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Pegvisomant, sold under the brand name Somavert, is a growth hormone receptor antagonist used in the treatment of acromegaly. It is primarily used if the pituitary gland tumor causing the acromegaly cannot be controlled with surgery or radiation, and the use of somatostatin analogues is unsuccessful, but is also effective as a monotherapy. It is delivered as a powder that is mixed with water and injected under the skin.
Read the full article on WikipediaAcromegaly Clinical criteria: Treatment Phase: Initial treatment Patient must not have previously received PBS-subsidised treatment with this drug for this condition, AND Patient must have an age- and sex-adjusted insulin-like growth factor 1 (IGF-1) concentration greater than the upper limit of normal (ULN), AND The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information, AND The treatment must not be given concomitantly with a PBS-subsidised somatostatin analogue. Somatostatin analogues include octreotide, lanreotide and pasireotide Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as: 1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR 2) IGF-1 level is greater than the age- and sex-adjusted ULN. If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA-approved Product Information, the application must provide details of contraindication. If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance. In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission. Biochemical evidence of remission is defined as normalisation of sex- and age- adjusted insulin-like growth factor 1 (IGF-1). Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF-1 levels measured every 4 to 6 weeks in order to maintain the serum IGF-1 level within the age-adjusted normal range based on the dosage recommendations in the TGA-approved Product Information. The authority application must be made in writing and must include: a) two completed authority prescription forms ; and b) a completed Acromegaly Pegvisomant initial PBS Authority Application - Supporting Information Form; and c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF-1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and d) a recent result of the IGF-1 level and the date of assessment ; and e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide No increase in the maximum quantity or number of units may be authorised for the loading dose.
“Pegvisomant blocks the action of growth hormone on the growth hormone receptor to reduce the production of IGF-1. IGF-1 is responsible for most of the symptoms of acromegaly, and the normalization of its levels can control the symptoms.”
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