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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

Common questions about SAPHRIS for bipolar I disorder in children
and teens ages 10 to 17

Q: What is SAPHRIS?

A: 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.

Q: Who should not take SAPHRIS?

A: People who should NOT take SAPHRIS include:

  • People who are allergic to any ingredients in SAPHRIS. Get emergency medical help if you are having an allergic reaction (eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or lightheadedness)
  • People with severe liver problems

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 of death. SAPHRIS is not approved for treating people with dementia-related psychosis.

Q: Will SAPHRIS cause sleepiness?

A: In the 3-week clinical study, about 50% of children and teens (10-17 years of age) taking SAPHRIS complained at least once of feeling sleepy, compared with 12% who were on a sugar pill (placebo). Among those who felt sleepy while on SAPHRIS, the vast majority described it as either mild or moderate. Do not let your child or teen drive or use dangerous machinery until you know how SAPHRIS affects him or her. SAPHRIS may make them drowsy.

Q: I’ve heard some medicines for bipolar l disorder can cause weight gain. Is the same true for SAPHRIS?

A: SAPHRIS has been associated with weight gain. On average, children and teens taking SAPHRIS gained about 3 to 4 pounds compared with those on placebo who gained about a pound during the 3-week clinical study. During treatment with SAPHRIS, their healthcare provider should check their weight regularly.

Q: Is SAPHRIS associated with restlessness or muscle stiffness?

A: In the 3-week clinical study of children and teens, ages 10 to 17, up to 5% of those taking SAPHRIS and 3% of those taking placebo showed signs of restlessness or muscle stiffness. If these symptoms occur, contact your child’s or teen’s healthcare provider. In some cases, muscle stiffness may become permanent.

Q: How does SAPHRIS affect blood sugar?

A: Increases in blood sugar were reported with SAPHRIS in the clinical study. If your child or teen has diabetes or risk factors for diabetes (eg, being overweight or a family history of diabetes), his or her blood sugar should be tested before starting SAPHRIS, and regularly during treatment. Some patients treated with atypical antipsychotics, like SAPHRIS, have had extremely high blood sugar, which led to coma or death. Tell the healthcare provider if your child or teen has symptoms of high blood sugar, such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak.

Q: How does SAPHRIS affect cholesterol or triglycerides?

A: Increases in cholesterol and triglycerides were reported with SAPHRIS in the clinical study. Your child’s or teen’s healthcare provider may decide to check his or her cholesterol and triglyceride levels during treatment.

Q: What are possible side effects of SAPHRIS?

A:
  • In clinical trials, the most common side effects in children (ages 10-17): 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 child's or teen's healthcare provider if they experience any side effect that bothers them or that does not go away. These are not all of the possible side effects of SAPHRIS.

Learn more and see risks and side effects of SAPHRIS.

Q: Which symptoms of my child’s or teen’s bipolar I disorder does SAPHRIS help with?

A: SAPHRIS is for the acute treatment of manic or mixed episodes associated with bipolar I disorder in children and teens (ages 10-17). Talk to your child’s or teen’s doctor about their specific symptoms and treatment.

Q: If my child or teen is currently taking another medicine, or if they were taking another medicine to treat the
symptoms of bipolar I disorder, how should my child or teen start taking SAPHRIS?

A: Follow your child’s or teen’s healthcare provider's instructions about how to appropriately start on SAPHRIS.

Q: How should my child or teen take SAPHRIS?

A: Click here for instructions on how to take SAPHRIS.

Q: How quickly does SAPHRIS dissolve?

A:. The whole tablet should be placed under the tongue to allow to dissolve completely. Your child or teen should not chew or swallow the tablet. SAPHRIS dissolves in saliva within seconds, helping your child or teen get the medicine his or her healthcare provider prescribed.

It is important that the SAPHRIS tablet is not removed from the tablet pack until your child or teen is ready to take it. Use dry hands when handling the tablet, and do not split, cut, or crush it. Also, it is important that your child or teen does not eat or drink for at least 10 minutes after taking SAPHRIS, and that they take it exactly as prescribed by their healthcare provider.

Instructions on how to take SAPHRIS.

Q: Can I put SAPHRIS in a weekly pillbox?

A: No. Keep SAPHRIS in the tablet pack that it comes in. The packaging was designed to help the tablets stay dry, which is important because if the tablets get wet, they may dissolve. If you want to be sure your child or teen has remembered to take SAPHRIS, you might want to use a calendar and have them put a check mark on it every time they take a tablet.

Q: What doses is SAPHRIS available in?

A: For patients ages 10 to 17, SAPHRIS is available in 2.5 mg, 5 mg, and 10 mg tablets. The healthcare provider will decide which dose is right for your child or teen.

Q: What if I’m having trouble paying for SAPHRIS?

A: Allergan, Inc., may be able to help. Call 1-800-851-0758 or visit www.Allergan.com/pap for more information.

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
  • 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
  • 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 children (ages 10-17): 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.