General Precautions
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1. |
CAVERJECT IMPULSE is designed for one use only. Following a
single use, the injection device and any remaining solution should
be properly discarded. |
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2. |
The overall incidence of penile fibrosis, including Peyronie's
disease, reported in clinical studies with CAVERJECT Sterile Powder
was 3%. In one self-injection clinical study where duration of use
was up to 18 months, the incidence of fibrosis was 7.8%. Regular
follow-up of patients, with careful examination of the penis, is
strongly recommended to detect signs of penile fibrosis. Treatment
with CAVERJECT should be discontinued in patients who develop penile
angulation, cavernosal fibrosis, or Peyronie’s disease. |
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3. |
Intracavernous injections of CAVERJECT can lead to increased
peripheral blood levels of PGE1 and its
metabolites, especially in those patients with significant corpora
cavernosa venous leakage. Increased peripheral blood levels of PGE1
and its metabolites may lead to hypotension and/or dizziness.
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4. |
Patients on anticoagulants, such as warfarin or heparin, may
have increased propensity for bleeding after intracavernosal injection.
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5. |
Underlying treatable medical causes of erectile dysfunction
should be diagnosed and treated prior to initiation of therapy with
CAVERJECT. |
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6. |
The safety and efficacy of combinations of CAVERJECT and other
vasoactive agents have not been systematically studied. Therefore,
the use of such combinations is not recommended. |
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7. |
CAVERJECT IMPULSE uses a superfine (29 gauge) needle. As with
all superfine needles, the possibility of needle breakage exists.
Careful instruction in proper patient handling and injection techniques
may minimize the potential for needle breakage. |
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8. |
The patient should be instructed not to re-use or to share needles
or syringes. As with all prescription medicines, the patient should
not allow anyone else to use his medicine. |
Information for the Patient:
To ensure safe and effective use of CAVERJECT, the patient should be
thoroughly instructed and trained in the self-injection technique before
he begins intracavernosal treatment with CAVERJECT at home. The desirable
dose should be established in the physician’s office.
Any reconstituted solution with precipitates or discoloration should
be discarded. The CAVERJECT IMPULSE syringe system is designed for one use
only and should be discarded after use. The device and the needle must be
properly discarded after use. Needles must not be re-used or shared with
other persons. Patient instructions for administration are included in each
package of CAVERJECT IMPULSE.
The dose of CAVERJECT that is established in the physician’s office should
not be changed by the patient without consulting the physician. The patient
may expect an erection to occur within 5 to 20 minutes. A standard treatment
goal is to produce an erection lasting no longer than 1 hour. Generally,
CAVERJECT should be used no more than 3 times per week, with at least 24
hours between each use.
Patients should be aware of possible side effects of therapy with CAVERJECT;
the most frequently occurring is penile pain after injection, usually mild
to moderate in severity. A potentially serious adverse reaction with intracavernosal
therapy is priapism. Accordingly, the patient should be instructed to contact
the physician's office immediately or, if unavailable, to seek immediate
medical assistance if an erection persists for longer than 4 hours.
The patient should report any penile pain that was not present before
or that increased in intensity, as well as the occurrence of nodules or
hard tissue in the penis to his physician as soon as possible. As with any
injection, an infection is a possibility. Patients should be instructed
to report to the physician any penile redness, swelling, tenderness or curvature
of the erect penis. The patient must visit the physician's office for regular
checkups for assessment of the therapeutic benefit and safety of treatment
with CAVERJECT.
Note: Use of intracavernosal CAVERJECT offers no protection from the
transmission of sexually transmitted diseases. Individuals who use CAVERJECT
should be counseled about the protective measures that are necessary to
guard against the spread of sexually transmitted diseases, including the
human immunodeficiency virus (HIV).
The injection of CAVERJECT can induce a small amount of bleeding at the
site of injection (see ADVERSE REACTIONS section hematoma, ecchymosis, hemorrhage
at the site of injection). In patients infected with blood-borne diseases,
this could increase the risk of transmission of blood-borne diseases between
partners.
In clinical trials, concomitant use of agents such as antihypertensive
drugs, diuretics, antidiabetic agents (including insulin), or non-steroidal
anti-inflammatory drugs had no effect on the efficacy or safety of CAVERJECT.
Carcinogenesis, Mutagenesis, and Impairment of Fertility:
Long-term carcinogenicity studies have not been conducted. Rat reproductive
studies indicate that alprostadil at doses of up to 0.2 mg/kg/day does not
adversely affect or alter rat spermatogenesis, providing a 200-fold margin
of safety compared with the usual human doses. The following battery of
mutagenicity assays revealed no potential for mutagenesis: bacterial mutation
(Ames), alkaline elution, rat micronucleus, sister chromatid exchange, CHO/HGPRT
mammalian cell forward gene mutation, and unscheduled DNA synthesis (UDS).
A 1-year irritancy study was conducted in three groups of 5 male Cynomolgus
monkeys injected intracavernosally twice weekly with either vehicle or 3
or 8.25 mcg of alprostadil/ injection. An additional two groups of 6 monkeys
each were injected with vehicle or with 8.25 mcg/injection twice weekly
as described previously plus they received multiple doses during weeks 44,
48, and 52. Three monkeys from each group were retained for a 4-week recovery
period. There was no evidence of drug-related penile irritancy or nonpenile
tissue lesions, which could be directly related to alprostadil. The irritancy,
which was noted for control and treated monkeys, was considered to be a
result of the injection procedure itself, and any lesions noted were shown
to be reversible. At the end of the 4-week recovery period, the histological
changes in the penis had regressed.
Pregnancy, Nursing Mothers, and Pediatric Use:
CAVERJECT is not indicated for use in pediatric patients or women.
Geriatric Use:
A total of 341 subjects included in clinical studies were 65 and older.
No overall differences in safety and effectiveness were observed between
these subjects and younger subjects, and the other reported clinical experience
has not identified differences in responses between elderly and younger
patients, but decreased sensitivity of some older individuals cannot be
ruled out.