How SAPHRIS can help
In clinical studies, SAPHRIS was proven to help manage the manic symptoms of bipolar I disorder in adults.
SAPHRIS helps with manic symptoms
The tables below show information about SAPHRIS and what this information can mean to you.
Important to know
What that means to you
In clinical studies, SAPHRIS was proven to work as an acute treatment of manic or mixed episodes of bipolar I disorder in adults.
In the clinical studies, measurements were used to rate the severity of manic symptoms. People who took SAPHRIS had improved scores on those measurements.
This means their manic symptoms were less severe than the symptoms of people who did not take medicine.
Taking SAPHRIS may help manage some of your manic symptoms.
Knowing that SAPHRIS has helped others in clinical studies may give you hope that it may work for you.
SAPHRIS also helps when taken with a mood stabilizer (lithium or valproate)
Important to know
What that means to you
In a clinical study, SAPHRIS was proven to help when taken with a mood stabilizer—lithium or valproate.
You may be taking lithium or valproate as part of your treatment plan. That's one important part of managing your bipolar I disorder.
In the clinical study, people whose manic symptoms were only partly helped after at least 2 weeks of treatment with lithium or valproate were also given SAPHRIS. Symptoms were less severe when people also took SAPHRIS.
The good news is that adding SAPHRIS to lithium or
valproate may help manage your manic symptoms even more.
Be sure to talk with your healthcare provider
to learn if SAPHRIS is an option for you. It is important for you to know about the possible risks and side effects of SAPHRIS.
Keeping track of your progress
Keep track of how you are doing. Use the online progress tracker
at the start of your treatment with SAPHRIS and during your treatment, especially before each visit with your healthcare provider. Share your completed tracker with your healthcare provider.
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 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.
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
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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