edex® is injected into a specific area of the penis. Please watch the Injection Procedure Instructional video below carefully before you prepare the edex® solution. edex® should always be used immediately after mixing.
If you have any questions after reading the instructions, talk to your doctor. Your physician is always your best source of information about using edex®.
edex® should be stored at approximately 77ºF (25ºC); however, the temperature can vary between 59º to 86ºF (15º to 30ºC). Avoid extremes in temperature. If you travel with edex®, do NOT store it in your checked luggage during air travel or leave it in a closed car.
edex® is a penile injection used to treat erectile dysfunction (ED) caused by conditions affecting
nerves, blood vessels, emotions, and/or a
combination of factors.
Men who have conditions that might result in long-lasting erections, such as sickle cell anemia or trait, leukemia and tumor of the bone marrow (multiple myeloma) should not use edex®. If you have any of these conditions, consult your doctor. Men with penile implants, severe penile curvature or those for whom sexual activity is not advised should not use edex®. edex® should not be used by women or children.
edex® generally should not be used in men who have been told by their healthcare provider to not have sexual activity because of heart problems.
Erections that last more than 6 hours can cause serious damage to the penile tissue and may result in permanent impotence. Call the prescribing physician right away or, if unavailable, seek professional help immediately if you still have an erection 6 hours after injection.
A common side effect of edex® is mild to moderate pain during injection. The erection may also be associated with a painful sensation. If you experience severe pain, call the prescribing physician.
Call your doctor if you notice any redness, lumps, swelling, tenderness, or curvature of the erect penis.
A small amount of bleeding at the injection site may occur. To prevent bruising, apply firm pressure at the injection site for 5 minutes; continue until bleeding stops. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.
There is a possibility of needle breakage with the use of edex®. To avoid breaking the needle, you should pay careful attention to your doctor’s instructions and try to handle the injection device properly. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your doctor. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor.
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.
There is no approved injectable treatment using multiple medications. In addition, there are no data on the efficacy and safety of these combinations.
This information should not take the place of talking with your doctor or healthcare professional. If you have any questions, talk to your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs. Contact Endo USA, Inc. at
1-800-462-3636 (ENDO), or FDA at
1-800-FDA-1088 or www.FDA.gov/medwatch.
Please see the full Prescribing Information and Patient Information for edex®.