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MUSE® (alprostadil) is a single-use, medicated transurethral system for the delivery of alprostadil to the male urethra. Alprostadil is suspended in polyethylene glycol 1450 (as excipient) and is formed into a medicated pellet (micro-suppository measuring 1.4 mm in diameter by 3 mm or 6 mm in length) that resides in the tip of a translucent hollow applicator. MUSE is administered by inserting the applicator stem into the urethra after urination. The pellet containing alprostadil is delivered by depressing the applicator button (see Figure 1). The components of the delivery system are constructed of medical grade polypropylene. Each MUSE system is packaged in an individual foil pouch.
Figure 1: Diagram of the MUSE Trans urethral System
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The active ingredient in MUSE is alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). The chemical name for alprostadil is prost-13-en-1-oic acid, 11,15-dihydroxy-9-oxo-(11α,13E,15S)-(1R,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid, and the molecular weight is 354.49. The empirical formula is C20H34O5. The structural formula of alprostadil is represented below:
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Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 mcg per 100 mL double-distilled water. The inactive ingredient in MUSE is polyethylene glycol 1450, USP. There are no other active agents or excipients in MUSE.
MUSE is available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg.
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.
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. Instruct patients to straighten their penis to its full length when inserting the MUSE applicator. 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.
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 Information), 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 dose of MUSE (250 mcg) is 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.
MUSE should be used as needed to achieve an erection. The maximum frequency of use is 2 administrations per 24-hour period. Each MUSE contains a single dose only and should be properly discarded after use.
MUSE is supplied in individual foil pouches containing one (1) single-dose system per pouch.
MUSE is available in unit cartons containing six (6) systems. MUSE is available in the following 3 dosage strengths:
| Dosage Strength | NDC Numbers | Identifying PackageColor | |
| Carton | Pouch | ||
| 250 mcg | 0037-8120-06 | 0037-8120-01 | Green |
| 500 mcg | 0037-8130-06 | 0037-8130-01 | Blue |
| 1000 mcg | 0037-8140-06 | 0037-8140-01 | Burgundy |
Store unopened foil pouches in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not expose MUSE to temperatures above 30°C (86°F). MUSE may be kept by the patient at room temperature, 20°C to 25°C (68°F to 77°F), for up to 14 days before use.
For more information, call Meda Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
This product’s labeling may have been updated. For the most recent prescribing information, visit www.musehcp.com.
Distributed by: Catalog Number: 05-10-00000X, IFU-1001-XX2. Revised: May 2024.
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 adverse reactions during in-clinic titration included pain in the penis (36%), urethra (13%), or testes (5%). These reactions were most commonly reported as mild and transient, but about 7% of patients withdrew at this stage because of adverse reactions. 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).
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 reactions. The following table summarizes the frequency of adverse reactions reported by patients using MUSE or placebo.
Adverse Reactions Reported by ≥ 2% of Patients Treated with MUSE, and More Common than on Placebo, at Home in Phase III Placebo-Controlled Clinical Studies for up to 3 Months
| Event | MUSE n = 486 |
Placebo n = 511 |
| UROGENITAL SYSTEM | ||
| Penile Pain | 32% | 3% |
| Urethral Burning | 12% | 4% |
| Minor Urethral Bleeding/Spotting | 5% | 1% |
| Testicular Pain | 5% | 1% |
| NERVOUS SYSTEM | ||
| Dizziness | 2% | < 1% |
| BODY AS A WHOLE | ||
| Flu Symptoms | 4% | 2% |
| Headache | 3% | 2% |
| Pain | 3% | 1% |
| Accidental Injury | 3% | 2% |
| Back Pain | 2% | 1% |
| Pelvic Pain | 2% | < 1% |
| RESPIRATORY | ||
| Rhinitis | 2% | < 1% |
| Infection | 3% | 2% |
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.
The most common adverse reactions 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 reaction 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 1-877-446- 3679 (1-877-4-INFO-RX) or contact FDA at 1-800-FDA-1088, fax 1-800-FDA-0178 or online at www.fda.gov/medwatch.
No Information Provided
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.
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. Advise the patient to read the FDAapproved patient labeling (Patient Information and Instructions for Use).
Patients should be instructed to inform their partners that MUSE offers no protection from the transmission of sexually transmitted diseases. Counsel patients about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus (HIV). Human semen contains PGE1, but additional amounts may be present from MUSE administration (see CLINICAL PHARMACOLOGY). Partners who have experienced an extended period of sexual abstinence should be encouraged to seek advice from a health care professional prior to resuming sexual intercourse. The use of a water-based lubricant may facilitate vaginal penetration.
It is recommended that couples using MUSE employ adequate contraception if the female partner is of childbearing potential. There is no information on the effects on early pregnancy of PGE1 at the levels received by female partners. MUSE has no contraceptive properties. MUSE should not be used if the female partner is pregnant, unless the couple uses a condom barrier.
Long-term carcinogenicity studies of alprostadil have not been conducted. Alprostadil showed no evidence of mutagenicity in vitro in the Ames bacterial reverse mutation test, the unscheduled DNA synthesis assay in rat hepatocytes, or the Chinese hamster ovary forward gene mutation assay; nor was there evidence of mutagenicity in vivo in the mouse micronucleus assay.
Alprostadil concentrations increased chromosomal aberrations above control incidence in the in vitro Chinese hamster ovary chromosomal aberration assay.
In dogs, sperm concentration, morphology, and motility were unaffected by daily intraurethral administration of up to 3000 mcg MUSE (alprostadil) for 13 weeks (200 mcg/kg/day or about 3.5 times the maximum recommended daily dose adjusted for body surface area). Alprostadil concentrations of 400 mcg/mL had no effect on human sperm motility or viability in vitro.
Alprostadil has been shown to be embryotoxic (decreased fetal weight) when administered as a subcutaneous bolus to pregnant rats at doses as low as 500 mcg/kg/day. Doses of 2000 mcg/kg/day resulted in increased resorptions, reduced numbers of live fetuses, increased incidences of visceral and skeletal variations (primarily left umbilical artery and generalized reduction in ossification of the entire skeleton) and gross visceral and skeletal malformations (primarily edema, hydrocephaly, anophthalmia/microphthalmia, and skeletal anomalies). The latter dose produced maternal toxicity (ataxia, lethargy, diarrhea, and retarded body weight gain).
When administered by continuous intravenous infusion, evidence of embryotoxicity (decreased fetal weight gain and increased incidence of hydroureter) was observed at 2000 mcg/kg/day, a dose that was also associated with a decrease in maternal weight gain. Intravaginal administration of up to 4000 mcg/day of MUSE (alprostadil) to pregnant rabbits (1100 mcg/kg/day or about 12.5 times the maximum recommended daily dose adjusted for body surface area) resulted in no evidence of harm to the fetus. MUSE should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.
MUSE is not indicated for use in newborns, children, or women.
Overdosage has not been reported with MUSE. Overdosage with MUSE may result in hypotension, persistent penile pain and possibly priapism (rigid erection lasting 4 or more hours). 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 contraindicated in men with any of the following:
Prostaglandin E1 is a naturally occurring acidic lipid that is synthesized from fatty acid precursors by most mammalian tissues and has a variety of pharmacologic effects. Human seminal fluid is a rich source of prostaglandins, including PGE1 and PGE2, and the total concentration of prostaglandins in ejaculate has been estimated to be approximately 100-200 mcg/mL. In vitro, alprostadil (PGE1) has been shown to cause dose-dependent smooth muscle relaxation in isolated corpus cavernosum and corpus spongiosum preparations. Additionally, vasodilation has been demonstrated in isolated cavernosal artery segments that were pre-contracted with either norepinephrine or prostaglandin F2α. When alprostadil was injected into the corpus cavernosum of pigtail monkeys in vivo, dose-dependent increases in cavernosal artery blood flow were observed.
In human studies using Doppler duplex ultrasonography, intraurethral administration of 500 mcg of MUSE resulted in an increase in cavernosal artery diameter and a 5- to 10-fold increase in peak systolic flow velocities. These results suggest that intraurethral alprostadil is absorbed from the urethra, transported throughout the erectile bodies by communicating vessels between the corpus spongiosum and corpora cavernosa, and able to induce vasodilation of the targeted vascular beds.
The vasodilatory effects of alprostadil on the cavernosal arteries and the trabecular smooth muscle of the corpora cavernosa result in rapid arterial inflow and expansion of the lacunar spaces within the corpora. As the expanded corporal sinusoids are compressed against the tunica albuginea, venous outflow through subtunical vessels is impeded and penile rigidity develops. This process is referred to as the corporal veno-occlusive mechanism.
The most notable systemic effects of alprostadil are vasodilation, inhibition of platelet aggregation, and stimulation of intestinal and uterine smooth muscle. Intravenous doses of 1 to 10 micrograms per kilogram of body weight lower blood pressure in mammals by decreasing peripheral resistance. Reflex increases in cardiac output and heart rate may accompany these effects.
About 80% of alprostadil administered by MUSE is absorbed within 10 minutes and is rapidly cleared from the systemic circulation by the lungs, leaving barely detectable systemic blood levels.
MUSE is designed to deliver alprostadil directly to the urethral lining for transfer via the corpus spongiosum to the corpora cavernosa. Intraurethral administration of MUSE is preceded by urination, and the residual urine disperses the medicated pellet, permitting alprostadil to be absorbed by the urethral mucosa. The transurethral absorption of alprostadil after MUSE administration is biphasic. Initial absorption is rapid, with approximately 80% of an administered dose absorbed within 10 minutes. The mean time to the maximum plasma PGE1 concentration after a 1000 mcg intraurethral dose of MUSE is approximately 16 minutes.
In 10 normal human volunteers, endogenous PGE1 levels in the ejaculate averaged 31 mcg (range 0-161 mcg). In these same volunteers, an average of 123 mcg of additional PGE1 (range 30-369 mcg) was present in the ejaculate obtained 10 minutes after the highest dose (1000 mcg) of MUSE. The mean total endogenous PGE content (PGE1, PGE2, 19-OH-PGE1, and 19-OHPGE2) of the ejaculate in these subjects was 444 mcg (range 0-1423 mcg).
Following MUSE administration, alprostadil is absorbed from the urethral mucosa into the corpus spongiosum. A portion of the administered dose is transported to the corpora cavernosa through collateral vessels, while the remainder passes into the pelvic venous circulation through veins draining the corpus spongiosum. The half-life of alprostadil in humans is short, varying between 30 seconds and 10 minutes, depending on the body compartment in which it is measured and the physiological status of the subject. Nearly all of the alprostadil entering the central venous circulation is removed in a single pass through the lungs; thus peripheral venous plasma levels of PGE1 are low or undetectable (< 2 picograms/mL) after MUSE administration. The mean maximum plasma PGE1 concentration following intraurethral administration of the highest dose of MUSE (1000 mcg) was barely detectable (11.4 picograms/mL). In a study of 14 subjects, the plasma PGE1 level was shown to be undetectable within 60 minutes of MUSE administration in most subjects.
Alprostadil is rapidly metabolized locally by enzymatic oxidation of the 15- hydroxyl group to 15-keto-PGE1. The enzyme catalyzing this process has been isolated from many tissues in the lower genitourinary tract including the urethra, prostate, and corpus cavernosum. 15-keto-PGE1 retains little (1-2%) of the biological activity of PGE1. 15-keto-PGE1 is rapidly reduced at the C13-C14 position to form the most abundant metabolite in plasma, 13,14- dihydro,15-keto PGE1 (DHK-PGE1), which is biologically inactive. The majority of DHK-PGE1 is further metabolized to smaller prostaglandin remnants that are cleared primarily by the kidney and liver. Between 60% and 90% of PGE1 has been shown to be metabolized after 1 pass through the pulmonary capillary beds.
After intravenous administration of tritium-labeled alprostadil in man, labeled drug disappears rapidly from the blood in the first 10 minutes, and by 1 hour radioactivity in the blood reaches a low level. The metabolites of alprostadil are excreted primarily by the kidney, with approximately 90% of an administered intravenous dose excreted in the urine within 24 hours of dosing. The remainder is excreted in the feces. There is no evidence of tissue retention of alprostadil or its metabolites following intravenous administration.
The near-complete pulmonary first-pass metabolism of PGE1 is the primary factor influencing the systemic pharmacokinetics of MUSE and is a reason that peripheral venous plasma levels of PGE1 are low or undetectable (< 2 picograms/mL) following MUSE administration. Patients with pulmonary disease therefore may have a reduced capacity to clear the drug. In patients with the adult respiratory distress syndrome (ARDS), pulmonary extraction of intravascularly administered alprostadil was reduced by approximately 15% compared to a control group of patients with normal respiratory function (66 ± 3.2% vs. 78 ± 2.4%).
The effects of age on the pharmacokinetics of alprostadil have not been evaluated.
The efficacy of MUSE was evaluated in 7 placebo-controlled trials of various design in over 2500 patients with a history of erectile dysfunction of various etiologies. These trials assessed erectile function in the clinic and sexual intercourse in outpatient settings. In studies of sexual performance, patients were screened in the clinic, generally using doses of 125 mcg to 1000 mcg, for a satisfactory erectile response, then sent home with the selected dose or placebo for evaluation of sexual performance. Not all patients beginning titration had a successful dose and some patients could not tolerate MUSE, principally because of penile pain, so that the success rates in the studies described below must be understood to represent response rates only in patients who were successfully titrated.
In 2 identical multicenter, double-blind, placebo-controlled, parallel-group studies, 1511 patients with a mean 4-year history of erectile dysfunction and at least a 3-month history of no erections adequate for sexual intercourse without medical assistance, were enrolled and began dose titration in the clinic with doses between 125 mcg and 1000 mcg. 996 patients (66%) completed dose titration, achieved an erection sufficient for intercourse, and were randomized equally to placebo or active treatment and followed during at-home treatment for up to 3 months. 874 patients and partners completed 3 months of follow-up. About 10%, 20%, 30%, and 40% of patients were titrated to 125 mcg, 250 mcg, 500 mcg, and 1000 mcg, respectively. Couples on active therapy were more likely to have at least 1 successful sexual intercourse (65% vs. 19%) than were couples on placebo. Among patients who reported successful intercourse at least once with active treatment, approximately 7 of 10 times MUSE was used, patients reported successful sexual intercourse. Results were similar in patients with erectile dysfunction stemming from surgery or trauma, diabetes, vascular disease, or other etiologies, and were similar between racial sub-groups. In administrations resulting in sexual intercourse, the duration of erections sufficient for penetration was 6 minutes on placebo and 16 minutes on active drug. Successful therapy with MUSE was associated with improvement in the quality of life measures of “emotional wellbeing” for patients and “relationship with partner” for both patients and their female partners.
MUSE
[myooz]
(alprostadil) urethral suppository
Read all of this Patient Information and Instructions for Use (see the other side of this Patient Information leaflet) before using MUSE as it contains important information. These materials provide visual instructions and more detailed information on how to use MUSE.
What is MUSE?
MUSE is a prescription medicine used to treat erectile dysfunction, commonly called impotence. Erectile dysfunction is the inability to attain or maintain an erection enough for sexual intercourse.
Do not use MUSE if you:
Before you use MUSE, tell your healthcare provider about all of your medical conditions, including if:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use MUSE?
What should I avoid while using MUSE?
What are the possible side effects of MUSE?
The most serious side effects of MUSE include:
The most common side effects of MUSE include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of MUSE. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Meda Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
How should I store MUSE?
Keep MUSE and all medicines out of the reach of children.
General information about the safe and effective use of MUSE.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MUSE for a condition for which it was not prescribed. Do not give MUSE to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about MUSE that is written for health professionals.
What are the ingredients in MUSE?
Active Ingredient: alprostadil
Inactive Ingredient: polyethylene glycol 1450, USP
For more information, call Meda Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
This Patient Information has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
MUSE
[myooz]
(alprostadil) urethral suppository
This Instructions for Use contains information on how to insert MUSE.
This medicine has been prescribed to you only, do not pass it on to others.
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MUSE is a single-dose applicator for the delivery of the urethral suppository into the male urethra for the treatment of erectile dysfunction.
The MUSE applicator contains a single dose in each foil pouch and the applicator is for 1 use only.
Storing MUSE
Important Information You Need to Know Before Inserting MUSE
Preparing to Insert MUSE
Step 1. Urinate and gently shake your penis immediately before you insert the MUSE applicator.
Step 2. Remove MUSE applicator from foil pouch.
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Step 3. Remove protective cover.
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Step 4. Inspect the MUSE applicator for the presence of the urethral suppository.
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Inserting MUSE
Refer to the Anatomy of the Penis figure below before proceeding to Step 5.
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Step 5. Prepare penis for MUSE applicator insertion.
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Step 6. Insert MUSE applicator into urethra opening up to the collar (Figure F).
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Step 7. Push down the button at the top of the MUSE applicator until it stops and hold for 5 seconds (Figure G).
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Step 8. Lift your finger off the button and gently move MUSE applicator side to side (Figure H).
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Step 9. Remove the MUSE applicator while keeping your penis upright (Figure I).
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Step 10. Inspect the tip to see that the urethral suppository is no longer in the tip. Do not touch the stem.
Step 11. Hold your penis upright and stretch it to its full length then roll your penis firmly between your hands for at least 10 seconds (Figure J).
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Note: Your penis may feel warm and somewhat sensitive to the touch. This effect is normal and may last a few hours.
Disposing of (Throwing Away) MUSE
Step 12. Replace the protective cover on the MUSE applicator, place it in the opened foil pouch, and throw it away in your household trash.
For more information, call Meda Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
