SAPHRIS is a prescription medicine approved for the treatment of schizophrenia in adults.
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
- 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
- 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;
What should I tell my healthcare provider before taking SAPHRIS?
Tell your healthcare provider about any medical conditions and if you have or have
- Diabetes or high blood sugar in you or your family
- High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels
- 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
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
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,
- 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.