MUSE

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 500 micrograms. Dosage may be increased in a stepwise manner (to 1000 micrograms), or decreased (to 250 or 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.

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).

System Organ Class Frequency Adverse Reaction Infections and infestations Uncommon Common cold Common Headache, dizziness Nervous system disorders Uncommon Syncope, pre- syncope, hypoaesthesia, hyperaesthesia Common Symptomatic hypotension, haematoma Vascular disorders Uncommon Vein disorder, peripheral vascular disorder, vasodilatation Gastrointestinal disorders Uncommon Nausea Uncommon Swelling of the leg veins, erythema, hyperhidrosis, rash, pruritus, scrotal erythema Skin and subcutaneous disorders Very rare Urticaria Common Muscle spasmsMusculoskeletal, connective tissue and bone disorders Uncommon Leg pain Very common Urethral burning Common Minor urethral bleeding Uncommon Dysuria, pollakiuria, micturition urgency, urethral haemorrhage Renal and Urinary disorders Rare Urinary tract infection 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 Reproductive system 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.

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. 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. 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.

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.

MUSE is contraindicated in the following patients: • Patients who have a known hypersensitivity to the active substance or to any of the excipients. • Patients with anatomical deformation of the penis, such as stenosis of the distal urethra, severe hypospadias, severe curvature, balanitis, acute or chronic urethritis, angulation, cavernosal fibrosis or Peyronie’s disease.

• Patients who have conditions that might predispose them to priapism, such as sickle cell anaemia or trait, thrombocythaemia, polycythaemia, multiple myeloma or leukemia; predisposition to venous thrombosis, or a history of recurrent priapism.

• Patients for whom sexual activity is inadvisable or contraindicated, such as 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.