Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Use in adults

Treatment of erectile dysfunction

Initiation of therapy: a medical professional should instruct each patient on the correct use of MUSE. The recommended starting dose is 250 micrograms.

Dosage may be increased in a stepwise manner (from 500 to 1000 micrograms), or decreased (to 125 micrograms) under medical supervision until the patient achieves a satisfactory response. After an assessment of the patient's skill and competence with the procedure, the chosen dose may then be prescribed for home use.

It is important for the patient to urinate before administration since a moist urethra makes administration of MUSE easier and is essential to dissolve the drug. To administer MUSE, remove the protective cover from the MUSE applicator, stretch the penis upward to its full length, and insert the applicator stem into the urethra. Depress the applicator button to release the medication from the applicator and remove the applicator from the urethra, (rocking the applicator gently prior to removal will ensure that the medication is separated from the applicator stem). Roll the penis between the hands for at least 10 seconds to ensure that the medication is adequately distributed along the wall of the urethra. If the patient feels a burning sensation it may help to roll the penis for an additional 30 to 60 seconds or until the burning subsides. The erection will develop within 5-10 minutes after administration and lasts approximately 30-60 minutes. After administration of MUSE, it is important to sit, or preferably, stand or walk for about 10 minutes while the erection is developing. More detailed information is given in the patient information leaflet. During home use, periodic checks of efficacy and safety are recommended.

Not more than 2 doses are recommended to be used in any 24-hour period, and not more than 7 doses are recommended to be used in a 7-day period. The prescribed dosage should not be exceeded.

Adjunct to other tests in the diagnosis and management of erectile dysfunction .

MUSE can be used as an adjunct in evaluating penile vascular function using Doppler duplex ultrasonography. It has been shown that a 500 microgram dose of MUSE has a comparable effect on penile arterial dilatation and peak systolic velocity flow to 10 microgram of alprostadil given by intracavernosal injection. At the time of discharge from the clinic, the erection should have subsided.

Child Dosage

Elderly Dosage

No adjustment for age is required.

Contra Indications

MUSE is contraindicated in men with any of the following conditions:

Hypersensitivity to the active substance or to any of the excipients.

Abnormal penile anatomy (stenosis of the distal urethra, severe hypospadia or severe curvature), balanitis, acute or chronic urethritis.

Conditions with an increased risk of priapism (sickle cell anaemia or trait, thrombocythaemia, polycythaemia, multiple myeloma; predisposition to venous thrombosis), or a history of recurrent priapism.

MUSE should not be used in men for whom sexual activity is inadvisable, as in men with unstable cardiovascular or unstable cerebrovascular conditions.

MUSE should not be used if the female partner is or may be pregnant unless the couple uses a condom barrier.

MUSE is contraindicated in women and children.

Special Precautions

Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of treatment with MUSE.

Incorrect insertion of MUSE may cause urethral abrasion and minor urethral bleeding. Patients on anticoagulants or with bleeding disorders may have an increased risk of urethral bleeding.

Patients should be asked to report promptly to their treating physician any erections lasting 4 hours or longer.

For treatment: Overdose. In clinical trials of MUSE, priapism (rigid erections 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. It may be necessary to reduce the dose or discontinue treatment in any patient who develops priapism.

Patients and their partners should be advised that MUSE offers no protection from transmission of sexually transmitted diseases. They should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus (HIV). The use of MUSE will not affect the integrity of condoms. Since MUSE may add small amounts of alprostadil to the naturally occurring PGE₁ already present in the semen, it is recommended that adequate contraception is used if the woman is of child-bearing potential.

Interactions

Systemic interactions are unlikely because of the low levels of alprostadil in the peripheral venous circulation, however the presence of medication affecting erectile function may influence the response to MUSE. Decongestants and appetite suppressants may diminish the effect of MUSE. Patients on anticoagulants or with bleeding disorders may have an increased risk of urethral bleeding. Insufficient data exists concerning the concomitant use of MUSE with vasoactive medications. There is the potential that this combination may increase the risk of hypotensive symptoms; this effect may be more common in the elderly.

There is limited information available in the literature concerning the concomitant use of MUSE and sildenafil for the treatment of erectile dysfunction. No conclusions can be drawn, however, regarding the safety or efficacy of this combination.

The use of MUSE in patients with penile implants has been reported in a limited number of cases in the literature. However no conclusions can be drawn regarding the safety or efficacy of this combination.

Adverse Reactions

The most frequently reported adverse events in treatment with MUSE are presented in the table below. (Very common> 1/10; Common> 1/100, <1/10; Uncommon>1/1000, <1/100; Rare>1/10000, <1/1000; Very rare <1/10000)

Vaginal burning/itching was reported by approximately 6% of partners of patients on active treatment. This may be due to resuming sexual intercourse or due to the use of MUSE.

Manufacturer

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