Approved Drug Label (PDF)
4
Contraindications
4.3
Monoamine Oxidase Inhibitors (MAOIs)
Newly added section
Ziprasidone is contraindicated in patients taking,
or within 14 days of stopping, MAOIs (including the MAOIs linezolid and
intravenous methylene blue) because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.4), Drug
Interaction (7.3)].
5
Warnings and Precautions
5.5 Serotonin Syndrome
Newly added section:
Ziprasidone can precipitate serotonin syndrome, a
potentially life-threatening condition. The risk is increased with concomitant
use of other serotonergic drugs (including selective serotonin reuptake
inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs),
triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone,
lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with
drugs that impair metabolism of serotonin, i.e., monoamine oxidase inhibitors
(MAOIs) [see Contraindications (4.3),
Adverse Reactions (6.2), Drug Interactions (7.3)].
Serotonin syndrome signs and symptoms may include
mental status changes (e.g., agitation, hallucinations, delirium, and coma),
autonomic instability (e.g., tachycardia, labile blood pressure, dizziness,
diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor,
rigidity, myoclonus, hyperreflexia, incoordination), seizures, and
gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
The concomitant use of GEODON with MAOIs is
contraindicated. In addition, do not initiate GEODON in a patient being treated
with MAOIs such as linezolid or intravenous methylene blue. If it is necessary
to initiate treatment with an MAOI such as linezolid or intravenous methylene
blue in a patient taking GEODON, discontinue GEODON before initiating treatment
with the MAOI [see Contraindications
(4.3), Drug Interactions (7.3)].
Monitor all patients taking GEODON for the emergence
of serotonin syndrome. Discontinue treatment with GEODON and any concomitant
serotonergic agents immediately if the above symptoms occur, and initiate
supportive symptomatic treatment. If concomitant use of GEODON with other
serotonergic drugs is clinically warranted, inform patients of the increased
risk of serotonin syndrome and monitor for symptoms.
…
5.15
Hyperprolactinemia
Additions and/or revisions underlined:
…
Published epidemiologic
studies have shown inconsistent results when exploring the potential
association between hyperprolactinemia and breast cancer.
…
6
Adverse Reactions
Addition of the following to the bulleted line listing:
The following adverse reactions are described in
more detail in other sections of the prescribing information:
Increased Mortality in Elderly Patients with
Dementia-Related Psychosis [see Boxed
Warning and Warnings and Precautions (5.1)]
Cerebrovascular Adverse Reactions, Including Stroke,
in Elderly Patients with Dementia- Related Psychosis [see Warnings and Precautions (5.2)]
QT Prolongation and Risk of Sudden Death [see Contraindications (4.2), Warnings and
Precautions (5.3)]
Serotonin Syndrome [see Contraindications (4.3), Warnings and Precautions (5.4), Drug
Interactions (7.1)]
Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.5)]
Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)]
Tardive Dyskinesia [see Warnings and Precautions (5.7)]
Metabolic Changes [see Warnings and Precautions (5.8)]
Rash [see
Warnings and Precautions (5.9)]
Orthostatic Hypotension [see Warnings and Precautions (5.10)]
Falls [see
Warnings and Precautions (5.11)]
Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.12)]
Seizures [see
Warnings and Precautions (5.13)]
Dysphagia [see
Warnings and Precautions (5.14)]
Hyperprolactinemia [see Warnings and Precautions (5.15)]
Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.16)]
Priapism [see
Warnings and Precautions (5.17)]
Body Temperature Regulation [see Warnings and Precautions (5.18)]
- Suicide [see
Warnings and Precautions (5.19)]
6.2
Postmarketing Experience
Additions and/or revisions underlined:
…
Psychiatric Disorders: Insomnia,
mania/hypomania, somnambulism
…
7
Drug Interactions
7.3
Pharmacodynamic Interactions
Newly added information:
…
- Risk
of serotonin syndrome with concomitant therapy with other serotonergic
drugs such as SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids,
lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort [see Contraindications (4.3), Warnings
and Precautions (5.4), Adverse Reactions (6.2)].
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of Geodon have not been
established in pediatric patients.
Geodon was studied in one 4-week, placebo-controlled
trial in patients 10 to 17 years of age with bipolar I disorder. However, the
data were insufficient to fully assess the safety of Geodon in pediatric
patients. Therefore, a safe and effective dose for use could not be established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT
COUNSELING INFORMATION
Newly added information:
Serotonin
Syndrome
Caution patients about the risk of serotonin
syndrome, particularly with the concomitant use of GEODON with other
serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants,
opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and
with drugs that impair the metabolism of serotonin (in particular, MAOIs, which
include those intended to treat psychiatric disorders and also others, such as
linezolid). Instruct patients to contact their health care provider, or report to
the emergency room, should they experience signs or symptoms of serotonin
syndrome [see Contraindication (4.3),
Warnings and Precautions (5.4), Drug Interactions (7.3)].
PATIENT
INFORMATION
Additions and/or revisions underlined:
Do not take GEODON if you:
…
are taking a monoamine
oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are
not sure if you take an MAOI, including linezolid or intravenous methylene
blue.
have stopped taking an MAOI
in the last 14 days.
- are allergic to ziprasidone
or any of the ingredients in GEODON.
…
Other
Important Safety Information
A potentially life-threatening problem called
serotonin syndrome can happen when you take GEODON with certain other
medicines.
See
“Who should NOT take GEODON?”
Call your healthcare provider if you have any of the
following signs and symptoms of serotonin syndrome: agitation, hallucinations,
coma, or other changes in mental status; racing heartbeat, high or low blood
pressure; coordination problems or muscle twitching; nausea, vomiting, or
diarrhea; sweating or fever; muscle rigidity.
Approved Drug Label (PDF)
8
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
(Pregnancy and Lactation Labeling Rule (PLLR) conversion; please refer
to label)
8.2
Lactation
(Pregnancy
and Lactation Labeling Rule (PLLR) conversion; additions and/or revisions
underlined)
Risk Summary
Limited data from
a published case report indicate
the presence of ziprasidone in human
milk. Although there are no
reports of adverse effects on a breastfed infant
exposed to ziprasidone via
breast milk, there are reports of
excess sedation, irritability, poor feeding,
and extrapyramidal symptoms (tremors
and abnormal muscle movements) in infants exposed to
other atypical antipsychotics
through breast milk. There is no information on the effects of ziprasidone on milk production. The developmental
and health benefits of breastfeeding should be considered along with the mother’s
clinical need for GEODON and any potential adverse
effects on the breastfed child
from GEODON or from
the mother’s underlying condition.
Clinical Considerations
Infants exposed to GEODON
should be monitored for
excess sedation, irritability, poor feeding,
and extrapyramidal symptoms (tremors
and abnormal muscle movements).
8.3
Females and Males of Reproductive
Potential
(Newly added subsection)
Infertility
Females
Based on the pharmacologic
action of ziprasidone (D2 antagonism),
treatment with GEODON 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)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions
underlined)
Severe Cutaneous
Adverse Reactions
Pregnancy
Advise
pregnant women to notify
their healthcare provider if they become
pregnant or intend to become
pregnant during treatment
with GEODON. Advise
patients that GEODON
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 exposure
registry that monitors
pregnancy outcomes
in women exposed to GEODON
during pregnancy.
Lactation
Advise
breastfeeding women using GEODON to monitor infants for
excess sedation, irritability, poor
feeding, and extrapyramidal
symptoms (tremors, and abnormal
muscle movements) and to seek medical
care if they notice these
signs.
Infertility
Advise females of reproductive potential that GEODON
may impair fertility due to an increase in serum prolactin levels. The effects on fertility
are reversible.
Patient Information
(Additions and/or
revisions underlined)
What To Tell Your Doctor
Before You Start GEODON
Only
your doctor can decide
if GEODON is right for you. Before
you start GEODON, be sure to tell your doctor if you:
- have had any problem
with the way your heart beats or any heart related illness or disease
any family history of heart disease, including recent heart attack
have had any problem
with fainting or dizziness
are taking
or have recently taken any prescription medicines
are taking
any over-the-counter medicines
you can buy without a prescription, including natural/herbal remedies
have had any problems
with your liver
are pregnant,
might be pregnant,
or plan to get pregnant
- are breastfeeding or plan to breastfeed
Other Important Safety
Information
Before
taking GEODON, tell your doctor if you
are pregnant
or plan on becoming
pregnant.
are breastfeeding or plan to breastfeed. GEODON
can pass into your breast milk. Talk to your healthcare provider about the best way to feed
your baby if you receive GEODON.
Approved Drug Label (PDF)
Boxed Warning
Text
deletions have shortened the section; please refer to label for complete
information.
5
Warnings and Precautions
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Additions
and/or revisions underlined:
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses
of 17 placebo-controlled trials (modal duration of 10 weeks), largely in
patients taking atypical antipsychotic drugs, revealed a risk of death in
drug-treated patients of between 1.6 to 1.7 times the risk of death in
placebo-treated patients. Over the course of a typical 10-week controlled trial,
the rate of death in drug-treated patients was about 4.5%, compared to a rate
of about 2.6% in the placebo group.
Although the causes of death were varied,
most of the deaths appeared to be either cardiovascular (e.g., heart failure,
sudden death) or infectious (e.g., pneumonia) in nature. GEODON is not
approved for the treatment of dementia-related psychosis.
5.2 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
Newly
added subsection:
In placebo-controlled trials in elderly
subjects with dementia, patients randomized to risperidone, aripiprazole, and
olanzapine had a higher incidence of stroke and transient ischemic attack,
including fatal stroke. GEODON is not approved for the treatment of patients
with dementia-related psychosis.
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