Edex

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• Professional Information

 

Edex Side Effects Center

What Is Edex?

Edex (alprostadil) is a vasodilator prescribed for the treatment of certain types of erectile dysfunction in men.

What Are Side Effects of Edex?

Side effects of Edex include:

• bleeding or bruising at the site of medication administration,
• unusual discharge from the penis,
• pain in the groin/penis/urethra/testicles/legs,
• redness of the penis,
• prolonged erection,
• headache,
• dizziness,
• back pain,
• skin problems,
• a rash on the skin of your penis,
• itching/warmth/numbness of your penis,
• vision problems,
• cough,
• stuffy nose,
• cold symptoms, or
• flu symptoms.

Dosage for Edex

When reconstituted in a single dose cartridge, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. The dosage range of Edex for the treatment of erectile dysfunction is 1 to 40 mcg and is first determined by the doctor. The intracavernous injection should be given over a 5 to 10 second interval. At home treatments require specific instructions given to the patient by the prescribing doctor.

What Drugs, Substances, or Supplements Interact with Edex?

Edex may interact with blood pressure medication, or blood thinners. Tell your doctor all medications and supplements you use.

Edex During Pregnancy and Breastfeeding

Edex is not indicated for use in women and is unlikely to be used during pregnancy or breastfeeding. Use a condom to prevent transfer of the medication in Edex to your sexual partner if she is pregnant or could become pregnant.

Additional Information

Our Edex (alprostadil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Edex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• bleeding after an injection;
• a painful erection that lasts 4 hours or longer;
• new or worsening pain in your penis; or
• redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.

Common side effects may include:

• mild pain in your penis, urethra, or testicles;
• redness of the penis; or
• warmth or burning in your urethra.

Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Edex (Alprostadil for Injection)

 

Edex Professional Information

SIDE EFFECTS

edex® (alprostadil for injection) , administered by intracavernous injection in doses ranging from 1 to 40 mcg per injection for periods up to 24 months, has been evaluated in clinical trials for safety in over 1,065 patients with erectile dysfunction. Discontinuation of therapy due to a side effect in clinical trials was required in approximately 9% of patients treated with edex® (alprostadil for injection) and in < 1% of patients treated with placebo.

Local Adverse Reactions

The following local adverse reactions were reported in studies including 1,065 patients treated with edex® (alprostadil for injection) for up to two years.

Penile Pain: With use of up to 24 months, penile pain was reported at least once by 29% of patients during injection, 35% of patients during erection, and by 30% of patients after erection. On a per injection basis, 15% of injections were associated with penile pain. Penile pain was judged by patients to be mild in intensity for 80% of painful injections, moderate in intensity for 16% of painful injections, and severe in intensity for 4% of painful injections. The frequency of penile pain reports decreased over time; forty-one percent of the patients experienced pain during the first 2 months and 3% of the patients experienced pain during months 21-24. In placebo-controlled studies, penile pain was reported by 31% of patients after edex® (alprostadil for injection) and by 9% of patients after placebo injection.

Prolonged Erection/Priapism: Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. In placebo-controlled studies, 3% of patients treated with edex® (alprostadil for injection) and < 1% of patients treated with placebo reported prolonged erections greater than four hours. 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. A higher incidence of prolonged erections was found in younger patients ( < 40 years), non-diabetic patients, and patients with psychogenic etiology of erectile dysfunction. (See WARNINGS.)

Hematoma/Ecchymosis: In patients treated with edex® (alprostadil for injection) for up to 24 months, local bleeding, hematoma and ecchymosis were observed in 15%, 5% and 4% of patients, respectively. In placebo-controlled studies, the frequency of local bleeding was 6% with injection of edex® (alprostadil for injection) and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique.

Local Adverse Reactions Reported by ≥ 1% of Patients All Study Periods*

Local Reaction	edex® (alprostadil for injection) N = 1065 n (%)	Local Reaction	edex® (alprostadil for injection) N = 1065 n (%)
Penile pain during injection	305 (29)	Ecchymosis	44 (4)
Penile pain during erection	368 (35)	Penile angulation	72 (7)
Penile pain after erection	317 (30)	Penile fibrosis	52 (5)
Penile pain (other)**	116 (11)	Cavernous body fibrosis	20 (2)
Prolonged erection		Peyronie's disease	11 (1)
> 4 ≤ 6 Hours	44 (4)	Faulty injection technique***	59 (6)
> 6 Hours	6 ( < 1)	Penis disorder	28 (3)
Bleeding	158 (15)	Erythema	17 (2)
Hematoma	56 (5)
* Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653. ** Penile pain reported without an association to injection site or erection, such as pain in penis and scrotum, pain in glans penis, and burning penile pain. *** Examples include injection into glans penis, urethra or subcutaneously.

Systemic Adverse Experiences

The following systemic adverse experiences were reported in controlled and uncontrolled studies in ≥ 1% of patients treated for up to 24 months with edex® (alprostadil for injection) .

Systemic Adverse Experiences Reported by ≥ 1% of Patients*

BODY SYSTEM Adverse Experience	edex® (alprostadil for injection) N = 1065 n (%)	BODY SYSTEM Adverse Experience	edex® (alprostadil for injection) N = 1065 n (%)	BODY SYSTEM Adverse Experience	edex® (alprostadil for injection) N = 1065 n (%)
RESPIRATORY		CARDIOVASCULAR		UROGENITAL
Upper respiratory tract		Hypertension	17 (2)	Prostate disorder	15 (1)
infection	58 (5)	Myocardial infarction	13 (1)	Testicular pain	13 (1)
Sinusitis	14 (1)	Abnormal ECG	12 (1)	Inguinal hernia	11 (1)
BODY AS A WHOLE		METABOLIC/NURITIONAL		DERMATOLOGIC
Influenza-like symptoms	35 (3)	Hypertriglyceridemia	17 (2)	Skin disorder	14 (1)
Headache	20 (2)	Hypercholesterolemia	12 (1)	SPECIAL SENSES
Infection	18 (2)	Hyperglycemia	12 (1)	Abnormal vision	11 (1)
Pain	16 (2)
MUSCULOSKELETAL
Back pain	23 (2)
Leg pain	13 (1)
* Protocol Numbers KU-620-001, KU-620-002, KU-620-003, F-8653.

Hemodynamic changes, manifested as increases or decreases in blood pressure and pulse rate, were observed during clinical studies but did not appear to be dose-dependent. Four patients ( < 1%) reported clinical symptoms of hypotension such as dizziness or syncope.

edex® (alprostadil for injection) had no clinically important effect on serum or urine laboratory tests.

Post-Marketing Adverse Experiences

Needle breakage.

Read the entire FDA prescribing information for Edex (Alprostadil for Injection)

&Copy; Edex Patient Information is supplied by Cerner Multum, Inc. and Edex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.