September 1997

NEW PRESCRIBING INFORMATION

The VIVUS Medical Services Department would like to notify you of important changes to the prescribing information for MUSE (alprostadil), which is indicated for the treatment of erectile dysfunction. VIVUS has made changes to the Package Insert and Patient Package Insert to clarify prescribing information and to reflect the marketing experience obtained since the launch of MUSE in December, 1996.

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 after MUSE 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
Director
Medical Services

Enclosures

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