Muse

Muse is a prescription medication used to certain types of erectile dysfunction. Muse belongs to a group of drugs called vasodilators. These work by relaxing the muscles and blood vessels in the penis so that an erection can occur.

This medication comes in suppository (pellet) and is placed into the urinary opening of the penis. You should be shown by a healthcare professional proper technique before self-use.

A common side effects of Muse is penis pain. 

Muse is part of the drug class:

• Drugs used in erectile dysfunction

Use Muse as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will teach you how to take this medicine.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• This medicine is for use in the urethra (the tube that urine passes through).
• This medicine works best if you pass urine before using.

What do I do if I miss a dose?

• This medicine is used on an as needed basis. Do not use more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Penile pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store unopened foil pouch in the refrigerator.
• Protect from heat.
• This medicine may be stored at room temperature for up to 2 weeks before use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Muse or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Muse. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

In-Clinic Titration:

In the 2 largest double-blind, parallel, placebo-controlled trials, 1511 patients received Muse at least 1 time in the clinic setting. The most frequently reported drug-related side effects during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%). These discomforts were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse events. Urethral bleeding/spotting and other minor abrasions to the urethra were reported in approximately 3% of patients. 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. (See WARNINGS).

Home Treatment:

996 patients (66% of those who began titration) were studied during the home treatment portion of 2 Phase III placebo-controlled studies. Fewer than 2% of patients discontinued from these studies primarily because of adverse events. The following table summarizes the frequency of adverse events reported by patients using Muse or placebo.

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.

Female Partner Adverse Events: 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.

To report suspected adverse reactions, contact Meda Pharmaceuticals Inc. at 1-888-345-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.

Overdosage has not been reported with Muse. Overdosage with Muse may result in hypotension, persistent penile pain, and possibly priapism (rigid erection lasting ≥6h). Priapism can result in permanent worsening of erectile function. Patients suspected of overdosage who develop these symptoms should be kept under medical supervision until systemic or local symptoms have resolved.

Muse is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. Muse should be administered as needed to achieve an erection. The onset of effect is within 5–10 minutes after administration. The duration of effect is approximately 30–60 minutes. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administering Muse prior to self-administration. The maximum frequency of use is no more than 2 systems per 24-hour period.

Initiation of Therapy:

Dose titration should be administered under the supervision of a physician to test a patient's responsiveness to Muse, to demonstrate proper administration technique (see detailed instructions for Muse administration in patient package insert), and to monitor for evidence of hypotension (see WARNINGS). Patients should be individually titrated to the lowest dose that is sufficient for sexual intercourse. The lower doses of Muse (125 mcg or 250 mcg) are recommended for initial dosing. If necessary, the dose should be increased (or decreased) on separate occasions in a stepwise manner until the patient achieves an erection that is sufficient for sexual intercourse.

Home Treatment Regimen:

Muse should be used as needed to achieve an erection. The maximum frequency of use is 2 administrations per 24-hour period. Each Muse is for single use only and should be properly discarded after use.

Store unopened foil pouches in a refrigerator at 2°– 8°C (36°– 46°F). Do not expose Muse to temperatures above 30°C (86°F). Muse may be kept by the patient at room temperature (below 30°C or 86°F) for up to 14 days prior to use.

Medical information line at Meda Pharmaceuticals Inc. 1-888-345-Muse (1-888-345-6873).

Muse and MEDA PHARMACEUTICALS are registered trademarks, and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

http://www.Muserx.net
Catalog Number: 05-10-00001E
IN-1001-03
Revised August 2014
U.S. Patent No. 5,886,039
©2014 Meda Pharmaceuticals Inc.

Muse®

(alprostadil) urethral suppository

PATIENT INFORMATION

Please read this pamphlet before using Muse® (alprostadil). This pamphlet is a quick reference source on important information about Muse for you and your partner. Before administering Muse, please review the patient video and education booklet. These materials provide visual instruction and more detailed information as well as practical tips on how to use Muse.

WHAT IS Muse?

Muse represents a unique approach for the treatment of erectile dysfunction, commonly called impotence. It is based on the discovery that the urethra (the normal pathway for urine) can absorb certain medications into the surrounding erectile tissues thereby creating an erection. There are 4 dose strengths available: 125, 250, 500, and 1000 micrograms. The Muse applicator (Fig.1) contained in each foil pouch is intended for 1 administration only. Your dose of Muse will be determined by you and your physician. After administration, the erection process will begin within 5 – 10 minutes, and may last 30 – 60 minutes. However, the actual duration will vary from patient to patient.

WHAT IS Muse USED FOR?

Muse is indicated for the treatment of erectile dysfunction. Erectile dysfunction is the inability to attain or maintain an erection sufficient for sexual intercourse.

WHO SHOULD NOT USE Muse?

You should not use Muse if you have any of the following:

• Known hypersensitivity to alprostadil (the active medication in Muse)
• An abnormally formed penis
• Have been advised not to undertake sexual activity
• Conditions that might result in long-lasting erections, such as sickle cell anemia or trait, leukemia, or tumor of the bone marrow (multiple myeloma)
• Muse should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Muse?

The most common side effects that have been observed using Muse follow:

• Aching in the penis, testicles, legs, and in the perineum (area between the penis and rectum)
• Warmth or burning sensation in the urethra
• Redness of the penis due to increased blood flow
• Minor urethral bleeding or spotting due to improper administration.

Side effects reported less frequently:

• Prolonged erection - PLEASE NOTE: IF YOUR ERECTION IS RIGID FOR MORE THAN 4 HOURS, CALL YOUR DOCTOR PROMPTLY.
• Swelling of leg veins
• Light-headedness/Dizziness
• Fainting - PLEASE NOTE: AFTER USING Muse, YOU SHOULD AVOID ACTIVITIES, SUCH AS DRIVING OR HAZARDOUS TASKS WHERE INJURY COULD RESULT IF DIZZINESS OR FAINTING WERE TO OCCUR. IN PATIENTS EXPERIENCING THESE SYMPTOMS, THE SYMPTOMS HAVE USUALLY OCCURRED DURING INITIATION OF THERAPY AND WITHIN ONE HOUR OF Muse ADMINISTRATION.
• Rapid pulse.

If you have a history of fainting be sure to discuss this with your doctor prior to using Muse. If you do experience dizziness or feel faint, this may be due to the lowering of your blood pressure. 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.

Call your doctor for medical advice about side effects. To report side effects, contact Meda Pharmaceuticals Inc. at 1-888-367-6873 or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch/report.htm.

Changing Your Dosage

It is assumed that you and your doctor have determined the proper dose of Muse. If you suspect that your dose needs to be increased or decreased to achieve the response that works best for you, please call your doctor to determine if your dose needs to be reevaluated. Do not use Muse more than twice in a 24-hour period.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF Muse FOR YOUR PARTNER?

The most common reported side effects observed in women whose partners use Muse are mild vaginal itching or burning. Using a water-based lubricant can help to make vaginal penetration easier. Your partner may want to consult her health care provider if she has not had sexual intercourse for an extended period of time.

IMPORTANT INFORMATION FOR YOU AND YOUR PARTNER

Pregnancy

Muse has no contraceptive properties.

Because Muse has not been tested during human pregnancy, it is recommended that couples use adequate contraception if the female partner is of childbearing potential. Muse should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.

Sexually Transmitted Diseases

Muse will not protect you or your partner from sexually transmitted diseases like chlamydia, gonorrhea, herpes simplex virus, viral hepatitis, human immunodeficiency virus (HIV - the virus that causes AIDS), human papilloma virus (genital warts), and syphilis. Latex condoms can protect against these sexually transmitted diseases.

HOW SHOULD I STORE Muse?

It is recommended that Muse be stored in a refrigerator. Muse may be kept at room temperature (less than 30°C/86°F) for up to 14 days prior to use. It is very important that Muse not be exposed to temperatures above 30°C/86°F since this will make Muse ineffective. Muse should not be exposed to high temperatures or placed in direct sunlight.

Storage When Traveling

When traveling, store Muse in a portable ice pack or cooler. Do not store in the trunk of a car or in baggage storage areas where Muse may be exposed to extremes in temperature.

HOW TO ADMINISTER Muse:

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.
2. Open the foil pouch by tearing fully across from the notched edge (Fig. 2). Let the Muse slide out of the pouch. Save the pouch for discarding the Muse applicator later.
3. To remove the protective cover from the applicator stem (Fig. 3), 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.
4. Visually inspect the Muse. 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 (Fig. 4).
5. Hold the applicator in a way which is the most comfortable for you. (Fig. 5a and 5b)
6. Please review Figure 6a, the anatomy of the penis. 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 (Fig. 6b). This straightens and opens the urethra. Slowly insert the Muse stem into the urethra up to the collar (Fig. 6c). If you feel any discomfort or a pulling sensation, withdraw the applicator slightly and then gently reinsert.
7. Gently and completely push down (Fig. 7) 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.
8. Gently rock the applicator from side to side. This will separate the medicated pellet from the applicator tip (Fig. 8). If you apply too much pressure you may scratch the lining of the urethra causing it to bleed.
9. Remove the applicator while keeping the penis upright.
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.
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 (Fig. 9). If you feel a burning sensation, it may help to continue to roll the penis for an additional 30 – 60 seconds or until the burning subsides.
12. Remember, each Muse is good for a single administration only. Replace the cover on the Muse applicator, place in the opened foil pouch, fold, and discard as normal household waste.

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.

ADDITIONAL INFORMATION AND PRACTICAL TIPS

Factors Which May Enhance Your Erection:

• Being well rested and relaxed
• Sexual foreplay with your partner or self-stimulation while sitting or standing
• Pelvic exercises (for example, Kegel exercises) these consist of tightening and releasing your pelvic and buttock muscles. These are the muscles you use to stop urination
• Various positions that may favor blood flow into the penis. Please refer to the patient starter booklet and video for illustrative examples.

Factors Which May Reduce Your Erection:

• Anxiety, fatigue, tension, and too much alcohol
• Lying on your back too soon after administration of Muse may decrease blood flow to the penis and result in loss of erection
• Urination or dribbling immediately following administration may result in loss of medication from the urethra
• Using medications that contain decongestants, such as over-the-counter cold remedies, allergy, sinus medications, and appetite suppressants, may block the effect of Muse.

COMMONLY ASKED QUESTIONS ABOUT Muse

Will insertion of Muse hurt?

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.

What are the side effects associated with Muse?

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.

(See also: “WHAT ARE THE POSSIBLE SIDE EFFECTS OF Muse?” on the other side.)

In women, mild vaginal itching and burning have been observed.

After I administer Muse, can we immediately lie down and begin sexual activity?

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.

Please review the video and patient starter booklet available from your doctor which illustrates various positions that will enhance your erection.

How long will the effect of Muse last?

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.

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

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.

How do I know if I have the correct dose of Muse?

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.

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

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

Can I reuse Muse?

No. Muse is intended for single-dose application only.

How do I dispose of the Muse applicator?

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

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

Note: Call your doctor promptly 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.

How often can I safely use Muse?

Muse should not be used more than twice per day.

If you have any additional questions about Muse, please call the toll free patient information line at Meda Pharmaceuticals Inc. 1-888-367-Muse (1-888-367-6873), or visit the Muse product web site, http://www.Muserx.net

Muse and MEDA PHARMACEUTICALS are registered trademarks, and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity.

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

http://www.Muserx.net

Catalog Number: 05-10-00000E
IS-1001-03
Revised August 2014
U.S. Patent No. 5,886,039
©2014 Meda Pharmaceuticals Inc.

Muse Principal Display Panel - 125 mcg pouch

NDC 0037-8110-01

Muse®
(alprostadil) urethral suppository

Transurethral System
125 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

Muse and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

LP-100100-03
Revised August 2014
Cat. No. 03-10-G01250D              U.S. Patent No. 5,886,039

Muse Principal Display Panel - 250 mcg pouch

NDC 0037-8120-01

Muse®
(alprostadil) urethral suppository

Transurethral System
250 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

Muse and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

LP-100200-03
Revised August 2014
Cat. No. 03-10-G02500D              U.S. Patent No. 5,886,039

Muse Principal Display Panel - 500 mcg pouch

NDC 0037-8130-01

Muse®
(alprostadil) urethral suppository

Transurethral System
500 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

Muse and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

LP-100300-03
Revised August 2014
Cat. No. 03-10-G05000D              U.S. Patent No. 5,886,039

Muse Principal Display Panel - 1000 mcg pouch

NDC 0037-8140-01

Muse®
(alprostadil) urethral suppository

Transurethral System
1000 mcg

Contents: One single-use applicator.

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Please read patient instruction leaflet regarding usage and storage.

Disposal: Replace cover on applicator, place in opened pouch, fold, and discard as normal household waste.

Rx only

Muse and MEDA PHARMACEUTICALS are registered trademarks and the MEDA PHARMACEUTICALS logo is a trademark of Meda AB or a related entity

Distributed by:
MEDA
PHARMACEUTICALS®
Somerset, New Jersey 08873-4120

LP-100400-03
Revised August 2014
Cat. No. 03-10-G10000D              U.S. Patent No. 5,886,039