
Healthcare Providers • Prescribing Information

What is bipolar I disorder?

If you have bipolar I disorder or care about someone who does, you know firsthand how hard it can be. Like other types of mental illness, bipolar I disorder is a disorder of the brain.

Bipolar I disorder is a serious illness. And it does not go away. With bipolar I disorder, there may be times when you feel like you’re in the driver’s seat. You know where you’re going and how to get there. At other times, you may feel like you’ve hit bumps in the road. Throughout your life, you will need to manage the symptoms. Learn more about the symptoms of bipolar I disorder.

Diagnosing bipolar I disorder A person may have symptoms for years before receiving a correct diagnosis of bipolar I disorder. For many people with bipolar I disorder, the path to a diagnosis is long and hard.

Causes of bipolar I disorder Scientists are working hard to find the causes of bipolar I disorder. But so far they still do not know exactly what causes it. Like other illnesses, bipolar I disorder may have several causes. Most experts believe that it is caused by a combination of factors.

Here is what is believed about the causes of bipolar I disorder:

Differences in brain chemistry and structure may be involved. Some imaging studies show that the brains of people with bipolar I disorder are different from the brains of people without it
Bipolar I disorder is known to run in families. Studies show that genes play a role in the disorder
In someone at genetic risk for bipolar I disorder, a stressful event—such as the loss of a loved one, an illness, money problems, or other major life changes—may set off the first episode of the disorder
In some people, drug or alcohol use may trigger the disorder. Learn steps you can take for healthy living

Counseling and the help of a support team may make a difference for people living with bipolar I disorder. Taking medicine may also be important. Learn more.

When talking with
your healthcare provider

You may want to ask:

Do I have bipolar I disorder?
What does it mean to have bipolar I disorder?

Print a list of questions to ask your healthcare provider.

For family and friends

Be aware of triggers

Certain events (such as a death in the family or a job loss) and certain behaviors (such as drug or alcohol use) may cause symptoms to appear or to get worse. Watch for triggers in your family member or friend.

Read showing your support to learn why it’s important to have a plan for getting help.

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).

Important Safety 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 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.

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

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.

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