriction, clinical features to confirm a diagnosis of AHP can include but are not limited to acute attacks of: abdominal, back, chest, extremities, and/or limb pain. At the time of the authority application, prescribers should request the appropriate number of vials for a single dose based on the patient's weight, as per the TGA-approved Product Information. The authority application must be made via the Online PBS Authorities System, or in writing via HPOS form upload or mail and must include: (1) The baseline number of porphyria attacks within a defined 6-month period [dates of the 6-month period must be included]. (2) Pathology measurements that indicate 4 times greater than the ULN of one of the following tests: (i) urinary porphobilinogen; (ii) plasma porphobilinogen; (iii) delta-aminolevulinic acid. Date of pathology report and unique identifying number/code that links the pathology result to the individual patient must be included. (3) Current weight of the patient. If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) 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).
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