Important risk and side effect information

Who should not take SAPHRIS?

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 a history of irregular heartbeats or who take certain medicines that may cause irregular heartbeats 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.

	What should I know about a possible serious allergic reaction?
	Do not take SAPHRIS 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.

	What is neuroleptic malignant syndrome (NMS)?
	NMS is a rare and potentially fatal side effect reported with SAPHRIS and similar medicines. Call 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. Treatment should be stopped if you have NMS.

When talking with
your healthcare provider

You may want to ask:

• If I’m having a side effect, how should I contact you?
• Are there steps I can take if I have side effects?
• Can I still take my other medicines during my treatment with SAPHRIS?

Print a list of questions to ask your healthcare provider.

	What is tardive dyskinesia (TD)?
	TD is a serious and sometimes permanent side effect reported with SAPHRIS and similar medicines. TD includes uncontrollable movements of the face, tongue, and other parts of the body. 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.

	Will SAPHRIS affect my blood sugar?
	High blood sugar and diabetes have been reported with SAPHRIS.  If you have diabetes or risk factors for diabetes, such as being overweight or having 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.
	Will I gain weight when I take SAPHRIS?
	Some patients may gain weight while taking SAPHRIS. In short-term clinical studies, people taking SAPHRIS gained about 3 pounds on average. About 6 in every 100 people studied gained a significant amount of weight (7% or more of their body weight). People taking a placebo in those studies gained less than 1 pound on average. And less than 1 in every 100 people taking placebo gained a significant amount of weight. Your healthcare provider should check your weight regularly. Talk with your healthcare provider about ways to control weight, such as eating a healthy, balanced diet and exercising.
	What else should I tell my healthcare provider?
	You should 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 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
	What other important information should I 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

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).

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.

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

SAPHRIS is a registered trademark of N.V. Organon, a subsidiary of Merck & Co., Inc.