Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
Additions and/or revisions underlined:
The following adverse
reactions were identified during post approval
of SEROQUEL. 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.
Adverse reactions
reported since market introduction which were temporally related to quetiapine therapy
include anaphylactic reaction,
cardiomyopathy, drug reaction with eosinophilia and systemic
symptoms (DRESS),
hyponatremia, myocarditis, nocturnal enuresis, pancreatitis, retrograde amnesia, rhabdomyolysis, syndrome
of inappropriate antidiuretic hormone secretion (SIADH), Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN), decreased
platelet count, serious
liver reactions (including hepatitis, liver necrosis, and hepatic failure),
agranulocytosis, intestinal obstruction, ileus, colon ischemia,
urinary retention, sleep apnea,
acute generalized exanthematous pustulosis (AGEP), confusional
state and cutaneous vasculitis.
Approved Drug Label (PDF)
7
Drug Interactions
7.1 Effect of Other Drugs on Quetiapine
(Additions
underlined)
…
Anticholinergic Drugs:
Concomitant
treatment with quetiapine and other drugs with anticholinergic activity can
increase the risk for severe gastrointestinal adverse reactions related to
hypomotility. SEROQUEL should be used with caution in patients receiving
medications having anticholinergic (antimuscarinic) effects [see Warnings and Precautions (5.20)].
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT
COUNSELING INFORMATION
(Additions and/or revisions
underlined)
Leukopenia/Neutropenia
Patients with a pre-existing low WBC or a history of
drug induced leukopenia/neutropenia should be advised that they should have
their CBC monitored while taking SEROQUEL. Patients should be advised to talk
to their doctor as soon as possible if they have a fever, flu-like symptoms,
sore throat, or any other infection as this could be a result of a very low WBC,
which may require SEROQUEL to be stopped and/or treatment to be given [see
Warnings and Precautions (5.10)].
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Postmarketing Experience
(Additions and/or
revisions underlined)
The
following adverse reactions were identified during post approval of SEROQUEL. 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.
Adverse
reactions reported since market introduction which were temporally related to
quetiapine therapy include anaphylactic reaction, cardiomyopathy, drug reaction
with eosinophilia and systemic symptoms (DRESS), hyponatremia, myocarditis,
nocturnal enuresis, pancreatitis, retrograde amnesia, rhabdomyolysis, syndrome
of inappropriate antidiuretic hormone secretion (SIADH), Stevens-Johnson
syndrome (SJS), toxic epidermal necrolysis (TEN), decreased platelet count,
serious liver reactions (including hepatitis, liver necrosis, and hepatic
failure), agranulocytosis, intestinal obstruction, ileus, colon ischemia,
urinary retention, sleep apnea, and acute generalized exanthematous
pustulosis (AGEP).
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(Pregnancy and
Lactation Labeling Rule (PLLR) conversion with extensive changes; please refer
to labeling for complete information)
8.2 Lactation
(Pregnancy and
Lactation Labeling Rule (PLLR) conversion)
Risk
Summary
Limited data from published literature report the presence
of quetiapine in human breast milk at relative infant dose of <1% of the maternal weight-adjusted dosage. There are no consistent adverse events that have been reported in infants exposed to quetiapine through breast milk. There is no information on the effects of quetiapine on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for SEROQUEL and any potential adverse effects on the breastfed child from SEROQUEL
or from the mother’s
underlying condition.
8.3 Females and Males of Reproductive Potential
(Pregnancy and
Lactation Labeling Rule (PLLR) conversion)
Infertility
Females
Based on
the pharmacologic action of quetiapine (D2 antagonism), treatment with SEROQUEL may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility
in females of reproductive potential.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
(additions are
underlined)
…
Before you take SEROQUEL, tell your healthcare
provider if you
have or have had:
diabetes or
high blood sugar in you
or
your family. Your healthcare provider should check your blood sugar before you
start SEROQUEL and also
during therapy.
high levels of total cholesterol, triglycerides
or
LDL-cholesterol or low levels of HDL-cholesterol
low or high blood
pressure
low white blood cell count
cataracts
seizures
abnormal thyroid tests
high prolactin levels
heart problems
liver problems
any other medical
condition
pregnancy or plans to
become pregnant. It is not known if
SEROQUEL will harm your unborn
baby.
If you become
pregnant while receiving SEROQUEL,
talk to your healthcare provider about registering with the
National Pregnancy Registry for Atypical Antipsychotics.
You can register by calling
1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
breast-feeding or
plans to breast-feed. SEROQUEL can pass into your breast milk. Talk to your healthcare provider about the
best way to feed
your baby if you receive
SEROQUEL.
if
you have or have had a condition where you
cannot completely empty
your bladder (urinary retention),
have an enlarged prostate,
or constipation, or increased
pressure inside your eyes.
PATIENT COUNSELING INFORMATION
(additions are
underlined)
Advise the patient
to read the FDA-approved patient labeling
(Medication Guide).
Patients should be advised of the following issues and asked to alert their prescriber if these
occur while taking SEROQUEL.
…
Pregnancy
Advise pregnant women to
notify their healthcare
provider if they become
pregnant or intend
to become pregnant
during treatment with
SEROQUEL. Advise patients
that SEROQUEL may cause extrapyramidal and/or withdrawal symptoms
(agitation, hypertonia, hypotonia, tremor,
somnolence, respiratory distress, and feeding disorder) in
a neonate. Advise patients
that there is a
pregnancy registry that monitors pregnancy outcomes
in women exposed to SEROQUEL
during pregnancy.
Infertility
Advise females of reproductive potential that SEROQUEL may impair
fertility due to an increase in serum prolactin
levels. The
effects on fertility are reversible.
Approved Drug Label (PDF)
5
Warnings and Precautions
Addition
of the following:
5.10
Leukopenia, Neutropenia and Agranulocytosis
Agranulocytosis (defined as
absolute neutrophil count <500/mm3) has been reported with quetiapine,
including fatal cases and cases in patients without pre-existing risk factors.
Neutropenia should be considered in patients presenting with infection,
particularly in the absence of obvious predisposing factor(s), or in patients
with unexplained fever, and should be managed as clinically appropriate.
5.20
Anticholinergic (antimuscarinic) Effects
Norquetiapine, an active metabolite
of quetiapine, has moderate to strong affinity for several muscarinic receptor
subtypes. This contributes to anticholinergic adverse reactions when SEROQUEL
is used at therapeutic doses, taken concomitantly with other anticholinergic
medications , or taken in overdose. SEROQUEL should be used with caution in
patients receiving medications having anticholinergic (antimuscarinic) effects.
Constipation was a commonly
reported adverse event in patients treated with quetiapine and represents a
risk factor for intestinal obstruction. Intestinal obstruction has been
reported with quetiapine, including fatal reports in patients who were
receiving multiple concomitant medications that decrease intestinal motility.
SEROQUEL should be used with
caution in patients with a current diagnosis or prior history of urinary
retention, clinically significant prostatic hypertrophy, constipation, or
increased intraocular pressure.
6
Adverse Reactions
ADVERSE
REACTIONS
Addition
of the following to the bulleted line listing:
6.1
Clinical Trials Experience
… The following adverse reactions have also been reported with quetiapine:
addition of the following:
dyspnea, eosinophilia, urinary
retention, intestinal obstruction
6.2
Postmarketing Experience
Additions
and/or revisions underlined:
… Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN), decreased platelet count, serious liver
reactions (including hepatitis, liver necrosis, and hepatic failure),
agranulocytosis, intestinal obstruction, ileus, colon ischemia, urinary
retention, and sleep apnea.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
Before you take
SEROQUEL, tell your healthcare provider if you have or have had:
if you have or have had a condition where you cannot
completely empty your bladder (urinary retention), have an enlarged prostate,
or constipation, or increased pressure inside your eyes.
What
are possible side effects of SEROQUEL? SEROQUEL can cause serious side effects,
including:
low white blood
cell count. Tell
your healthcare provider as soon as possible if you have a fever, flu-like
symptoms, or any other infection, as this could be a result of a very low white
blood cell count. Your healthcare provider may check your white blood cell
level to determine if further treatment or other action is needed.
The
most common side effects of SEROQUEL include: In Adults:
drowsiness
sudden drop in blood pressure upon standing
weight gain
sluggishness
abnormal liver tests
upset stomach
In
Children and Adolescents:
drowsiness
dizziness
fatigue
PATIENT COUNSELING INFORMATION
Additions
and/or revisions underlined:
Leukopenia/Neutropenia
… their CBC monitored while taking
SEROQUEL. Patients should be advised to talk to their doctor as soon as
possible if they have a fever, flu-like symptoms, sore throat, or any other
infection as this could be a result of a very low WBC, which may require
SEROQUEL to be stopped and/or treatment to be given.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.8 Falls
(new
subsection added)
Atypical antipsychotic drugs,
including SEROQUEL, 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
(addition
underlined)
…
• Falls
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide
(addition
underlined)
What are possible side
effects of SEROQUEL?
…
• falls can happen in some
people who take SEROQUEL. These falls may cause serious injuries.
...
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