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Edex

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Edex

Warnings
Precautions

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® (alprostadil for injection) 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.

PRECAUTIONS

General

  1. Intracavernous injections of edex® (alprostadil for injection) 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 Peyronie's disease, reported in clinical studies up to 24 months with edex® (alprostadil for injection) was 7.8%. Treatment with edex® (alprostadil for injection) should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease. Treatment can be resumed if the penile abnormality subsides.
  3. The safety and efficacy of combinations of edex® (alprostadil for injection) and other vasoactive agents have not been systematically studied. Therefore, the use of such combinations is not recommended.
  4. After injection of the edex® (alprostadil for injection) 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® (alprostadil for injection) .
  6. edex® (alprostadil for injection) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies have not been conducted. Alprostadil showed no evidence of mutagenicity in three in vitroassays 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 vivorat 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® (alprostadil for injection) is < 1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60 kg subject).

Pregnancy, Nursing Mothers and Pediatric Use

edex® (alprostadil for injection) 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.

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

Warnings
Precautions
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