Drug: Edex

edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex (α-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E1 (PGE1 ). edex® (alprostadil for injection) is supplied in single-dose, dual-chamber cartridges. edex® (alprostadil for injection) is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex (alprostadil for injection) ® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® (alprostadil for injection) cartridges are supplied in three strengths: 10 mcg cartridge (10.75 mcg alprostadil, 347.55 mcg α-cyclodextrin, 51.06 mg lactose); 20 mcg cartridge (21.5 mcg alprostadil, 695.2 mcg α-cyclodextrin, 51.06 mg lactose); 40 mcg cartridge (43.0 mcg alprostadil, 1,390.3 mcg α-cyclodextrin, 51.06 mg lactose). The edex® (alprostadil for injection) injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® (alprostadil for injection) injection device is used to administer the intracavernous injection of alprostadil. The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C20 H34 O5 and the molecular weight is 354.49. The chemical structure is: The α-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of α-cyclodextrin is C36 H60 O30 and the molecular weight is 972.85. The chemical structure is: Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the α-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5 or 43.0 mcg of alprostadil is placed into the edex® (alprostadil for injection) injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.

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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 Edex (alprostadil for injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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edex® (alprostadil for injection) in the Treatment of Erectile Dysfunction The dosage range of edex® (alprostadil for injection) for the treatment of erectile dysfunction is 1 to 40 mcg. The intracavernous injection should be given over a 5 to 10 second interval. In a study with a dose range of 1 to 20 mcg of edex® (alprostadil for injection) , the mean dose was 10.7 mcg at the end of the dose titration period. In two studies with a dose range of 1 to 40 mcg of edex® (alprostadil for injection) , the mean dose was 21.9 mcg at the end of the dose titration period. Doses greater than 40 mcg have not been studied. A ½ inch, 27 to 30 gauge needle is generally recommended for the intracavernous injection. The patient is advised not to exceed the optimum edex® (alprostadil for injection) dose which was determined in the doctor's office. The lowest possible effective dose should always be used. 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. It 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. At-Home (Maintenance Therapy) Dosing Instructions The first injections of edex® (alprostadil for 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 instruct the patient to discard any needles which become bent during the self-injection procedure as these needles may break. The physician should make a careful assessment of the patient's skills and competence with the self-injection procedure. The intracavernous injection must be done under sterile conditions. The site of injection is usually along the 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 before injection. The dose of edex® (alprostadil for 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 edex® (alprostadil for injection) should be reduced. The lowest effective dose should be used at home. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. Dose adjustment may be required and should be made only after consultation with the physician. Careful and continuous 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 edex® (alprostadil for 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 edex® (alprostadil for injection) cartridge and needle are intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the needles and cartridges. 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 edex® (alprostadil for injection) should be adjusted, if needed. The patient is instructed to follow the enclosed PATIENT INFORMATION pamphlet. Preparation of Solution The edex® (alprostadil for injection) injection device is used to reconstitute the single-dose, dual-chamber cartridge. The plunger is used to force the sterile 0.9% sodium chloride (1.075 mL) in one chamber into the chamber containing alprostadil. After reconstitution, the edex® (alprostadil for injection) injection device is used to administer the intracavernous injection of alprostadil. The reusable edex® (alprostadil for injection) injection device is for use only with the cartridges and needles included in the edex® (alprostadil for injection) Cartridge Packs. Prepare the edex® (alprostadil for injection) solution immediately before use. Do not administer unless solution is clear. Do not add any drugs or solutions to the edex® (alprostadil for injection) solution. Discard any unused solution remaining in the cartridge. The reconstituted solution should not be stored. The edex® (alprostadil for injection) cartridge contains a solid layer or lyophilized cake of dry white powder approximately 3/8” in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. CAUTION: Do not reuse any solution remaining in the cartridge due to the possibility of bacterial contamination. Administration edex® (alprostadil for injection) is given as an intracavernous injection over a 5 to 10 second interval. See PATIENT INFORMATION for edex® (alprostadil for injection) . Stability The single-dose, dual-chamber cartridge should be reconstituted only when it is certain that the patient is ready to administer the drug. The reconstituted drug solution should be used immediately after reconstitution. Any solution remaining in the cartridge should be discarded.

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The pharmacodynamic interaction between heparin (5,000 IU) and alprostadil intravenous infusion (90 mcg over 3 hours) was investigated. The results indicate significant changes in partial thromboplastin time (140% increase) and thrombin time (120% increase). Therefore, caution should be exercised with concomitant administration of heparin and edex® (alprostadil for injection) . (Also, see drug-drug interaction studies in CLINICAL PHARMACOLOGY, Pharmacokinetics subsection.) Information for Patients To ensure safe and effective use of edex® (alprostadil for injection) , the patient should be thoroughly instructed and trained in the self-injection technique before he begins intracavernous treatment with edex® (alprostadil for injection) at home. The desirable dose should be established in the physician's office. The instructions for preparation of the edex® (alprostadil for injection) solution should be carefully followed. The reconstituted solution may initially appear cloudy due to small air bubbles. Do not use the solution if it remains cloudy, contains precipitates, or is discolored. The reconstituted solution should be gently mixed, not shaken. A PATIENT INFORMATION pamphlet is included in each package of edex® (alprostadil for injection) cartridges. edex® (alprostadil for injection) should be used immediately after reconstitution. The patient should follow the instructions in the patient information pamphlet to limit the possibility of bacterial contamination. The reconstituted cartridge is designed for one use only and should be discarded after use. The edex® (alprostadil for injection) cartridge contains a solid layer or Iyophilized cake of dry white powder approximately 3/8” in thickness. A normal cake may appear cracked or crumbled. If the cartridge is damaged, the cake may shrink in size. Do not use the cartridge if it appears damaged or the cake is substantially reduced in size. If the dosage prescribed is less than 1 mL of edex® (alprostadil for injection) solution, excess solution will be expelled through the needle as the plunger is pushed and the upper rim of the top stopper reaches the correct volume mark for the prescribed dose. The needle must be properly discarded after use; it must not be reused or shared with other persons. The dose of edex® (alprostadil for injection) that is established in the physician's office should not be changed by the patient without consulting the physician. The patient may expect an erection to occur within 5 to 20 minutes. A standard treatment goal is to produce an erection lasting no longer than 1 hour. edex® (alprostadil for injection) should be used no more than 3 times per week, with at least 24 hours between each use. Patients should be aware of possible side effects of therapy with edex® (alprostadil for injection) ; the most frequently occurring is penile pain during and/or after injection, usually mild to moderate in severity. A potentially serious adverse reaction with intracavernous therapy is priapism. Accordingly, the patient should be instructed to contact the physician's office immediately or, if unavailable, to seek immediate medical assistance if an erection persists for longer than 6 hours. The patient should report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis to his physician as soon as possible. As with any injection, infection is possible. Patients should be instructed to report to the physician any penile redness, swelling, tenderness or curvature of the erect penis. The patient must visit the physician's office for regular checkups for assessment of the therapeutic benefit and safety of treatment with edex® (alprostadil for injection) . Note: Individuals who are sexually active should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). Use of intracavernous edex® (alprostadil for injection) offers no protection from the transmission of sexually transmitted or blood-borne diseases. The injection of edex® (alprostadil for injection) can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the risk of transmission of blood-borne diseases between partners. Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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edex® (alprostadil for injection) is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

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edex® (alprostadil for injection) should not be used in patients who have a known hypersensitivity to alprostadil or other prostaglandins, in patients who have conditions that might predispose them to priapism, such as sickle cell anemia or trait, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. Patients with penile implants should not be treated with edex® (alprostadil for injection) . edex® (alprostadil for injection) should not be used in men for whom sexual activity is inadvisable or contraindicated. edex® (alprostadil for injection) should not be used in women and children and is not for use in newborns. Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

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Limited data are available in regard to edex® (alprostadil for injection) overdose in humans. Systemic reactions are uncommon with intracavernous injection of edex® (alprostadil for injection) . Hypotension occurred in less than 1% of patients treated with edex® (alprostadil for injection) . A single dose rising tolerance study in healthy volunteers indicated that single intravenous doses of alprostadil from 1 to 120 mcg were well tolerated. Beginning with a 40 mcg bolus intravenous dose, the frequency of drug-related systemic adverse events increased in a dose-dependent manner, characterized mainly by facial flushing. The primary symptom of an edex® (alprostadil for injection) overdose is a prolonged erection or priapism. Because of the potential for tissue hypoxia and possible necrosis, it is strongly recommended to treat an erection lasting more than 6 hours. The patient is strongly encouraged to go to the nearest emergency room if his personal physician is not available. In the event of an overdose, supportive therapy according to the presence of other symptoms is recommended.

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edex® (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex® (alprostadil for injection) injection device. One chamber of the cartridge contains 10.75, 21.5 or 43.0 mcg of alprostadil as a white, sterile, lyophilized powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. When the cartridge is placed into the edex® (alprostadil for injection) injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. edex® (alprostadil for injection) Cartridge 2 Pack contains one reusable edex® (alprostadil for injection) injection device, two single-dose, dual-chamber cartridges, two ½ inch, 29 gauge (0.33 mm x 12.7 mm) needles, and four alcohol swabs. edex® (alprostadil for injection) Cartridge 6 Pack contains one reusable edex® (alprostadil for injection) injection device, six single-dose, dual-chamber cartridges, six ½ inch, 29 gauge (0.33 mm x 12.7 mm) needles, and twelve alcohol swabs. The edex® (alprostadil for injection) cartridges are supplied in the following packages: edex® (alprostadil for injection) Cartridge 2 Pack (includes one injection device, two cartridges, two needles and four alcohol swabs) 10 mcg 1 x 2 Pack NDC 0091-1110-16 20 mcg 1 x 2 Pack NDC 0091-1120-16 40 mcg 1 x 2 Pack NDC 0091-1140-16 edex® (alprostadil for injection) Cartridge 6 Pack (includes one injection device, six cartridges, six needles and twelve alcohol swabs) 10 mcg 1 x 6 Pack NDC 0091-1110-20 20 mcg 1 x 6 Pack NDC 0091-1120-20 40 mcg 1 x 6 Pack NDC 0091-1140-20 Store at 25°C (77°F); excursions permitted between 15° - 30°C (59° - 86°F). Manufactured for: SCHWARZ PHARMA, Milwaukee, WI 53201, USA. By Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg, Germany. Rev. 01/06. FDA rev date: 6/9/2006 Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General
  1. Intracavernous injections of edex® (alprostadil for injection) can lead to increased peripheral blood levels of PGE1 and its metabolites, especially in those patients with significant corpora cavernosa venous leakage. Increased peripheral blood levels of PGE1 and its metabolites may lead to hypotension and/or dizziness.
  2. Regular follow-up of patients, with careful examination of the penis at the start of therapy and at regular intervals (e.g. 3 months), is strongly recommended to identify any penile changes. The overall incidence of penile fibrosis, including Peyronie's disease, reported in clinical studies up to 24 months with edex® (alprostadil for injection) was 7.8%. Treatment with edex® (alprostadil for injection) should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease. Treatment can be resumed if the penile abnormality subsides.
  3. The safety and efficacy of combinations of edex® (alprostadil for injection) and other vasoactive agents have not been systematically studied. Therefore, the use of such combinations is not recommended.
  4. After injection of the edex® (alprostadil for injection) solution, compression of the injection site for five minutes, or until bleeding stops, is necessary. Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for bleeding after intracavernous injection.
  5. Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with edex® (alprostadil for injection) .
  6. edex® (alprostadil for injection) uses a superfine (29 gauge) needle. As with all superfine needles, the possibility of needle breakage exists. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage.
  7. The patient should be instructed not to reuse or to share needles or cartridges. As with all prescription medicines, the patient should not allow anyone else to use his medicine.
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted. Alprostadil showed no evidence of mutagenicity in three in vitroassays including the AMES bacterial reverse mutation assay, a forward gene mutation assay in Chinese hamster lung (V79) cells, and a chromosome aberration assay in human peripheral lymphocytes. Alprostadil did not produce damage to chromosomes or the mitotic apparatus in the in vivorat micronucleus test. Alprostadil did not cause any adverse effects on fertility or general reproductive performance when administered intraperitoneally to male or female rats at dose levels from 2 to 200 mcg/kg/day. The high dose of 200 mcg/kg/day is about 300 times the maximum recommended human dose (MRHD) on a body weight basis. The human dose of edex® (alprostadil for injection) is < 1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60 kg subject). Pregnancy, Nursing Mothers and Pediatric Use edex® (alprostadil for injection) is not indicated for use in women or pediatric patients. Geriatric Use Of the approximately 1,065 patients who entered the in-office dose-titration period in clinical studies, 25% were 65 years or older. In clinical studies, geriatric patients required, on average, higher minimally effective doses and had a higher rate of lack of effect (optimum dose not determined). Overall differences in safety were not observed between these geriatric patients and younger patients. Geriatric patients should be dosed and titrated according to the same DOSAGE AND ADMINISTRATION recommendations as younger patients, and the lowest possible effective dose should always be used. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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