Approved Drug Label (PDF)
4
Contraindications
Additions and revisions underlined:
CAVERJECT IMPULSE
is contraindicated:
in men who have a known
hypersensitivity to the drug [see Adverse
Reactions (6.1)]
in men who- have conditions that predispose them to priapism,
such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia
[see Warnings and Precautions (5.1)]
for the treatment of erectile dysfunction in men with fibrotic conditions of the
penis, such as anatomical
deformation, angulation, cavernosal fibrosis, or Peyronie’s disease [see Warnings and Precautions (5.2)]
in men with penile implants.
5
Warnings and Precautions
5.7 Needle Breakage
Additions and revisions underlined:
CAVERJECT
IMPULSE uses a superfine (29 gauge) needle for administration. As with all superfine needles, the possibility of needle
breakage exists. Needle breakage, with a portion of the
needle remaining in the penis, has been reported and,
in some cases, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage. [see Dosage and
Administration (2.3) and Adverse Reactions (6.2)].
5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol
6
Adverse Reactions
6.2 Post-marketing Experience
Additions and revisions underlined:
The following additional adverse reactions have been
reported during post approval use of CAVERJECT IMPULSE. Because these reactions are reported voluntarily from a population of uncertain size, it
is not always possible to reliably estimate their frequency or
establish a causal relationship to drug exposure.
Injury and procedural complication:
device malfunction/failure, needle breakage, drug ineffective and drug effect
decreased.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and revisions underlined:
. . .
When self-administering the patient should be
instructed to [see Dosage and Administration (2.3, 2.4)]:
- Discard any
reconstituted solution with
precipitates or discoloration
- Administer the injection
along the dorso-lateral aspect of the proximal third of the penis
- Wipe the intended injection site with an alcohol
swab prior to injection
- Avoid visible veins during
injection
- Alternate the side of the penis that is injected
and the site of injection
- Compress the site of injection with an alcohol
swab or sterile
gauze for 5 minutes
- Use each
CAVERJECT IMPULSE system only
once and discard after use
- Not use a bent needle. Do not attempt
to straighten a bent needle.
Remove the needle
from the syringe, discard it,
and attach a new, unused sterile needle to the syringe
- Not re-use or share needles
and to properly discard
after use.
Needle Breakage
Advise patients that needle breakage
has occurred during self-injection of CAVERJECT. Advise
patients to insert the needle
perpendicular to the long axis of the
penis to avoid bending or breakage of
the needle [see Warnings and Precautions
(5.7) and Adverse Reactions (6.2)].
Patient Information
Additions and revisions underlined:
. . .
Do not use CAVERJECT
IMPULSE if you:
are allergic to alprostadil or any of the
ingredients in CAVERJECT. See the end of
this leaflet for a complete
list of ingredients in CAVERJECT.
have certain medical
problems that might cause
you to have an erection
that lasts for more than 4 hours, such as sickle cell anemia, sickle cell trait, multiple myeloma, leukemia.
have a deformed penis shape
have a penile implant
. . .
What are the
possible side effects of CAVERJECT IMPULSE? CAVERJECT IMPULSE
may cause serious
side effects, including:
. . .
needle breakage. There is a possibility of
needle breakage with use of
CAVERJECT IMPULSE. To best avoid breaking the needle, you should pay careful
attention to your healthcare provider’s instructions and
handle the syringe and needle
properly. If the needle is bent at
any time, do not attempt to straighten it and do not use it. A bent and re-
straightened needle is more likely to break. Remove the needle from the
syringe, discard, and attach a new, unused sterile needle to the syringe.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.8 Benzyl Alcohol (addition underlined)
The preservative benzyl alcohol
contained in CAVERJECT IMPULSE has been associated with serious adverse events,
including the “gasping syndrome”, and death in pediatric patients. The minimum
amount of benzyl alcohol at which toxicity may occur is not known. The risk of
benzyl alcohol toxicity depends on the quantity administered and the liver
and kidneys’ capacity to detoxify the chemical. Premature and low-birth
weight infants may be more likely to develop toxicity. CAVERJECT IMPULSE is not
indicated for pediatric patients.
Approved Drug Label (PDF)
5
Warnings and Precautions
Needle Breakage
- Needle breakage, with a portion of the needle remaining in the penis,
has been reported and, in some cases, required hospitalization and
surgical removal…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PCI - Dosing and Self-Administration
When self-administering the patient should be instructed to:
- Do
not use a bent needle. If the needle is bent, it must not be used; they
should also not attempt to straighten a bent needle. They should remove
the needle from the syringe, discard it, and attach a new, unused
sterile needle to the syringe.
PI - What are the possible side effects of CAVERJECT IMPULSE?
CAVERJECT IMPULSE may cause serious side effects, including:
- Needle breakage.
- needle
properly... If the needle is bent at any time, do not attempt to
straighten it and do not use it. A bent and re-straightened needle is
predisposed to breakage. Remove the needle from the syringe, discard,
and attach a new, unused sterile needle to the syringe… If the needle…
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