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Important Risk Information

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. Continued below

How SAPHRIS can help children and teens (ages 10-17)
with bipolar I disorder

Medicine—along with counseling and support—is an important part of the treatment of bipolar I disorder in your child or teen. It can help with managing their symptoms

SAPHRIS (asenapine) is an FDA-approved prescription medicine for children and teens ages 10 to 17. It can be used alone for the acute treatment of manic or mixed episodes associated with bipolar I disorder.

SAPHRIS was specifically tested in children and teens ages 10 to 17 with bipolar I disorder

In a clinical study, SAPHRIS helped control overall manic symptoms across all 3 dosage strengths.

In a large pediatric bipolar mania clinical study
Effective across all 3 dosage strengths
What that means to you and your child or teen

More than 400 children and teens (ages 10-17) with acute manic symptoms of bipolar I disorder participated in this study in which 302 were given SAPHRIS and 101 were given a sugar pill (placebo).

SAPHRIS reduced symptoms of mania in manic or mixed episodes associated with bipolar I disorder, starting at the lowest dose.

In the 3-week clinical study:

1) SAPHRIS was tested in 3 dosage groups: 2.5 mg, 5 mg, and 10 mg twice a day.

2) All participants started on 2.5 mg twice a day.

3) If they were put into the 5 mg group, the dose was increased to 5 mg twice a day after 3 days.

4) If they were put into the 10 mg group, the dose was increased from 2.5 mg to 5 mg twice a day after 3 days and then to 10 mg twice a day after another 3 days.

SAPHRIS also reduced overall severity of bipolar l illness, as rated by doctors using a research scale.

Having 3 effective dosage strengths gives their healthcare provider the ability to find the best dose for them.

Watching your child or teen go through a manic or mixed episode can be difficult. That is why it is important to talk with their healthcare provider about how to best handle these situations.

You may want to ask about how to cope with your child’s or teen’s behavior and if there are any support groups that you and/or your child or teen can join.

Making appropriate treatment choices with your child’s or teen’s healthcare provider is the next step in helping your child or teen with their bipolar I disorder.

Be sure to talk with your child’s or teen’s healthcare provider to learn if SAPHRIS is the right treatment option. It is also important for you both to know about the possible risks and side effects of SAPHRIS.

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, 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 before and regularly during treatment
  • 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
  • Falls: SAPHRIS may increase risk of falls, which could cause fractures or other injuries
  • 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
  • Seizures
  • 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
  • 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. The most common side effects in children (ages 10-17) were sleepiness, dizziness, strange sense of taste, numbing of the mouth, nausea, increased appetite, feeling tired, and weight gain
  • 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.