Local Adverse Reactions: The following local adverse reaction
information was derived from controlled and uncontrolled studies of CAVERJECT
Sterile Powder, including an uncontrolled 18-month safety study.
Local Adverse Reactions Reported by ≥ 1% of Patients Treated with
CAVERJECT Sterile Powder for up to 18 Months
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% (see WARNINGS).
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, irritation, sensitivity, phimosis, pruritus, erythema, venous
leak, painful erection, and abnormal ejaculation.
Systemic Adverse Events: The following systemic adverse event
information was derived from controlled and uncontrolled studies of CAVERJECT
Sterile Powder, including an uncontrolled 18-month safety study.
Systemic Adverse Events Reported by ≥ 1% of Patients Treated with
CAVERJECT Sterile Powder for up to 18 Months
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 mcg and above 30 mcg of alprostadil, respectively, and appeared to be
dose-dependent. However, these changes were usually clinically unimportant;
only three patients discontinued the treatment because of symptomatic hypotension.
CAVERJECT had no clinically important effect on serum or urine laboratory
tests.
The safety of CAVERJECT IMPULSE was evaluated in a study that compared
the formulation of alprostadil for injection contained in CAVERJECT IMPULSE
with the formulation contained in CAVERJECT Sterile Powder. The doses used
by the 87 patients in this crossover study were the same for both formulations.
The number and type of events reported for CAVERJECT IMPULSE were consistent
between formulations in this study and in other controlled and uncontrolled
studies with CAVERJECT Sterile Powder.