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Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (see Boxed Warning). Continued below

Common questions about SAPHRIS for bipolar I disorder

Q: What is SAPHRIS?
A: SAPHRIS is a type of medicine called an atypical antipsychotic. It is approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. It may be taken alone or with a mood stabilizer (lithium or valproate).
Q: Who should not take SAPHRIS?
A: People who should NOT take SAPHRIS include:
  • Elderly people who have dementia-related psychosis
  • People who are allergic to any ingredients in SAPHRIS
  • Children under the age of 18 years
  • People with severe liver problems
  • People who have certain heart conditions such as irregular heartbeats or people taking certain medicines that may cause an irregular heartbeat
Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended during treatment with SAPHRIS.

Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (see Boxed Warning). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.
Q: What symptoms of bipolar I disorder does SAPHRIS help with?
A: SAPHRIS helps manage the acute symptoms of manic or mixed episodes associated with bipolar I disorder. A mixed episode includes symptoms of mania and depression.
Q: What are the most common side effects of SAPHRIS?
A: In clinical trials, the most common side effects that occurred with SAPHRIS were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness.
Q:  If I was taking a different medicine or medicines before, how should I start taking SAPHRIS?
A: Follow your healthcare provider's instructions about how and when to start SAPHRIS.
Q: How do I take SAPHRIS?
Q: How quickly does SAPHRIS dissolve?
A: SAPHRIS starts to dissolve right after you place the tablet under your tongue. It is important that you do not eat or drink for at least 10 minutes after taking SAPHRIS and that you take it exactly as prescribed by your healthcare provider.
Q: How do I store SAPHRIS?
A: SAPHRIS should be stored at room temperature. Be sure to keep it out of the reach of children. Do not take SAPHRIS if it has not been stored correctly. Tell your healthcare provider if you need another prescription for SAPHRIS.
Q: Can I put SAPHRIS in a weekly pillbox?
A: No. Keep SAPHRIS in the tablet pack that it comes in. That will ensure that the tablets stay dry, which is important because the tablets may dissolve if they get wet. If you want to be sure you've remembered to take SAPHRIS, you might want to use a calendar and put a check mark every time you take a tablet.
Q: What doses is SAPHRIS available in?
A: SAPHRIS is available in 2 doses: 5 milligrams and 10 milligrams. Your healthcare provider will decide which dose is right for you.
Q: What if I am having trouble paying for my Forest medicine?
A: Forest Laboratories, Inc. may be able to help. Call 1-800-851-0758 for more information.

SAPHRIS is a prescription medicine approved for the treatment of manic or mixed episodes associated with bipolar I disorder in adults. It may be taken alone or with lithium or valproate.

Important Risk Information

Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (See Boxed Warning). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Serious allergic reaction: Do not take SAPHRIS (asenapine) if you are allergic to any of its ingredients. Seek immediate emergency assistance if you have symptoms of a serious allergic reaction, such as difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.

Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. These can be signs of a rare and potentially fatal side effect (NMS) that has been reported with SAPHRIS and similar medicines. Treatment should be stopped if you have NMS.

Tardive dyskinesia (TD): Tell your healthcare provider if you experience uncontrollable movements of the face, tongue, or other parts of the body. These could be signs of a serious and sometimes permanent side effect (TD). The risk for developing TD and the chance that it will become permanent is thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if the person stops taking the medicine.

High blood sugar: If you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with SAPHRIS. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.

Weight gain: Some patients may gain weight while taking SAPHRIS. Your healthcare provider should check your weight regularly.

Also tell your healthcare provider if:
  • You have or had low white blood cell counts, because low white blood cell counts and related conditions have been reported with SAPHRIS and similar medicines
  • You have any reactions under your tongue (where you place SAPHRIS), such as sores, blisters, peeling/sloughing or inflammation, because these reactions have been reported with SAPHRIS
  • You have certain heart conditions such as irregular heartbeats, or take certain medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
  • You have a seizure disorder, have had seizures, or have conditions that increase your risk for seizures
  • You are taking or plan to take prescription and over-the-counter medicines, because there is a risk for drug interactions with SAPHRIS
  • You have thoughts of suicide or of hurting yourself or others. Symptoms of bipolar I disorder or schizophrenia may include these thoughts. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away
  • You have or have had swallowing problems, because SAPHRIS and medicines like it have been associated with swallowing problems
  • You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
  • You are pregnant or planning to get pregnant while taking SAPHRIS
Other important information to remember:
  • Get up slowly after sitting or lying down to avoid getting dizzy, especially at the start of treatment, or when your dose is increased. Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with SAPHRIS
  • Do NOT drive or use dangerous machines until you know how SAPHRIS affects you, because SAPHRIS and medicines like it can affect your judgment, thinking, and motor skills
  • Be careful when exercising or when doing things likely to cause dehydration or make you warm, because SAPHRIS may make you more sensitive to heat. You may have trouble cooling off
  • Do NOT drink alcohol
  • Breastfeeding is NOT recommended
  • The most common side effects that occurred with SAPHRIS were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness

This is not a complete summary of safety information. Please discuss the full Prescribing Information for SAPHRIS with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

Please click here for Prescribing Information, including the Boxed Warning about increased risk of death in elderly people with dementia-related psychosis (a severe mental health problem), and discuss it with your healthcare provider.

© 2013 Merck Sharp & Dohme B.V.; used by Forest Laboratories, Inc. under license.
© 2014 Forest Laboratories, Inc.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Forest Laboratories, Inc.
under license from Merck Sharp & Dohme B.V.
SPH17003 05/14