Dementia-Related Psychosis
Saphris is not approved for the treatment of dementia-related psychosis.
Older adults with dementia-related psychosis who take antipsychotic medications have an increased risk of death and may also have a higher risk of stroke or other serious cardiovascular events.
Neuroleptic Malignant Syndrome
Saphris can rarely cause neuroleptic malignant syndrome (NMS), a serious reaction to antipsychotic medications.
Seek immediate medical attention if you develop symptoms such as:
- High fever
- Severe muscle stiffness
- Confusion
- Heavy sweating
- Fast or irregular heartbeat
- Changes in blood pressure
NMS is a medical emergency.
Tardive Dyskinesia
Long-term use of Saphris may cause tardive dyskinesia, a condition involving involuntary and sometimes persistent movements.
Symptoms may include:
- Lip smacking
- Tongue movements
- Facial grimacing
- Repetitive movements of the arms or legs
Contact your healthcare provider if you notice new or unusual movements.
Blood Sugar, Weight, and Cholesterol Changes
Saphris may cause metabolic changes, including:
- Increased blood sugar
- Weight gain
- Increased cholesterol
- Increased triglycerides
Your healthcare provider may monitor your weight, blood sugar, and lipid levels during treatment.
Tell your healthcare provider if you develop increased thirst, frequent urination, unusual hunger, or unexplained weight changes.
Heart Problems
Tell your healthcare provider if you have a history of:
- Heart attack
- Heart failure
- Irregular heart rhythm
- Low blood pressure
- Fainting
Saphris may affect heart rhythm or blood pressure in some patients.
Dizziness and Fainting
Saphris may cause dizziness, lightheadedness, or fainting, especially when standing up quickly.
Rise slowly from sitting or lying positions and use caution until you know how the medication affects you.
Drowsiness and Reduced Alertness
Saphris may cause drowsiness or reduced alertness.
Avoid driving, operating machinery, or performing other activities that require concentration until you know how Saphris affects you.
Seizure Risk
Tell your healthcare provider if you have a history of seizures or a condition that increases seizure risk.
Saphris may lower the seizure threshold in some patients.
Drug Interactions
Saphris can interact with other medications.
Tell your healthcare provider about all prescription medications, over-the-counter products, vitamins, supplements, and herbal products you use.
Some medications may increase drowsiness, affect heart rhythm, or change the amount of Saphris in your body.
Do Not Stop Saphris on Your Own
Do not stop Saphris suddenly without speaking with your healthcare provider.
Stopping treatment may cause schizophrenia or bipolar symptoms to return or worsen. Some patients may also experience symptoms such as nausea, vomiting, insomnia, or agitation.
Your healthcare provider can help you stop treatment safely if needed.
Pregnancy
Tell your healthcare provider if you are pregnant, think you may be pregnant, or plan to become pregnant.
Using antipsychotic medications during the third trimester may cause movement-related or withdrawal symptoms in newborns.
Your healthcare provider will weigh the benefits of treatment against the potential risks during pregnancy.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
It is not known with certainty how much asenapine passes into human breast milk. Your healthcare provider can help determine whether Saphris or breastfeeding is appropriate based on the potential benefits and risks.
Regular Monitoring
Your healthcare provider may monitor:
- Weight
- Blood sugar
- Cholesterol and triglycerides
- Blood pressure
- Heart rhythm
- Movement-related side effects
- Mood and behavior
Regular follow-up helps make sure Saphris remains safe and effective.
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