Approved Drug Label (PDF)
5
Warnings and Precautions
5.6 Injection site ulceration, necrosis,
and infection
Additions and/or revisions underlined:
Injections that are too superficial (into the dermis)
may result in skin ulceration and necrosis [see
Injection Technique (2.3)]. Cases of injection site ulceration, necrosis, and infection
have been reported with the administration of KYBELLA. Some cases of
injection site infection have included cellulitis and abscess requiring
intravenous antibiotic treatment and incision and drainage. Do not
administer KYBELLA into the affected area until complete resolution of the
adverse reaction.
6
Adverse Reactions
6.2 Postmarketing Experience
Additions and/or revisions underlined:
The
following adverse reactions
have been identified during post-approval use of KYBELLA. 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 KYBELLA exposure.
Administration site conditions: injection
site ulceration, necrosis,
infection, alopecia, and scarring.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Advise patients to
contact their healthcare providers if patients begin to develop signs of
marginal mandibular nerve paresis (e.g., asymmetric smile, facial muscle weakness),
difficulty swallowing, or worsening of existing symptoms.
Advise patients
to contact their healthcare providers
for development of erythema, pain, open sore(s) or drainage from
the treatment area.
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or revisions underlined)
The
following adverse reactions have been identified during post-approval use of
KYBELLA®. 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 KYBELLA® exposure.
Administration
site conditions:
injection site ulceration, necrosis, alopecia, and scarring.
Immune System
Disorders: Hypersensitivity
reactions including rash, urticaria, and itching.
Nervous System
Disorders: Oral
hypoaesthesia and oral paraesthesia.
8
Use in Specific Populations
8.5 Geriatric Use
(Additions and/or revisions underlined)
The
clinical trials of KYBELLA® did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger
subjects. Other reported clinical
experience has not identified differences in responses between the elderly and
younger subjects. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or other drug therapy.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
(Additions and/or revisions underlined)
…
Call your
healthcare provider if you:
begin to develop weakness in the muscles of your face,
or your smile becomes uneven
you have difficulty swallowing, or if any of the
symptoms that you already have get worse
- develop open sores
or drainage from the treatment area
The most common
side effects of KYBELLA include:
These
are not all of the possible side effects of KYBELLA.
Call
your doctor for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Risk of injecting in proximity to vulnerable anatomic structures
(Additions and/or revisions underlined)
To
avoid potential tissue damage, KYBELLA® should not be injected into or in close
proximity (1-1.5 cm) to salivary glands, lymph nodes and muscles.
Care
should be taken to avoid inadvertent injection directly into an artery or a
vein as it can result in vascular injury.
6
Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or revisions underlined)
The
following adverse reactions have been identified during post-approval use of
KYBELLA®. 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 KYBELLA® exposure.
Administration
site conditions:
injection site ulceration, necrosis, alopecia, and scarring.
Immune System
Disorders: Hypersensitivity
reactions including rash, urticaria, and itching.
Nervous System
Disorders: Oral
hypoaesthesia and oral paraesthesia.
Procedural
Complications: Vascular injury due to inadvertent intravascular
injection.
8
Use in Specific Populations
8.5 Geriatric Use
(Additions and/or revisions underlined)
The
clinical trials of KYBELLA® did not include sufficient numbers of subjects aged
65 and over to determine whether they respond differently from younger
subjects. Other reported clinical
experience has not identified differences in responses between the elderly and
younger subjects. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or other drug therapy.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT INFORMATION
(Additions and/or revisions underlined)
…
What are the
possible side effects of KYBELLA? KYBELLA can cause serious side effects,
including:
...
Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
KYBELLA® (deoxycholic acid) injection is contraindicated in the presence
of infection at the
injection sites.
5
Warnings and Precautions
5.1 Marginal mandibular nerve injury
(Additions and/or revisions are underlined)
Cases of marginal mandibular nerve
injury, manifested as an asymmetric smile or facial muscle
weakness (paresis),
were reported during clinical trials. To
avoid the potential for nerve injury, KYBELLA® (deoxycholic acid) injection should
not be injected into or in close
proximity to the marginal
mandibular branch of the
facial nerve…
5.5 Injection site alopecia
(Newly
added subsection)
Cases
of injection site alopecia have been reported with
the administration of KYBELLA®. The onset and
duration of this adverse
reaction may vary among
individuals and may persist. Consider withholding subsequent
treatments until resolution of the adverse reaction.
5.6 Injection site ulceration and necrosis
(Newly
added subsection)
Injections that are
too superficial (into the
dermis) may result
in skin ulceration and necrosis. Cases
of injection site ulceration
and necrosis have been reported
with the administration of KYBELLA®. Do
not administer KYBELLA® into
the affected area until complete
resolution of the adverse reaction.
6
Adverse Reactions
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
(Newly
added subsection)
The
following adverse reactions have been identified during post-approval use of KYBELLA®. 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 KYBELLA® exposure.
Administration site
conditions:
injection site ulceration, necrosis and
alopecia.
8
Use in Specific Populations
8.1 Pregnancy
(Additions and/or revisions are underlined)
Risk Summary
There are no
adequate and well-controlled
studies of KYBELLA® (deoxycholic acid) injection in pregnant women
to inform the drug-associated risk…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions
and/or revisions are underlined)
Advise
the patient to read the FDA-approved patient labeling (Patient Information).
Advise
patients to contact their
healthcare providers if patients
begin to develop signs of marginal
mandibular nerve paresis (e.g., asymmetric
smile, facial muscle weakness), difficulty swallowing,
or
worsening of existing
symptoms.
Advise
patients to contact their healthcare providers for development of open sores(s) or drainage
from the treatment area.
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