edex® is an FDA-approved,
dual chamber injection therapy for ED
For men with erectile dysfunction (ED) due to neurogenic, vasculogenic, psychogenic, or
mixed etiology, consider edex® if they do not wish to take oral therapy.1,2
- FDA approved3
- Approved for over 2 decades3
Financial support for your patients. Prescription assistance is
available to your patients who qualify
Designed for rapid onset of action within 5 to 20 minutes
Effect lasts for up to 1 hour
Instruct patients to seek immediate medical assistance for any
erection that persists longer than 6 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency
Convenient, single-use, dual chamber cartridge
Available in 10-mcg, 20-mcg, and 40-mcg cartridges
No refrigeration required
- Inform patients to store at 25°C (77°F); temperature variations between
15° - 30°C (59° - 86°F) are allowed
- As with any drug product, extremes in temperature should be avoided. Inform patients, when traveling, to not store in checked luggage during air travel or leave in a closed automobile
No external mixing
Available in 2- and 6-cartridge packages
This image is of a model and is for illustrative purposes only.
edex® (alprostadil for injection) is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
IMPORTANT SAFETY INFORMATION about edex®
- edex® is contraindicated in men with conditions that might predispose them to priapism such as sickle cell anemia or sickle cell trait, multiple myeloma,
or leukemia. edex® should not be used for the treatment of ED in men with fibrotic conditions of the penis, such as cavernosal fibrosis or Peyronie’s
disease. Patients with penile implants should not be treated with edex®.
- 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 less than 1% with long-term use for up to 24 months. If priapism occurs, the patient should seek immediate medical
attention. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. To minimize the chances of prolonged
erection or priapism, edex® should be titrated slowly to the lowest effective dose determined by the physician.
- Intracavernous injections of edex® 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
- Regular follow-up of patients, with careful examination of the penis at the start of therapy and at regular intervals (eg, 3 months), is strongly
recommended to identify any penile changes. Treatment with edex® should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or
Peyronie’s disease. Treatment can be resumed if the penile abnormality subsides.
- The safety and efficacy of combinations of edex® and other vasoactive agents have not been systematically studied. Therefore, the use of such
combinations is not recommended.
- After injection of the edex® 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. Caution should be exercised with
concomitant administration of heparin and edex®.
- edex® is not a cure for erectile dysfunction. The underlying treatable medical causes should be diagnosed and treated prior to initiation of therapy. The
therapeutic effect of each dose is temporary. edex® should be used no more than 3 times per week with at least 24 hours between each dose.
- edex® 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.
- 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.
- There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile
dysfunction, including edex®, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular
status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of
appropriate treatment following a complete medical assessment.
- edex® offers no protection from sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site
can increase the risk of transmission of blood-borne diseases between partners.
- edex® is not indicated for use in women or pediatric patients.
- 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.
- The most common local adverse reactions were penile pain during and/or after injection and during erection and bleeding.
- The patient should call his doctor if he sees any redness, lumps, swelling, tenderness or curvature of the erect penis.
Please see the full Prescribing Information for edex®.
References: 1. edex® [package insert]. Lake Forest, IL: Actient Pharmaceuticals,
LLC. 2. Montorsi F, Salonia A, Deho F, et al. Pharmacological
management of erectile dysfunction. Brit J Urol Intl. 2003;91:446–454.
3. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Accessed November 2017.
This page is intended for US healthcare professionals only.