How to use MUSE

MUSE uses an applicator for delivery of a medicated pellet containing alprostadil that is gently inserted into the tip of the penis. For your patients' convenience, each MUSE application comes in an individually wrapped foil pouch.

Determine the dose

  • Four dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1,000 mcg1
  • Base dosage strength on lowest dose sufficient for sexual intercourse1
    • 125 mcg or 250 mcg recommended for initial dosing
  • MUSE should not be used more than twice in a 24-hour period1

Have your patients follow these simple instructions to achieve the best results.

Step 1

Immediately prior to administration, urinate and gently shake the penis several times to remove excess urine. A moist urethra makes administration of MUSE easier. The medicated pellet has been specially developed to dissolve in the small quantity of urine that remains in the urethra after urination.

Step 2

Open the foil pouch by tearing fully across, beginning from the notched edge. Let the MUSE applicator slide out of the pouch. Save the pouch for discarding the MUSE applicator later.

Step 3

To remove the protective cover from the applicator stem, hold the body of the applicator with your thumb and forefinger. Twist the body and pull out the applicator from the cover, being careful not to push in or pull out the applicator button. Avoid touching the applicator stem and tip. Save the cover for discarding the MUSE applicator later.

Step 4

Visually inspect the MUSE applicator. The MUSE system is see-through, and you will be able to see the medicated pellet at the end of the stem. Make sure that the pellet is present before insertion.

Step 5

Hold the applicator in a way that is the most comfortable for you.

Step 6

Please review the anatomy of the penis, in the figure at right.

While sitting or standing, whichever is more comfortable for you, take several seconds to gently and slowly stretch the penis upward to its full length, with gentle compression from top to bottom of the glans. This straightens and opens the urethra.

Slowly insert the MUSE applicator stem into the urethra, up to the collar of the applicator. If you feel any discomfort or a pulling sensation, withdraw the applicator slightly and then gently reinsert.

Step 7

Gently and completely push down the button at the top of the applicator until it stops. It is important to do this to ensure that the medicated pellet is completely released. Hold the applicator in this position for 5 seconds.

Step 8

Gently rock the applicator from side to side. This will separate the medicated pellet from the applicator tip. If you apply too much pressure you may scratch the lining of the urethra, causing it to bleed.

Step 9

Remove the applicator while keeping the penis upright.

Step 10

Visually inspect the applicator tip to see that the medication is no longer in the applicator. Do not touch the stem. If you notice some residual medication in the end of the applicator, gently reinsert into the urethra and repeat steps 7, 8, and 9.

Step 11

Holding the penis upright and stretched to its full length, roll the penis firmly between your hands for at least 10 seconds. This will ensure that the medication is adequately distributed along the walls of the urethra. If you feel a burning sensation, it may help to continue to roll the penis for an additional 30 to 60 seconds, or until the burning subsides.

Step 12

Remember, each MUSE applicator is good for a single administration only. Replace the cover on the MUSE applicator, place it in the opened foil pouch, then fold the pouch and discard as normal household waste.

Important:

After you have administered MUSE, it is important to sit or, preferably, stand or walk about for 10 minutes while the erection is developing. This increases blood flow to the penis and will enhance your erection.

Reference: 1. MUSE [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014.

More Important Safety Information

MUSE is contraindicated in men with any of the following:

  • Known hypersensitivity to alprostadil
  • Abnormal penile anatomy: MUSE is contraindicated in patients with urethral stricture, balanitis (inflammation/infection of the glans of the penis), severe hypospadias and curvature, and in patients with acute or chronic urethritis
  • Sickle cell anemia or trait, thrombocythemia, polycythemia, multiple myeloma: MUSE is contraindicated in patients who are prone to venous thrombosis or who have a hyperviscosity syndrome and are therefore at increased risk of priapism (rigid erection lasting 6 or more hours)
  • MUSE should not be used in men for whom sexual activity is inadvisable
  • MUSE should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier

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. 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.

A complete medical history and physical examination should be undertaken to exclude reversible causes of erectile dysfunction prior to the initiation of MUSE therapy. In addition, underlying disorders that might preclude the use of MUSE should be sought.

Cardiovascular effects: During in-clinic dosing, patients should be monitored for symptoms of hypotension, and the lowest effective dose of MUSE should be prescribed.

Hematologic effects: Patients administering MUSE improperly may be at risk of urethral abrasion resulting in minor bleeding or spotting. Patients on anticoagulant therapy or with bleeding disorders may be at higher risk of bleeding. Patients on anticoagulant therapy have been safely treated with MUSE; however, the risk/benefit ratio in these patients should be considered prior to prescribing MUSE.

Resumption of sexual activity: Sexual intercourse is considered a vigorous physical activity, and it increases heart rate as well as cardiac work. Physicians may want to examine the cardiac fitness of patients prior to treating erectile dysfunction.

Priapism and prolonged erection: In clinical trials of MUSE, priapism (rigid erection lasting ≥ 6 hours) and prolonged erection (rigid erection lasting 4 hours and < 6 hours) were reported infrequently (< 0.1% and 0.3% of patients, respectively). Nevertheless, these events are a potential risk of pharmacologic therapy and can cause penile injury. Physicians should lower the dose or consider discontinuing MUSE treatment in any patient who develops priapism or prolonged erection.

Drug-Drug Interactions: 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 medications. In addition, the presence of medications in the circulation that attenuate erectile function may influence the response to MUSE.

Drug-Device Interactions: Use of MUSE in patients with penile implants has not been studied.

Sexual Preference: There is no experience in homosexual men and no experience with other than vaginal intercourse.

In two double-blind, parallel, placebo-controlled trials, 1511 patients received MUSE at least 1 time in the clinic. The most frequently reported (≥ 2%) drug-related side effects during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%), dizziness (4%), urethral bleeding/spotting and other minor abrasions to the urethra (3%), hypotension (3%), and syncope (0.4%).

996 patients (66% of those who began titration) were studied during the home treatment portion of the two studies. The most frequently reported (≥ 2%) adverse events with MUSE vs placebo, respectively, were penile pain (32% vs 3%), urethral burning (12% vs 4%), minor urethral bleeding/spotting (5% vs 1%), testicular pain (5% vs 1%), flu symptoms (4% vs 2%), headache (3% vs 2%), pain (3% vs 1%), accidental injury (3% vs 2%), respiratory infection (3% vs 2%), dizziness (2% vs < 1%), back pain (2% vs 1%), pelvic pain (2% vs < 1%) and rhinitis (2% vs < 1%).

The most common drug-related adverse event reported by female partners during placebo-controlled clinical studies was vaginal burning/itching, reported by 5.8% of partners of patients on active vs. 0.8% of partners of patients on placebo. It is unknown whether this adverse event experienced by female partners was a result of the medication or a result of resuming sexual intercourse, which occurred much more frequently in partners of patients on active medication.

Indications

MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 855-543-3784.

For additional information, please see the Full Prescribing Information.