Renal Dose Adjustments (Based on CrCl)
- 10-50 mL/min: Do not exceed 40 mg/day
Hepatic Dose Adjustments
- Child-Pugh Class B and C: Do not exceed 40 mg/day
See Supplemental Patient Information
- Lurasidone is not recommended for treatment of dementia-related psychosis [US Black Box Warning]
- There is an increased risk of death in elderly patients with dementia-related psychosis receiving conventional or atypical antipsychotics; most deaths were due to cardiovascular or infectious events [US Black Box Warning]
- Children, adolescents, and young adults receiving antidepressants have an increased risk of suicidal thoughts and behavior [US Black Box Warning]
- The risk of suicidal thoughts does not seem to increase with antidepressant use beyond age 24; and decreases with antidepressant use beyond
65 years of age [US Black Box Warning] - Increased incidence of cerebrovascular adverse reactions (transient ischemic attacks and cerebrovascular accidents), including fatalities, has been reported in elderly patients with dementia treated with atypical antipsychotics
- A potentially fatal symptom complex, named neuroleptic malignant syndrome (NMS), has been reported in association with antipsychotic drugs, including lurasidone. If NMS has been diagnosed, discontinue antipsychotic drugs, provide intensive symptomatic treatment and medical monitoring, and initiate therapy of any concomitant serious medical problems
- If antipsychotic drug treatment is deemed necessary after recovery from NMS, carefully consider the potential reintroduction of drug therapy. Carefully monitor patients if therapy is reintroduced, as recurrences of NMS have been reported
- Potentially irreversible, involuntary, dyskinetic movements referred to as tardive dyskinesia may develop in patients receiving antipsychotic drugs. This risk increases as the treatment duration and the total cumulative antipsychotic drug dose increase. Discontinue therapy if signs and symptoms of tardive dyskinesia occur in a patient receiving lurasidone
- Therapy is associated with metabolic changes that may increase cardiovascular/cerebrovascular risk, including hyperglycemia, dyslipidemia, and weight gain
- Hyperglycemia, sometimes extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients receiving atypical antipsychotics. All patients receiving therapy should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients with diabetes mellitus or at risk for diabetes who are starting treatment with lurasidone should undergo fasting blood glucose testing at the beginning of treatment and regularly during therapy
- Undesirable alterations in lipids may occur during lurasidone therapy
- Clinical monitoring of weight is recommended during therapy as weight gain has been observed with lurasidone use
- Therapy may elevate prolactin levels. Hyperprolactinemia may result in reduced pituitary gonadotropin secretion, which may inhibit reproductive function by impairing gonadal steroidogenesis in both male and female patients. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density
- Therapy may cause leukopenia, neutropenia, and agranulocytosis. Frequently perform CBC counts during the first few months of therapy in patients with a history of a clinically significant low WBC or a history of drug-induced leukopenia/neutropenia
- Suspend therapy at the first sign of decline in WBC, in the absence of other causative factors. Carefully monitor patients with neutropenia for fever or other symptoms or signs of infection and initiate appropriate medical therapy if such signs or symptoms occur
- Lurasidone may induce orthostatic hypotension and syncope, due to its alpha1-adrenergic receptor antagonism effect. Use cautiously in patients with known cardiovascular or cerebrovascular disease, or in those predisposed to hypotension
- Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold such as Alzheimer's dementia, particularly in patients 65 yrs or older
- Therapy may significantly impair cognitive and motor skills; exercise caution while operating machinery, including motor vehicles
- Therapy may disrupt body's ability to reduce core body temperature; exercise caution while prescribing therapy for patients with conditions that may induce elevated core body temperature (e.g., exposure to extreme heat, exercising strenuously, dehydration, receiving concomitant anticholinergic medication)
- Closely monitor patients for suicidal tendencies during lurasidone therapy as the possibility of suicide attempt exists in psychotic illness. Prescription should be written for the smallest quantity of tablets consistent with effective patient management in order to reduce the risk of overdose
- Esophageal dysmotility and aspiration have been associated with antipsychotic drugs. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, especially those with advanced Alzheimer's dementia. Avoid therapy in patients at risk for aspiration pneumonia
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Dementia
- CNS depressant use
- Alcohol use
- History of NMS
- History of MI or IHD
- Hypotension
- Hypovolemia
- Dehydration
- History of seizure disorder
- Geriatric patients
Supplemental Patient Information
- Advise patients not to perform activities requiring mental alertness, such as driving a motor vehicle or operating machinery, until they are reasonably certain that the therapy does not affect them adversely
- Inform patients to notify their physician if they become pregnant or plan to become pregnant during therapy
- Instruct patients to avoid alcohol during therapy
- Advise patients regarding appropriate care in avoiding overheating and dehydration
Pregnancy Category:B
Breastfeeding: Safety unknown. No data available regarding lurasidone use during breastfeeding; hence, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 August 2011). Manufacturer recommends lurasidone administration in breastfeeding women only if the potential benefit justifies the potential risk to the child.
Pricing data from www.DrugStore.com in U.S.A.
- Latuda 80 MG TABS [Bottle] (SUNOVION PHARMACEUTICALS)
30 mg = $535.98
90 mg = $1559.9
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
