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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

Continuing your child’s or teen’s treatment

Taking medicine every day

Taking medicine is an important part of treating bipolar I disorder. Making sure your child or teen (ages 10-17) is taking SAPHRIS as prescribed can help him or her manage the manic symptoms of bipolar I disorder. Learn more about helping them stay on treatment.

Setting treatment goals and taking steps to reach them

As your child or teen continues their treatment, you may want to discuss their treatment goals with them. You may find that simply having set goals for them can be helpful. It also may be helpful to have a plan you both can follow. Managing symptoms is an important part of the plan. Work closely with their healthcare provider.

Setting Treatment Goals

Write the treatment goals down on a piece of paper:
Sometimes seeing the goals in writing can help you both think more clearly about them.

Share goals with your child’s or teen’s healthcare provider. The healthcare provider can talk about the ways:

  • Symptoms of bipolar I disorder may affect the ability of your child or teen to set realistic goals
  • Managing bipolar I disorder symptoms may help your child or teen as they work toward their goals

Talk with your family members or friends about your child’s or teen’s goals: People who know them well, like teachers and neighbors, can help you both set goals.

Think about your child’s or teen’s goals in small steps: Small steps are likely to help with building confidence. With each step reached, they may see the bigger picture as less out of reach.

Provide motivation: It is important to be fully engaged in your child’s or teen’s treatment plan. This may help convince your child or teen to take an active role in his or her treatment plan, too.

Remind your child or teen to be kind to themselves: Change can be difficult. At times, they may be working steadily toward their goals. And other times they may lose sight of their progress, which can be discouraging. Help them remember that a positive outlook is important.

Try to help your child or teen stay focused: Reminding them how important these goals are in managing their symptoms of bipolar I disorder can be helpful.

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Letting children or teens do what they need to do for themselves

When coping with bipolar I disorder, there may be times when your child or teen may feel like they’re fully in control.

Other times, they may feel like they’ve hit bumps in the road. Because of this, you must teach them that the key to taking care of themselves is realizing that they are worthy of that effort. Sometimes taking care of themselves can be the last thing on their mind. But they must come to realize that their health matters most.

Counseling may help your child or teen, as well as you, deal with the symptoms of bipolar I disorder. Being well also means managing other parts of their life that may affect your child’s or teen’s bipolar I disorder. Staying active, eating well, and getting enough rest are important parts to living a healthy life and may make a difference to you both.

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Support can make a difference to children and teens with bipolar I disorder

It may help to know that:

  • Family education programs are available to educate family members about bipolar I disorder and ways in which they can help
  • Support groups provide a place for people, including children and teens with bipolar I disorder, to meet to help and support one another. Find a list of organizations that may be able to help

Support can also involve helping them understand that taking care of themselves involves taking care of their body, too. Take steps to ensure your child or teen lives a healthy lifestyle, including being active, eating a balanced diet, and getting an adequate amount of rest.

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Click here to go to the next section, Their support team.

For family and friends
Helping them stay on treatment

One important way to show your support is to help your family member or friend stay on treatment.

SAPHRIS—Insurance coverage

Most people with insurance coverage have access to SAPHRIS with no restrictions. This includes people who have private insurance or Medicare Part D. Contact your child’s or teen’s insurance company to learn about coverage for SAPHRIS. You can also talk with your child’s or teen’s healthcare provider.

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.