INDICATION AND IMPORTANT SAFETY INFORMATION
Fanapt® (iloperidone) is a prescription medication used for
the treatment of schizophrenia in adults.
Deciding to look at alternate medications is something your health care
provider may do. Your health care provider needs to consider that Fanapt®
may change your heart rhythm (meaning there is more time between heartbeats).
When taking other drugs that may cause this same change in heart rhythm,
you are at a higher risk of a serious, even life-threatening medical issue
(torsade de pointes) which may result in sudden death. In many cases, your
healthcare provider may prescribe another medication like Fanapt® first.
Fanapt® needs to be taken as directed starting at a low dose and slowly
increasing the strength. This may delay the control of symptoms in the
first 1 to 2 weeks of treatment.
BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS:
Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk of
death. Fanapt® is not approved for use in patients with dementia-related
psychosis.
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Patients should not use Fanapt® if they have a known allergy to
Fanapt® or its ingredients. Allergic reactions, including anaphylaxis,
rapid swelling of the skin (angioedema), and other symptoms of allergy
(eg, throat tightness; swelling of the throat, face, lips, mouth and
tongue; hives; rash and itching) have been reported.
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An increased risk of stroke has been reported in clinical studies of
elderly people with dementia-related psychosis. Fanapt® is not approved
for use in people with dementia-related psychosis.
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Fanapt® may change your heart rhythm (meaning there is more time between
heartbeats). Heart rhythm changes have occurred in patients taking
Fanapt® and are a risk factor for serious, even life-threatening medical
issues. You should tell your health care provider if you have or have
had heart problems. Contact your health provider right away if you feel
faint or have unpleasant feelings of irregular or forceful heartbeats
as any of these feelings could be a sign of a rare, but serious side
effect that could be fatal. You should not use Fanapt® with other drugs
that are known to cause these same heart rhythm issues.
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Tell your health care provider if you have some or all of the following
symptoms: very high fever, rigid muscles, shaking, confusion, sweating
or increased heart rate and blood pressure. These may be signs of a
condition called neuroleptic malignant syndrome (NMS), a rare but serious
side effect that could be fatal. This may happen with Fanapt® or drugs
like it.
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Abnormal or uncontrollable movements of the face, tongue, or other parts
of the body may be signs of a serious condition called tardive dyskinesia
(TD), which could become permanent. The chance of this condition going
away decreases, depending on how long and how much medication has been
taken. Tell your healthcare provider if you have body movements you can't
control.
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Fanapt® and medicines like it have been associated with metabolic changes
(high blood sugar, high cholesterol and triglycerides, and weight gain)
that can increase cardiovascular/cerebrovascular risks.
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Tell your health care provider if you have diabetes or risk factors for
diabetes (for example, obesity, family history of diabetes) or if you
have unexpected increases in thirst, urination or hunger. If so, your
blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia),
which in some cases can be serious and associated with coma or death,
have been reported in patients taking Fanapt® and medicines like it.
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Changes in cholesterol and triglycerides have been seen in patients taking
Fanapt® and medicines like it. Check with your healthcare provider while
on treatment.
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Some patients may gain weight while taking Fanapt®. Your health care
provider should check your weight regularly.
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Tell your health care provider about any medical conditions that you
have including problems with your liver. Fanapt® is not recommended for
patients with severe liver problems.
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Tell your health care provider if you have a history of or have a
condition that may increase your risk for seizures before you begin
taking Fanapt®.
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Light-headedness or faintness caused by a sudden change in heart rate
and blood pressure when rising quickly from a sitting or lying position
(orthostatic hypotension) has been reported with Fanapt®. This condition
is most common when you start therapy, when restarting treatment, or
when the dose of Fanapt® is increased. You should consult your health
care provider if you have or have had heart problems or conditions that
lead to these sudden changes since Fanapt® should be used with caution
in these patients.
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Fanapt® may increase the risk of falls, which could cause fractures or
other injuries.
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Decreases in infection-fighting white blood cells (WBCs) have been
reported in some patients taking antipsychotic agents. Patients with a
preexisting history of low WBC count or who have experienced a low WBC
count due to drug therapy should have their blood tested and monitored
during the first few months of therapy. Some (including fatal) cases of
agranulocytosis, a serious decrease in specific types of WBCs called
neutrophils or granulocytes, have been reported in drugs like Fanapt®.
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Fanapt® can increase the level of the hormone prolactin. Tell your
healthcare provider if you experience breast enlargement, breast pain,
or breast discharge, abnormal menstrual cycles in females or impotence
in males. If elevated levels of prolactin persist, this may lead to bone
loss.
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Medicines like Fanapt® can impact your body's ability to reduce your
body temperature. You should avoid overheating and dehydration Fanapt®
and medicines like it have been associated with swallowing problems
(dysphagia). If you have or have had swallowing problems, you should
tell your healthcare provider.
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As with many conditions that affect the way you think or feel, thoughts
of suicide may occur. If you get these feelings, seek help immediately
from your health care provider, or local emergency room.
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For males, in the rare event you have a painful or prolonged erection
(priapism) lasting 4 or more hours, stop using Fanapt® and seek
immediate medical attention.
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Fanapt® and medicines like it can affect your judgment, thinking, or
motor skills. You should not drive or operate hazardous machinery,
including automobiles, until you know how Fanapt® affects you.
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The most common side effects for Fanapt® versus placebo were dizziness,
dry mouth, feeling unusually tired or sleepy, stuffy nose, feeling
faint/1ight-headed when standing quickly, racing heartbeat, and weight
gain. The average weight gain in clinical studies lasting 4 to 6 weeks
was 5 pounds. If you experience any of these symptoms, talk with your
health care provider.
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When taking Fanapt®, you should avoid drinking alcohol, and you should
not breastfeed. You should notify your healthcare provider if you become
pregnant or intend to become pregnant while taking Fanapt®. Tell your
healthcare provider about all prescription and non-prescription
medicines and supplements you are taking. Some medications may interact
with Fanapt®.
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To access the full Prescribing Information, including BOXED WARNING,
visit www.Fanapt.com.
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You are encouraged to report negative side effects of prescription drugs
to the FDA.
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Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
