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Palovarotene, sold under the brand name Sohonos, is a medication used for the treatment of heterotopic ossification and fibrodysplasia ossificans progressiva. It is a highly selective retinoic acid receptor gamma (RARγ) agonist. It is taken by mouth.
Read the full article on WikipediaFibrodysplasia ossificans progressiva (FOP) Clinical criteria: Treatment Phase: Chronic treatment Patient must have a diagnosis of FOP, confirmed by genetic testing. Treatment criteria: Must be treated by a specialist medical practitioner experienced in the diagnosis and management of FOP; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of FOP. Population criteria: Patient must be a female aged 8 years or older; OR Patient must be a male aged 10 years or older. At the time of the authority application, the medical practitioner must request the appropriate combination of packs to provide treatment at the recommended dose for chronic treatment, based on the age and weight of the patient, adequate for 4 weeks according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Appropriate genetic testing constitutes testing for a pathogenic variant of the Activin A receptor type I (ACVR1) gene. Confirm that evidence of the presence of a pathogenic mutation of the ACVR1 gene is documented/retained in the patient's medical records once only with the first PBS prescription. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) 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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