VIRIDAL DUO

Posology Adults:

Dosage for diagnosis of erectile dysfunction Injections for diagnostic evaluation and dose titration must be performed by the treating physician. He will determine an individual dose suitable to produce an erectile response for diagnostic purposes.

5 mcg. 5 mcg to 5 mcg Viridal Duo. Most of the patients require between 10 and 20 mcg per injection. Some patients may need to be titrated to higher doses. Doses exceeding 20 mcg should be prescribed with particular care in patients with cardiovascular risk factors.

The dose per injection should never exceed 40 mcg. Dosage for the treatment of erectile dysfunction Treatment initiation and dose titration Injections for treatment initiation and dose titration must be performed by the treating physician.

25 mcg Viridal Duo in patients with erectile dysfunction of primary neurological origin. 5 mcg is the recommended starting dose. 5 mcg to 5 mcg. Most patients require between 10 and 20 mcg per injection. Some patients may need to be titrated to higher doses.

The dose per injection should never exceed 40 mcg. Dosage for self-injection therapy Before starting treatment at home, each patient or the patient’s partner has to be taught by a physician how to prepare the drug and perform the injection.

In no cases should the injection therapy be started without precise instructions by the physician. The patient should only use his optimum individual dosage which has been pre- determined by his physician using the above-mentioned procedure.

This dose should allow the patient to have an erection at home, which should not last longer than one hour. If he experiences prolonged erections beyond 2 hours but less than 4 hours, the patient is recommended to contact his physician to re-establish the dose of the drug.

The maximum injection frequency recommended is 3 times a week with an interval of at least 24 hours between the injections. g. every three months, the physician should re-evaluate the patient. g. haematoma, fibrosis or nodules should be noted and controlled.

Following discussion with the patient, an adjustment of dosage may be necessary. Paediatric population The safety and efficacy of Viridal Duo in children under 18 years of age has not yet been established. No data are available. Elderly The safety and efficacy of Viridal Duo in patients over 80 years of age has not yet been established.

No data are available. Method of preparation and administration Intracavernosal use The drug solution should be prepared shortly before the injection. Prior to injection the needle should be screwed onto the tip of the injector. After disinfecting the tip of the cartridge with one of the alcohol swabs, the cartridge should then be inserted into the injector.

The tip should face towards the front of the applicator. Put the cartridge into the Easy Duo device. Screw the syringe and plunger together. Hold the device in the vertical position and push the plunger upwards. The solvent will by-pass the upper stopper into the front chamber and dissolve the dry substance within a few seconds.

As soon as the dry substance is reconstituted, the larger external and the smaller inner protective cap have to be removed from the needle. The device is still held in the vertical position and the air should then be expelled out of the cartridge by tapping against the cartridge and by carefully pushing the plunger until the air is pushed out.

The plunger is pushed up until the grey stopper reaches the prescribed dose. Viridal Duo is injected into either the right or the left cavernous body of the penile shaft. Once the needle is in the cavernous body, the injection should be done within 5 to 10 seconds and is very easy without much resistance if the needle is in the correct position.

The development of an erection will start approximately 5 – 15 minutes after the injection. Notes Injections for treatment initiation, diagnostic evaluation and dose titration must be performed by the treating physician. 125 ml injection volume from the carpoule containing 10 mcg Viridal Duo.

Under aseptic conditions the solution can be extracted from the carpoule through the rubber seal. Unused solution must be discarded immediately.

Summary of the safety profile:

The most frequent adverse effect following an intracavernous injection was pain in the penis. Thirty percent of patients reported pain at least once. Pain was associated with 11% of the injections administered. In most cases pain was assessed as mild or moderate.

Three per cent of patients discontinued treatment because of pain. Penile fibrosis, including angulation, fibrotic nodules, and Peyronie’s disease, was reported in 3% of clinical trial patients overall. In one self-injection study in which the duration of use was up to 18 months, the incidence of penile fibrosis was higher, approximately 8%.

Haematoma and ecchymosis at the injection site, which is related with the injection technique rather than the effect of alprostadil, was reported by 3% and 2% of patients, respectively. Prolonged erection (an erection for 4 - 6 h) developed in 4% of patients.

4%. In most cases it disappeared spontaneously. Adverse drug reactions reported during clinical trials and post marketing experience are presented in the table below.

Tabulated list of adverse reactions:

Frequencies are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (>1/10,000, < 1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). g. fibrotic nodules, plaques at the site of injection or in the corpus cavernosum) can occur during long term treatment Reproductive system and breast disorders Uncommon Fibrotic alterations associated with slight penile axis deviations, erectile dysfunction, balanoposthitis, priapism (mainly seen during dose titration), phimosis, painful erection, ejaculation disorder, testicular pain, scrotal disorder, scrotal erythema, scrotal pain, pelvic pain, testicular swelling, testicular oedema, scrotal oedema, spermatocele, testicular disorder, testicular mass Rare Fibrotic changes of the cavernous body during a long term treatment lasting up to 4 years.

Common Ecchymosis, injection site haematoma, burning sensation during injection and after the injection, pain of mostly mild intensity at the site of injection. Uncommon Spot-like haemorrhage / spot-like bruises at the site of puncture, haemosiderin deposits, inflammation, oedema peripheral, oedema, injection site haemorrhage, injection site mass, injection site inflammation, injection site pruritis, injection site swelling and reddening, injection site oedema, injection site irritation, injection site anaesthesia, injections site pain, injection site warmth, asthenia, haemorrhage General disorders and administrative site conditions Not known Penile oedema Investigations Uncommon Blood pressure decreased, heart rate increased, blood creatinine increased 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 national reporting system listed below. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The physician should carefully select patients suitable for self-injection therapy. Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with Viridal Duo. Sexual stimulation and intercourse can lead to cardiac and/or pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease.

These patients when using Viridal Duo should engage in sexual activity with caution and patients should be examined and cleared for stress resistance by a cardiologist before treatment. Viridal Duo should be used with caution in patients with cardiovascular and cerebrovascular risk factors.

Viridal Duo should be used cautiously in patients with a history of gastrointestinal disease, including erosive gastritis; gastrointestinal bleeding and gastric and/or duodenal ulcer. 5). Those patients should be closely monitored for signs and symptoms of bleeding.

Priapism (erection lasting over six hours) may occur following intracavernosal administration of alprostadil. Prolonged erections of more than four hours can be dangerous. 9). Therefore it is recommended that the patient has an emergency telephone number of his attending physician or of a clinic experienced in therapy of erectile dysfunction.

Prolonged erection may damage penile erectile tissue and lead to irreversible erectile dysfunction. To minimise the risk, select the lowest effective dose and instruct the patient to immediately report to his prescribing physician, or, if unavailable, seek immediate medical assistance for any erection that persist longer than four hours.

Treatment of priapism should be according to established medical practice. 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.

Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of Viridal Duo. 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 Viridal Duo should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease.

Patients who have to be treated with alpha-adrenergic drugs due to prolonged erections (see: overdose) may in the case of concomitant therapy with monoamino-oxidase-inhibitors, develop a hypertensive crisis. g. smooth muscle relaxing agents or alpha- adrenergic blocking agents may lead to prolonged erection and must not be used concomitantly.

5). g. monitoring of the clotting parameters. 5). Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernous injection. To prevent abuse, self-injection therapy with Viridal Duo should not be used by patients with drug addiction and/or disturbances of psychological or intellectual development.

g. higher frequencies than recommended, an increased risk of penile scarring cannot be excluded. Use of intracavernous alprostadil offers no protection from the transmission of sexually transmitted diseases. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).

In some patients, injection of Viridal Duo can induce a small amount of bleeding at the injection site. In patients infected with blood borne diseases, this could increase the transmission of such diseases to the partner. For this reason we recommend that a condom is used for intercourse after injecting Viridal Duo.

Viridal Duo is for intracavernous injection. Subcutaneous injection or injections at areas of the penis other than the cavernous body should be avoided. The injection should be performed under hygienic conditions to avoid infections.

In any condition that precludes safe self-injection like poor manual dexterity, poor visual acuity or morbid obesity, the partner should be trained in the injection technique and should perform the injection. Up to now, there is no clinical experience in patients under 18 and over 80 years of age.

Reconstituted solutions of Viridal Duo are intended for single use only. The injection delivery system / Syringe and remaining solution should be properly discarded. Human semen contains PGE1, but additional amounts may be present due to administration of Viridal Duo.

6). Viridal Duo must not be used for sexual intercourse with a pregnant woman without a condom.

1. g. sickle-cell anaemia or trait, multiple myeloma or leukaemia or patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie’s disease. Patients with penis implants should not use Viridal Duo.

g. patients suffering from severe heart disease).