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ExcelFemale
HRT in Women
Bremelanotide for HSDD
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<blockquote data-quote="madman" data-source="post: 190108" data-attributes="member: 13851"><p><strong>Relevance to Patient Care and Clinical Practice</strong> </p><p></p><p><span style="color: rgb(184, 49, 47)"><em>Bremelanotide’s place in therapy is unknown, as the HSDD guidelines were most recently updated in 2017.1</em></span> <span style="color: rgb(184, 49, 47)">Although the trials met statistical significance for change in FSFI and FSDS scores, the clinical benefit may only be modest. There was no statistically significant change in sexually satisfying events, which may affect the perceived benefit of bremelanotide.</span></p><p><span style="color: rgb(184, 49, 47)"></span></p><p><span style="color: rgb(184, 49, 47)"><em>The only other FDA-approved treatment indicated for HSDD is flibanserin, which was approved in 2015.3 Prior HSDD treatments were used off-label. The availability of drugs with a specific HSDD indication has the potential to give many women access to improved sexual functioning.</em></span></p><p><span style="color: rgb(184, 49, 47)"><em></em></span></p><p><span style="color: rgb(184, 49, 47)"><em><u><strong>Bremelanotide’s current AWP is $269 per autoinjector, available in a box of 4 autoinjectors for a total of $1078 per box</strong></u><strong>.</strong>21</em></span> <span style="color: rgb(44, 130, 201)"><em>The cost may be outweighed by the benefits over flibanserin, including dosing on demand and as needed.</em></span></p><p></p><p><span style="color: rgb(184, 49, 47)"><em>Flibanserin is an oral medication dosed as 100 mg daily at bedtime.6 Unlike bremelanotide, flibanserin did not increase blood pressure but did cause hypotension and syncope. Flibanserin has several key interactions, including CYP3A4, CYP2C19, and alcohol. Concomitant use of flibanserin and alcohol markedly increases the risk of hypotension/syncope; therefore, a boxed warning exists to abstain from alcohol during use. Bremelanotide and alcohol do not interact based on a placebo-controlled double-blind crossover study.7,11 </em></span></p><p></p><p><em><span style="color: rgb(184, 49, 47)"><u><strong>Flibanserin is approximately $960 for 30 tablets,22 which may represent a cost-savings compared with the maximum monthly bremelanotide regimen</strong></u><strong>.</strong> </span></em><span style="color: rgb(44, 130, 201)"><em>Alcohol consumption, concomitant medications, cardiovascular risk, and cost should all be considered when determining if a patient is a candidate for flibanserin or bremelanotide.6,7 Additional prescribing considerations for bremelanotide are outlined in Table 4.</em></span></p></blockquote><p></p>
[QUOTE="madman, post: 190108, member: 13851"] [B]Relevance to Patient Care and Clinical Practice[/B] [COLOR=rgb(184, 49, 47)][I]Bremelanotide’s place in therapy is unknown, as the HSDD guidelines were most recently updated in 2017.1[/I][/COLOR] [COLOR=rgb(184, 49, 47)]Although the trials met statistical significance for change in FSFI and FSDS scores, the clinical benefit may only be modest. There was no statistically significant change in sexually satisfying events, which may affect the perceived benefit of bremelanotide. [I]The only other FDA-approved treatment indicated for HSDD is flibanserin, which was approved in 2015.3 Prior HSDD treatments were used off-label. The availability of drugs with a specific HSDD indication has the potential to give many women access to improved sexual functioning. [U][B]Bremelanotide’s current AWP is $269 per autoinjector, available in a box of 4 autoinjectors for a total of $1078 per box[/B][/U][B].[/B]21[/I][/COLOR] [COLOR=rgb(44, 130, 201)][I]The cost may be outweighed by the benefits over flibanserin, including dosing on demand and as needed.[/I][/COLOR] [COLOR=rgb(184, 49, 47)][I]Flibanserin is an oral medication dosed as 100 mg daily at bedtime.6 Unlike bremelanotide, flibanserin did not increase blood pressure but did cause hypotension and syncope. Flibanserin has several key interactions, including CYP3A4, CYP2C19, and alcohol. Concomitant use of flibanserin and alcohol markedly increases the risk of hypotension/syncope; therefore, a boxed warning exists to abstain from alcohol during use. Bremelanotide and alcohol do not interact based on a placebo-controlled double-blind crossover study.7,11 [/I][/COLOR] [I][COLOR=rgb(184, 49, 47)][U][B]Flibanserin is approximately $960 for 30 tablets,22 which may represent a cost-savings compared with the maximum monthly bremelanotide regimen[/B][/U][B].[/B] [/COLOR][/I][COLOR=rgb(44, 130, 201)][I]Alcohol consumption, concomitant medications, cardiovascular risk, and cost should all be considered when determining if a patient is a candidate for flibanserin or bremelanotide.6,7 Additional prescribing considerations for bremelanotide are outlined in Table 4.[/I][/COLOR] [/QUOTE]
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ExcelFemale
HRT in Women
Bremelanotide for HSDD
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