MUSE Urethral Stick Ref.[8671] Active ingredients: Alprostadil

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

Painful erection is more likely to occur in patients with anatomical deformations of the penis, such as angulation, phimosis, cavernosal fibrosis, Peyronie’s disease or plaques.

Incorrect insertion of MUSE may cause urethral abrasion and minor urethral bleeding. In patients infected with blood born diseases, this could increase the transmission of such diseases to their partner.

Patients on anticoagulants or with bleeding disorders may have an increased risk of urethral bleeding.

Priapism (erection lasting over six hours) may occur following administration of MUSE. Treatment of priapism should not be delayed more than 6 hours (please refer to Section 4.9 Overdose). Instruct patients to immediately report to their prescribing physician, or, if unavailable, seek immediate medical assistance for any erection that persists longer than 4 hours. Treatment of priapism should be according to established medical practice.

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). To minimize the risk, select the lowest effective dose. It may be necessary to reduce the dose or discontinue treatment in any patient who develops priapism.

Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and

Peyronie’s disease may occur following the administration of MUSE. The occurrence of fibrosis may increase with increased duration of use. Regular follow-up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis or Peyronie’s disease. Treatment with MUSE should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie’s disease.

MUSE should be used with caution in patients who have experienced transient ischaemic attacks or those with unstable cardiovascular disorders.

MUSE is not intended for co-administration with any other agent for the treatment of erectile dysfunction (see also 4.5).

The potential for abuse of MUSE should be considered in patients with a history of psychiatric disorder or addiction.

Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease. These patients when using MUSE should engage in sexual activity with caution.

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.

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.

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.

The effects of combinations of alprostadil with other treatments for erectile dysfunction (e.g. sildenafil) or other drugs inducing erection (e.g. papaverine) have not been formally studied. No conclusions can therefore be drawn regarding the safety or efficacy of this combination.

Sympathomimetics may reduce the effect of alprostadil. Alprostadil may enhance the effects of antihypertensives, anticoagulants and platelet aggregation inhibitors.

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.

MUSE may add small amounts of alprostadil to the naturally occurring PGE₁ already present in the semen. A condom barrier should therefore be used during sexual intercourse if the female partner is pregnant to avoid irritation of the vagina and guard against any risk to the foetus.

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. In patients experiencing hypotension and/or syncope, these events have usually occurred during initial titration and within one hour of drug administration.

The most frequently reported adverse effect following treatment with MUSE was pain in the penis. In most cases, pain was assessed as mild or moderate.

Penile fibrosis, including angulation, fibrotic nodules, and Peyronie’s disease, was reported in 3% of clinical trial patients overall.

Adverse drug reactions reported during treatment with MUSE are presented in the table below. Frequencies are Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (>1/10,000 to <1/1,000); Very rare (<1/10,000); not known (cannot be estimated from the available data).
Infections and infestations

Infections and infestations

Uncommon: Common cold

Nervous system disorders

Common: Headache, dizziness

Uncommon: Syncope, pre-syncope, hypoaesthesia, hyperaesthesia

Vascular disorders

Common: Symptomatic hypotension, haematoma

Uncommon: Vein disorder, peripheral vascular disorder, vasodilatation

Gastrointestinal disorders

Uncommon: Nausea

Skin and subcutaneous disorders

Uncommon: Swelling of the leg veins, erythema, hyperhidrosis, rash, pruritus, scrotal erythema

Very rare: Urticaria

Musculoskeletal, connective tissue and bone disorders

Common: Muscle spasms

Uncommon: Leg pain

Renal and Urinary disorders

Very common: Urethral burning

Common: Minor urethral bleeding

Uncommon: Dysuria, pollakiuria, micturition urgency, urethral haemorrhage

Rare: Urinary tract infection

Reproductive system

Very common: Penile pain

Common: Erection increased, Peyronie’s disease, penis disorder, vaginal burning/itching (in partners)

Uncommon: Perineal pain, erectile dysfunction, ejaculation disorder, balanitis, painful erection, phimosis, priapism, testicular pain, scrotal disorder, scrotal erythema, scrotal pain, spermatocele, scrotal oedema, testicular disorder, testicular swelling, testicular oedema, testicular mass, pelvic pain

Rare: Penile fibrosis

Investigations

Uncommon: Blood pressure decreased, heart rate increased, blood creatinine increased

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.