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Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs, including SAPHRIS, are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis. Continued below
My health matters to me.

Living with bipolar I disorder

Bipolar I disorder is a serious mental illness. But there is good news. Medicine, counseling, and support may help make a difference. When you are living with bipolar I disorder, it is also important to know about triggers and have a plan for what to do if triggers occur.

Medicine is one important part of treatment for bipolar I disorder:

It is important to know that:
  • Medicine does not cure bipolar I disorder
  • Medicine can help manage certain symptoms of bipolar I disorder

Counseling can help people with bipolar I disorder

Counseling can help people with bipolar I disorder to:
  • Take a more active role in managing the disorder
  • Recognize symptoms and triggers
  • Take a more active role in managing the disorder
  • Recognize symptoms and triggers
  • Have a plan for getting help
  • Learn to change harmful or negative thoughts or actions
  • Improve communication and problem-solving skills
  • Manage daily routines

Support can make a difference to people with bipolar I disorder:

It may help you to know that:
  • Family education programs allow family members to learn about bipolar I disorder and ways they can help
  • Support groups provide a place for people with bipolar I disorder to meet to help and support one another. Find a list of organizations that may be able to help
It may help you to know that:
  • Family education programs allow family members to learn about bipolar I disorder and ways they can help
  • Support groups provide a place for people with bipolar I disorder to meet to help and support one another. Find a list of organizations that may be able to help
Steps you can take for healthy living include eating a balanced diet, being active, and getting enough rest. Taking care of yourself involves taking care of your body, too.

Learning about triggers

As you are working toward your goals, you will want to try to avoid triggers. These are events or situations that can cause your symptoms to get worse. Knowing your triggers may be helpful to you.

For some people, triggers may include:
  • Not getting enough sleep or sleeping too much
For some people, triggers may include:
  • Not getting enough sleep or sleeping too much
  • Using alcohol or drugs
  • Going through a stressful time

You may want to think about what triggers cause your symptoms to return or get worse. Knowing your triggers may help you avoid them. Your healthcare providers, family members, or friends can tell you the triggers they have noticed. And they can share their thoughts about how those triggers seemed to affect you.

Avoiding triggers makes sense. And many times it is possible. For example, you can set up routines to follow each day. And you can try to get enough sleep each night. Keep in mind, though, that there will still be ups and downs with bipolar I disorder. But knowing your triggers and having a plan may make a difference.

Making a plan for what to do if triggers occur

Sometimes it is not possible to avoid triggers, such as the stress caused by moving from one home to another or changing jobs. By knowing your triggers, you can plan ahead for what to do if they occur.

As part of your plan for what to do if a trigger occurs, be sure to:
  • Tell your healthcare provider what you are going through and about any symptoms or changes that you notice
  • Ask for help from your family members or friends
  • Keep taking SAPHRIS as your healthcare provider has told you
  • Have a written plan for getting help if your symptoms get worse. Your plan should include the telephone numbers of people to call if you need their help

When talking with
your healthcare provider
You may want to ask:
  • Do I need medicine to help manage bipolar I disorder symptoms?
  • What medicine do you think is right for me?
  • Can you help me find a counselor and support group?
 
For family and friends
Going to appointments

It may help to go to healthcare provider appointments with your family member or friend. You can ask questions and hear information directly. That can be reassuring to your family member or friend.

You may want to attend family education programs or support groups. There are a number of support organizations to help you.


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.

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