CAVERJECT

This medicine is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally recommended. The dose of alprostadil should be individualised for each patient by careful titration under supervision by a physician.

The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis that is injected and the site of injection must be alternated; prior to the injection, the injection site must be cleansed with an alcohol swab.

To reconstitute this medicine using the prefilled diluent syringe: flip off the plastic cap from the vial, and use one of the swabs to wipe the rubber cap. Fit the 22 gauge needle to the syringe. Inject the 1 ml of diluent into the vial, and shake to dissolve the powder entirely.

Withdraw slightly more than the required dose of alprostadil solution, remove the 22 gauge needle, and fit the 30 gauge needle. Adjust volume to the required dose for injection. Following administration, any unused contents of the vial or syringe should be discarded.

A. As an aid to aetiologic diagnosis. i) Subjects without evidence of neurological dysfunction; 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. 9) should be employed prior to the subject leaving the clinic to prevent a risk of priapism.

Over 80% of subjects may be expected to respond to a single 20 micrograms dose of alprostadil. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.

ii) Subjects with evidence of neurological dysfunction; these patients can be expected to respond to lower doses of alprostadil. In subjects 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) should be employed prior to the subject leaving the clinic to prevent a risk of priapism. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. B.

5 micrograms, a third of 5 micrograms, and subsequent incremental increases of 5 micrograms until an optimal dose is achieved. 5 micrograms. 5 micrograms if there is no response. Subsequent incremental increases of 5-10 micrograms should be given until an optimal dose is achieved.

If there is no response to the administered dose, then the next higher dose may be given within 1 hour. If there is a response, there should be at least a 1-day interval before the next dose is given. The usual maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

The first injections of alprostadil must be done by medically trained personnel. After proper training and instruction, alprostadil may be injected at home. If self-administration is planned, the physician should make an assessment of the patient's skill and competence with the procedure.

g. every 3 months) particularly in the initial stages of self injection therapy when dose adjustments may be needed. The dose that is selected for self-injection treatment should provide 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.

Doses of greater than 60 micrograms of alprostadil are not recommended. The lowest effective dose should be used.

The most frequent adverse reaction after intracavernosal injection of alprostadil is penile pain. Thirty percent of the patients reported penile pain at least once; however, this event was associated with only 11% of the administered injections.

In the majority of the cases, penile pain was rated mild or moderate in intensity. 3% of patients discontinued treatment because of penile pain. Prolonged erection (defined as an erection that lasts for 4 to 6 hours) after intracavernosal administration of alprostadil was reported in 4% of patients.

4%. In the majority of cases, spontaneous detumescence occurred. Penile fibrosis, including angulation, fibrotic nodules and Peyronie's disease was reported in 3% of clinical trial patients overall, however, 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 site of injection, which is related to the injection technique rather than to the effects of alprostadil, occurred in 3% and 2% of patients, respectively. Penile oedema or rash was reported by 1% of alprostadil treated patients.

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 Frequency Undesirable effects Infections and Infestations Uncommon Fungal infection, Common cold Uncommon Presyncope, Hypoaesthesia, HyperaesthesiaNervous System Disorders Not known Cerebrovascular accident Eye Disorders Uncommon Mydriasis Uncommon Supraventricular extrasystolesCardiac Disorders Not known Myocardial ischaemia Vascular Disorders Uncommon Venous haemorrhage, Hypotension, Vasodilatation, Peripheral vascular disorder, Vein disorder Gastrointestinal Disorders Uncommon Nausea, Dry mouth Skin and Subcutaneous Tissue Disorders Uncommon Erythema, Rash, Hyperhidrosis, Pruritus System Organ Class Frequency Undesirable effects Musculoskeletal and Connective Tissue Disorders Common Muscle spasms Renal and Urinary Disorders Uncommon Urethral haemorrhage, Haematuria, Dysuria, Pollakiuria, Micturition urgency Very common Penile pain Common Peyronie’s disease, Penis disorder, Erection increased Reproductive System and Breast Disorders Uncommon 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 Common Injection site haematoma, Haematoma, Ecchymosis General Disorders and Administration Site Conditions Uncommon 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 Uncommon 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.

4 Benzyl alcohol). 2 Posology and method of administration This medicine is administered by direct intracavernous injection. A half inch, 27 to 30 gauge needle is generally recommended. The dose of alprostadil should be individualised for each patient by careful titration under supervision by a physician.

The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorsolateral aspect of the proximal third of the penis. Visible veins should be avoided. Both the side of the penis that is injected and the site of injection must be alternated; prior to the injection, the injection site must be cleansed with an alcohol swab.

To reconstitute this medicine using the prefilled diluent syringe: flip off the plastic cap from the vial, and use one of the swabs to wipe the rubber cap. Fit the 22 gauge needle to the syringe. Inject the 1 ml of diluent into the vial, and shake to dissolve the powder entirely.

Withdraw slightly more than the required dose of alprostadil solution, remove the 22 gauge needle, and fit the 30 gauge needle. Adjust volume to the required dose for injection. Following administration, any unused contents of the vial or syringe should be discarded.

A. As an aid to aetiologic diagnosis. i) Subjects without evidence of neurological dysfunction; 20 micrograms alprostadil to be injected into the corpus cavernosum and massaged through the penis. 9) should be employed prior to the subject leaving the clinic to prevent a risk of priapism.

Over 80% of subjects may be expected to respond to a single 20 micrograms dose of alprostadil. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state.

ii) Subjects with evidence of neurological dysfunction; these patients can be expected to respond to lower doses of alprostadil. In subjects 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) should be employed prior to the subject leaving the clinic to prevent a risk of priapism. At the time of discharge from the clinic, the erection should have subsided entirely and the penis must be in a completely flaccid state. B.

5 micrograms, a third of 5 micrograms, and subsequent incremental increases of 5 micrograms until an optimal dose is achieved. 5 micrograms. 5 micrograms if there is no response. Subsequent incremental increases of 5-10 micrograms should be given until an optimal dose is achieved.

If there is no response to the administered dose, then the next higher dose may be given within 1 hour. If there is a response, there should be at least a 1-day interval before the next dose is given. The usual maximum recommended frequency of injection is no more than once daily and no more than three times weekly.

The first injections of alprostadil must be done by medically trained personnel. After proper training and instruction, alprostadil may be injected at home. If self-administration is planned, the physician should make an assessment of the patient's skill and competence with the procedure.

g. every 3 months) particularly in the initial stages of self injection therapy when dose adjustments may be needed. The dose that is selected for self-injection treatment should provide 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.

Doses of greater than 60 micrograms of alprostadil are not recommended. The lowest effective dose should be used. 1; in patients who have conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiple myeloma, or leukaemia; or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease.

Patients with penile implants should not be treated with alprostadil. Alprostadil should not be used in men for whom sexual activity is inadvisable or contraindicated. 4 Special warnings and precautions for use Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil.

To minimize the risk, select the lowest effective dose. Patients should be instructed to report immediately to a physician, or if unavailable to seek immediate medical assistance for any erection lasting for a prolonged time period, such as 4 hours.

9) and 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 alprostadil. The occurrence of fibrosis may increase […]

1; in patients who have conditions that might predispose them to priapism, such as sickle cell anaemia or trait, multiple myeloma, or leukaemia; or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease.

Patients with penile implants should not be treated with alprostadil. Alprostadil should not be used in men for whom sexual activity is inadvisable or contraindicated.