Second-line therapy for treatment of ED in patients not responding to psychotherapy/behavioral therapy, vacuum constriction devices, and/or oral, selective phosphodiesterase (PDE) type 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) and in whom attempts at identifying and modifying any drug-related (e.g., certain antihypertensive agents) or other potentially reversible medical causes of ED have proved inadequate.
Selective oral PDE type 5 inhibitor therapy preferred as first-line treatment of ED unless contraindicated.
Intraurethral therapy generally preferred over intracavernosal vasoactive therapy because it is less invasive; however intracavernosal therapy is most effective nonsurgical treatment for ED.
Consider intraurethral therapy for patients with inadequate responses to or who are not candidates for selective oral PDE type 5 inhibitor therapy.
Effective in patients with organic (neurogenic and/or mild to moderate vasculogenic) ED or with psychogenic ED.
Not recommended for simply enhancing erections in men who are not impotent† because of GU risks. (See Priapism and also GU Effects, under Cautions.)
Manufacturers state that safety and efficacy of alprostadil in combination with other vasoactive therapy for erectile dysfunction not established and currently not recommended. However, American Urological Association (AUA) and other clinicians state that combination therapy with other intracavernosal vasoactive agents increased efficacy and decreased adverse effects relative to alprostadil alone. Combined therapy with intraurethral alprostadil and vacuum constriction device or oral selective PDE type 5 inhibitor increased efficacy relative to alprostadil alone.
Adjunct to other vascular testing (e.g., duplex ultrasonography, cavernosometry/cavernosography, angiography, radioisotope penogram) in differential diagnosis of ED and evaluation of hemodynamic status of erectile tissue.
Used to provide adequate circulation and oxygenation and prevent or correct resultant acidemia until corrective or palliative surgery can be performed.
Do not use in neonates with respiratory distress syndrome. (See Respiratory Distress Syndrome under Cautions.)
Dosage and Administration
General
ED
Initiate and titrate dosage in medical setting (e.g., clinician’s office); patient must remain in this setting until complete detumescence occurs.
Carefully individualize dosage according to patient’s erectile response toward therapeutic goal of achieving erection satisfactory for intercourse, but persists for ≤1 hour. (See Priapism under Cautions.)
Titrate dosage slowly to lowest possible effective level to avoid priapism. Erections persisting >1 hour increase risk of priapism. (See Priapism under Cautions.)
Initiate maintenance home treatment regimens at dosage determined as optimal during titration in medical setting. Further dosage adjustments may be required. Dosage determined by clinician in medical setting should not be changed without consulting clinician.
Use only by trained personnel in facilities providing pediatric intensive care. Monitor respiratory status of neonate throughout administration; facilities and equipment for assisted ventilation should be readily available. (See Boxed Warning.)
Adjust dosage using lowest possible effective dosage for shortest period necessary to provide desired effects.
If long-term infusion considered (e.g., when surgery deferred in poor-risk neonate), carefully weigh risks of prolonged therapy against anticipated benefits. (See GI Effects, Musculoskeletal Effects, and also Cardiovascular and Cerebrovascular Effects, under Cautions.)
In neonates with restricted pulmonary blood flow, monitor measures of improved blood oxygenation.
In neonates with restricted systemic blood flow, monitor measures of improved systemic BP and blood pH.
Periodically monitor arterial BP via umbilical artery catheter, auscultation, or Doppler transducer. (See Cardiovascular and Cerebrovascular Effects under Cautions.)
Administration
Administer by continuous IV or intra-arterial infusion to maintain patency of ductus arteriosus in neonates with congenital heart disease.
Administer by intracavernosal injection for treatment and diagnosis of ED or by intraurethral suppository for treatment of ED.
IV and Intra-arterial Infusion
For solution and compatibility information, see Compatibility under Stability.
To maintain patency of ductus arteriosus, administer by continuous IV infusion into a large vein (peripheral or central); preferred route of administration.
Alternatively, administer by controlled intra-arterial infusion through an umbilical artery catheter placed at ductal opening or main pulmonary artery.
If flushing occurs during intra-arterial infusion, reposition catheter or convert to IV infusion.
A controlled-infusion device (e.g., an electronic volumetric controller, volumetric IV infusion pump) or other apparatus to ensure precise control of the flow rate should be used; inadvertent rapid administration could result in toxicity (e.g., apnea). (See Boxed Warning.)
Dilution
Alprostadil for injection concentrate must be diluted prior to IV or intra-arterial infusion.
Add 1 mL of alprostadil concentrate to 0.9% sodium chloride or 5% dextrose injection to provide solution containing 2–20 mcg/mL of drug, depending on controlled-infusion device employed and needs of neonate.
When using a device with a volumetric infusion chamber, add appropriate volume of diluent to chamber first and then add 1 mL of drug concentrate to diluent.
Dilution of Alprostadil Concentrate for Injection
Add 1 vial (volume of 500 mcg/mL concentrate)
to Compatible IV Solution (volume of solution)
to Make (final dilution concentration)
1 mL
250 mL
2 mcg/mL
1 mL
100 mL
5 mcg/mL
1 mL
50 mL
10 mcg/mL
1 mL
25 mL
20 mcg/mL
Rate of Administration
Sample infusion rates to deliver a dosage of 0.1 mcg/kg of body weight per minute can be obtained from the following table:
Infusion Rates to Provide Dosage of 0.1 mcg/kg per Minute
Final Dilution Concentration
Infusion rate
2 mcg/mL
0.05 mL/minute per kg of body weight
5 mcg/mL
0.02 mL/minute per kg of body weight
10 mcg/mL
0.01 mL/minute per kg of body weight
20 mcg/mL
0.005 mL/minute per kg of body weight
Decrease rate of infusion immediately if clinically important decrease in arterial BP, fever, or hypotension occurs. (See Cardiovascular and Cerebrovascular Effects under Cautions.) Once symptoms subside, increase rate cautiously, if necessary.
Intracavernosal Administration
Administer by intracavernosal injection into the penis.
Vary injection site to minimize adverse effects related to repeated local injection.
Prior to administration using Caverject® impulse® dual-chambered syringe system, set dose to be delivered by slowly turning the end of the plunger rod clockwise until the number visible in the dose window matches the appropriate dose of the drug (in mcg).
Reconstituted solutions of alprostadil for intracavernosal injection are intended for single-use only. Properly dispose of single-use delivery device and any remaining solution following use.
Reconstitution
Caverject®: Reconstitute vial labeled as containing 20 or 40 mcg of alprostadil powder with 1 mL of bacteriostatic or sterile water for injection (with benzyl alcohol) supplied by manufacturer, to provide a solution containing 20.5 or 41.1 mcg/mL, respectively, and delivering 20 or 40 mcg/mL. (See Pediatric Use under Cautions.) Use a 3 mL syringe with a 27- to 30-gauge, 0.5-inch needle. Swirl contents of vial gently until clear solution obtained. Withdraw desired dose of reconstituted solution into same syringe prior to administration.
Caverject® impulse® dual-chambered syringe system: Reconstitute by turning plunger rod clockwise until rod meets resistance to force diluent (sterile bacteriostatic water for injection) into chamber containing sterile powder. Mix contents of syringe thoroughly by turning device upside down several times until solution is clear.
edex® dual-chambered system: Place cartridge containing alprostadil lyophilized powder into edex® injection device and push plunger of device until 2 gray rubber stoppers touch to force diluent (1.075 mL of 0.9% sodium chloride injection) into upper chamber containing drug powder. Gently move injection device back and forth until solution is clear. Do not use if cartridge is damaged or cake of drug powder is substantially <(3/8) inch in thickness.
Intracavernosal Injection Technique
Hold head (glans) of penis (if uncircumcised, pull back foreskin initially) between thumb and forefinger, and stretch lengthwise along thigh while sitting upright or slightly reclined. Inject into a corpus cavernosum of the penis (underneath the tunica albuginea along dorsolateral aspect of proximal third of penis) using a steady motion. Avoid blood vessels, corpus spongiosum, subcutaneous tissue, urethra, and dorsal neural vascular structures as injection sites.
Inject dose slowly (over 5–10 seconds); apply pressure to injection site with alcohol swab for 5 minutes (or until bleeding stops) after needle is withdrawn. If bleeding continues or recurs, abstain from intercourse. (See Hematologic Effects under Cautions.)
If solution does not inject easily or if a burning pain at injection site occurs, reposition needle by moving needle slightly or partially withdrawing needle until solution can be injected easily and painlessly.
If needle bends severely at anytime during reconstitution or injection, discard needle, and replace with new unused needle.
Rate of Administration
Inject slowly (over 5–10 seconds).
Intraurethral Administration
Administer intraurethrally as a suppository.
Urinate immediately prior to administration and gently shake penis to remove excess urine. Microsuppository (medicated pellet) is designed to dissolve in small quantity of urine remaining in urethra after urination.
Insert intraurethral suppository according to manufacturer's instructions. After insertion, inspect applicator to confirm that urethral suppository is no longer in applicator tip. If some residual medication is left in applicator, repeat insertion procedure. Urination or dribbling immediately following intraurethral administration may result in loss of drug from urethral area.
After insertion of suppository, hold penis upright, and stretch to its full length. Roll penis firmly between hands for ≥10 seconds to ensure that drug distributes adequately along walls of urethra. If a burning sensation occurs, roll penis for additional 30–60 seconds or until burning subsides.
After administration, increase blood flow to penis by sitting, standing, or walking for 10 minutes. Lying down (especially on back) immediately after administration may reduce penile blood flow and subsequent development of erection. During sexual activity, use positions that favor blood flow into penis.
Neonates: Initially, 0.1 mcg/kg per minute. However, adequate clinical response reported with 0.05 mcg/kg per minute in some neonates.
If response inadequate, may increase dosage gradually to ≤0.4 mcg/kg per minute. However, dosages >0.1 mcg/kg per minute generally have not produced additional benefit.
After therapeutic response achieved, reduce infusion rate to provide the lowest possible dosage that maintains response; progressively taper dosage from 0.1 down to 0.05 to 0.025 to 0.01 mcg/kg per minute until lowest effective dose reached.
Continue therapy until surgical repair is complete, usually ≤24–48 hours after initiation.
If complications occur, consider lower infusion rate or discontinuance of infusion. (See IV and Intra-arterial Infusion: Rate of Administration under Dosage and Administration.)
If apnea or bradycardia occurs, discontinue infusion and initiate appropriate treatment. In some cases, reinitiate infusion cautiously if continued therapy considered necessary.
Adults
ED
Initiation and Titration for ED of Neurogenic, Vasculogenic, Psychogenic, or Mixed Etiology
Intraurethral Suppository
Initially, 125 or 250 mcg. If no response, increase subsequent doses in a stepwise manner to 500 mcg or 1 mg, as needed, on separate occasions. Use ≤2 urethral suppositories within 24 hours.
Initiation and Titration for ED of Pure Neurogenic Etiology
Intracavernosal Injection
Caverject® vials and single-use, dual-chambered injection device: Initially, 1.25 mcg. If no response, double second dose to 2.5 mcg after ≤1 hour. Do not administer >2 doses within 24 hours. If additional dosage titration required, administer 5 mcg during next 24 hours. Increase subsequent dosage in 5-mcg increments, with each incremental increase separated by ≥24 hours, until optimum response achieved. (See General: ED, under Dosage and Administration.)
edex® reusable dual-chambered injection device: Initially, 1.25 mcg. If no response, double second dose to 2.5 mcg after ≤1 hour; if still no response, increase to 5 mcg after ≤1 hour. Increase subsequent dosage in 5-mcg increments, until optimum response achieved. (See General: ED, under Dosage and Administration.) If a partial response observed at any point in dosage titration, wait ≥1 day before resuming dose titration.
Initiation and Titration for ED of Vasculogenic, Psychogenic, or Mixed Etiology
Intracavernosal Injection
Caverject® vials and single-use, dual-chambered injection devices: Initially, 2.5 mcg. If partial response observed, double dose to 5 mcg after ≤1 hour. If no response, increase second dose to 7.5 mcg after ≤1 hour. Administer ≤2 doses within ≤24 hours. If additional titration required, increase dosage in increments of 5–10 mcg at intervals of ≥24 hours until optimum response achieved. (See General: ED, under Dosage and Administration.)
edex® reusable dual-chambered injection device: Initially, 2.5 mcg. If no response, increase second dose to 7.5 mcg after ≤1 hour, followed by increments of 5–10 mcg at intervals of ≤1 hour until a response occurs. If partial response observed with 2.5 mcg, wait ≥24 hours before doubling dose to 5 mcg, followed by increments of 5–10 mcg at intervals of ≥24 hours until optimum response achieved. (See General: ED, under Dosage and Administration.)
Maintenance (Self-administration)
Intraurethral Suppository
Initially, self-administer dose determined as optimal during titration in a medical setting (e.g., physician’s office); administer ≤2 urethral suppositories within a 24-hour period.
Intracavernosal Injection
Initially, self-administer dose determined as optimal during titration in a medical setting (e.g., physician’s office); administer no more frequently than 3 times weekly with >1 day elapsing between each dose.
If required, adjust dosage only after consultation with a clinician (not independently by the patient), following the same initial titration guidelines.
Diagnostic Use
Intracavernosal Injection
Adjunct to other vascular testing: Use single dose that produces firm erection.
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