Lurasidone

>10%

Somnolence, dose related (22%)

Akathisia, dose related (15%)

Fasting glucose increased (10-14%)

Nausea (12%)

Parkinsonism (11%)

1-10%

Vomiting (8%)

Dyspepsia (8%)

Anxiety (8%)

Agitation (6%)

Anxiety (6%)

Dystonia (5%)

Dizziness (5%)

Fatigue (4%)

Back pain (4%)

Restlessness (3%)

Salivary hypersecretion (2%)

Postmarketing Reports

Hypersensitivity (urticaria, throat swelling, tongue swelling, and dyspnea)

Hyponatremia

Serious side effects have been reported including:

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Medicines like lurasidone can increase the risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). lurasidone should not be used to treat people with dementia-related psychosis.
2. Increased risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
   • Talk to your, or your family member's, healthcare provider about:
     • all risks and benefits of treatment with antidepressant medicines.
     • all treatment choices for depression or other serious mental illness.
   • Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
   • 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

Do not take lurasidone if you:

• are allergic to lurasidone hydrochloride or any of the other ingredients in lurasidone.
• are 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.

Grapefruit and grapefruit juice may interact with lurasidone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

If you take too much lurasidone, call your healthcare provider or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

Lurasidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Lurasidone is used to treat schizophrenia in adults and teenagers who are at least 13 years old. Lurasidone is also used to treat episodes of depression in adults with bipolar disorder (manic depression).

Lurasidone may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In the U.S.

• Latuda

Available Dosage Forms:

• Tablet

Therapeutic Class: Antipsychotic

Take lurasidone only as directed by your doctor even if you feel well. Do not take more of lurasidone and do not take it more often than your doctor ordered. lurasidone works best if there is a constant amount in the blood. To keep blood levels constant, take lurasidone at the same time each day and do not miss any doses.

lurasidone should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You must take lurasidone with food (containing at least 350 calories).

Do not eat grapefruit or drink grapefruit juice while you are using lurasidone.

Dosing

The dose of lurasidone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of lurasidone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For schizophrenia:
    • Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 160 mg per day.
    • Children 13 to 17 years of age—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of lurasidone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Absence of or decrease in body movement
• difficulty with swallowing
• drooling
• inability to sit still
• incremental or ratchet-like movement of the muscle
• loss of balance control
• mask-like face
• muscle discomfort
• muscle trembling, jerking, or stiffness
• need to keep moving
• restlessness
• rigid or stiff muscles
• shakiness in the legs, arms, hands, or feet
• shuffling walk
• slow movements
• slow reflexes
• slurred speech
• stiffness of the arms and legs
• tic-like (jerky) movements of the head, face, mouth, and neck
• trembling or shaking of the hands or feet
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

• Arm, back, or jaw pain
• blurred vision
• burning while urinating
• changes in patterns and rhythms of speech
• chest pain or discomfort
• chills
• cold sweats
• confusion
• convulsions
• difficult or painful urination
• difficulty opening the mouth
• difficulty with breathing
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fixed position of the eye
• headache
• high fever
• inability to move the eyes
• inability to speak
• increased blinking or spasms of the eyelid
• increased sweating
• lockjaw
• loss of bladder control
• muscle spasm, especially of the neck and back
• nervousness
• pale skin
• pounding in the ears
• seizures
• severe muscle stiffness
• severe or sudden headache
• slow or fast heartbeat
• slurred speech
• sticking out of the tongue
• sweating
• temporary blindness
• tiredness
• trouble with breathing, speaking, or swallowing
• troubled breathing with exertion
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions
• unusual tiredness or weakness
• unusually pale skin
• weakness in the arm or leg on one side of the body, sudden and severe

• Black, tarry stools
• bloody urine
• breast pain or swelling
• cough
• dark-colored urine
• decreased frequency or amount of urine
• fever
• increased thirst
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, fingers, or lower legs
• swollen glands
• troubled breathing
• vomiting
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• belching
• drowsiness
• dry mouth
• heartburn
• hyperventilation
• indigestion
• irritability
• relaxed and calm
• sleepiness or unusual drowsiness
• stomach discomfort, upset, or pain
• trouble sleeping
• unusually deep sleep
• unusually long duration of sleep

• Abnormal dreams
• anxiety
• back pain
• blurred vision
• burning feeling in the chest or stomach
• decreased appetite
• diarrhea
• feeling of constant movement of self or surroundings
• indigestion
• itching or skin rash
• sensation of spinning
• sweating
• tenderness in the stomach area
• watering of mouth and drooling

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• unexpected or excess milk flow from the breasts

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• It is used to treat schizophrenia.
• It is used to treat low mood (depression) in people with bipolar disorder.

Mean AUC0-last was 1.5 times higher in subjects with mild hepatic impairment (Child-Pugh class A), 1.7 times higher in subjects with moderate hepatic impairment (Child-Pugh class B), and 3 times higher in subjects with severe hepatic impairment (Child-Pugh class C) compared with the values for healthy matched subjects. Mean Cmax was 1.3, 1.2, and 1.3 times higher for patients with mild, moderate, and severe hepatic impairment, respectively, compared with the values for healthy matched subjects (Citrome 2011).

Schizophrenia:

Adolescents ≤17 years: Oral: Initial: 40 mg once daily; increase dose further based on response and tolerability; maximum recommended dose: 80 mg/day

Adolescents >17 years: Refer to adult dosing.

Data not available.

Administration advice:
-Tablets should be swallowed whole, and should be taken with food containing at least 350 calories.
-Grapefruit and grapefruit juice should be avoided.

Storage requirements: Protect from light.

General:
-Controlled clinical trials assessing long-term (e.g., longer than 6 weeks) use are not available; the physician who prescribes this drug should periodically re-evaluate the long-term risks and benefits for the individual patient.
-Improvements may take days to weeks; patients should be closely monitored during this time.

Monitoring:
-Cardiovascular: Orthostatic vital signs in at-risk patients
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.
-Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient advice:
-Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; what to watch for and when to seek medical advice.
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should avoid overheating and dehydration.
-Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.