How SAPHRIS can help
In clinical studies, SAPHRIS was proven to help manage the manic symptoms of
bipolar I disorder in adults.
SAPHRIS helps with manic symptoms
The tables below show information about SAPHRIS and what this information can mean
Important to know
What that means to you
In clinical studies, SAPHRIS was proven to work as an acute treatment of manic or
mixed episodes of bipolar I disorder in adults.
In the clinical studies, measurements were used to rate the severity of manic symptoms.
People who took SAPHRIS had improved scores on those measurements.
This means their manic symptoms were less severe than the symptoms of people who
did not take medicine.
Taking SAPHRIS may help manage some of your manic symptoms.
Knowing that SAPHRIS has helped others in clinical studies may give you hope that
it may work for you.
SAPHRIS also helps when taken with either lithium or valproate
Important to know
What that means to you
In a clinical study, SAPHRIS was proven to help when taken with a mood stabilizer—lithium
You may be taking lithium or valproate as part of your treatment plan. That's one
important part of managing your bipolar I disorder.
In the clinical study, people whose manic symptoms were only partly helped after
at least 2 weeks of treatment with lithium or valproate were also given SAPHRIS.
Symptoms were less severe when people also took SAPHRIS.
The good news is that adding SAPHRIS to lithium or valproate may help manage your
manic symptoms even more.
Be sure to talk with your healthcare
to learn if SAPHRIS is an option for you. It is important for you
to know about the possible risks and
side effects of SAPHRIS.
Who should not take SAPHRIS?
People who should NOT take SAPHRIS include:
- Elderly people who have dementia-related psychosis
- People who are allergic to any ingredients in SAPHRIS
- Children under the age of 18 years
- People with severe liver problems
- People who have certain heart conditions such as irregular heartbeats or people
taking certain medicines that may cause an irregular heartbeat
Tell your healthcare provider if you are breastfeeding or planning to breastfeed.
Breastfeeding is not recommended during treatment with SAPHRIS.
SAPHRIS is a prescription medicine approved for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. It may be taken alone or with lithium or valproate.
Important Risk Information
Elderly people with dementia-related psychosis (a severe mental health problem) taking
atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared
with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people
with dementia-related psychosis (See Boxed Warning). An increased risk for stroke and ministroke
has been reported in elderly people with dementia-related psychosis.
Serious allergic reaction: Do not take SAPHRIS (asenapine) if you are allergic to any of its
ingredients. Seek immediate emergency assistance if you have symptoms of a serious allergic
reaction, such as difficulty breathing; itching; swelling of the face, tongue, or throat; or
Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have high
fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or
muscle pain and weakness. These can be signs of a rare and potentially fatal side effect (NMS)
that has been reported with SAPHRIS and similar medicines. Treatment should be stopped if you
Tardive dyskinesia (TD): Tell your healthcare provider if you experience uncontrollable movements
of the face, tongue, or other parts of the body. These could be signs of a serious and sometimes
permanent side effect (TD). The risk for developing TD and the chance that it will become permanent
is thought to increase the longer a person takes the medicine and the more medicine a person takes
over time. TD can develop after a person has been taking the medicine for a short time at low doses,
although this is much less common. There is no known treatment for TD, but it may go away partially
or completely if the person stops taking the medicine.
High blood sugar: If you have diabetes or risk factors for diabetes, such as being overweight or
a family history of diabetes, your blood sugar should be tested at the beginning of and throughout
treatment with SAPHRIS. Complications of diabetes can be serious and even life threatening. Tell
your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty
all the time, going to the bathroom a lot, or feeling weak or hungry.
Weight gain: Some patients may gain weight while taking SAPHRIS. Your healthcare provider should
check your weight regularly.
Also tell your healthcare provider if:
- You have or had low white blood cell counts, because low white blood cell counts
and related conditions have been reported with SAPHRIS and similar medicines
- You have any reactions under your tongue (where you place SAPHRIS), such as sores,
blisters, peeling/sloughing or inflammation, because these reactions have been
reported with SAPHRIS
- You have certain heart conditions such as irregular heartbeats, or take certain
medicines that can cause irregular heartbeats, because SAPHRIS should be avoided
in these circumstances
- You have a seizure disorder, have had seizures, or have conditions that increase
your risk for seizures
- You are taking or plan to take prescription and over-the-counter medicines, because
there is a risk for drug interactions with SAPHRIS
- You have thoughts of suicide or of hurting yourself or others. Symptoms of bipolar I
disorder or schizophrenia may include these thoughts. If you have these thoughts at
any time, tell your healthcare provider or go to an emergency room right away
- You have or have had swallowing problems, because SAPHRIS and medicines like it have
been associated with swallowing problems
- You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence,
because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may
continue to be high when SAPHRIS is used over time
- You are pregnant or planning to get pregnant while taking SAPHRIS
Other important information to remember:
- Get up slowly after sitting or lying down to avoid getting dizzy, especially at the
start of treatment, or when your dose is increased. Light-headedness or faintness
caused by a sudden change in heart rate and blood pressure when rising quickly from
a sitting position has been reported with SAPHRIS
- Do NOT drive or use dangerous machines until you know how SAPHRIS affects you,
because SAPHRIS and medicines like it can affect your judgment, thinking, and motor
- Be careful when exercising or when doing things likely to cause dehydration or make you
warm, because SAPHRIS may make you more sensitive to heat. You may have trouble cooling
- Do NOT drink alcohol
- Breastfeeding is NOT recommended
- The most common side effects that occurred with SAPHRIS were sleepiness, dizziness,
uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of
the mouth, and restlessness
This is not a complete summary of safety information. Please discuss the full Prescribing
Information for SAPHRIS with your doctor.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call