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DOSAGE AND ADMINISTRATION
The dose of CAVERJECT (alprostadil injection) should be individualized for each patient by careful titration under supervision by the physician. In clinical studies, patients were treated with CAVERJECT (alprostadil injection) in doses ranging from 0.2 to 140 micrograms; however, since 99% of patients received doses of 60 micrograms or less, doses of greater than 60 micrograms are not recommended. In general, the lowest possible effective dose should always be employed. In clinical studies, over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of CAVERJECT (alprostadil injection) . A 1/2-inch, 27- to 30- gauge needle is generally recommended.
Initial Titration in Physician's Office
Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology. Dosage titration should be initiated at 2.5 micrograms of alprostadil. If there is a partial response, the dose may be increased by 2.5 micrograms to a dose of 5 micrograms and then in increments of 5 to 10 micrograms, depending upon erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. If there is no response to the initial 2.5-microgram dose, the second dose may be increased to 7.5 micrograms, followed by increments of 5 to 10 micrograms. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.
Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury). Dosage titration should be initiated at 1.25 micrograms of alprostadil. The dose may be increased by 1.25 micrograms to a dose of 2.5 micrograms, followed by an increment of 2.5 micrograms to a dose of 5 micrograms, and then in 5-microgram increments until the dose that produces an erection suitable for intercourse and not exceeding a duration of 1 hour is reached. The patient must stay in the physician's office until complete detumescence occurs. If there is no response, then the next higher dose may be given within 1 hour. If there is a response, then there should be at least a 1-day interval before the next dose is given.
The majority of patients (56%) in one clinical study involving 579 patients were titrated to doses of greater than 5 micrograms but less than or equal to 20 micrograms. The mean dose at the end of the titration phase was 17.8 micrograms of alprostadil.
The first injections of CAVERJECT (alprostadil injection) must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The physician should make a careful assessment of the patient's skills and competence with this procedure. The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorso-lateral aspect of the proximal third of the penis. Visible veins should be avoided. The side of the penis that is injected and the site of injection must be alternated; the injection site must be cleansed with an alcohol swab.
The dose of CAVERJECT (alprostadil injection) that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse and that is maintained for no longer than 1 hour. If the duration of erection is longer than 1 hour, the dose of CAVERJECT (alprostadil injection) should be reduced. Selfinjection therapy for use at home should be initiated at the dose that was determined in the physician's office; however, dose adjustment, if required (up to 57% of patients in one clinical study), should be made only after consultation with the physician. The dose should be adjusted in accordance with the titration guidelines described above. The effectiveness of CAVERJECT (alprostadil injection) for long-term use of up to 6 months has been documented in an uncontrolled, self-injection study. The mean dose of CAVERJECT (alprostadil injection) at the end of 6 months was 20.7 micrograms in this study.
Careful and cont inuous follow-up of the patient while in the self-injection program must be exercised. This is especially true for the initial self-injections, since adjustments in the dose of CAVERJECT (alprostadil injection) may be needed. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. The reconstituted vial of CAVERJECT (alprostadil injection) is intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the syringe, needle, and vial.
While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of CAVERJECT (alprostadil injection) should be adjusted, if needed.
CAVERJECT (alprostadil injection) as an Adjunct to the Diagnosis of Erectile Dysfunction
In the simplest diagnostic test for erectile dysfunction (pharmacologic testing), patients are monitored for the occurrence of an erection after an intracavernosal injection of CAVERJECT (alprostadil injection) . Extensions of this testing are the use of CAVERJECT (alprostadil injection) as an adjunct to laboratory investigations, such as duplex or Doppler imaging, 133Xenon washout tests, radioisotope penogram, and penile arteriography, to allow visualization and assessment of penile vasculature. For any of these tests, a single dose of CAVERJECT (alprostadil injection) that induces an erection with firm rigidity should be used.
General Procedure for Solution Preparation
CAVERJECT (alprostadil injection) is packaged in a 5-milliliter glass vial. Bacteriostatic water for injection or sterile water, both preserved with benzyl alcohol 0.945% w/v, must be used as the diluent for reconstitution. After reconstitut ion with 1 milliliter of diluent, the volume of the result ing solut ion is 1.13 millili ters. One milliliter of this solut ion will contain 5.4, 10.5, 20.5 or 41.1 micrograms of alprostadil depending on vial strength, 172 milligrams of lactose, 47 micrograms of sodium citrate and 8.4 milligrams of benzyl alcohol. The deliverable amount of alprostadil is 5, 10, 20 or 40 micro- grams per milliliter because approximately 0.4 microgram for the 5 microgram strength, 0.5 microgram for the 10 and 20 microgram strengths and 1.1 microgram for the 40 microgram strength is lost due to adsorption to the vial and syringe. After reconstitution, the solution of CAVERJECT (alprostadil injection) should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit.
CAVERJECT (alprostadil injection) is a dry lyophilized powder and is supplied in vials containing 6.15, 11.9, 23.2 or 46.4 micrograms of alprostadil for intracavernosal administration. Store the 5, 10 and 20 microgram strengths at or below 25°C (77°F).
Store the 40 microgram strength at 2° to 8°C (36° to 46°F) until dispensed. After dispensing, the CAVERJECT (alprostadil injection) 40 microgram strength may be stored at or below 25°C (77°F) for 3 months or until expiration date, whichever occurs first.
When reconstituted and used as directed, the deliverable amount of alprostadil is 5, 10, 20 or 40 micrograms, respectively. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen. Only the accompanying diluent or bacteriostatic water for injection with benzyl alcohol should be used when reconstituting CAVERJECT (alprostadil injection) . CAVERJECT (alprostadil injection) is available in the following packages:
6-5 microgram vials....................................NDC 0009-5131-02
6-10 microgram vials....................................NDC 0009-3778-05
6-20 microgram vials....................................NDC 0009-3701-05
6-40 microgram vials....................................NDC 0009-7686-04
Other available packages:
6-20 microgram vials with diluent syringes.........................NDC 0009-3701-01
Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA. Revised October 2003. FDA Rev date: 9/2/2003
Last reviewed on RxList: 3/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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