Patient questions

Patients for whom you prescribe or are considering prescribing MUSE will have plenty of questions about whether it's right for them, and about how to use it.

Below are the most commonly asked questions by men considering or currently using MUSE, along with recommended answers.

Q. How should I store MUSE?

A. MUSE should be stored in a refrigerator. For more comfortable administration, allow MUSE to warm to room temperature for about 30 minutes before use. MUSE can be kept at room temperature (less than 30°C/86°F) for up to 14 days. Never expose MUSE to temperatures above 30°C/86°F, because this will cause it to become ineffective.

Q. Can I bring MUSE with me when I travel?

A. When traveling, store MUSE in a small, portable ice pack or cooler. Don't store MUSE in the trunk of a car or in baggage storage areas where it may be exposed to extreme temperatures.

Q. Is there anything that will keep MUSE from being effective?

A. If you are experiencing anxiety, fatigue, or tension, or drink too much alcohol, it may keep MUSE from working as well as it can.

Urinating or dribbling immediately after you apply MUSE may result in loss of medication from the urethra. Additionally, using medications that contain decongestants, such as over-the-counter cold remedies, allergy and sinus medications, and appetite suppressants may block the effect of MUSE.

Lastly, lying on your back too soon after you take MUSE may decrease blood flow to the penis and result in loss of erection.

Q. Will insertion of MUSE hurt?

A. At first, you may feel some minor discomfort from insertion. Urinating prior to administration will reduce the chance of discomfort or abrasions, and is important for dissolving the medicated pellet. Be sure to straighten your penis to its full length when inserting the MUSE applicator. With repeated use, administration will become much easier.

Q. What are the side effects associated with MUSE?

A. Most of the side effects reported in men are relatively minor, and include burning and aching in the penis and groin. Rarely noted are prolonged erection, light-headedness, dizziness, fainting, rapid pulse, and swelling of the leg veins. If you feel dizzy, light-headed, faint, or experience rapid pulse, lie down immediately and raise your legs. If symptoms persist, call your doctor promptly. Because of the potential for these side effects, MUSE titration should be carried out under medical supervision. In women, mild vaginal itching and burning have been observed.

Q. After I administer MUSE, can we immediately lie down and begin sexual activity?

A. You can begin sexual activity, but having the man lie down, especially on his back shortly after administration, is not recommended. This will reduce blood flow to the penis and may reduce the erection. It is important to sit, stand, or walk about for 10 minutes after administration. Many couples have used this time to incorporate various types of foreplay. After this initial period, you can assume different positions leading to sexual intercourse. Some couples have noticed that the erection is better maintained in positions that favor blood flow into the penis during intercourse.

Q. How long will the effect of MUSE last?

A. An erection should begin within 5-10 minutes after administering MUSE. The duration of effect is approximately 30-60 minutes. However, the actual duration will vary from patient to patient.

Q. What will the erection be like? How will it compare to the erections I had when I was younger?

A. An effective dose of MUSE should produce an erection sufficient for sexual intercourse. MUSE may not create an erection such as those you experienced when you were younger. Some patients may experience some mild pain and aching in the penis or groin area. Also, your erection may continue after orgasm.

Q. How do I know if I have the correct dose of MUSE?

A. You and your physician will determine the appropriate dose of MUSE. If your erection cannot be maintained for the time needed to have foreplay and sexual intercourse, you may need to have your dose increased. Similarly, an erection that lasts longer than desired may require a dose decrease. Call your doctor if you suspect you may require a dosing adjustment.

Q. After my erection is over, will my penis feel sensitive?

A. Your penis may feel full, warm, and somewhat sensitive to the touch. These effects are normal and may last a few hours.

Q. Can I reuse MUSE?

A. No. MUSE is intended for single-dose application only.

Q. How do I dispose of the MUSE applicator?

A. After you have administered MUSE, replace the cover on the applicator, place in the opened foil pouch, fold, and discard as normal household waste.

Q. If my erection lasts longer than desired, what should I do?

A. Seek immediate medical attention if you have a rigid erection that lasts more than 4 hours.

An application of ice packs to the inner thigh may shorten the duration of the erection, since the cold will restrict blood flow to the penis. If used, ice packs should be applied alternately to each inner thigh for a period not exceeding 10 minutes.

Q. How often can I safely use MUSE?

A. MUSE should not be used more than twice per day.

You'll find more information for your patients in the MUSE Patient Brochure.

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Important Risk Information

CONTRAINDICATIONS

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 (see Precautions below).

MUSE should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

PRECAUTIONS

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 (see Contraindications above) 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 antihypertensive medications may increase the risk of hypotension. It is therefore advised that caution be used in the administration of MUSE to individuals on antihypertensive 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.

WARNINGS: 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 1 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.

INFORMATION FOR PATIENTS: Patients should be informed that MUSE offers no protection from the transmission of sexually transmitted diseases. Patients and partners who use MUSE need to be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus (HIV).

Although unreported in clinical trials, there is the possibility that an overdosage of MUSE can cause priapism, a painful erection of the penis sustained for hours and unrelieved by sexual intercourse or masturbation. This condition is serious and, if untreated, it can lead to permanent inability to have an erection. Patients who experience a prolonged erection should seek prompt medical attention. Patients should be instructed how to administer MUSE. A patient package insert must be given to each patient at the initiation of MUSE therapy.

ADVERSE REACTIONS

Most frequently reported drug-related side effects include penile pain, urethral burning, urethral bleeding/spotting, testicular pain, hypotension and dizziness.