Edex

The active ingredient in Edex is alprostadil. It relaxes smooth muscle and widens blood vessels in the penile tissue. Edex addresses erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed causes.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Edex. However, the following is a synopsis of the general guidelines for the use of Edex:

1. Ensure you get training from your doctor on the self-injection technique to safely administer this medication. The first dose will be injected at your physician’s office.

2. Always wash and dry your hands before and after injecting this medication.

3. Remove the seal from the base of the needle, ensuring not to touch the exposed needle.

4. Connect the needle to the tip of the injection device, turning clockwise until tight.

5. Twist the blue part of the plunger clockwise to unscrew it from the injection device.

6. Wipe the tip of a cartridge with an alcohol swab, then insert it into the injection device with the tip facing the attached needle.

7. Re-attach the plunger, then, while holding it upright, press down on the plunger until the 2 gray rubber stoppers touch.

8. Move the injection device back and forth until the drug is dissolved and the solution is clear.

9. Holding the device upright, carefully remove the external and internal protective caps - pull them straight off without twisting. Keep the external cap for later (don’t throw it out).

10. Tap the cartridge until air bubbles float to the top, then push the plunger until a drop of solution appears at the end of the needle.

11. Next, push the plunger until the upper rim of the stopper reaches your dose. Set the injection device on a clean, level surface while you prep the injection site.

12. For administration, wipe the injection site - left or right side of the penis, not on top or bottom with a new alcohol swab and let it air dry.

13. When injecting, be sure to avoid any visible veins and alternate sides and sites for injection. Take hold of the penis from the tip, and squeeze gently, ensuring to stretch the foreskin if present.

14. Remove the cap and insert the needle at a 90-degree angle on the side of the penis into the corpora cavernosa (bulgy part). Once inserted, push the plunger slowly to inject the medication until it stops. Hold for a few seconds, then pull the needle out and apply pressure.

15. Using an alcohol swab or gauze, compress the site of injection for 5 minutes, or until bleeding stops.

16. Carefully replace the large external cap onto the needle, then remove the needle from the injection device by turning counterclockwise. Discard the needle in a sharps container.

17. Clean the reusable injection device with warm water and soap after each use. Once dry, replace it in the carrying case.

18. Each needle is single-use only - do not reuse them. Do not use Edex more than three times per week or more than once in a 24-hour period.

19. This medication does not protect you from sexually transmitted diseases.

Some mild or common side effects of Edex include:

• Injection site reactions, such as a small amount of bleeding or bruising.
• Penile pain or discomfort after injection.
• Mild dizziness or low blood pressure.
• Flushing or sensation of warmth.

Some individuals may experience serious side effects while using Edex. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Prolonged erection lasting more than 4 hours (priapism). Go to the emergency room if this occurs.
• Symptoms of very low or high blood pressure, chest pain, or trouble breathing.
• Needle breakage during injection.
• Signs of infection at the injection site: increasing pain, redness, swelling, discharge.
• Allergic reaction: hives, swelling of lips/throat, trouble breathing.

These are not all of the possible side effects of Edex. You should always seek medical advice from your prescribing physician for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Edex, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Conditions that increase the risk of very long erection (priapism), such as Sickle cell anemia or trait, Multiple myeloma, or Leukemia.

Penile implants or penile fibrosis or curvature issues (such as Peyronie’s disease) – Edex is contraindicated in these cases.

Heart disease or uncontrolled high blood pressure (because of effects on blood vessels).

A bleeding disorder.

Men who have conditions that predispose to priapism: sickle cell anemia or trait, multiple myeloma, or leukemia.

Men with penile implants or men with fibrotic conditions of the penis (such as Peyronie’s disease or cavernous fibrosis).

Known hypersensitivity to alprostadil or any component of the injection (including the alfadex complex or lactose).

People where sexual activity is not advised.

Edex usually starts working within about 5 to 20 minutes after injection. The erection typically lasts for up to about one hour, depending on the individual and dose.

When Edex is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions.

Because it is administered locally, very small amounts of this drug are found in the blood, where they can interact with other medications. Caution is advised when it is used in combination with blood pressure-lowering medications or heparin.

Edex is supplied in single-dose, dual-chamber cartridges intended for use with the reusable Edex injection device. The available cartridge strengths are:

10 mcg cartridge (delivers ~10 mcg of alprostadil)

20 mcg cartridge (delivers ~20 mcg of alprostadil)

40 mcg cartridge (delivers ~40 mcg of alprostadil)

It should be kept at room temperature out of the reach of children and pets. Do not reuse any reconstituted solution — once the cartridge has been mixed and used (or partially used), discard it immediately.

It is manufactured by Endo USA.

No, there is no generic version of Edex, but alprostadil is available in other dosage forms.

Edex is used as needed, and if you find it is not working for you, talk to your doctor about alternative options such as Viagra (sildenafil) or Cialis (tadalafil) to treat your erectile dysfunction.

This medication should only be used in males.

This medication should only be used in males.