edex^Ã?, 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^Ã? and in <1% of patients treated with placebo.

The following local adverse reactions were reported in studies including 1,065 patients treated with edex^Ã? 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^Ã? 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^Ã? 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. (See WARNINGS.)

Hematoma/Ecchymosis: In patients treated with edex^Ã? 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^Ã? and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique.

* 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.

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^Ã?.

* 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^Ã? had no clinically important effect on serum or urine laboratory tests.

Post-Marketing Adverse Experiences

Needle breakage.

The pharmacodynamic interaction between heparin (5,000 IU) and alprostadil intravenous infusion (90 mcg over 3 hours) was investigated. The results indicate significant changes in partial thromboplastin time (140% increase) and thrombin time (120% increase). Therefore, caution should be exercised with concomitant administration of heparin and edex^Ã?.

(Also, see drug-drug interaction studies in CLINICAL PHARMACOLOGY, Pharmacokinetics subsection.)

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