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What Is edex^®?

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.

IMPORTANT SAFETY INFORMATION about edex^®

Who Should NOT Use edex^®?

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.

What Are the Risks of Using edex^®?

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.

Side Effects Associated with edex^®

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.

Other Important Information

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.

Using edex^®

• It is very important that you follow the directions for using edex^® carefully. If you have any questions, talk to your doctor or pharmacist. edex^® can only be obtained with a prescription from your doctor. You or your partner should be well trained on the proper injection method before using edex^® at home. Be sure to use only the dose prescribed by your doctor. edex^® should always be used immediately after mixing it. Do not reuse or share needles or cartridges. As with all prescription medicines, you should not allow anyone else to use your medicine.

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.