ミューズ

ペニス座薬（外用薬）ミューズ　 MUSE (alprostadil)

MUSE は viagra と違って100％の臨床効果があると言われているが、今までにない副作用の報告もあるという。この薬は直接 penis の urethralorfice より挿入するもので、事前15〜30分前に行えばよい。効果は抜群、ほぼ100％ということでviagra のような目立った副作用も見られないと言うが。製薬会社によれば下記の４点での副作用の情報を提供している。

１　投薬後一時間以内に失神したという報告がある

２　ミューズ使用時、薬相互の増強作用が見られることがある。特に抗圧剤との併用で、薬が増強されることがある。

３ 症状を伴うことなく、血圧の低下が起こってくる。

４　下肢静脈の怒張（静脈瘤の形成）、下肢末梢の疼痛、脈拍の増加等が２％の割合で発現している。

クスリ自体は、プロスタグランディンＥ1で塩酸パパベリン同様１００％有効で当然のことだ。ただ外用薬で器具を使用するので当然ながら外傷等のアクシデントも危惧される。

NEW PRESCRIBING INFORMATION（Dr Spirak's letter）

Dear : Our current prescribing information contains the following warning: "Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, MUSE titration should be carried out under medical supervision." Our Medical Services Department has received three reports of patients who were discharged from clinic after MUSE administration and had syncopal episodes shortly thereafter. We have therefore provided additional guidance in the warning section of our package Insert:

"During post-marketing surveillance syncope occurring within one hour of administration has been reported. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur afterMUSE administration."

VIVUS would also like to remind physicians that dose titration should be administered under medical supervision to test the patient's responsiveness to MUSE, to demonstrate proper administration technique, and to monitor for evidence of hypotension. The lowest effective dose of MUSE should be prescribed.

The revised Package Insert also mentions a potentially important drug-drug interaction (see new text in italics):

"Because there are low or undetectable (<2 picograms/mL) amounts of alprostadil found in the peripheral venous circulation following MUSE administration, systemic drug-drug interactions with MUSE are unlikely. Although formal studies have not been conducted, the concomitant use of MUSE and anti-hypertensive medications may increase the risk of hypotension. It is therefore advised that caution be used in the administration of MUSE to individuals on anti-hypertensive medication. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to MUSE."

The revised Package Insert also includes text to clarify that while symptomatic lowering of blood pressure was observed in 3% of patients, some lowering of blood pressure may occur without symptoms. The new language in the "adverse reactions, in-clinic titration" section appears below (see new text in italics):

"Symptomatic lowering of blood pressure (hypotension) occurred in 3% of patients; in addition, some lowering of blood pressure may occur without symptoms. Dizziness was reported in 4% of patients. Syncope (fainting) was reported by 0.4% of patients."

We have also added a new paragraph at the end of the "adverse reactions,home treatment" section:
"Other drug-related side effects observed during in-clinic titration and home treatment include swelling of leg veins, leg pain, perineal pain, and rapid pulse, each occurring in <2% of patients."

VIVUS has revised its Patient Package Insert to be consistent with the above information.

Since the introduction of MUSE, the product has been prescribed to more that 300,000 patients in the US. VIVUS is committed to keeping healthcare professionals and patients informed of the latest prescribing

information to ensure the safe and effective use of our product. Please feel free to contact us at 1-888-345-6873. Enclosed you will please find the updated Package Insert and the Patient Package Insert. VIVUS encourages you to review these carefully.

Sincerely yours, Alfred P. Spivack, MD