The dose of CAVERJECT should be individualized for each patient by careful
titration under supervision by the physician. In clinical studies, patients
were treated with CAVERJECT Sterile Powder in doses ranging from 0.2 to
140 mcg; however, since 99% of patients received doses of 60 mcg or less,
doses of greater than 60 mcg are not recommended. In general, the lowest
possible effective dose should always be employed. In clinical studies,
over 80% of patients experienced an erection sufficient for sexual intercourse
after intracavernosal injection of CAVERJECT.
Initial Titration in Physician's Office:
Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology.
Dosage titration should be initiated at 2.5 mcg of alprostadil. The 10 mcg
strength of CAVERJECT IMPULSE is designed to allow delivery of a 2.5 mcg
dose of alprostadil (see General Procedure for Solution Preparation). If
there is a partial response at
2.5 mcg, the dose may be increased by 2.5 mcg to a dose of 5 mcg within
1 hour. No more than 2 doses during initial titration should be given within
a 24-hour period. If additional titration is required, doses in increments
of 5 to 10 mcg may be given at least 24 hours apart until the dose that
produces an erection suitable for intercourse and not exceeding a duration
of 1 hour is reached. If there is no response to the initial 2.5-mcg dose,
the second dose may be increased to 7.5 mcg within 1 hour. No more than
2 doses during initial titration should be given within a 24-hour period.
If additional titration is required, doses in increments of 5 to 10 mcg
may be given at least 24 hours apart. The patient must stay in the physician's
office until complete detumescence occurs.
Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury).
Dosage titration should be initiated at 1.25 mcg of alprostadil. Because
CAVERJECT IMPULSE is designed to deliver doses of 2.5 mcg or greater (see
General Procedure for Solution Preparation), CAVERJECT Sterile Powder or
CAVERJECT Injection may be used for an initial dose of 1.25 mcg. The initial
dose may be increased by
1.25 mcg to a dose of 2.5 mcg within 1 hour. No more than 2 doses during
initial titration should be given within a 24-hour period. If additional
titration is required, a dose of 5 mcg may be given during the next 24 hours.
Thereafter, doses in increments of 5 mcg may be given at least 24 hours
apart until the dose that produces an erection suitable for intercourse
and not exceeding a duration of 1 hour is reached. The patient must stay
in the physician's office until complete detumescence occurs.
The majority of patients (56%) in one clinical study involving 579 patients
with erectile dysfunction of various etiologies were titrated to doses of
greater than 5 mcg but less than or equal to 20 mcg. The mean dose at the
end of the titration phase was 17.8 mcg of alprostadil.
Maintenance Therapy:
The first injections of CAVERJECT must be done at the physician's office
by medically trained personnel. Self-injection therapy by the patient should
be started only after the patient is properly instructed and well trained
in the self-injection technique. The physician should make a careful assessment
of the patient's skills and competence with this procedure. The intracavernosal
injection must be done under sterile conditions. The site of injection is
usually along the dorso-lateral aspect of the proximal third of the penis.
Visible veins should be avoided. The side of the penis that is injected
and the site of injection must be alternated; the injection site must be
cleansed with an alcohol swab.
The dose of CAVERJECT that is selected for self-injection treatment should
provide the patient with an erection that is satisfactory for sexual intercourse
and that is maintained for no longer than 1 hour. If the duration of erection
is longer than 1 hour, the dose of CAVERJECT should be reduced. Self-injection
therapy for use at home should be initiated at the dose that was determined
in the physician's office; however, dose adjustment, if required (up to
57% of patients in one clinical study), should be made only after consultation
with the physician. The dose should be adjusted in accordance with the titration
guidelines described above. The effectiveness of CAVERJECT for long-term
use of up to 6 months has been documented in an uncontrolled, self-injection
study. The mean dose of CAVERJECT Sterile Powder at the end of 6 months
was 20.7 mcg in this study. CAVERJECT IMPULSE in the 10 mcg strength is
designed to deliver a minimum dose of 2.5 mcg and a maximum dose of 10 mcg.
CAVERJECT IMPULSE in the 20 mcg strength is designed to deliver a minimum
dose of 5 mcg and a maximum dose of 20 mcg. The physician should determine
the most suitable formulation of CAVERJECT for the individual patient (CAVERJECT
IMPULSE, CAVERJECT Sterile Powder, or CAVERJECT Injection).
Careful and continuous follow-up of the patient while in the self-injection
program must be exercised. This is especially true for the initial self-injections,
since adjustments in the dose of CAVERJECT may be needed. The recommended
frequency of injection is no more than 3 times weekly, with at least 24
hours between each dose. All formulations of CAVERJECT are intended for
single use only and should be discarded after use. The user should be instructed
in the proper disposal of the injection materials (e.g., device, needles).
While on self-injection treatment, it is recommended that the patient
visit the prescribing physician's office every 3 months. At that time, the
efficacy and safety of the therapy should be assessed, and the dose of CAVERJECT
should be adjusted, if needed.
CAVERJECT as an Adjunct to the Diagnosis of Erectile Dysfunction:
In the simplest diagnostic test for erectile dysfunction (pharmacologic
testing), patients are monitored for the occurrence of an erection after
an intracavernosal injection of CAVERJECT. Extensions of this testing are
the use of CAVERJECT as an adjunct to laboratory investigations, such as
duplex or Doppler imaging, 133Xenon washout tests,
radioisotope penogram, and penile arteriography, to allow visualization
and assessment of penile vasculature. For any of these tests, a single dose
of CAVERJECT that induces an erection with firm rigidity should be used.
General Procedure for Solution Preparation:
CAVERJECT IMPULSE consists of a disposable, single-dose, dual-chamber
syringe system. The system includes a glass cartridge, which contains sterile,
freeze-dried alprostadil in the front chamber and sterile bacteriostatic
water for injection in the rear chamber. Following proper reconstitution
instructions, the 10 mcg strength syringe can deliver up to 0.5 mL of solution.
Each 0.5 mL of solution contains
10 mcg of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose,
23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. The delivery
device can be set to deliver a solution volume of 0.125, 0.25, 0.375, or
0.50 mL to enable administration of 2.5, 5, 7.5, or 10 mcg of alprostadil.
Following proper reconstitution instructions, the 20 mcg strength syringe
can deliver up to 0.5 mL of solution. Each 0.5 mL of solution contains 20
mcg of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose,
23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol. The delivery
device can be set to deliver a solution volume of 0.125, 0.25, 0.375, or
0.50 mL to enable administration of 5, 10, 15, or 20 mcg of alprostadil.
After reconstitution, the solution of CAVERJECT should be used within 24
hours when stored at or below 25°C (77°F). Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to
administration whenever the solution and container permit. The product should
not be used if particulate matter or discoloration are present. Following
a single use, the injection device and any remaining solution should be
properly discarded.
Caution: CAVERJECT IMPULSE is for single use only. Do not use
any remaining CAVERJECT solution.