Latuda

Schizophrenia

Latuda is prescribed to treat schizophrenia in adults and adolescents who are at least 13 years old. It helps manage symptoms such as hallucinations, delusions, and disorganized thinking.

Bipolar Depression

This medication is also used to treat major depressive episodes associated with bipolar I disorder (bipolar depression). It is approved for use in:

• Adults
• Children and adolescents aged 10 to 17 years

For bipolar depression, Latuda may be used alone as a monotherapy or in combination with other medications, such as lithium or valproate.

How Latuda Works in the Brain

Latuda belongs to a class of medications known as atypical antipsychotics. While the precise way it works is not completely known, researchers believe it helps manage symptoms by changing the activity of certain natural chemicals in the brain.

These chemicals, called neurotransmitters, act as messengers between nerve cells. Latuda primarily affects two key neurotransmitters:

• Dopamine: This chemical plays a role in how the brain processes information and emotions. Overactivity of dopamine is often linked to symptoms like hallucinations or disorganized thinking. Latuda helps block certain dopamine receptors to bring these levels into balance.
• Serotonin: This chemical is closely tied to mood regulation. Latuda interacts with several types of serotonin receptors, which is thought to help relieve symptoms of depression and improve overall mood.

By balancing the effects of these chemicals, Latuda helps stabilize mood and improve clarity of thought for individuals with schizophrenia or bipolar depression.

Common Side Effects

Many people taking Latuda experience mild to moderate side effects. These may include:

• Drowsiness or feeling tired
• Nausea and vomiting
• Restlessness or an inability to sit still (akathisia)
• Muscle stiffness, tremors, or slow movement
• Weight gain
• Runny nose or sore throat

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Uncontrolled muscle movements: Twitching or uncontrollable movements in the face, tongue, or other body parts (tardive dyskinesia).
• Neuroleptic Malignant Syndrome: A rare but life-threatening reaction that causes high fever, stiff muscles, confusion, sweating, and changes in heart rate or blood pressure.
• High blood sugar: Symptoms may include increased thirst, frequent urination, extreme hunger, or weakness.
• Low white blood cell count: This can increase the risk of infections; watch for fever, chills, or sore throat.
• Dizziness or fainting: A sudden drop in blood pressure, especially when standing up from a sitting or lying position.
• Difficulty swallowing: This may lead to food or liquid entering the lungs.
• Seizures: Convulsions or sudden changes in consciousness.
• Heat sensitivity: Difficulty cooling down after exercise or exposure to high temperatures.

Boxed Warnings

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Latuda is not approved for the treatment of patients with dementia-related psychosis. Additionally, antidepressants and certain antipsychotics may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Healthcare providers should monitor for clinical worsening or unusual changes in behavior.

Contraindications

Latuda should not be used by individuals with a known hypersensitivity to lurasidone hydrochloride. It is also contraindicated for use with strong CYP3A4 inhibitors (such as ketoconazole or clarithromycin) and strong CYP3A4 inducers (such as rifampin or St. John's wort), as these substances can significantly alter the levels of the medication in the bloodstream.

Serious Adverse Reactions

• Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially fatal reaction to antipsychotic drugs. Symptoms include high fever, muscle rigidity, delirium, and autonomic instability.
• Tardive Dyskinesia: This condition involves involuntary, repetitive body movements, often in the face or tongue. The risk increases with the duration of treatment and the total cumulative dose.
• Metabolic Changes: Treatment may lead to high blood sugar (hyperglycemia), which in extreme cases can lead to coma or death. It may also cause increases in blood fats (cholesterol and triglycerides) and significant weight gain.
• Blood Disorders: There is a risk of a severe drop in white blood cell counts (leukopenia, neutropenia, and agranulocytosis), which can increase the risk of infection.

Other Precautions

Latuda may cause orthostatic hypotension, a sudden drop in blood pressure when standing up, which can lead to dizziness or fainting. It may also cause drowsiness or impair judgment and motor skills; caution is advised when operating heavy machinery or driving until the effects of the medication are known.

The medication can interfere with the body's ability to regulate its core temperature, making it harder to cool down after strenuous exercise or exposure to extreme heat. There is also a risk of seizures in patients with a history of convulsions or conditions that lower the seizure threshold. Difficulty swallowing (dysphagia) has also been associated with antipsychotic use.

Pregnancy

Taking Latuda during the third trimester of pregnancy may cause the newborn to experience withdrawal symptoms or extrapyramidal symptoms. These symptoms can include tremors, muscle stiffness, jitteriness, breathing problems, and difficulty feeding. While some infants recover quickly, others may require medical support or prolonged hospitalization.

It is important not to stop taking Latuda suddenly if you become pregnant, as a relapse of symptoms could occur. Healthcare providers may recommend enrolling in a pregnancy registry to monitor the health of both the parent and the baby during and after pregnancy. This helps researchers understand the effects of antipsychotic medications during pregnancy.

Breastfeeding

It is currently unknown if Latuda passes into human breast milk or how it might affect a nursing infant. Because many medications are excreted in milk and there is a potential for serious side effects in the baby, you should discuss the risks and benefits of breastfeeding while using this medication with your healthcare provider. A decision will typically involve weighing the importance of the drug to the parent's health against the potential risks to the infant.

Dosage Forms

Latuda is available as a film-coated tablet for oral administration. These tablets are intended to be swallowed whole and must be taken with food to ensure the medication is properly absorbed by the body.

The tablets are manufactured in several different versions. Each version is identified by a unique color, shape, and marking on the surface of the tablet. A healthcare professional will prescribe the specific tablet version that is appropriate for the individual patient.

FDA Approval Status

Latuda (lurasidone) was first approved by the U.S. Food and Drug Administration (FDA) in 2010. It is classified as an atypical antipsychotic medication.

Approved Indications

The FDA has approved Latuda for the following specific uses:

• Schizophrenia: For the treatment of schizophrenia in adults and adolescents aged 13 to 17 years.
• Bipolar Depression: For the treatment of major depressive episodes associated with Bipolar I Disorder (bipolar depression). It is approved for use in adults and pediatric patients aged 10 to 17 years. In adults, it may be used as monotherapy or as adjunctive therapy with lithium or valproate.

Boxed Warnings

Latuda carries the FDA's most serious warning, known as a boxed warning, for two specific risks:

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Latuda is not approved for the treatment of patients with dementia-related psychosis.
• Suicidal Thoughts and Behaviors: While used for bipolar depression, Latuda and similar medications may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Healthcare providers should monitor all patients closely for clinical worsening or unusual changes in behavior, especially during the first few months of treatment.

Regulatory History

Since its initial 2010 approval for schizophrenia, the FDA expanded Latuda's indications to include adult bipolar depression in 2013, adolescent schizophrenia in 2017, and pediatric bipolar depression in 2018.

Weight Changes and Latuda

Weight gain is a recognized side effect of Latuda (lurasidone). As an atypical antipsychotic, Latuda can cause metabolic changes that may lead to an increase in body weight.

Monitoring and Management

Because of the risk of weight gain, healthcare providers usually perform the following:

• Check weight and body mass index (BMI) before starting treatment.
• Monitor weight regularly during the course of therapy.
• Assess for other metabolic changes, such as increases in blood sugar or cholesterol levels.

In clinical trials, weight gain was reported in both adults and children taking Latuda. However, the extent of weight gain can vary significantly between individuals. If you notice a significant or rapid increase in weight while taking this medication, you should consult your healthcare provider to discuss management strategies.