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Latuda: Patient counseling information

14.1. Schizophrenia

The efficacy of Latuda for the treatment of schizophrenia was established in four short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.8 years, range 18-72) who met DSM-IV criteria for schizophrenia. One study included an active-control arm (olanzapine) to assess assay sensitivity.

Several instruments were used for assessing psychiatric signs and symptoms in these studies:

1. Positive and Negative Syndrome Scale (PANSS), is a multi-item inventory of general psychopathology used to evaluate the effects of drug treatment in schizophrenia. PANSS total scores may range from 30 to 210.

2. Brief Psychiatric Rating Scale derived (BPRSd), derived from the PANSS, is a multi-item inventory primarily focusing on positive symptoms of schizophrenia, whereas the PANSS includes a wider range of positive, negative and other symptoms of schizophrenia. BPRSd scores may range from 18 to 126.

3. The Clinical Global Impression severity scale (CGI-S) is a validated clinician-rated scale that measures the subject’s current illness state on a 1 to 7-point scale.

The endpoint associated with each instrument is change from baseline in the total score to the end of week 6. These changes are then compared to placebo changes for the drug and control groups.

The results of the studies follow:

1. In a 6-week, placebo-controlled trial (N=145) involving two fixed doses of Latuda (40 or 120 mg/day), both doses of Latuda at Endpoint were superior to placebo on the BPRSd total score, and the CGI-S.

2. In a 6-week, placebo-controlled trial (N=180) involving a fixed dose of Latuda (80 mg/day), Latuda at Endpoint was superior to placebo on the BPRSd total score, and the CGI-S.

3. In a 6-week, placebo and active-controlled trial (N=473) involving two fixed doses of Latuda (40 or 120 mg/day) and an active control (olanzapine), both Latuda doses and the active control at Endpoint were superior to placebo on the PANSS total score, and the CGI-S.

4. In a 6-week, placebo-controlled trial (N=489) involving three fixed doses of Latuda (40, 80 or 120 mg/day), only the 80 mg/day dose of Latuda at Endpoint was superior to placebo on the PANSS total score, and the CGI-S.

Latuda 20mg/ 40mg / 80mg/ 120mg

Thus, the efficacy of Latuda at doses of 40, 80 and 120 mg/day was established in two studies for each dose. However, the 120mg dose did not appear to add additional benefit over the 40 mg dose (Table: Summary of Results for Primary Efficacy Endpoints).

Table: Summary of Results for Primary Efficacy Endpoints

Study Number Primary Endpoint LS Mean (SE)a Difference from Placebo in Change from Baseline
    Latuda
40 mg/day
Latuda
80 mg/day
Latuda
120 mg/day
Olanzapine
15 mg/day
1 BPRSd -5.6*
(2.1)
-6.7*
(2.2)
2 BPRSd -4.7*
(1.8)
3 PANSS -9.7*
(2.9)
-7.5*
(3.0)
-12.6*
(2.8)
4 PANSS -2.1
(2.5)
-6.4*
(2.5)
-3.5
(2.5)

*adjusted p-value <0.05 (except for olanzapine)

a Least Squares Mean (Standard Error)

Examination of population subgroups based on age (there were few patients over 65), gender and race did not reveal any clear evidence of differential responsiveness.

Latuda tablets are white to off-white, round (40 mg), or pale green, oval (80 mg) and identified with strength specific one-sided debossing , “L40″ (40 mg), or “L80″ (80 mg). Tablets are supplied in the following strengths and package configurations (Table: Package Configuration for Latuda Tablets):

Table: Package Configuration for Latuda Tablets

Tablet Strength Package Configuration NDC Code
40 mg Bottles of 30 63402-304-30
  Bottles of 90 63402-304-90
  Bottles of 500 63402-304-50
  Box of 70
10 blister cards, 7 tablets each
63402-304-70 Carton
63402-304-07 Blister
  Box of 100 (Hospital Unit Dose)
10 blister cards, 10 tablets each
63402-304-10 Carton
63402-304-01 Blister
80 mg Bottles of 30 63402-308-30
  Bottles of 90 63402-308-90
  Bottles of 500 63402-308-50
  Box of 70
10 blister cards, 7 tablets each
63402-308-70 Carton
63402-308-07 Blister
  Box of 100 (Hospital Unit Dose)
10 blister cards, 10 tablets each
63402-308-10 Carton
63402-308-01 Blister

Storage

Store Latuda tablets at 25°C (77°F); excursions permitted to 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature].

Physicians are advised to discuss with patients for whom they prescribe Latuda all relevant safety information including, but not limited to, the following:

17.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Latuda is not approved for elderly patients with dementia-related psychosis [see Boxed Warning; Warnings and Precautions [5.1)].

17.2 Neuroleptic Malignant Syndrome

Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)].

17.3 Hyperglycemia and Diabetes Mellitus

Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus. Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions [5.5)].

Latuda-Medication

17.4 Orthostatic Hypotension

Patients should be advised of the risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.8)].

17.5 Leukopenia/Neutropenia

Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking Latuda [see Warnings and Precautions (5.7)].

17.6 Interference with Cognitive and Motor Performance

Patients should be cautioned about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that Latuda therapy does not affect them adversely [see Warnings and Precautions (5.10)].

17.7 Pregnancy and Nursing

Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with Latuda [see Use in Specific Populations (8.1)].

17.8 Concomitant Medication and Alcohol

Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions. Patients should be advised to avoid alcohol while taking Latuda [see Dmg Interactions (7)].

17.9 Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.11)].

Latuda (lurasidone HCI) Tablets

Manufactured for:

Sunovion Pharmaceuticals Inc.

Fort Lee, NJ 07024

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