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Edex
Overview
What is 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 E (PGE). edex is supplied in single-dose, dual-chamber cartridges.
edex is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex 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 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 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 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 CHO 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 CHO 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 injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.
What does Edex look like?
What are the available doses of Edex?
Sorry No records found.
What should I talk to my health care provider before I take Edex?
Sorry No records found
How should I use Edex?
edex is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
The dosage range of edex 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, 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, 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 dose which was determined in the doctor's office. The lowest possible effective dose should always be used.
What interacts with Edex?
- edexshould not be used:
- in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia
- for the treatment of ED in men with fibrotic conditions of the penis, such as cavernosal fibrosis or Peyronie’s disease
- in men with penile implants
What are the warnings of Edex?
Theoretically, with overdosage, a curare-like action may occur, i.e., neuro-muscular blockade leading to muscular weakness and possible paralysis.
What are the precautions of Edex?
General
1) Intracavernous injections of edex can lead to increased peripheral blood levels of PGE and its metabolites, especially in those patients with significant corpora cavernosa venous leakage. Increased peripheral blood levels of PGE 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 was 7.8%. Treatment with edex 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 and other vasoactive agents have not been systematically studied. Therefore, the use of such combinations is not recommended.
4) After injection of the edex 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.
6) edex 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)
8)
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including edex, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
Drug Interactions
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.
(Also, seestudies in.)
Information for Patients
To ensure safe and effective use of edex, the patient should be thoroughly instructed and trained in the self-injection technique before he begins intracavernous treatment with edex at home. The desirable dose should be established in the physician's office. The instructions for preparation of the edex 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 cartridges.
edex 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.
If the dosage prescribed is less than 1 mL of edex 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 dose of edex 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 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; 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.
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 offers no protection from the transmission of sexually transmitted or blood-borne diseases. The injection of edex 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term carcinogenicity studies have not been conducted. Alprostadil showed no evidence of mutagenicity in three in vitro assays 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 vivo rat 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 is <1 mcg/kg (MRHD is 40 mcg and the calculation assumes a 60 kg subject).
Pregnancy, Nursing Mothers and Pediatric Use
edex 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.
What are the side effects of Edex?
edex, 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 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 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 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 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.)
Hematoma/Ecchymosis
In patients treated with edex 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 and 3% with injection of placebo. In most cases, these reactions were attributed to faulty injection technique.
| Local Reaction | edex | Local Reaction | edex |
| N = 1065n (%) | N = 1065n (%) | ||
| 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) |
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.
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 had no clinically important effect on serum or urine laboratory tests.
| BODY SYSTEM Adverse Experience | edex N = 1065n (%) | BODY SYSTEM Adverse Experience | edex N = 1065n (%) | BODY SYSTEM Adverse Experience | edex N = 1065n (%) |
| 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 | |||||
| Influenza-like symptoms | 35 (3) | METABOLIC/NURITIONAL | DERMATOLOGIC | ||
| Headache | 20 (2) | Hypertriglyceridemia | 17 (2) | Skin disorder | 14 (1) |
| Infection | 18 (2) | Hypercholesterolemia | 12 (1) | SPECIAL SENSES | |
| Pain | 16 (2) | Hyperglycemia | 12 (1) | Abnormal vision | 11 (1) |
| MUSCULOSKELETAL | |||||
| Back pain | 23 (2) | ||||
| Leg pain | 13 (1) |
Post-Marketing Adverse Experiences
Needle breakage.
What should I look out for while using Edex?
edexshould not be used:
Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. 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. Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism. To minimize the chances of prolonged erection or priapism, edex should be titrated slowly to the lowest effective dose (see). The patient must be instructed to immediately report to his prescribing physician or, if unavailable, to seek immediate medical assistance for any erection that persists longer than six hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
What might happen if I take too much Edex?
Limited data are available in regard to edex overdose in humans. Systemic reactions are uncommon with intracavernous injection of edex. Hypotension occurred in less than 1% of patients treated with edex. A single dose rising tolerance study in healthy volunteers indicated that singledoses of alprostadil from 1 to 120 mcg were well tolerated. Beginning with a 40 mcg bolusdose, 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 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.
In the event of an overdose, supportive therapy according to the presence of other symptoms is recommended.
How should I store and handle Edex?
Store at controlled room temperature 68° - 77°F (20° - 25°C) with excursions permitted between 59° - 86°F (15° - 30°C). [See USP Controlled Room Temperature.] Do not freeze or refrigerate.edex (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex 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 injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. edex Cartridge 2 Pack contains one reusable edex injection device, two single-dose, dual-chamber cartridges, two ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and four alcohol swabs. edex Cartridge 6 Pack contains one reusable edex injection device, six single-dose, dual-chamber cartridges, six ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and twelve alcohol swabs.The edex cartridges are supplied in the following packages:edex (alprostadil for injection) is available in single-dose, dual-chamber cartridges intended for use with the reusable edex 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 injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively. edex Cartridge 2 Pack contains one reusable edex injection device, two single-dose, dual-chamber cartridges, two ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and four alcohol swabs. edex Cartridge 6 Pack contains one reusable edex injection device, six single-dose, dual-chamber cartridges, six ½ inch, 29 gauge (0.33 mm × 12.7 mm) needles, and twelve alcohol swabs.The edex cartridges are supplied in the following packages:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Alprostadil is a smooth muscle relaxant. Precontracted isolated preparations of the human corpus cavernosum, corpus spongiosum and cavernous artery are relaxed by alprostadil. Alprostadil has been shown to bind to specific receptors in human penile tissue. Two types of receptors that differ in their PGE binding affinity have been identified. The binding of alprostadil to its receptors is accompanied by an increase in intracellular cAMP levels. Human cavernous smooth muscle cells respond to alprostadil by releasing intracellular calcium into the surrounding medium. Smooth muscle relaxation is associated with a reduction of the cytoplasmic free calcium concentration. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum which is essential for the maintenance of a flaccid and non-erect penis.
Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernous arteries. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.
Non-Clinical Toxicology
edexshould not be used:Prolonged erections greater than four hours in duration occurred in 4% of all patients treated up to 24 months. 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. Pharmacologic intervention and/or aspiration of blood from the corpora was necessary in 1.6% of 311 patients with prolonged erections/priapism. To minimize the chances of prolonged erection or priapism, edex should be titrated slowly to the lowest effective dose (see). The patient must be instructed to immediately report to his prescribing physician or, if unavailable, to seek immediate medical assistance for any erection that persists longer than six hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
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.
(Also, seestudies in.)
1) Intracavernous injections of edex can lead to increased peripheral blood levels of PGE and its metabolites, especially in those patients with significant corpora cavernosa venous leakage. Increased peripheral blood levels of PGE 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 was 7.8%. Treatment with edex 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 and other vasoactive agents have not been systematically studied. Therefore, the use of such combinations is not recommended.
4) After injection of the edex 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.
6) edex 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)
8)
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including edex, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
edex, 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 and in <1% of patients treated with placebo.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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