LATUDA (lurasidone hydrochloride) tablet

Lurasidone hydrochloride is a white to off-white powder. It is very slightly soluble in water, practically insoluble or insoluble in 0.1 N HCl, slightly soluble in ethanol, sparingly soluble in methanol, practically insoluble or insoluble in toluene and very slightly soluble in acetone.

LATUDA tablets are intended for oral administration only. Each tablet contains 40 mg, or 80 mg of lurasidone hydrochloride.

Inactive ingredients are mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, magnesium stearate, Opadry® and carnauba wax. Additionally, the 80 mg tablet contains yellow ferric oxide and FD&C Blue No.2 Aluminum Lake.

The efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia.

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration].

Coadministration with a strong CYP3A4 inhibitor (e.g., ketoconazole) and inducer (e.g.,rifampin)

• Cerebrovascular Adverse Reactions: An increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs.
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
• Tardive Dyskinesia: Discontinue if clinically appropriate
• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain
  • Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes.
  • Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Gain in body weight has been observed, clinical monitoring of weight is recommended.
• Hyperprolactinemia: Prolactin elevations may occur
• Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotics. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors.
• Orthostatic Hypotension and Syncope: Dizziness, tachycardia or bradycardia, and syncope may occur, especially early in treatment. Use with caution in patients with known cardiovascular or cerebrovascular disease, and in antipsychotic-naïve patients
• Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery
• Suicide: The possibility of a suicide attempt is inherent in schizophrenia. Closely supervise high-risk patients .
• See Full Prescribing Information for additional WARNINGS and PRECAUTIONS

DRUG INTERACTIONS
LATUDA is not recommended to be used in combination with strong CYP3A4 inhibitors, e.g., ketoconazole.

Dose adjustment is recommended for moderate CYP3A4 inhibitors (e.g. diltiazem)
LATUDA is not recommended to be used in combination with strong CYP3A4 inducers, e.g., rifampin.

USE IN SPECIFIC POPULATIONS
-Geriatric Use: No dose adjustments required.
-Pregnancy: Use LATUDA during pregnancy only if the potential benefit justifies the potential risk.
-Nursing Mothers: Breast feeding is not recommended.
-Pediatric Use: Safety and effectiveness have not been established.
-Renal Impairment: Dose adjustment is recommended.
-Hepatic Impairment: Dose adjustment is recommended.

Schizophrenia
The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.

Administration Instructions
LATUDA should be taken with food (at least 350 calories).

Dosage in Special Populations
Dosage adjustments are not recommended on the basis of age, gender, and race.

Dose adjustment is recommended in moderate and severe renal impairment patients. The dose in these patients should not exceed 40 mg/day.

Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day.

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inhibitors: When coadministration of LATUDA with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole).

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inducers: LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin).

Table 1: LATUDA Tablet Presentations Tablet Strength Tablet Color/Shape Tablet Markings
40 mg white to off-white round 'L40'
80 mg pale green oval 'L80'

For Customer Service, call 1-888-394-7377.
For Medical Information, call 1-800-739-0565.
To report suspected adverse reactions, call 1-877-737-7226.

Revised: October 2010
901456R01

LATUDA is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd.

© 2010 Sunovion Pharmaceuticals Inc.