Saphris

The active ingredient in Saphris is asenapine.

Asenapine is an atypical antipsychotic medication that affects several neurotransmitters in the brain, including dopamine and serotonin. By balancing these chemicals, Saphris helps improve the symptoms of schizophrenia and bipolar I disorder. The effects of asenapine come from its ability to influence mood, behavior, and thinking patterns, helping many patients feel more stable and focused.

How does Saphris work?

The active ingredient in Saphris is asenapine.

Asenapine is an atypical antipsychotic medication that affects several neurotransmitters in the brain, including dopamine and serotonin. By balancing these chemicals, Saphris helps improve the symptoms of schizophrenia and bipolar I disorder. The effects of asenapine come from its ability to influence mood, behavior, and thinking patterns, helping many patients feel more stable and focused.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Saphris. However, the following is a synopsis of the general guidelines for the use of Saphris:

• Saphris is taken as sublingual tablets that are placed under the tongue. Keep the tablet in its blister pack until you are ready to take it. Using dry hands, gently remove the tablet and place it under your tongue.
• Allow the tablet to dissolve completely. Do not chew, swallow, or crush it.
• Avoid eating or drinking for 10 minutes after each dose.
• Saphris is usually taken twice daily, or as directed by your health care provider.
• Take your next dose at the scheduled time. Do not take extra tablets if you miss a dose without speaking to a health care provider.
• Saphris may be used alone (monotherapy) or together with medications such as lithium or valproate for bipolar I disorder.
• Continue taking Saphris even when you feel better unless your health care provider instructs you otherwise.
• This medication may increase your blood sugar. If you are diabetic, you may need to monitor your blood sugar more frequently.

Some mild or common side effects of Saphris seen in clinical trials include:

• Drowsiness.
• Trouble sleeping.
• Constipation.
• Dizziness or feeling lightheaded.
• Dry mouth.
• Weight gain or increased appetite.
• Changes in blood pressure, including low blood pressure when standing (orthostatic hypotension).
• Akathisia or restlessness.
• Mild extrapyramidal symptoms (EPS) such as muscle stiffness or tremors.

Some individuals may experience serious side effects while using Saphris. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Neuroleptic malignant syndrome (NMS) symptoms include high fever, muscle stiffness, confusion, and changes in body temperature.
• Severe allergic reaction with swelling of the face, blisters in the mouth, or trouble breathing.
• Tardive dyskinesia, including uncontrollable facial or body movements.
• Signs of dementia-related psychosis complications in elderly patients.
• Heart rhythm problems or symptoms of QT prolongation.
• Trouble swallowing (dysphagia).
• High prolactin levels (hyperprolactinemia). Symptoms include changes in menstrual bleeding patterns, fertility problems, and mood problems in females.
• High blood sugar or hyperglycemia, including increased thirst or frequent urination.
• Unusual bruising, signs of leukopenia or neutropenia, or low white blood cell count.

These are not all of the possible adverse reactions of Saphris. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Saphris, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Heart disease, low blood pressure, or a history of heart rhythm abnormalities.

Diabetes, high blood sugar, or risk factors for hyperglycemia.

A history of neuroleptic malignant syndrome, muscle stiffness, or body temperature problems.

Problems with swallowing or frequent choking.

High cholesterol or metabolic concerns.

Parkinson's disease or a history of EPS or dyskinesia.

A history of seizures or CNS disorders.

Mental health concerns require close supervision.

Elderly patients with dementia-related psychosis.

Known hypersensitivity to asenapine, including severe allergic reaction or swelling of the face.

Severe liver impairment.

Some patients may begin to notice improvements in symptoms such as agitation or mood swings within the first week. However, the full effects of asenapine on schizophrenia or bipolar I disorder may take several weeks.

When Saphris is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Medications that affect serotonin, such as paroxetine or fluvoxamine.

Other antipsychotics, including risperidone, olanzapine, aripiprazole, ziprasidone, or chlorpromazine.

Drugs that affect heart rhythm, such as amiodarone or thioridazine.

Blood pressure medications that may increase the risk of low blood pressure.

Carbamazepine and other medications that affect liver enzymes.

Valproate and lithium when used for bipolar I disorder.

Over-the-counter products that cause drowsiness.

It is available as sublingual tablets containing 5mg or 10mg of asenapine maleate.

It should be stored at room temperature, away from the reach of children or pets.

It is manufactured by Organon Canada.

Yes, it is available from many manufacturers of generic drugs.

Do not stop taking Saphris suddenly without consulting your health care provider. Stopping abruptly may cause withdrawal symptoms or a return of schizophrenia or bipolar symptoms.

Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Notify your doctor right away if you become pregnant or think you may be pregnant while taking Saphris.

Asenapine may pass into breast milk, and breastfeeding is generally not recommended while taking Saphris.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.