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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
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How to take SAPHRIS

Be sure to read these instructions carefully and talk with your healthcare provider if you have questions about taking SAPHRIS sublingual tablets.

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

Your healthcare provider will decide how long you should take SAPHRIS tablets. Talk with your healthcare provider if you have questions about how or when to take SAPHRIS.

Before taking SAPHRIS

SAPHRIS is taken in a way that is different from how you may take other medicines. Before taking SAPHRIS:
  • Make sure your hands are dry
  • Do NOT touch the tablet with wet or damp hands. This may cause the tablet to dissolve
  • Do NOT remove the tablet from the tablet pack until you are ready to take it
  • Do NOT eat or drink anything for 10 minutes after taking SAPHRIS

Your SAPHRIS tablets

Saphris Tablets

Read these directions carefully. SAPHRIS is taken in a way that is different from how you may take other medicines. You place SAPHRIS under your tongue. SAPHRIS is not chewed or swallowed.

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.
Step 1


Firmly press and hold thumb button,
then pull out the tablet pack.
  • Do not push the tablet through the tablet pack
  • Do not cut or tear the tablet pack
Step 2


Peel back the colored tab.
Step 3


Gently remove the tablet.
  • Do not split, cut, or crush the tablet
Step 4


Place the whole tablet under tongue and allow it to dissolve completely.
  • Do not chew or swallow the tablet
  • Do not eat or drink for 10 minutes
Step 5


Slide the tablet pack back into case until it clicks.

After taking SAPHRIS:

  • Your tongue may feel numb for a little while after taking SAPHRIS. Talk with your healthcare provider if you have questions
  • Do NOT eat or drink anything for 10 minutes after taking SAPHRIS. Eating or drinking during this time may affect how well SAPHRIS works
It is important for you to know about the possible risks and side effects of SAPHRIS.

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.


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The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Allergan under license from Merck Sharp & Dohme B.V.
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