IMPORTANT RISK INFORMATION
What is the most important information I should know about SAPHRIS?
Elderly people with dementia-related psychosis (having lost touch with reality due
to confusion and memory loss) taking antipsychotic drugs are at an increased risk for
death. SAPHRIS is not approved for treating people with dementia-related psychosis.
SAPHRIS may cause serious side effects, including:
Stroke (which can be fatal) in elderly people with dementia
Neuroleptic malignant syndrome (NMS): Call your healthcare provider right away if
you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure;
or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS. SAPHRIS
should be stopped if you have NMS
Tardive dyskinesia (TD): Tell your healthcare provider if you cannot control the movements
of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent
side effect called TD. Risk of developing TD and the chance that it will become permanent are thought
to increase the longer a person takes the medicine and the more medicine a person takes over time. TD
can develop even after a person has been taking the medicine for a short time at low doses. TD may not
go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS
Problems with your metabolism, which may increase your risk for heart disease or stroke, such as:
High blood sugar and diabetes: If you have diabetes or risk factors for diabetes
(eg, being overweight or family history of diabetes), your blood sugar should be tested before
you start SAPHRIS and regularly during treatment. Complications of diabetes can be serious and
even life threatening. Tell your healthcare provider if you have symptoms such as feeling very
thirsty or very hungry, urinating more than usual, or feeling weak
Increased blood cholesterol or triglycerides: Your healthcare provider may decide to
check your cholesterol and triglyceride levels during treatment
Weight gain: Weight gain has been reported with SAPHRIS. Your healthcare provider
should check your weight regularly
Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting
or lying position. Ask your healthcare provider about ways to reduce feeling dizzy or lightheaded upon standing,
such as sitting on the edge of the bed for several minutes before getting up in the morning or slowly rising after sitting
Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs,
including SAPHRIS. This may increase your risk of infection. Very low white blood cell counts, which can be fatal,
have been reported with other antipsychotics
Increases in prolactin levels: Tell your healthcare provider if you experience a lack of menstrual periods,
leaking or enlarged breasts, or impotence, because SAPHRIS may raise the levels of prolactin. The levels may continue
to be high when SAPHRIS is used over time
Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how
SAPHRIS affects you. SAPHRIS may make you drowsy
Increased body temperature: SAPHRIS may make you more sensitive to heat. You may have trouble cooling off.
Be careful when exercising or when doing things likely to cause dehydration or make you warm
Suicide: Tell your healthcare provider right away or go to an emergency room if you have thoughts of suicide
or of hurting yourself or others. People with schizophrenia and bipolar disorder may have these thoughts
Difficulty swallowing: SAPHRIS and medicines like it have been associated with difficulty swallowing
Who should not take SAPHRIS?
Do not take SAPHRIS if you have certain liver problems, or if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness).
What should I tell my healthcare provider before taking SAPHRIS?
Tell your healthcare provider about any medical conditions and if you have or have had:
Diabetes or high blood sugar in you or your family
High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol
Seizures or conditions that increase your risk for seizures
Low or high blood pressure
Low white blood cell count
Certain heart problems such as irregular heartbeats or are at risk for these problems, or if you take medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. SAPHRIS may cause harm to your unborn baby. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including SAPHRIS, during pregnancy. For information, contact the program at
1-866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. SAPHRIS may affect the way other medicines work, and other medicines may affect how SAPHRIS works.
What are possible side effects of SAPHRIS?
The most common side effects in adults were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness
Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or inflammation. Choking has also been reported
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of SAPHRIS.
Please see the full Prescribing Information, including Boxed Warning.