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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. (See WARNINGS.)

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*

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*

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.

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® (alprostadil for injection) .

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

Information for Patients

To ensure safe and effective use of edex® (alprostadil for injection) , the patient should be thoroughly instructed and trained in the self-injection technique before he begins intracavernous treatment with edex® (alprostadil for injection) at home. The desirable dose should be established in the physician's office. The instructions for preparation of the edex® (alprostadil for injection) solution should be carefully followed. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. The reconstituted solution should be gently mixed, not shaken. A PATIENT INFORMATION pamphlet is included in each package of edex® (alprostadil for injection) cartridges.

edex® (alprostadil for injection) should be used immediately after reconstitution. The patient should follow the instructions in the patient information pamphlet to limit the possibility of bacterial contamination. The reconstituted cartridge is designed for one use only and should be discarded after use. The edex® (alprostadil for injection) cartridge contains a solid layer or Iyophilized cake of dry white powder approximately 3/8” in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size.

If the dosage prescribed is less than 1 mL of edex® (alprostadil for injection) solution, excess solution will be expelled through the needle as the plunger is pushed and the upper rim of the top stopper reaches the correct volume mark for the prescribed dose. The needle must be properly discarded after use; it must not be reused or shared with other persons.

The dose of edex® (alprostadil for injection) that is established in the physician's office should not be changed by the patient without consulting the physician. The patient may expect an erection to occur within 5 to 20 minutes. A standard treatment goal is to produce an erection lasting no longer than 1 hour. edex® (alprostadil for injection) should be used no more than 3 times per week, with at least 24 hours between each use.

Patients should be aware of possible side effects of therapy with edex® (alprostadil for injection) ; the most frequently occurring is penile pain during and/or after injection, usually mild to moderate in severity. A potentially serious adverse reaction with intracavernous therapy is priapism. Accordingly, the patient should be instructed to contact the physician's office immediately or, if unavailable, to seek immediate medical assistance if an erection persists for longer than 6 hours.

The patient should report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis to his physician as soon as possible. As with any injection, infection is possible. Patients should be instructed to report to the physician any penile redness, swelling, tenderness or curvature of the erect penis. The patient must visit the physician's office for regular checkups for assessment of the therapeutic benefit and safety of treatment with edex® (alprostadil for injection) .

Note: Individuals who are sexually active should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). Use of intracavernous edex® (alprostadil for injection) offers no protection from the transmission of sexually transmitted or blood-borne diseases. The injection of edex® (alprostadil for injection) can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the risk of transmission of blood-borne diseases between partners.

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.