Asenapine (By mouth)

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Asenapine (a-SEN-a-peen)

Treats schizophrenia (a mental disorder) and bipolar disorder (manic-depressive illness).

Brand Name(s)

Saphris

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• To use the sublingual tablet:
  • Make sure your hands are dry before you handle the tablet.
  • Do not open the blister pack that contains the tablet until you are ready to take it.
  • Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil.
  • Place the tablet under your tongue. It should melt quickly.
  • Do not crush, chew, or swallow the tablet.
  • Do not eat or drink anything for at least 10 minutes after using this medicine.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using fluvoxamine (Luvox®), paroxetine (Paxil®), medicine for heart rhythm problems (such as amiodarone, procainamide, quinidine, sotalol, Betapace®, Cordarone®, or Procanbid®), medicine for mental illness (such as chlorpromazine, thioridazine, ziprasidone, Geodon®, Mellaril®, or Thorazine®), or medicine to treat an infection (such as gatifloxacin, moxifloxacin, Avelox®, or Tequin®).
• Make sure your doctor knows if you are also using medicine to lower blood pressure, such as atenolol, hydrochlorothiazide (HCTZ), lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, or Zestril®.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease, diabetes, trouble with swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, heart rhythm problems (such as QT prolongation, slow heartbeat), mineral imbalance (low potassium or magnesium in the blood), or a history of a heart attack or stroke.
• Some side effects are more likely to happen in elderly people with dementia or other memory problems. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease with dementia).
• This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
• Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
• This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
• This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; dizziness or lightheadedness; trouble breathing; trouble swallowing; or any swelling of your hands, face, tongue, or throat while you are using this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
• You might get overheated while using this medicine. Drink plenty of water during hot weather, while exercising, or while using a hot tub or sauna. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might have an upset stomach or vomit. Call your doctor if you are too hot and can not cool down after drinking cool water and moving away from the heat.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate.
• Chills, cough, sore throat, and body aches.
• Fast, slow, pounding, or uneven heartbeat.
• Fever, sweating, confusion, uneven heartbeat, or muscle stiffness.
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw).
• Lightheadedness, dizziness, or fainting.
• Mood or behavioral changes, or thoughts of hurting yourself or others.
• Neck muscle spasm, throat tightness, difficulty with swallowing or breathing, or sticking out of the tongue.
• Problems with balance or walking.
• Seizures.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Swelling of the breasts or unusual milk production.
• Trouble with speaking or swallowing.
• Twitching or muscle movements you cannot control.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Constipation, vomiting, stomach pain, or upset stomach.
• Drooling.
• Headache.
• Joint or muscle pain.
• Sleepiness or unusual drowsiness.
• Trouble sleeping.
• Weight gain.