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Romiplostim, sold under the brand name Nplate among others, is a fusion protein analog of thrombopoietin, a hormone that regulates platelet production.
Read the full article on WikipediaSevere thrombocytopenia Clinical criteria: Treatment Phase: Initial treatment - New patient The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP), AND Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy, AND Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy, AND The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition. The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application; (a) a platelet count of less than or equal to 20,000 million per L; OR (b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range. The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised. Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks. Authority approval will not be given for doses higher than 10 micrograms/kg/week The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (a) details of a platelet count supporting the diagnosis of ITP. All reports must be documented in the patient's medical records. 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). The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
“1 to 34 days”
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