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What should I discuss with my healthcare provider before taking asenapine (Saphris)?

Asenapine is not for use in psychotic conditions related to dementia. Asenapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use asenapine if you are allergic to it.

To make sure you can safely take asenapine, tell your doctor if you have any of these other conditions:

• liver disease;
• heart disease, high blood pressure, heart rhythm problems;
• a history of heart attack or stroke;
• a history of breast cancer;
• seizures or epilepsy;
• diabetes (asenapine may raise your blood sugar);
• trouble swallowing;
• Parkinson's disease;
• a history of low white blood cell (WBC) counts; or
• a personal or family history of"Long QT syndrome."

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking asenapine, do not stop taking it without your doctor's advice.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Asenapine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to anyone younger than 18 years old without the advice of a doctor.

How should I take asenapine (Saphris)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Asenapine is usually taken 2 times per day. Follow your doctor's instructions.

To take asenapine sublingual (under the tongue) tablets:

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the colored tab from the tablet blister. Do not push a tablet through the blister or you may damage the tablet.
• Using dry hands, gently remove the tablet and place it under your tongue. It will begin to dissolve right away.
• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
• Swallow several times as the tablet dissolves. Do not eat or drink anything for 10 minutes after the tablet has dissolved.

Asenapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking asenapine.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

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