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^Ã? 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.

1) Intracavernous injections of edex^Ã? can lead to increased peripheral blood levels of PGE₁ and its metabolites, especially in those patients with significant corpora cavernosa venous leakage. Increased peripheral blood levels of PGE₁ and its metabolites may lead to hypotension and/or dizziness.

2) Regular follow-up of patients, with careful examination of the penis at the start of therapy and at regular intervals (e.g. 3 months), is strongly recommended to identify any penile changes. The overall incidence of penile fibrosis, including Peyronies disease, reported in clinical studies up to 24 months with edex^Ã? was 7.8%. Treatment with edex^Ã? should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronies disease. Treatment can be resumed if the penile abnormality subsides.

3) The safety and efficacy of combinations of edex^Ã? and other vasoactive agents have not been systematically studied. Therefore, the use of such combinations is not recommended.

4) After injection of the edex^Ã? solution, compression of the injection site for five minutes, or until bleeding stops, is necessary. Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for bleeding after intracavernous injection.

5) Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with edex^Ã?.

6) edex^Ã? uses a superfine (29 gauge) needle. As with all superfine needles, the possibility of needle breakage exists. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage.

7) The patient should be instructed not to reuse or to share needles or cartridges. As with all prescription medicines, the patient should not allow anyone else to use his medicine.

Information for Patients

To ensure safe and effective use of edex^Ã?, the patient should be thoroughly instructed and trained in the self-injection technique before he begins intracavernous treatment with edex^Ã? at home. The desirable dose should be established in the physicians office. The instructions for preparation of the edex^Ã? 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^Ã? cartridges.

edex^Ã? 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^Ã? 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^Ã? 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^Ã? that is established in the physicians 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^Ã? 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^Ã?; 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 physicians 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 physicians office for regular checkups for assessment of the therapeutic benefit and safety of treatment with edex^Ã?.

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^Ã? offers no protection from the transmission of sexually transmitted or blood-borne diseases. The injection of edex^Ã? 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted. Alprostadil showed no evidence of mutagenicity in three in vitro assays including the AMES bacterial reverse mutation assay, a forward gene mutation assay in Chinese hamster lung (V79) cells, and a chromosome aberration assay in human peripheral lymphocytes. Alprostadil did not produce damage to chromosomes or the mitotic apparatus in the in vivo rat micronucleus test.

Alprostadil did not cause any adverse effects on fertility or general reproductive performance when administered intraperitoneally to male or female rats at dose levels from 2 to 200 mcg/kg/day. The high dose of 200 mcg/kg/day is about 300 times the maximum recommended human dose (MRHD) on a body weight basis. The human dose of edex^Ã? is <1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60 kg subject).

Pregnancy, Nursing Mothers and Pediatric Use edex^Ã? is not indicated for use in women or pediatric patients.

Geriatric Use Of the approximately 1,065 patients who entered the in-office dose-titration period in clinical studies, 25% were 65 years or older. In clinical studies, geriatric patients required, on average, higher minimally effective doses and had a higher rate of lack of effect (optimum dose not determined). Overall differences in safety were not observed between these geriatric patients and younger patients. Geriatric patients should be dosed and titrated according to the same DOSAGE AND ADMINISTRATION recommendations as younger patients, and the lowest possible effective dose should always be used.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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