Asenapine

Older adults with dementia (loss of memory and brain function) may have an increased risk of death if treated with antipsychotic medications such as asenapine. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment.

Asenapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking asenapine.

Talk to your doctor about the risk(s) of taking asenapine.

Asenapine is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar I disorder (a disease that causes depression, mania, and other abnormal moods). Asenapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Asenapine comes as a sublingual tablet to dissolve under the tongue. Take twice a day. Take asenapine at around the same times every day.

Take asenapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not remove asenapine sublingual tablets from the package until just before you are ready to take them, and be sure that your hands are dry when you handle the tablets. When you are ready to take a tablet, follow the package directions to remove the tablet from the case without pushing the tablet through the tablet pack or breaking the tablet. After you remove the tablet, place it under your tongue and wait for it to dissolve. Do not swallow, split, chew, or crush the tablet. Do not eat or drink anything for 10 minutes after the tablet dissolves.

Your doctor may need to increase or decrease your dose depending on how well the medication works for you and the side effects you experience. Tell your doctor how you are feeling during your treatment with asenapine.

Asenapine may help to control your symptoms but will not cure your condition. Continue to take asenapine even if you feel well. Do not stop taking asenapine without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking asenapine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with asenapine. Make sure you have discussed any medications you are currently taking or plan to take before starting asenapine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking asenapine, please get the advice of your doctor or pharmacist.
• tell your doctor if you or anyone in your family has or has ever had diabetes; if you have severe diarrhea or vomiting or you think you may be dehydrated; a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); low blood pressure; a heart attack; heart failure; a slow or irregular heartbeat; a stroke or TIA (ministroke); seizures; breast cancer; a low level of white blood cells in your blood or a decrease in white blood cells caused by a medication you have taken; dyslipidemia (high cholesterol levels); trouble keeping your balance; any condition that makes it difficult for you to swallow; or heart or liver disease.
• tell your doctor if you are pregnant, if you plan to become pregnant or are breastfeeding. If you become pregnant while taking asenapine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking asenapine.
• you should know that asenapine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that asenapine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking asenapine. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that asenapine may make it harder for your body to cool down when it gets very hot. While you are taking asenapine, you should avoid excessive exercise, stay inside as much as possible and dress lightly in hot weather, stay out of the sun, and drink plenty of fluids.
• you should know that you may experience hyperglycemia (increase in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking asenapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking asenapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Asenapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• nausea
• increased appetite, weight gain
• increase in amount of saliva in the mouth
• change in taste
• loss of feeling in the lips or mouth
• dizziness, feeling unsteady, or having trouble keeping your balance
• excessive tiredness
• restlessness or constant urge to keep moving

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTION section, call your doctor immediately or get emergency medical treatment:

• rash, itching, hives; difficulty breathing or swallowing; hoarseness; wheezing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• fever; stiff muscles; sweating; confusion; sweating; or fast, pounding, or irregular heartbeat
• spasm or tightening of the neck muscles
• uncontrollable movements of the arms, legs, face, mouth, tongue, jaw, lips or cheeks
• falling down
• seizures
• sore throat, chills, cough, and other signs of infection
• red or brown colored urine

Asenapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• confusion
• agitation

Keep all appointments with your doctor and the laboratory. Your weight should be checked regularly while you are receiving this medication.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Saphris^®