INDICATIONS AND USAGE edex ® is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

WARNINGS Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months.

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.

Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism.

To minimize the chances of prolonged erection or priapism, edex ® should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION ).

The patient must be instructed to immediately report to his prescribing physician or, if unavailable, to seek immediate medical assistance for any erection that persists longer than six hours.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

ADVERSE REACTIONS edex ® , 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 ® 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 ® 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; 41% of the patients experienced pain during the first 2 months and 3% of the patients experienced pain during months 21 to 24.

In placebo-controlled studies, penile pain was reported by 31% of patients after edex ® 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 ® 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 ® 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 ® 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 1 Local Reaction edex® Local Reaction edex® N = 1065 N = 1065 n (%) 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) 2 116 (11) Cavernous body fibrosis 20 (2) Prolonged erection Peyronie's disease 11 (1) > 4 ≤ 6 Hours 44 (4) Faulty injection technique 3 59 (6) > 6 Hours 6 (<1) Penis disorder 28 (3) Bleeding 158 (15) Erythema 17 (2) Hematoma 56 (5) 1 Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653.

2 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.

3 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 ® .

Systemic Adverse Experiences Reported by ≥1% of Patients 1 BODY SYSTEM edex ® BODY SYSTEM edex ® BODY SYSTEM edex ® Adverse Experience N = 1065 Adverse Experience N = 1065 Adverse Experience N = 1065 n (%) n (%) 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 Influenza-like symptoms 35 (3) METABOLIC/NUTRITIONAL DERMATOLOGIC Headache 20 (2) Hypertriglyceridemia 17 (2) Skin disorder 14 (1) Infection 18 (2) Hypercholesterolemia 12 (1) SPECIAL SENSES Pain 16 (2) Hyperglycemia 12 (1) Abnormal vision 11 (1) MUSCULOSKELETAL Back pain 23 (2) Leg pain 13 (1) 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 ® had no clinically important effect on serum or urine laboratory tests.

Post-Marketing Adverse Experiences Needle breakage.