Local Adverse Reactions: The following local adverse reaction information was derived from con- trolled and uncontrolled studies, including an uncontrolled 18-month safety study.
Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT for up to 18 Months*
N = 1861
N = 1861
|Penile pain||37%||Penis disorder***||3%|
|Prolonged erection||4%||Injection site ecchymosis||2%|
|Penile fibrosis**||3%||Penile rash||1%|
|Injection site hematoma||3%||Penile edema||1%|
| * Except for penile pain (2%), no significant local adverse reactions were reported by 294 patientswho received 1 to 3 injections of placebo.
** See General Precautions.
*** Includes numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, penile skin tear, strange feeling of penis, discoloration of penile head, itch at tip of penis.
Penile Pain: Penile pain after intracavernosal administration of CAVERJECT was reported at least once by 37% of patients in clinical studies of up to 18 months in duration. In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain. The frequency of penile pain was 2% in 294 patients who received 1 to 3 injections of placebo.
Prolonged Erection/Priapism: In clinical trials, prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as erection that lasted 6 hours or longer. The frequency of prolonged erection after intracavernosal administration of CAVERJECT was 4%, while the frequency of priapism was 0.4%. In the majority of cases, spontaneous detumescence occurred. To minimize the chances of prolonged erection or priapism, CAVERJECT should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION section). The patient must be instructed to immediately report to his physician or, if unavailable, to seek immediate medical assistance for any erection that persists for longer than 4 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Hematoma/Ecchymosis: The frequency of hematoma and ecchymosis was 3% and 2%, respectively. In most cases, hematoma/ecchymosis was judged to be a complication of a faulty injection technique. Accordingly, proper instruction of the patient in self-injection is of importance to minimize the potential of hematoma/ecchymosis (see DOSAGE AND ADMINISTRATION).
The following local adverse reactions were reported by fewer than 1% of patients after injection of CAVERJECT: balanitis, injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, yeast infection, irri tation, sensit ivity, phimosis, pruritus, erythema, venous leak, painful erect ion, and abnormal ejaculat ion.
Systemic Adverse Events: The following systemic adverse event information was derived from controlled and uncontrolled studies, including an uncontrolled 18-month safety study.
Systemic Adverse Events Reported by ≥ 1% of Patients Treated with CAVERJECT for up to 18 Months*
|Body System/Reaction|| CAVERJECT
N = 1861
|Body System/Reaction (continued)|| CAVERJECT
N = 1861
|Cardiovascular System||Urogenital System|
|Central Nervous System||Miscellaneous|
|Upper respiratory infection||4%|
| * No significant adverse events were reported by 294 patients who received 1 to 3 injections ofplacebo.
** prostatitis, pain, hypertrophy, enlargement
*** pain in various anatomical structures other than injection site
**** injuries, fractures, abrasions, lacerations, dislocat ions
The following systemic events, which were reported for < 1% of patients in clinical studies, were judged by investigators to be possibly related to use of CAVERJECT: testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, pelvic pain, hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, hypesthesia, non-generalized weakness, diaphoresis, rash, non-application site pruritus, skin neoplasm, nausea, dry mouth, increased serum creatinine, leg cramps, and mydriasis.
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 of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discont inued the treatment because of symptomatic hypotension.
CAVERJECT had no clinically important effect on serum or urine laboratory tests.