Latuda (lurasidone) Patient Information

Generic Name: lurasidone
Brand Name: Latuda

Latuda (lurasidone HCI) Full Prescribing Information
Latuda Medication Guide

Lurasidone is used for:

Treating schizophrenia and bipolar depression. It may also be used for other conditions as determined by your doctor.

Lurasidone is an atypical antipsychotic. It works by affecting certain substances in the brain.

Do NOT use Lurasidone if:

• you are allergic to any ingredient in Lurasidone
• you are taking carbamazepine, clarithromycin, efavirenz, certain HIV protease inhibitors (eg, ritonavir), a hydantoin (eg, phenytoin), itraconazole, ketoconazole, nefazodone, nevirapine, phenobarbital, primidone, a rifamycin (eg, rifampin), St. John's wort, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lurasidone:

Some medical conditions may interact with Lurasidone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

• if you have a history of seizures, heart problems (eg, heart failure, slow or irregular heartbeat), abnormal electrocardiogram (ECG), a heart attack, a stroke, blood vessel problems (including in the brain), high or low blood pressure, low white blood cell levels, or high cholesterol or triglyceride levels
• if you have a history of kidney or liver problems, neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence
• if you have diabetes or are very overweight, or if a family member has had diabetes
• if you have Alzheimer disease, dementia, Parkinson disease, or trouble swallowing
• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
• if you are dehydrated, have very low blood volume, drink alcohol, or will be exposed to very high temperatures
• if you have not previously been taking an antipsychotic medicine

Some MEDICINES MAY INTERACT with Lurasidone. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Alpha-blockers (eg, doxazosin) or medicines for high blood pressure because the risk of low blood pressure and fainting may be increased
• Anticholinergics (eg, scopolamine) because the risk of overheating may be increased
• Aprepitant, azole antifungals (eg, ketoconazole, itraconazole), clarithromycin, diltiazem, erythromycin, fluconazole, fosaprepitant, HIV protease inhibitors (eg, ritonavir), nefazodone, telithromycin, verapamil, or voriconazole because they may increase the risk of Lurasidone's side effects
• Carbamazepine, efavirenz, hydantoins (eg, phenytoin), nevirapine, phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Lurasidone's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lurasidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lurasidone:

Use Lurasidone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Lurasidone by mouth with food (at least 350 calories).
• Take Lurasidone on a regular schedule to get the most benefit from it. Taking Lurasidone at the same time each day will help you remember to take it.
• Continue to take Lurasidone even if you feel well. Do not miss any doses.
• If you miss a dose of Lurasidone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Lurasidone.

Important safety information:

• Lurasidone may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lurasidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are taking Lurasidone.
• Check with your doctor before using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Lurasidone; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Lurasidone may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not become overheated in hot weather or while you are being active; heatstroke may occur.
• Watch patients who take Lurasidone closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
• Lurasidone may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lurasidone may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• NMS is a possibly fatal syndrome that can be caused by Lurasidone. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Some patients who take Lurasidone may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Lurasidone in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Lurasidone.
• Lurasidone may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
• Lab tests, including fasting blood glucose and complete blood cell counts, may be performed while you use Lurasidone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Lurasidone with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness when standing or uncontrolled muscles movements.
• Lurasidone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Lurasidone while you are pregnant. Using Lurasidone during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Lurasidone is found in breast milk. If you are or will be breast-feeding while you use Lurasidone, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Lurasidone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; anxiety; dizziness; drowsiness; fatigue; lightheadedness; nausea; restlessness; stomach upset; vomiting; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased sweating; one-sided weakness; new or worsening mental or mood changes (eg, aggression, depression, severe anxiety); seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, jerking or twisting, twitching of the face or tongue); vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; irregular heartbeat; seizures; severe drowsiness or dizziness; unusual muscle movements.

Proper storage of Lurasidone:

Store Lurasidone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lurasidone out of the reach of children and away from pets.

General information:

• If you have any questions about Lurasidone, please talk with your doctor, pharmacist, or other health care provider.
• Lurasidone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lurasidone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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Last revision: 02/2011

Latuda (lurasidone HCI) Full Prescribing Information
Latuda Medication Guide

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