CAVERJECT IMPULSE®Dual Chamber System alprostadil for injection Warnings

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Prescribing Information

CAVERJECT IMPULSE^® Dual Chamber System (alprostadil for injection)
Warnings


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Prolonged erection defined as erection lasting > 4 to ≤ 6 hours in duration occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT Sterile Powder. The incidence of priapism (erections lasting > 6 hours in duration) was 0.4% with the same length of use. Pharmacologic intervention and/or aspiration of blood from the corpora cavernosum was performed in 2 of the 7 patients with priapism.

To minimize the chances of prolonged erection or priapism, CAVERJECT should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION). 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 4 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

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CAVERJECT IMPULSE Indication and Important Safety Information

Please scroll to see the Indication below.

Important Safety Information

CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

The most common side effect of CAVERJECT IMPULSE was penile pain, reported by 37% of patients in clinical studies. Only 3% discontinued CAVERJECT IMPULSE for this reason.

CAVERJECT IMPULSE should not be used in men hypersensitive to alprostadil, men with conditions that may predispose them to priapism, men with anatomical deformities of the penis, men with penile implants, or men for whom sexual activity is not advisable or is contraindicated. Penile fibrosis, including Peyronie's disease, was reported in clinical trials with CAVERJECT IMPULSE.

Patients should be instructed to report any erection lasting 4 hours or longer. Treatment of priapism should not be delayed more than 6 hours.

Each patient should be titrated to the lowest effective dose.

The product information in this site is intended only for residents of the United States.

Indication

CAVERJECT^® (CAVERJECT IMPULSE^®, CAVERJECT Sterile Powder^®, and CAVERJECT Injection^®) is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.

Intracavernosal CAVERJECT is also indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Please see full prescribing information.

CAVERJECT IMPULSE^® Dual Chamber System (alprostadil for injection)

caverject_impulse_safety_information.htm

Full Prescribing Information