Adverse reactions : תופעות לוואי

4.8      Undesirable effects

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. The frequency of priapism (defined as an erection that lasts 6 hours or longer) was 0.4%. 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          Uncommon      Fungal infection, Common cold
Infestations
Nervous System          Uncommon      Presyncope, Hypoaesthesia, Hyperaesthesia Disorders               Not known     Cerebrovascular accident
Eye Disorders           Uncommon      Mydriasis
Cardiac Disorders       Uncommon      Supraventricular extrasystoles
Not known     Myocardial ischaemia
Vascular Disorders      Uncommon      Venous haemorrhage, Hypotension, Vasodilatation, Peripheral vascular disorder, Vein disorder
Gastrointestinal        Uncommon      Nausea, Dry mouth
Disorders
Skin and                Uncommon      Erythema, Rash, Hyperhidrosis, Pruritus Subcutaneous Tissue
Disorders
Musculoskeletal and     Common        Muscle spasms
Connective Tissue
Disorders
Renal and Urinary       Uncommon      Urethral haemorrhage, Haematuria, Dysuria, Disorders                             Pollakiuria, Micturition urgency Reproductive System     Very          Penile pain and Breast Disorders    common
Common        Peyronie’s disease, Penis disorder, Erection increased 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
General Disorders       Common        Injection site haematoma, Haematoma, Ecchymosis and Administration      Uncommon      Haemorrhage, Injection site haemorrhage, Site Conditions                       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.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/