EDEX SIDE EFFECTS
- Generic Name: alprostadil for injection
- Brand Name: Edex
- Drug Class: Prostaglandins, Genitourinary
SIDE EFFECTS
edex® (alprostadil for injection) , administered by intracavernous injection in doses ranging from 1 to 40 mcg per injection for periods up to 24 months, has been evaluated in clinical trials for safety in over 1,065 patients with erectile dysfunction. Discontinuation of therapy due to a side effect in clinical trials was required in approximately 9% of patients treated with edex® (alprostadil for injection) and in < 1% of patients treated with placebo.
Local Adverse Reactions
The following local adverse reactions were reported in studies including 1,065 patients treated with edex® (alprostadil for injection) for up to two years.
Penile Pain: With use of up to 24 months, penile pain was reported at least once by 29% of patients during injection, 35% of patients during erection, and by 30% of patients after erection. On a per injection basis, 15% of injections were associated with penile pain. Penile pain was judged by patients to be mild in intensity for 80% of painful injections, moderate in intensity for 16% of painful injections, and severe in intensity for 4% of painful injections. The frequency of penile pain reports decreased over time; forty-one percent of the patients experienced pain during the first 2 months and 3% of the patients experienced pain during months 21-24. In placebo-controlled studies, penile pain was reported by 31% of patients after edex® (alprostadil for injection) and by 9% of patients after placebo injection.
Prolonged Erection/Priapism: Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. In placebo-controlled studies, 3% of patients treated with edex® (alprostadil for injection) and < 1% of patients treated with placebo reported prolonged erections greater than four hours. The incidence of priapism (erections greater than 6 hours in duration) was < 1% with long-term use for up to 24 months. In the majority of cases, spontaneous detumescence occurred. A higher incidence of prolonged erections was found in younger patients ( < 40 years), non-diabetic patients, and patients with psychogenic etiology of erectile dysfunction.
Hematoma/Ecchymosis: In patients treated with edex® (alprostadil for injection) for up to 24 months, local bleeding, hematoma and ecchymosis were observed in 15%, 5% and 4% of patients, respectively. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex® (alprostadil for injection) and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique.
Local Adverse Reactions Reported by ≥ 1% of Patients All Study Periods*
| Local Reaction | edex® (alprostadil for injection) N = 1065 n (%) |
Local Reaction | edex® (alprostadil for injection) N = 1065 n (%) |
| Penile pain during injection | 305 (29) | Ecchymosis | 44 (4) |
| Penile pain during erection | 368 (35) | Penile angulation | 72 (7) |
| Penile pain after erection | 317 (30) | Penile fibrosis | 52 (5) |
| Penile pain (other)** | 116 (11) | Cavernous body fibrosis | 20 (2) |
| Prolonged erection | Peyronie’s disease | 11 (1) | |
| > 4 ≤ 6 Hours | 44 (4) | Faulty injection technique*** | 59 (6) |
| > 6 Hours | 6 ( < 1) | Penis disorder | 28 (3) |
| Bleeding | 158 (15) | Erythema | 17 (2) |
| Hematoma | 56 (5) | ||
| * Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653. ** Penile pain reported without an association to injection site or erection, such as pain in penis and scrotum, pain in glans penis, and burning penile pain. *** Examples include injection into glans penis, urethra or subcutaneously. |
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Systemic Adverse Experiences
The following systemic adverse experiences were reported in controlled and uncontrolled studies in ≥ 1% of patients treated for up to 24 months with edex® (alprostadil for injection) .
Systemic Adverse Experiences Reported by ≥ 1% of Patients*
| BODY SYSTEM Adverse Experience |
edex® (alprostadil for injection) N = 1065 n (%) |
BODY SYSTEM Adverse Experience |
edex® (alprostadil for injection) N = 1065 n (%) |
BODY SYSTEM Adverse Experience |
edex® (alprostadil for injection) N = 1065 n (%) |
| RESPIRATORY | CARDIOVASCULAR | UROGENITAL | |||
| Upper respiratory tract | Hypertension | 17 (2) | Prostate disorder | 15 (1) | |
| infection | 58 (5) | Myocardial infarction | 13 (1) | Testicular pain | 13 (1) |
| Sinusitis | 14 (1) | Abnormal ECG | 12 (1) | Inguinal hernia | 11 (1) |
| BODY AS A WHOLE | METABOLIC/NURITIONAL | DERMATOLOGIC | |||
| Influenza-like symptoms | 35 (3) | Hypertriglyceridemia | 17 (2) | Skin disorder | 14 (1) |
| Headache | 20 (2) | Hypercholesterolemia | 12 (1) | SPECIAL SENSES | |
| Infection | 18 (2) | Hyperglycemia | 12 (1) | Abnormal vision | 11 (1) |
| Pain | 16 (2) | ||||
| MUSCULOSKELETAL | |||||
| Back pain | 23 (2) | ||||
| Leg pain | 13 (1) | ||||
| * Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653. | |||||
Hemodynamic changes, manifested as increases or decreases in blood pressure and pulse rate, were observed during clinical studies but did not appear to be dose-dependent. Four patients ( < 1%) reported clinical symptoms of hypotension such as dizziness or syncope.
edex® (alprostadil for injection) had no clinically important effect on serum or urine laboratory tests.
Post-Marketing Adverse Experiences
Needle breakage.
SRC: NLM .