Use in older adults:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as asenapine have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment.

Asenapine transdermal patches are 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 using asenapine transdermal patches. For more information visit the FDA website: http://www.fda.gov/Drugs.

Talk to your doctor about the risk(s) of using asenapine transdermal patches.

Asenapine transdermal patches are used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Asenapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Transdermal asenapine comes as a patch to apply to the skin. It is usually applied once a day. Apply the asenapine patch at around the same time each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use the asenapine skin patch exactly as directed. Do not apply it more or less often than prescribed by your doctor.

Your doctor will probably start you on a low dose of asenapine and gradually increase your dose, not more often than once a week.

Transdermal asenapine may help to control your symptoms but will not cure your condition. Continue to use asenapine patches even if you feel well. Do not stop using asenapine patches without talking to your doctor.

Apply the patch to clean, dry, intact skin that is relatively free of hair (upper back, upper arm, abdomen [stomach area], or hip). Choose an area where the patch will not be rubbed by tight clothing. Do not apply the patch to an open wound or cut, to skin that is irritated, red, or to skin that is affected by a rash, burn, or other skin problem. Select a different area each day to avoid skin irritation. Be sure to remove the current patch before you apply a new one.

If your skin is irritated or burns after you apply an asenapine patch, remove the patch and apply a new patch to a different area.

After you apply an asenapine patch, you should wear it all the time until you are ready to remove it and put on a new patch. If the patch loosens before it is time to replace it, try to press it back in place with your fingers. If the patch cannot be pressed back on or falls off, dispose of it and apply a new patch to a different area. However, you should remove the new patch at the time that you were scheduled to remove the original patch.

While you are wearing an asenapine patch, protect the patch from direct heat such as heating pads, electric blankets, hair dryers, heat lamps, saunas, hot tubs, and heated water beds.You may shower while you are wearing an asenapine patch, but do not take a bath or go swimming.

To apply the patch, follow these steps:

1. Choose the area where you will apply the patch. Clean and dry the spot where you will apply the patch. Be sure the skin is free of powders, oil, and lotions.
2. Select a patch in a sealed pouch and cut the pouch open with scissors. Be careful not to cut the patch.
3. Remove the patch from the pouch and hold it with the protective liner facing you.
4. Peel the first piece of liner off one side of the patch. Be careful not to touch the sticky side with your fingers. A second strip of liner should remain stuck to the patch.
5. Press the patch firmly onto your skin with the sticky side down.
6. Remove the second strip of protective liner and press the rest of the sticky side of the patch firmly against your skin. Be sure that the patch is pressed flat against the skin with no bumps or folds and the edges are firmly attached to the skin.
7. Wash your hands with soap and water after you handle the patch.
8. After you have worn the patch for 24 hours, use your fingers to peel the patch off slowly and gently. Fold the patch in half with the sticky sides together and dispose of it safely, out of reach of children and pets.
9. Apply a new patch to a different area immediately by following steps 1 to 8.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

Before using transdermal asenapine,

• Tell your doctor and pharmacist if you are allergic to asenapine, any other medications, or any of the ingredients in asenapine transdermal patches. Ask your pharmacist for a list of the ingredients.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alpha blockers such as doxazosin (Cardura), prazosin (Minipress), and terazosin; angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, in Zestoretic), moexipril, perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Inderal, InnoPran); certain antibiotics including ciprofloxacin (Cipro), enoxacin (not available in the U.S.), gatifloxacin (Tequin) (not available in the U.S.), and moxifloxacin (Avelox); antihistamines; certain medications for irregular heartbeat such as amiodarone (Cordarone, Pacerone), procainamide, quinidine, and sotalol (Betapace, Sorine); diuretics (‘water pills’); fluvoxamine (Luvox); medications for glaucoma, inflammatory bowel disease, motion sickness, myasthenia gravis, Parkinson’s disease, ulcers, or urinary problems; medications for mental illness such as chlorpromazine (Thorazine), thioridazine, and ziprasidone (Geodon); and paroxetine (Paxil, Pexeva). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with asenapine transdermal patches, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor if you have liver disease. Your doctor may tell you not to use asenapine transdermal patches.
• 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; if you have ever used street drugs or misused prescription medications; and if you have or have ever had thoughts about harming or killing yourself; 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; osteoporosis; 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; a low level of potassium or magnesium in your blood; dyslipidemia (high cholesterol levels); trouble keeping your balance; any condition that makes it difficult for you to swallow; or heart disease.
• Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while using transdermal asenapine, call your doctor. Transdermal asenapine may cause problems in newborns following delivery if it is used during the last months of pregnancy.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using transdermal 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.
• Ask your doctor about the safe use of alcoholic beverages while you are using transdermal asenapine. Alcohol can make the side effects of asenapine worse.
• You should know that transdermal 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 using asenapine transdermal patches. 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 using transdermal 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 using 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 using transdermal asenapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are using transdermal 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.

Apply the missed patch as soon as you remember it. However, you should still remove the patch at your regular patch removal time. If it is almost time for the next patch, skip the missed patch and continue your regular dosing schedule. Do not apply extra patches to make up for a missed dose.

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

• Dryness, redness, itching, peeling, swelling, irritation, hardness, pain, or discomfort at application site
• Dry mouth
• Constipation
• Diarrhea
• Vomiting
• Heartburn
• Increased appetite
• Headache
• Weight gain
• Loss of feeling in the lips or mouth
• Dizziness, feeling unsteady, or having trouble keeping your balance
• Excessive tiredness
• Lack of energy
• Restlessness or constant urge to keep moving
• Pain in the joints, arms, or legs

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:

• Hives
• Rash
• Itching
• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue, lips, or eyes
• Hoarseness
• Wheezing
• Fever
• Muscle stiffness or pain
• Spasm or tightening of the neck muscles
• Confusion
• Fast or irregular heartbeat
• Sweating
• Uncontrollable movements of the arms, legs, face, mouth, tongue, jaw, lips, or cheeks
• Falling
• Seizures
• Sore throat, chills, cough, and other signs of infection

Asenapine patches may cause other side effects. Call your doctor if you have any unusual problems while using 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 (http://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 any patches that are outdated or no longer needed by opening each pouch, folding each patch in half with the sticky sides together. Place the folded patch in the original pouch and dispose of it safely, out of the reach of children and pets.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

If someone swallows, chews, or sucks on asenapine patches, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.