This site is intended only for residents of the United States, its territories, and Puerto Rico.


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.

Continuing your treatment

Taking medicine every day

Taking medicine is an important part of treating bipolar I disorder. Taking SAPHRIS can help you manage the symptoms of bipolar I disorder. It’s important to take your medicine every day as prescribed. Learn more about staying on treatment.

Doing what you need to do for yourself

When you are coping with bipolar I disorder, there may be times when you feel like you’re in the driver’s seat. You know where you are going and how to get there. At other times, you may feel as if you’ve hit bumps in the road. Part of taking care of yourself is realizing that you are worth taking care of. Sometimes taking care of yourself can be the last thing on your list. You may feel too busy or too focused on the needs of other people in your life. But you matter, too.

Counseling may help you deal with symptoms of bipolar I disorder. Being well also means managing other parts of your life that may affect your bipolar I disorder. That’s why being active, eating well, and getting enough rest are also parts of living a healthy life.

Setting treatment goals and taking steps to reach them

As you continue your treatment, you may want to think about your treatment goals. You may find that simply having goals can be helpful. It also may be helpful to have a plan you can follow. Managing your symptoms is an important part of your plan. And so is working closely with your healthcare provider.

When setting your treatment goals, you may want to:
  • Write your treatment goals down on a piece of paper. Sometimes seeing your goals in writing can help you think more clearly about them
  • Share your goals with your healthcare provider. Your healthcare provider can talk with you about the ways:
    • Symptoms of bipolar I disorder may affect your ability to set realistic goals
    • Managing your bipolar I disorder symptoms may help you as you are working toward your goals
  • Talk with your family members or friends about your goals. People who know you well can help you set goals that are right for you
  • Think about your goals in small steps. You may build confidence with each step you take. And your goals may seem more doable
  • Be kind to yourself. Change can be hard. At times, you may be working steadily toward your goals. And other times you may lose sight of them. That is understandable. Try to focus once more on how important your goals are to you

Learning what can help you

You are working hard to take care of yourself and stay on track. Knowing what can help you is important. Learn what you may be able to do to help yourself and what may cause problems for you.


May help you
  • Taking medicines as prescribed
  • Not using alcohol
  • Taking medicines as prescribed
  • Not using alcohol
  • Not using illegal drugs
  • Having a routine
  • Sleeping and waking up at regular times every day
  • Having a support system
    • Healthcare professionals
    • Family
    • Friends
    • Others with bipolar I disorder
    • Counseling
    • Self-help groups

May cause problems for you
  • Stopping medicine without talking with your healthcare provider
  • Using alcohol
  • Stopping medicine without talking with your healthcare provider
  • Using alcohol
  • Using illegal drugs
  • Changing your usual sleep schedule
  • Not staying in touch with your support system
  • Changes in your social or work roles
  • Stress
For family and friends
Healthy living and
staying on treatment

One important way to show your support is to help your family member or friend stay on treatment. You can also suggest steps for healthy living.



 
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 insurance company to learn about your coverage for SAPHRIS. You can also talk with your 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, 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.

The product information provided in this site is intended only for residents of the United States. The products discussed on this site may have different product labeling outside of the United States. The health information described on this site is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.


Allergan® and its design are trademarks of Allergan, Inc.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Allergan under license from Merck Sharp & Dohme B.V.
© 2017 Merck Sharp & Dohme B.V.; used by Allergan under license.
All other trademarks are the property of their respective owners.
© 2017 Allergan. All rights reserved.
SPH39730_v2 06/17