Presentation and Status in Health Basket
1 X 10 mcg/vial
1 X 20 mcg/vial
This product is administered by direct intracavernosal injection. A ½-inch, 27- to 30-gauge needle is generally recommended. The dose should be individualized for each patient by careful titration under supervision by the physician. In clinical studies, patients were treated in doses ranging from 0.2 to 20 micrograms; however, since 99% of patients received doses of 20 micrograms or less, doses of greater than 20 micrograms are not recommended. In general, the lowest possible effective dose should always be employed. For full details see prescribing information.
Erectile dysfunction, adjunctive to diagnosis of erectile dysfunction.
This product should not be used in patients who have a known hypersensitivity to the drug or to other prostaglandins, or 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 this product. This product should not be used in women or children and is not for use in newborns. This product should not be used in men for whom sexual activity is inadvisable or contraindicated.
Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil. To minimize the risk, select the lowest effective dose.
Patients should be instructed to report immediately to a physician, or if unavailable to seek immediate medical assistance for any erection lasting for a prolonged time period, such as 4 hours.
Treatment of priapism should not be delayed more than 6 hours and should be according to established medical practice.
Painful erection is more likely to occur in patients with anatomical deformations of the penis, such as angulation, phimosis, cavernosal fibrosis, Peyronie’s disease or plaques.
Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and Peyronie’s disease may occur following the intracavernosal administration of alprostadil.
The occurrence of fibrosis may increase with increased duration of use. Regular follow-up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis or Peyronie’s disease. Treatment with alprostadil should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie’s disease.
Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection.
Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with alprostadil.
Use of intracavernosal alprostadil offers no protection from the transmission of sexually transmitted diseases. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). In some patients, injection of alprostadil can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the transmission of such diseases to their partner.
Alprostadil should be used with caution in patients with cardiovascular and cerebrovascular risk factors.
Alprostadil should be used with caution in patients who have experienced transient ischaemic attacks or those with unstable cardiovascular disorders.
Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease.
These patients when using alprostadil should engage in sexual activity with caution.
Alprostadil is not intended for co administration with any other agent for the treatment of erectile dysfunction.
The potential for abuse of alprostadil should be considered in patients with a history of psychiatric disorder or addiction.
Caverject uses a superfine needle for administration. As with all superfine needles, the possibility of needle breakage exists.
Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal.
Careful patient instruction in proper handling and injection techniques may minimise the potential for needle breakage.
The patient should be instructed that, if the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
The following adverse reactions information was obtained from clinical studies sponsored by Upjohn involving 1712 patients treated with this product. The most frequent adverse reaction after intracavernosal injection is penile pain. In studies, 34% of the patients reported penile pain during erection at least once, however, this event was associated with only 11% of the administered injections. In the majority of the cases, burning sensation or tension in the penis was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain. Hematoma at the site of injection, which is related to the injection technique rather than to the effects of alprostadil, occurs in 3% of patients. The frequency of prolonged erection (defined as an erection that lasts for 4 hours) was 2%. The frequency of priapism (defined as an erection that lasts 4 hours or longer) was 0.5%. In the majority of cases, spontaneous detumescence occurred. The following local adverse reactions occurred in 1.0-1.5% of patients: injection site ecchymosis, penile rash, penile edema, and penile fibrosis. The following local adverse reactions were reported by fewer than 1% of patients: balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, urethral bleeding, and penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation. In terms of systemic events, the following were reported for fewer than 1% of patients in clinical studies, and were judged to be possibly related to use: testicular pain, testicular swelling, scrotal erythema, pain or tightness, urinary frequency, urinary urgency, impaired urination, hypotension, vasodilatation, hypertension, supraventricular extrasystole, peripheral vascular disorder, dizziness, hypesthesia, buttock weakness, localized pain (buttocks pain, leg pain, genital pain, abdominal pain), headache, pelvic pain, back pain, flu syndrome, cardiac arrhythmias, shock and collapse. Hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at doses above 20 micrograms and above 30 micrograms, respectively, and appeared to be dose-dependent. Only three patients (0.2%) discontinued the treatment because of symptomatic hypotension. This product had no clinically important effect on serum or urine laboratory tests.
The effects of combinations of alprostadil with other treatments for erectile dysfunction (e.g. sildenafil) or other drugs inducing erection (e.g. papaverine) have not been formally studied. Such agents should not be used in combination with alprostadil due to the potential for inducing prolonged erections.
Sympathomimetics may reduce the effect of alprostadil. Alprostadil may enhance the effects of antihypertensives, vasodilative agents, anticoagulants and platelet aggregation inhibitors.
Pregnancy and Lactation
In man, prolonged erection and/or priapism are known to occur following intracavernosal administration of vasoactive substances, including alprostadil. The treatment of priapism may include different approaches such as aspiration, intracavernosal injection of sympathomimetic amines or surgery. Patients should be instructed to report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer.
Excipient with known effect:
Each 1ml of reconstituted solution contains 8.4 mg of benzyl alcohol, equivalent to 8.4 mg/ml.
The combined daily metabolic load of benzyl alcohol from all sources should be considered, especially in patients with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
This medicine is only indicated for intracavernosal injection. Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Premature and low-birth weight infants may be more likely to develop toxicity. Caverject is not indicated
for paediatric use.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.