Lurasidone

Lurasidone is a prescription medication used to treat Schizophrenia and Bipolar Depression. 

• Lurasidone is available under the following different brand names: Latuda

Adult and pediatric dosage

Tablet

• 20mg
• 40mg
• 60mg
• 80mg
• 120mg

Schizophrenia

Adult dosage

• 40 mg orally once daily initially; not to exceed 160 mg/day
• Initial dose titration is not required; shown to be effective in a dose range of 40-160 mg/day

Pediatric dosage

• Children younger than 13 years of age: Safety and efficacy not established
• Children 13-17 years of age: 
• Starting dose: 40 mg orally once daily; initial dose titration is not required
• Effective dosage range: 40-80 mg/day; not to exceed 80 mg/day

Bipolar Depression

Adult dosage

Monotherapy

• 20 mg orally once daily initially; may increase the dose if needed, not to exceed 120 mg/day
• In monotherapy study, a higher dose range (80-120 mg/day) did not provide additional efficacy compared to the lower dose range (20-60 mg/day)
• Adjunctive therapy
• 20 mg orally once daily initially; may increase the dose if needed, not to exceed 120 mg/day

Pediatric dosage

• Indicated as monotherapy for major depressive episode associated with bipolar I disorder (bipolar depression) in adolescents between 10-17 years of age
• 20 mg orally once a day; initial dose titration is not required
• May increase dose after 1 week based on clinical response; not to exceed 80 mg once daily, the effective dose range is 20-80 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Lurasidone include:

• drowsiness, 
• weight gain, 
• tremors, 
• muscle stiffness, 
• slow muscle movement, 
• feeling restlessness, 
• inability to sit still, 
• nausea, 
• vomiting, 
• runny nose, and 
• sleep problems (insomnia)

Serious side effects of Lurasidone include:

• hives, 
• rash, 
• swelling in the face, tongue, and throat, 
• mood or behavior changes, 
• anxiety, 
• panic attacks, 
• trouble sleeping, 
• impulsive behavior, 
• irritableness, 
• agitation, 
• hostility, 
• aggression, 
• restlessness, 
• hyperactivity (mentally or physically),
• increased depression, 
• thoughts of self-harm, 
• new or unusual muscle movements you cannot control, 
• lightheadedness, 
• seizure, 
• irregular menstrual periods, 
• breast or vaginal changes (in women), 
• nipple discharge (in women),
• breast swelling (in men), 
• impotence, 
• trouble swallowing, 
• racing thoughts, 
• increased energy, 
• decreased need for sleep, 
• risk-taking behavior, 
• talkativeness, 
• fever, 
• chills, 
• mouth sores, 
• skin sores, 
• sore throat, 
• cough, 
• trouble breathing, 
• increased thirst, 
• increased urination, 
• hunger, 
• dry mouth, 
• fruity breath odor, 
• very stiff (rigid) muscles, 
• high fever, 
• sweating, 
• confusion, 
• fast or uneven heartbeats, and
• tremors

Rare side effects of Lurasidone include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Lurasidone has severe interactions with at least 38 other drugs.
• Lurasidone has serious interactions with at least 21 other drugs.
• Lurasidone has moderate interactions with at least 340 other drugs.
• Lurasidone has minor interactions with the following drugs:
  • ruxolitinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity 
• Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil)
• Coadministration with strong CYP3A4 inducers (e.g., rifampin, St. John’s wort, phenytoin, carbamazepine)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Lurasidone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lurasidone?”

Cautions

• Possibility of suicide attempt inherent to psychotic illness; close supervision required when therapy is initiated, the dosage is changed, or drug is discontinued; the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use (e.g., over 4 months) is unknown; there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression
• Antidepressant treatment can increase the risk of developing a manic or hypomanic episode, particularly in patients with bipolar disorder
• Patients with Parkinson’s disease or dementia with Lewy bodies are reported to have an increased sensitivity to antipsychotic medication
• Orthostatic hypotension and syncope were reported, possibly due to its alpha-1receptor antagonism
• Risk of the neuroleptic malignant syndrome (NMS) reported in association with administration of antipsychotic drugs, including lurasidone; clinical manifestations of NMS (e.g., hyperpyrexia, muscle rigidity, altered mental status, evidence of autonomic instability); additional symptoms (e.g., elevated creatine phosphokinase, myoglobinuria [rhabdomyolysis], acute renal failure); the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment; if NMS is suspected, immediately discontinue therapy and provide intensive symptomatic treatment and monitoring
• Hyperprolactinemia reported; galactorrhea, amenorrhea, gynecomastia, and impotence reported with prolactin-elevating compounds; long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in both female and male patients
• Exercise caution in patients with a history of seizures or with conditions that lower the seizure threshold (e.g., Alzheimer’s dementia); conditions that lower the seizure threshold may be more prevalent in patients 65 years of age or older. 
• May cause leukopenia, neutropenia, and agranulocytosis; monitor patients with neutropenia should for fever or other signs of infection and treat promptly if symptoms occur; discontinue treatment in patients with severe neutropenia (ANC less than 1,000/mm³) and follow WBC until recovery
• May disrupt body temperature regulation
• May lead to cognitive and motor impairment; caution patients about operating hazardous machinery
• Incidence of cerebrovascular effects (e.g., transient ischemic attacks, stroke) may increase
• Esophageal dysmotility or aspiration may occur
• May increase QT interval: In trials, increase in baseline adjusted QTc intervals did not exceed mean based on individual correction method (QTcI) was 7.5 ms (120-mg dose) and 4.6 ms (600-mg dose) observed at 2-4 hours after dosing; additionally, in a separate trial, QTc did not increase by greater than 60 msec from baseline or exceed 500 msec with supratherapeutic doses (ie, 120 mg/day, 600 mg/day)
• Acute overdose: If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when given to patients with acute lurasidone overdose
• Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess the risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects

Metabolic changes with atypical antipsychotic use

• Hyperglycemia, some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, reported; monitor glucose control in patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics
• Monitor symptoms of hyperglycemia (e.g., polydipsia, polyuria, polyphagia, weakness)
• In the 6-week, placebo-controlled study of pediatric patients with bipolar depression, the mean change in fasting glucose was +1.6 mg/dL for lurasidone 20-80 mg/day
• Undesirable alterations in lipids observed
• Weight gain observed; clinically monitor weight

Tardive dyskinesia

• Extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia may occur; risk of tardive dyskinesia may increase in the elderly; risk of dystonia may increase with high doses
• The risk of developing tardive dyskinesia and the likelihood of it becoming irreversible may increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase

Drug interactions overview

• Coadministration with strong (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and moderate CYP3A4 inhibitors increased exposure of lurasidone (see Dosage Modifications, Contraindications)
• Coadministration with strong (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine) and moderate CYP3A4 inducers decreased exposure of lurasidone (see Dosage Modifications, Contraindications)

Pregnancy and Lactation

• Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lurasidone during pregnancy
• National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-andresearchprograms/pregnancyregistry 
• Unknown whether a drug is distributed in breast milk
• Lurasidone is present in rat milk
• Consider development and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on the breastfed infant from therapy or underlying maternal condition