MEDICATION GUIDE

8474721/0423F

Lurasidone Hydrochloride (loo-RAS-i-done HYE-droe-KLOR-ide) tablets

What is the most important information I should know about lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Medicines like lurasidone hydrochloride tablets can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Lurasidone hydrochloride tablets are not approved for the treatment of people with dementia-related psychosis.
• Increased risk of suicidal thoughts or actions in children and young adults. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed.
• Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

• Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

What is Lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets is a prescription medicine used:

• Alone to treat people 10 years of age and older with depressive episodes that happen with Bipolar I Disorder (bipolar depression).
• With the medicine lithium or valproate to treat adults with depressive episodes that happen with Bipolar I Disorder (bipolar depression).

It is not known if Lurasidone hydrochloride tablets are safe and effective in children:

• less than 10 years of age with bipolar depression.
• for the treatment of irritability associated with autistic disorder.

Do not take lurasidone hydrochloride tablets if you are:

• allergic to lurasidone hydrochloride or any of the ingredients in lurasidone hydrochloride tablets. See the end of this medication guide for a complete list of ingredients in lurasidone hydrochloride tablets.
• taking certain other medicines called CYP3A4 inhibitors or inducers including ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, rifampin, avasimibe, St. John’s wort, phenytoin, or carbamazepine. Ask your healthcare provider if you are not sure if you are taking any of these medicines.

Before taking lurasidone hydrochloride tablets, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had heart problems or stroke
• have or have had low or high blood pressure
• have or have had diabetes or high blood sugar, or have a family history of diabetes or high blood sugar
• have or have had high levels of total cholesterol or triglycerides
• have or have had high prolactin levels
• have or have had low white blood cell count
• have or have had seizures
• have or have had kidney or liver problems
• are pregnant or plan to become pregnant. It is not known if lurasidone hydrochloride tablets will harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take lurasidone hydrochloride tablets during pregnancy.
  • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with lurasidone hydrochloride tablets.
  • If you become pregnant during treatment with Lurasidone hydrochloride tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1‐866‐961‐2388 or go to http://womensmentalhealth.org/clinical‐and‐researchprograms/pregnancyregistry/.
• are breastfeeding or plan to breastfeed. It is not known if lurasidone hydrochloride passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with lurasidone hydrochloride tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Lurasidone hydrochloride tablets and other medicines may affect each other causing possible serious side effects.

Lurasidone hydrochloride tablets may affect the way other medicines work, and other medicines may affect how lurasidone hydrochloride tablets works.

Your healthcare provider can tell you if it is safe to take lurasidone hydrochloride tablets with your other medicines. Do not start or stop any other medicines during treatment with lurasidone hydrochloride tablets without talking to your healthcare provider first.

Know the medicines you take. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.

How should I take lurasidone hydrochloride tablets?

• Take Lurasidone hydrochloride tablets exactly as your healthcare provider tells you to take it. Do not change the dose or stop taking Lurasidone hydrochloride tablets without first talking to your healthcare provider.
• Take lurasidone hydrochloride tablets by mouth, with food (at least 350 calories).
• If you take too much lurasidone hydrochloride tablets, call your healthcare provider or poison control center or go to the nearest hospital emergency room right away.

What should I avoid while taking lurasidone hydrochloride tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Lurasidone hydrochloride tablets affects you. Lurasidone hydrochloride tablets may make you drowsy.
• Avoid eating grapefruit or drinking grapefruit juice during treatment with Lurasidone hydrochloride tablets. Grapefruit and grapefruit juice may affect the amount of Lurasidone hydrochloride tablets in your blood.
• Do not become too hot or dehydrated during treatment with lurasidone hydrochloride tablets.
• Do not exercise too much.
• In hot weather, stay inside in a cool place if possible.
• Stay out of the sun.
• Do not wear too much clothing or heavy clothing.
• Drink plenty of water.

What are the possible side effects of lurasidone hydrochloride tablets?
Lurasidone hydrochloride tablets may cause serious side effects, including:

• See “What is the most important information I should know about lurasidone hydrochloride tablets?”
• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
  • high fever
  • stiff muscles
  • confusion
  • increased sweating
  • changes in your breathing, heart rate, and blood pressure
• Uncontrolled body movements (tardive dyskinesia). Lurasidone hydrochloride tablets may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking lurasidone hydrochloride tablets. Tardive dyskinesia may also start after you stop taking lurasidone hydrochloride tablets.
• Problems with your metabolism such as:
• high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take lurasidone hydrochloride tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start and during treatment with lurasidone hydrochloride tablets.

Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with lurasidone hydrochloride tablets:

• feel very thirsty
• need to urinate more than usual
• feel very hungry
• feel weak or tired
• feel sick to your stomach
• feel confused, or your breath smells fruity
• increased fat levels (cholesterol and triglycerides) in your blood.
• weight gain. You and your healthcare provider should check your weight regularly during treatment with lurasidone hydrochloride tablets.
• Increased prolactin levels in your blood (hyperprolactinemia). Your healthcare provider may do blood tests to check your prolactin levels during treatment with lurasidone hydrochloride tablets. Tell your healthcare provider if you have any of the following signs and symptoms of hyperprolactinemia:
• Females:
• absence of your menstrual cycle
• secretion of breast milk when you are not breastfeeding
• Males:
• problems getting or maintaining an erection (erectile dysfunction)
• enlargement of breasts (gynecomastia)

Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with lurasidone hydrochloride tablets.

Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

Falls. Lurasidone hydrochloride tablets may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.

Seizures (convulsions)

• Problems controlling your body temperature so that you feel too warm. See “What should I avoid while taking lurasidone hydrochloride tablets?”
• Mania or hypomania (manic episodes) in people with a history of bipolar disorder. Symptoms may include:
  • greatly increased energy
  • severe problems sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

Difficulty swallowing

The most common side effects of lurasidone hydrochloride tablets include:

• Adults with bipolar depression:
• restlessness and feeling like you need to move around (akathisia)
• difficulty moving, slow movements, muscle stiffness, or tremor
• sleepiness or drowsiness
• Children 10 to 17 years of age with bipolar depression:

1. nausea
2. weight gain
3. problems sleeping (insomnia)

These are not all of the possible side effects of lurasidone hydrochloride tablets.

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

How should I store lurasidone hydrochloride tablets?

• Store lurasidone hydrochloride tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep lurasidone hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of lurasidone hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lurasidone hydrochloride tablets for a condition for which it was not prescribed. Do not give lurasidone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about lurasidone hydrochloride tablets that is written for health professionals.

What are the ingredients in lurasidone hydrochloride tablets?
Active ingredient: lurasidone hydrochloride
Inactive ingredients: mannitol, lactose monohydrate, pregelatinized starch, croscarmellose sodium, povidone, anhydrous citric acid, magnesium stearate, hypromellose, titanium dioxide and Polyethylene glycol. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No. 1 Aluminum Lake.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Alkem Laboratories Ltd.

For more information about the drug product, call 1-877-272-7901.
For more information about the packaging or labeling, call American Health Packaging at 1‐800‐707‐4621.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
American Health Packaging
Columbus, OH 43217

8474721/0423F