CAVERJECT DUAL CHAMBER

Posology No formal studies with Caverject have been performed in patients younger than 18 years and older than 75 years. Method of administration Caverject Dual Chamber should be administered by direct intracavernosal injection using the 1/2-inch 29 gauge needle provided.

The usual site of injection is along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis and the site of injection must be altered between injections. The initial injections of Caverject Dual Chamber must be administered by medically trained personnel and after proper training, alprostadil may be injected at home.

g. every 3 months) particularly in the initial stages of self-injection therapy when dose adjustments may be needed. The dose of Caverject Dual Chamber should be individualised for each patient by careful titration under a physician’s supervision.

The lowest effective dose should be used that provides the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produces a duration of the erection not exceeding one hour.

If the duration is longer, the dose should be reduced. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms. The delivery device is designed to deliver a single dose which can be set at 25% increments of the nominal dose.

Doses greater than 40 micrograms of alprostadil are not routinely justified. 5 micrograms. 5 micrograms if there is no response. Subsequent incremental increases of 5 to 10 micrograms should be given until an optimal dose is identified.

If there is no response to the administered dose, then the next higher dose may be given within one hour. If there is a response, there should be a one day interval before the next dose is given. 5 micrograms, it should be considered to dose titrate with Caverject Powder for Injection.

5 micrograms. Apart from the starting dose, it is possible to dose titrate with either Caverject Dual Chamber or Caverject Powder for Injection with similar increments to the treatment of non-neurogenic erectile dysfunction. The maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

Adjunct to aetiologic diagnosis Patients without evidence of neurological dysfunction: 10 to 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. Over 80% of patients may be expected to respond to a single 20 micrograms dose of alprostadil.

Patients with evidence of neurological dysfunction:

These patients can be expected to respond to lower doses of alprostadil. In patients with erectile dysfunction caused by neurologic disease/trauma, the dose for diagnostic testing must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate.

9). At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. In case of lack of erectile response during the titration phase, patients should be monitored for systemic adverse effects.

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 to 6 hours) developed in 4% of patients. 4%. In most cases it disappeared spontaneously. Tabulated list of adverse reactions Adverse drug reactions reported during clinical trials and post marketing experience are presented in the table below, frequencies are very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); not known (cannot be estimated from the available data).

The adverse drug reactions are listed in order of decreasing medical seriousness within each frequency category and system organ class. System Organ Class Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Not known (cannot be estimated from the available data) Infections and infestations Fungal infection, Common cold System Organ Class Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Not known (cannot be estimated from the available data) Nervous system disorders Presyncope, Hypoaesthesia, Hyperaesthesia Cerebrovascular accident Eye disorders Mydriasis Cardiac disorders Supraventricular extrasystoles Myocardial ischaemia Vascular disorders Venous haemorrhage, Hypotension, Vasodilatation, Peripheral vascular disorder, Vein disorder Gastrointestinal disorders Nausea, Dry mouth Skin and subcutaneous tissue disorders Rash, Hyperhidrosis, Pruritus, Erythema Musculoskeletal and connective tissue disorders Muscle spasms Renal and urinary disorders Urethral haemorrhage, Haematuria, Dysuria, Pollakiuria, Micturition urgency Reproductive system and breast disorders Penile pain Peyronie’s disease, Penis disorders (including penile fibrosis, angulation and fibrotic nodules), Erection increased Priapism, Pelvic pain, Testicular mass, Spermatocele, Testicular swelling, Testicular oedema, Testicular disorder, Scrotal pain, Scrotal erythema, Scrotal oedema, Testicular pain, Scrotal disorder, Painful erection, Balanitis, Phimosis, Erectile dysfunction, Ejaculation disorder System Organ Class Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Not known (cannot be estimated from the available data) General disorders and administration site conditions Injection site haematoma, Ecchymosis Haemorrhage, Injection site haemorrhage, Inflammation, Injection site inflammation, Injection site warmth, Injection site oedema, Injection site swelling, Injection site pain, Injection site irritation, Asthenia, Injection site anaesthesia, Oedema, Oedema peripheral, Injection site pruritus Investigations Blood creatinine increased, Blood pressure decreased, Heart rate 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4 Benzyl alcohol). 2 Posology and method of administration Posology No formal studies with Caverject have been performed in patients younger than 18 years and older than 75 years. Method of administration Caverject Dual Chamber should be administered by direct intracavernosal injection using the 1/2-inch 29 gauge needle provided.

The usual site of injection is along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis and the site of injection must be altered between injections. The initial injections of Caverject Dual Chamber must be administered by medically trained personnel and after proper training, alprostadil may be injected at home.

g. every 3 months) particularly in the initial stages of self-injection therapy when dose adjustments may be needed. The dose of Caverject Dual Chamber should be individualised for each patient by careful titration under a physician’s supervision.

The lowest effective dose should be used that provides the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produces a duration of the erection not exceeding one hour.

If the duration is longer, the dose should be reduced. The majority of patients achieve a satisfactory response with doses in the range of 5 to 20 micrograms. The delivery device is designed to deliver a single dose which can be set at 25% increments of the nominal dose.

Doses greater than 40 micrograms of alprostadil are not routinely justified. 5 micrograms. 5 micrograms if there is no response. Subsequent incremental increases of 5 to 10 micrograms should be given until an optimal dose is identified.

If there is no response to the administered dose, then the next higher dose may be given within one hour. If there is a response, there should be a one day interval before the next dose is given. 5 micrograms, it should be considered to dose titrate with Caverject Powder for Injection.

5 micrograms. Apart from the starting dose, it is possible to dose titrate with either Caverject Dual Chamber or Caverject Powder for Injection with similar increments to the treatment of non-neurogenic erectile dysfunction. The maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

Adjunct to aetiologic diagnosis Patients without evidence of neurological dysfunction: 10 to 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. Over 80% of patients may be expected to respond to a single 20 micrograms dose of alprostadil.

Patients with evidence of neurological dysfunction:

These patients can be expected to respond to lower doses of alprostadil. In patients with erectile dysfunction caused by neurologic disease/trauma, the dose for diagnostic testing must not exceed 10 micrograms and an initial dose of 5 micrograms is likely to be appropriate.

9). At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. In case of lack of erectile response during the titration phase, patients should be monitored for systemic adverse effects.

1. • Conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiple myeloma, or leukaemia. • Anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. • Penile implants.

g. patients suffering from severe heart disease). 4 Special warnings and precautions for use Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with alprostadil.

Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil. To minimise the risk, select the lowest effective dose. Patients should be instructed to immediately report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer.

9). 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 Caverject Dual Chamber.

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 Caverject Dual Chamber should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease.

Patients on anticoagulants such as warfarin or heparin may […]

1. • Conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiple myeloma, or leukaemia. • Anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. • Penile implants.

g. patients suffering from severe heart disease).