Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
The
following adverse reactions have been identified during postapproval use of
ABILIFY. 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: occurrences of allergic
reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria,
or oropharyngeal spasm), blood glucose fluctuation, drug reaction with
eosinophilia and systemic symptoms (DRESS), hiccups, oculogyric crisis,
pathological gambling, and fecal incontinence.
8
Use in Specific Populations
8.1 Pregnancy
Additions and/or
revisions underlined:
.
. .
Risk
Summary
Neonates
exposed to antipsychotic drugs, including ABILIFY, during the third trimester
of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following
delivery (see Clinical Considerations).
Overall available data from published epidemiologic studies of pregnant women
exposed to aripiprazole have not established a drug-associated risk of major
birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are risks to the
mother associated with untreated schizophrenia, bipolar I disorder, or major
depressive disorder, and with exposure to antipsychotics, including ABILIFY,
during pregnancy (see Clinical
Considerations).
Aripiprazole
exposure during pregnancy can have variable effects on milk supply in the
post-partum period [see Use in Specific
Populations (8.2)].
.
. .
8.2 Lactation
Additions and/or
revisions underlined:
Risk
Summary
Aripiprazole
is present in human breast milk. Based on published case reports and
pharmacovigilance reports, aripiprazole exposure during pregnancy and/or the
postpartum period can lead to variable effects on milk supply in the
post-partum period, including clinically relevant decreases in milk supply
which may be reversible with discontinuation of the drug. There are also
reports of aripiprazole exposure during pregnancy and no maternal milk supply
in the post-partum period. Effects on milk supply are likely mediated through
decreases in prolactin levels, which have been observed [see Adverse Reactions (6.1)]. Monitor the breastfed infant for
dehydration and lack of appropriate weight gain. The developmental and health
benefits of breastfeeding should be considered along with the mother’s clinical
need for ABILIFY and any potential adverse effects on the breastfed infant from
ABILIFY or from the underlying maternal condition.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Counseling Information
Additions and/or
revisions underlined:
.
. .
Lactation
Abilify
use during pregnancy may affect milk supply. Advise the lactating patient to
discuss any plans for breastfeeding with their healthcare provider, and to
monitor the breastfed infant for dehydration and lack of appropriate weight
gain [see Use in Specific Populations
(8.2)].
Approved Drug Label (PDF)
6
Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
Other Adverse Reactions Observed during Clinical Trial Evaluation of
Aripiprazole
… Investigations: frequent - blood
prolactin decreased, weight decreased; infrequent
…
8
Use in Specific Populations
8.5 Geriatric Use
‘patients’ replaces ‘subjects’
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
ABILIFY. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to establish a causal relationship to
drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema,
laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological
gambling, hiccups, blood glucose fluctuation, oculogyric crisis, and drug
reaction with eosinophilia and systemic symptoms (DRESS).
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
ABILIFY. Because these reactions are reported voluntarily from a population of
uncertain size, it is not always possible to establish a causal relationship to
drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema,
laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological
gambling, hiccups, blood glucose fluctuation, oculogyric crisis, and drug
reaction with eosinophilia and systemic symptoms (DRESS).
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy
and Lactation Labeling Rule (PLLR) Conversion; extensive changes – please refer
to labeling)
8.2
Lactation
(Pregnancy
and Lactation Labeling Rule (PLLR) Conversion; Additions and/or revisions are underlined)
Risk Summary
Limited
data from published literature report the presence of aripiprazole in human
breast milk, at relative infant doses ranging between 0.7% to 8.3% of
the maternal weight-adjusted dosage. There are reports of poor weight gain
in breastfed infants exposed to aripiprazole and reports of inadequate
milk supply in lactating women taking aripiprazole.
The development and health benefits
of breastfeeding should
be considered along with the mother’s clinical
need for ABILIFY
and any potential adverse effects on the breastfed infant from
ABILIFY or from the underlying maternal
condition.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.9 Falls
(Newly added subsection)
Antipsychotics, including
ABILIFY, may cause somnolence, postural hypotension, motor and sensory instability,
which may lead to falls and, consequently, fractures or other injuries. For patients
with diseases, conditions, or medications that could exacerbate these effects, complete
fall risk assessments when initiating antipsychotic treatment and recurrently for
patients on long-term antipsychotic therapy.
6
Adverse Reactions
(Additions and/or
revisions are underlined)
The following adverse
reactions are discussed in more detail in other sections of the labeling:
Approved Drug Label (PDF)
5
Warnings and Precautions
Pathological Gambling and Other Compulsive Behaviors
- Post-marketing case reports suggest that
patients can experience intense urges, particularly for gambling, and the
inability to control these urges while taking aripiprazole. Other compulsive
urges, reported less frequently include: sexual urges, shopping, eating or
binge eating, and other impulsive or compulsive behaviors. Because patients may
not recognize these behaviors as abnormal, it is important for prescribers to
ask patients or their caregivers specifically about the development of new or
intense gambling urges, compulsive sexual urges, compulsive shopping, binge or
compulsive eating, or other urges while being treated with aripiprazole. It
should be noted that impulse-control symptoms can be associated with the
underlying disorder. In some cases, although not all, urges were reported to
have stopped when the dose was reduced or the medication was discontinued.
Compulsive behaviors may result in harm to the patient and others if not
recognized. Consider dose reduction or stopping the medication if a patient
develops such urges.
6
Adverse Reactions
The
following adverse reactions are discussed in more detail in other sections of
the labeling:
·
Pathological Gambling and Other Compulsive
Behaviors
(addition)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MG - What are the possible side effects of ABILIFY?
ABILIFY may cause serious side effects,
including:
Unusual urges. Some people taking ABILIFY have
had unusual urges, such as gambling, binge eating or eating that you cannot
control (compulsive), compulsive shopping and sexual urges.
- If you or your
family members notice that you are having unusual urges or behaviors, talk to your
healthcare provider.
PCI - Discuss the following issues with patients prescribed ABILIFY:
Pathological Gambling and Other
Compulsive Behaviors
- Advise patients and their caregivers of
the possibility that they may experience compulsive urges to shop, intense
urges to gamble, compulsive sexual urges, binge eating and/or other compulsive
urges and the inability to control these urges while taking aripiprazole. In
some cases, but not all, the urges were reported to have stopped when the dose
was reduced or stopped.
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