Lurasidone

DEA Class;  Rx

Common Brand Names; Latuda

Hypersensitivity

Coadministration with strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil)

Coadministration with strong CYP3A4 inducers (eg, rifampin, St. John’s wort, phenytoin, carbamazepine)

• Somnolence, dose related (15-26%)
• Akathisia, dose related (6-22%)
• Extrapyramidal disorder, dose related (6-22%)
• Parkinsonism, dose related (6-17%)
• Fasting glucose increased, dose related (10-14%)
• Nausea, dose related (9-13%)
• Insomnia, dose-related (7-11%)
• Agitation, dose related (3-10%)
• Vomiting, dose related (6-8%)
• Dyspepsia, dose related (5-8%)
• Anxiety, dose related (3-8%)
• Elevated serum creatinine, dose related (1-7.2%)
• Dystonia (5%)
• Dizziness, dose related (4-6%)
• Fatigue (4%)
• Back pain, dose related (2-4%)
• Restlessness (3%)
• Salivary hypersecretion, dose related (1-4%)
• Hypertension
• Rash
• Pruritus
• CPK increased
• Abdominal pain
• Diarrhea
• Blurred vision
• Tachycardia
• Anemia
• AV block 1st degree
• Angina pectoris
• Bradycardia
• Vertigo
• Gastritis
• Rhabdomyolysis
• Cerebrovascular accident
• Dysarthria
• Abnormal dreams
• Panic attack
• Sleep disorder
• Dysuria
• Renal failure
• Amenorrhea
• Dysmenorrhea
• Breast enlargement
• Breast pain

Possibility of suicide attempt inherent to psychotic illness; close supervision required when therapy is initiated, 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 (eg, >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 reported, possibly due to its alpha-1receptor antagonism

Risk of neuroleptic malignant syndrome (NMS) reported in association with administration of antipsychotic drugs, including lurasidone; clinical manifestations of NMS (eg, hyperpyrexia, muscle rigidity, altered mental status, evidence of autonomic instability); additional symptoms (eg, 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

Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms after delivery

Unknown whether 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 breastfed infant from therapy or from underlying maternal condition