When to take latuda?

Latuda: A New Treatment Option for Bipolar Depression

The depressive episodes that accompany bipolar disorder have often perplexed both people who have bipolar disorder and the professionals who want to help treat them. People with ordinary clinical depression — at one time called unipolar depression — often have a few treatment options to choose from, usually starting with psychotherapy or antidepressants.

But using antidepressants in the treatment of depression of someone who has bipolar disorder can have unexpected — and unwanted — effects. Studies of antidepressant use in bipolar disorder have been decidedly mixed.

So it’s always welcome news when a new medication — or a new use for an existing medication — has been approved. Such is the case with Latuda (lurasidone).

Bipolar depression is a frustrating component of bipolar disorder to treat. The most recent meta-analytic study on the use of antidepressants to treat bipolar depression found little support for their use. Two previous meta-analyses came to contradictory conclusions.

The usefulness of antidepressants in bipolar depression therefore remains controversial. Current guidelines generally recommend the cautious antidepressant use in combination with mood stabilizers to reduce the risk of mood elevation or cycle acceleration.

With the arrival of atypical antipsychotic medications, people with bipolar disorder now have an additional treatment choice to help with the alleviation of depression symptoms.

Latuda (lurasidone) is one such atypical antipsychotic. It was first approved for the treatment of schizophrenia in late 2010; in the summer of 2013, its approved use was extended to help in the treatment of bipolar depression by the U.S. Food and Drug Administration. In schizophrenia, dosing usually starts at 40 mg/daily, but for bipolar depression treatment, 20 mg/daily is recommended. The dose can be increased if needed, but shouldn’t exceed 120 mg/day (160 mg/day in schizophrenia).

Like other atypical antipsychotics, it should be taken with food and it shouldn’t be used in people with liver disease, heart disease, heart problems or a history of heart attacks, or people with high cholesterol.

Latuda is well-tolerated by most people who take it. The most common side effects reported while taking Latuda are somnolence — a strong desire to sleep — (22%) and akathisia — a feeling of inner restlessness that makes it difficult for a person to be able to sit or stay still for long periods of time — (15%). Both of these are dose-related, and can often be controlled by changing the dosing.

Fasting glucose increased — higher blood sugar — (10-14%) and nausea (12%) have also been reported as common side effects. Some people complained of muscle stiffness, or muscle twitching, uncontrollable movements of your eyes, lips, tongue, face, arms, or legs, but these were less common.

Most people who take Latuda are going to start seeing improvement of their symptoms in 3 to 4 weeks. Like all psychiatric medications, Latuda may or may not work for your bipolar depression symptoms. A doctor can’t tell you if it’s going to work for you ahead of time; the only way to know is to try it.

While you are taking Latuda, you may be more sensitive to temperature extremes — so you should avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

The biggest downside to Latuda? Well, because it’s new and still patented, it’s expensive. However, I noticed they do have a savings program that can significantly reduce your co-pay if you qualify.

It’s good to have treatment options, so in that respect, I’m glad to see Latuda is available as one more option to help in the treatment of bipolar depression.

Latuda: A New Treatment Option for Bipolar Depression

Latuda Side Effects – What You Need to Know About Bipolar Medication Options

  • Treatment

By Steve Levine, M.D. October 15, 2019

About the Author Dr. Steve Levine is a board-certified psychiatrist internationally recognized for his contributions to advancements in mental health care. Though he is a psychiatrist who places great emphasis on the importance of psychotherapy, medication is often a necessary component of treatment, and he was dissatisfied with the relatively ineffective available options with burdensome side effects. Dr. Levine pioneered a protocol for the clinical use of ketamine infusions, has directly supervised many thousands of infusions and has helped establish similar programs across the country and around the world.

How Fast Does Latuda Work? Side Effects For Bipolar Medication, Depression & Latuda Alternatives

Are there medications available to treat bipolar disorder that will not cause serious side effects?

Medication options are fairly limited for bipolar depression and recently a new drug, Latuda (Lurasidone), has been FDA-approved to treat bipolar depression. In addition to Latuda, Seroquel and the combination pill of Zyprexa/Prozac are also FDA approved to treat bipolar depression. Latuda, an atypical antipsychotic, was originally designed to treat adults with schizophrenia and then it was looked at specifically as a bipolar depression treatment. Latuda is the first medication approved for bipolar depression that can be taken either: (1) on its own (as monotherapy) or with a mood-stabilizing medication like Lithium or Valproate (as adjunctive therapy).

Bipolar disorder is a mental health condition in which patients suffer from both episodes of mania and depression. The depressive component of bipolar disorder is also known as bipolar depression. At Actify Neurotherapies, under Dr. Steven Levine’s proven and tested ketamine protocols, patients have seen success rates >70% in treating all forms of depression (major depression, bipolar depression, postpartum depression). Patients who have failed 2 or more trials of oral medications or cannot tolerate the side effects of oral medications are excellent candidates for Ketamine infusion therapy.

Bipolar disorder is both a recurrent and chronic condition with a lifetime prevalence of around 1% with an average age of onset around 25. Men and women are equally affected and bipolar disorder currently affects 5.7 million American adults. There are several medication classes available to help treat bipolar disorder depending on whether it is a depressive, mixed or manic episode. Medication treatment options for bipolar disorder include the standard mood stabilizers (such as Lithium, Depakote, and Lamictal) +/- antipsychotics (such as Zyprexa, Risperdal, and Seroquel) and antidepressants. In this article, we focus on the treatment of bipolar depression, more specifically Latuda vs. Ketamine for bipolar depression.

Latuda Side Effects, Risks, and Dosing

It is thought that Latuda works on several receptors in the brain including dopamine, serotonin, norepinephrine and histamine. The dosing range is 40 to 120 mg taken once daily. In addition, Latuda should be taken with at least 350 calories to help aid its absorption. Like most oral antipsychotic medications, Latuda does not work instantly and can often take weeks to months before the provider and patient can decide if the treatment is working. The most common side effects of Latuda include nausea, sleepiness or drowsiness, restlessness or feeling like you need to move around (akathisia), and difficulty moving, slow movements, muscle stiffness, or tremor. Other potential side effects of Latuda include an increase in blood sugars with increased risk of diabetes, increased risk of high cholesterol, weight gain, neuroleptic malignant syndrome, tardive dyskinesia, stroke, and death. Latuda is not approved for treating elderly patients with dementia-related psychosis because it has been proven to increase suicidal thoughts, behaviors, and mortality in these patients. Patients should have their glucose levels and lipids checked when starting Latuda and again at 3 months thereafter with subsequent intervals after that point determined by their doctor.

Medication Alternatives without Similar Latuda Side Effects

Ketamine is a medication currently being used to treat bipolar depressive episodes with great success and little to no side effects or drug interations. A recent meta-analysis titled Efficacy of Ketamine in Bipolar Depression¹ concluded that “Ketamine causes rapid and robust antidepressant response in patients with bipolar depression”. At Actify Neurotherapies, around 70% of our patients with bipolar depression have found significant improvement in their symptoms. Ketamine is given as an outpatient, intravenous infusion over 40 minutes with the direct supervision of a nurse and physician. When Ketamine infusions work in relieving symptoms of bipolar depression, patients see signs of improvement in hours to days instead of weeks to months, like with Latuda. In addition, Ketamine infusions have transient, minor side effects during the infusion but once the infusion is completed you won’t find the persistent side effects of Latuda described above.

Latuda Side Effects – You Have Options

For some patients who are currently taking Latuda to combat bipolar depression but not getting the relief they hoped for, Ketamine infusions are a great option as an add-on therapy or a potential replacement treatment to prevent depressive episodes. Perhaps you are finding some success with Latuda, but still have the ‘blahs’ of depression where you aren’t finding joy in as many places as you used to. If that’s the case, you should note a second major conclusion from the meta-analysis cited above: they also found that Ketamine reduced levels of anhedonia (the ‘blahs’ of depression) independent of depressive symptoms. This means that even if you thought Latuda was getting your depression to a reasonable place, there could be hope for even more symptom relief with ketamine.

Citations

Steven Levine, MD is the Chief Medical Officer of Actify. He has been treating patients with ketamine therapy since 2011.

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased risk of death in elderly people with dementia-related psychosis. Medicines like LATUDA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LATUDA is not approved for the treatment of people with dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, 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. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, 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. Report any change in these symptoms immediately to the doctor.

LATUDA may cause serious side effects, including:

  • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death
  • Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your health care 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, increased sweating, stiff muscles, confusion, or changes in your breathing, heart rate, and blood pressure
  • Uncontrolled body movements (tardive dyskinesia). LATUDA 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 LATUDA. Tardive dyskinesia may also start after you stop taking LATUDA
  • Problems with your metabolism such as:
    • High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who take LATUDA. 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 health care provider should check your blood sugar before you start and during treatment with LATUDA
      • – Call your health care provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: 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 health care provider should check your weight regularly during treatment with LATUDA
  • Increased prolactin levels in your blood (hyperprolactinemia). Your health care provider may do blood tests to check your prolactin levels during treatment with LATUDA. Tell your health care provider if you have any of the following signs and symptoms of hyperprolactinemia:
    • Females: absence of your menstrual cycle or secretion of breast milk when you are not breastfeeding
    • Males: problems getting or maintaining an erection (erectile dysfunction) or enlargement of breasts (gynecomastia)
  • Low white blood cell count. Your health care provider may do blood tests during the first few months of treatment with LATUDA
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position
  • Falls. LATUDA 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. Do not become too hot or dehydrated during treatment with LATUDA. 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
  • 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, or talking more or faster than usual
  • Difficulty swallowing

Do not drive, operate heavy machinery, or do other dangerous activities until you know how LATUDA affects you. LATUDA may make you drowsy.

Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood.

Do not take LATUDA if you are allergic to any of the ingredients in LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your health care provider if you are not sure if you are taking any of these medications.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LATUDA and other medicines may affect each other, causing possible serious side effects. LATUDA may affect the way other medicines work, and other medicines may affect how LATUDA works. Your health care provider can tell you if it is safe to take LATUDA with your other medicines. Do not start or stop any other medicines during treatment with LATUDA without talking to your health care provider first.

Before taking LATUDA, tell your health care 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 LATUDA will harm your unborn baby. Talk to your health care provider about the risk to your unborn baby if you take LATUDA during pregnancy
    • Tell your health care provider if you become pregnant or think you are pregnant during treatment with LATUDA
    • If you become pregnant during treatment with LATUDA, talk to your health care provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or going to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
  • are breastfeeding or plan to breastfeed. It is not known if LATUDA passes into your breast milk. Talk to your health care provider about the best way to feed your baby during treatment with LATUDA

The most common side effects of LATUDA include:

  • Adults with schizophrenia: sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, or muscle stiffness; and nausea
  • Adolescents (13 to 17 years) with schizophrenia: sleepiness or drowsiness; nausea; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation; and vomiting
  • Adults with bipolar depression: restlessness or feeling like you need to move around (akathisia); difficulty moving or slow movements; and sleepiness or drowsiness
  • Children (10 to 17 years) with bipolar depression: nausea; weight gain; and problems sleeping (insomnia)

These are not all the possible side effects of LATUDA. For more information, ask your health care provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

INDICATIONS

LATUDA is a prescription medicine used:

  • To treat adults and adolescents (13 to 17 years) with schizophrenia
  • Alone to treat adults, children and teens (10 to 17 years) 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)

Lurasidone

Before taking lurasidone,

  • tell your doctor and pharmacist if you are allergic to lurasidone, any other medications, or any of the ingredients in lurasidone tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking carbamazepine (Carbatrol, Epitol, Tegretol); clarithromycin (Biaxin, in Prevpac); ketoconazole; mibefradil; phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); ritonavir (Norvir); St. John’s wort; or voriconazole (Vfend). Your doctor will probably tell you not to take lurasidone if you are taking either of these medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; atazanavir (Reyataz); bosentan (Tracleer); diltiazem (Cardizem, Cartia, Taztia, Tiazac, others); efavirenz (Sustiva, in Atripla); erythromycin (E.E.S., E-Mycin, Ery-Tab, others); etravirine (Intelence); fluconazole (Diflucan); indinavir (Crixivan); ipratropium (Atrovent, in Combivent, in Duoneb); itraconazole (Sporanox); medications to control anxiety, sedatives, sleeping pills, or tranquilizers; medications to control blood pressure; medications for glaucoma, inflammatory bowel disease, motion sickness, myasthenia gravis, Parkinson’s disease, ulcers, or urinary problems; modafinil (Provigil); nafcillin; nefazodone; nelfinavir (Viracept); phenobarbital; pioglitazone (Actos, in Duetact, in Actoplus Met); rifabutin (Mycobutin); or verapamil (Calan, Verelan, others, in Tarka); Other medications may also interact with lurasidone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you use or have ever used street drugs or have overused prescription medications and if you have or have ever had a stroke; a ministroke (TIA); chest pain, heart disease, or a heart attack; an irregular heartbeat; heart failure; Parkinson’s disease (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); Alzheimer’s disease (a brain disease that slowly destroys the memory and ability to think, learn, communicate and handle daily activities); seizures; dementia; breast cancer; trouble keeping your balance; any condition that makes it difficult for you to swallow; high or low blood pressure; high prolactin levels; a high level of fats (cholesterol and triglycerides) in your blood; a low number of white blood cells; kidney disease; liver disease; high blood sugar; or if you or anyone in your family has or has ever had diabetes. Tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
  • 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 taking lurasidone, call your doctor. Lurasidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lurasidone.
  • you should know that lurasidone may make you drowsy. Do not drive a car or operate hazardous machinery until you know how this medication affects you.
  • you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking 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 taking lurasidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking lurasidone: 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.
  • you should know that lurasidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking lurasidone. 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 lurasidone may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to exercise or be exposed to extreme heat.
  • you should know that lurasidone may cause an increase in weight. It is important to have your weight checked periodically while you are taking this medication.

What is Latuda?

Latuda is a medication known as an atypical antipsychotic that is used to treat symptoms of schizophrenia. The drug is also sometimes prescribed to treat depressive symptoms in bipolar disorder.

When did the U.S. Food and Drug Administration (FDA) approve the medication?

Latuda was first approved by the FDA to treat schizophrenia in 2010.

Is there a generic version of Latuda?

No, there is currently no generic version of Latuda available for sale in the United States.

Are there any major differences between Latuda and other antipsychotics used to treat Latuda?

Latuda belongs to the class of medications known as atypical antipsychotics or second generation psychotics. Talk to your doctor about what might work best for you and the costs and benefits of taking the medication. Some people may need to try several different antipsychotics before they find the most effective with the fewest side effects.

Can children take Latuda?

The effectiveness and safety of the medication has not been tested in patients less than 18 years old. Talk to your child’s doctor about the risks of using the medication.

Are there potential interaction issues for people taking Latuda and any other drugs?

Tell your doctor if you take ketoconazole or rifampin. There are hundreds of other drugs which are known to interact with Latuda in major, moderate, or mild ways, so let your doctor know what other medications you are taking before you begin taking the medication. Some of these include antidepressants, antihistamines, carbamazepine, clarithromycin, diltiazem, erythromycin, indinavir, ipratropium, itraconazole, anxiety medication, sedatives, sleep medications, tranquilizers, blood pressure medication, medication for glaucoma, inflammatory bowel disease, motion sickness, myasthenia gravis, Parkinson’s disease, ulcers, or urinary problems, nefazodone, nelfinavir, phenobarbital, phenytoin, pioglitazone, rifabutin, ritonavir, or verapamil.

Are there any other medical conditions that would make someone ineligible for Latuda therapy?

Talk to your doctor about other medical conditions before you take Latuda, such as dementia, stroke, heart conditions, seizures, neuroleptic malignant syndrome (NMS), diabetes, or tardive dyskinesia.

What is the typical dose that would be prescribed to someone taking Latuda?

Typical starting dosage for treating schizophrenia in adults is 40 mg taken once daily. Dosage is not to exceed 80 mg once daily.

What do I do if I miss a dose?

Take the dose of Latuda when you remember, but skip the missed dose if it it’s almost time for your next dose. You should never take extra doses of the medication to make up for missed doses.

What common side effects can Latuda cause?

The common side effects of Latuda can include:

  • Drowsiness
  • Nausea
  • Weakness
  • Restlessness
  • Anxiety
  • Increased saliva
  • Uncontrollable movements
  • Shuffling walk
  • Vomiting
  • Decreased sexuality ability
  • Late or missed menstrual period
  • Breast enlargement

Doctors recommend that you not drink alcohol while on the medication. It also is recommended that you wait to drive or operate machinery until you know how the medication affects you. Report major side effects to your doctor immediately, which can include difficulty swallowing or breathing, sore throat, swelling, shortness of breath, abnormal heartbeat, fever, cough, chills, sweating, confusion, muscle stiffness, and unusual facial or body movements. You can also report side effects to the FDA at 1-800-FDA-1088 or online.

What are the potential long-term effects of taking Latuda?

Your doctor should monitor for progression of potential long-term side effect of atypical antipsychotics, which can include tardive dyskinesia (TD). Atypical antipsychotics may also increase the risk of cardiovascular side effects, diabetes, weight gain, and high cholesterol.

Is it safe for a woman who is pregnant, about to become pregnant, or nursing to take Latuda?

There have been no controlled human pregnancy studies on the effects of Latuda, but exposure to antipsychotic medication during the third trimester of pregnancy can lead to withdrawal symptoms in infants after delivery. It is not known whether the drug can be transferred via human breast milk and harm a baby, but animal studies indicate the drug may be present in breast milk and potentially harm a nursing infant. Therefore, talk to your doctor if you are pregnant, planning to become pregnant, or are nursing before you take Latuda.

Can symptoms occur if Latuda is discontinued?

It’s important not to discontinue use of the drug if you feel better. Maintain contact with your doctor and seek medical attention if necessary when discontinuing the drug. Talk to your doctor about how to mitigate potential withdrawal symptoms, which can include dizziness, anxiety, aches, confusion, vision problems, fatigue, nausea, psychotic symptoms, restlessness, sleep problems, sweating, tremors, and weight loss.

What should I do if I overdose on Latuda?

Seek immediate help or call the Poison Help Line at 1-800-222-1222 if you overdose, as it can be fatal. Symptoms may include quick or irregular heartbeat or seizures.

Is Latuda habit-forming?
Latuda has no habit-forming potential, but it is not recommended that you discontinue use of the drug before talking with your doctor, as withdrawal symptoms can occur.

How much does Latuda cost?

According to goodrx.com, 30 tablets of 40 mg Latuda cost approximately $1,050.

Are there any disadvantages to Latuda?

The biggest disadvantages of Latuda are the potential long-term side effects, which can include tardive dyskinesia, hyperglycemia, and weight gain.

DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider. This article mentions drugs that were FDA-approved and available at the time of publication and may not include all possible drug interactions or all FDA warnings or alerts. The author of this page explicitly does not endorse this drug or any specific treatment method. If you have health questions or concerns about interactions, please check with your physician or go to the FDA site for a comprehensive list of warnings.

Article Sources Last Updated: Feb 21, 2018

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

Increased risk of death in elderly people with dementia-related psychosis. Medicines like LATUDA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LATUDA is not approved for the treatment of people with dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or behaviors in some children, teenagers, 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. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, 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. Report any change in these symptoms immediately to the doctor.

LATUDA may cause serious side effects, including:

  • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death
  • Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your health care 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, increased sweating, stiff muscles, confusion, or changes in your breathing, heart rate, and blood pressure
  • Uncontrolled body movements (tardive dyskinesia). LATUDA 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 LATUDA. Tardive dyskinesia may also start after you stop taking LATUDA
  • Problems with your metabolism such as:
    • High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who take LATUDA. 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 health care provider should check your blood sugar before you start and during treatment with LATUDA
      • – Call your health care provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking LATUDA: 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 health care provider should check your weight regularly during treatment with LATUDA
  • Increased prolactin levels in your blood (hyperprolactinemia). Your health care provider may do blood tests to check your prolactin levels during treatment with LATUDA. Tell your health care provider if you have any of the following signs and symptoms of hyperprolactinemia:
    • Females: absence of your menstrual cycle or secretion of breast milk when you are not breastfeeding
    • Males: problems getting or maintaining an erection (erectile dysfunction) or enlargement of breasts (gynecomastia)
  • Low white blood cell count. Your health care provider may do blood tests during the first few months of treatment with LATUDA
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position
  • Falls. LATUDA 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. Do not become too hot or dehydrated during treatment with LATUDA. 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
  • 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, or talking more or faster than usual
  • Difficulty swallowing

Do not drive, operate heavy machinery, or do other dangerous activities until you know how LATUDA affects you. LATUDA may make you drowsy.

Avoid eating grapefruit or drinking grapefruit juice while you take LATUDA since these can affect the amount of LATUDA in the blood.

Do not take LATUDA if you are allergic to any of the ingredients in LATUDA or take certain medications called CYP3A4 inhibitors or inducers. Ask your health care provider if you are not sure if you are taking any of these medications.

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LATUDA and other medicines may affect each other, causing possible serious side effects. LATUDA may affect the way other medicines work, and other medicines may affect how LATUDA works. Your health care provider can tell you if it is safe to take LATUDA with your other medicines. Do not start or stop any other medicines during treatment with LATUDA without talking to your health care provider first.

Before taking LATUDA, tell your health care 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 LATUDA will harm your unborn baby. Talk to your health care provider about the risk to your unborn baby if you take LATUDA during pregnancy
    • Tell your health care provider if you become pregnant or think you are pregnant during treatment with LATUDA
    • If you become pregnant during treatment with LATUDA, talk to your health care provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or going to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
  • are breastfeeding or plan to breastfeed. It is not known if LATUDA passes into your breast milk. Talk to your health care provider about the best way to feed your baby during treatment with LATUDA

The most common side effects of LATUDA include:

  • Adults with schizophrenia: sleepiness or drowsiness; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, or muscle stiffness; and nausea
  • Adolescents (13 to 17 years) with schizophrenia: sleepiness or drowsiness; nausea; restlessness or feeling like you need to move around (akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; runny nose/nasal inflammation; and vomiting
  • Adults with bipolar depression: restlessness or feeling like you need to move around (akathisia); difficulty moving or slow movements; and sleepiness or drowsiness
  • Children (10 to 17 years) with bipolar depression: nausea; weight gain; and problems sleeping (insomnia)

These are not all the possible side effects of LATUDA. For more information, ask your health care provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

INDICATIONS

LATUDA is a prescription medicine used:

  • To treat adults and adolescents (13 to 17 years) with schizophrenia
  • Alone to treat adults, children and teens (10 to 17 years) 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)

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