Paliperidone (Page 9 of 10)

14.2 Schizoaffective Disorder

Adults

The acute efficacy of paliperidone extended-release tablets (3 mg to 12 mg once daily) in the treatment of schizoaffective disorder was established in two placebo-controlled, 6-week trials in non-elderly adult subjects. Enrolled subjects 1) met DSM-IV criteria for schizoaffective disorder, as confirmed by the Structured Clinical Interview for DSM-IV Disorders, 2) had a Positive and Negative Syndrome Scale (PANSS) total score of at least 60, and 3) had prominent mood symptoms as confirmed by a score of at least 16 on the Young Mania Rating Scale and/or Hamilton Rating Scale for Depression. The population included subjects with schizoaffective bipolar and depressive types. In one of these trials, efficacy was assessed in 211 subjects who received flexible doses of paliperidone extended-release tablets (3 mg to 12 mg once daily). In the other study, efficacy was assessed in 203 subjects who were assigned to one of two dose levels of paliperidone extended-release tablets: 6 mg with the option to reduce to 3 mg (n = 105) or 12 mg with the option to reduce to 9 mg (n = 98) once daily. Both studies included subjects who received paliperidone extended-release tablets either as monotherapy [no mood stabilizers and/or antidepressants (55%)] or as an adjunct to mood stabilizers and/or antidepressants (45%). The most commonly used mood stabilizers were valproate and lithium. The most commonly used antidepressants were SSRIs and SNRIs. Paliperidone extended-release tablets were dosed in the morning without regard to meals. Studies were carried out in the United States, Eastern Europe, Russia, and Asia.

Efficacy was evaluated using the PANSS, a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. As secondary outcomes, mood symptoms were evaluated using the Hamilton Depression Rating Scale (HAM-D-21) and the Young Mania Rating Scale (YMRS).

The paliperidone extended-release tablets group in the flexible-dose study (dosed between 3 mg/day and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of paliperidone extended-release tablets in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS. Numerical improvements in mood symptoms were also observed, as measured by the HAM-D-21 and YMRS. In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day),paliperidone extended-release tablets were not significantly different from placebo as measured by the PANSS.

Taking the results of both studies together, paliperidone extended-release tablets improved the symptoms of schizoaffective disorder at endpoint relative to placebo when administered either as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. An examination of population subgroups did not reveal any evidence of differential responsiveness on the basis of gender, age, or geographic region. There were insufficient data to explore differential effects based on race.

16 HOW SUPPLIED/STORAGE AND HANDLING

Paliperidone extended-release tablets are available in the following strengths and packages. All tablets are capsule-shaped.

1.5 mg tablets are brown, capsule-shaped, film-coated tablets, with a small orifice on one end, and imprinted with “A86” on the body. They are available in bottles of 30 with child-resistant closure (NDC 27808-222-01).

3 mg tablets are white, capsule-shaped, film-coated tablets, with a small orifice on one end, and imprinted with “A87” on the body. They are available in bottles of 30 with child-resistant closure (NDC 27808-223-01).

6 mg tablets are beige, capsule-shaped, film-coated tablets, with a small orifice on one end, and imprinted with “A88” on the body. They are available in bottles of 30 with child-resistant closure (NDC 27808-224-01).

9 mg tablets are pink, capsule-shaped, film-coated tablets, with a small orifice on one end, and imprinted with “A89” on the body. They are available in bottles of 30 with child-resistant closure (NDC 27808-225-01)

Storage and Handling

Store up to 25ºC (77ºF); excursions permitted from 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in tight (USP) containers.

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe paliperidone extended-release tablets.

Neuroleptic Malignant Syndrome (NMS)

Counsel patients about a potentially fatal adverse reaction, Neuroleptic Malignant Syndrome (NMS), that has been reported in association with administration of antipsychotic drugs. Advise patients, family members, or caregivers to contact their healthcare provider or report to the emergency room if they experience signs and symptoms of NMS, including hyperpyrexia, muscle rigidity, altered mental status including delirium, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions (5.3)].

Tardive Dyskinesia

Counsel patients on the signs and symptoms of tardive dyskinesia and to contact their healthcare provider if these abnormal movements occur [see Warnings and Precautions (5.5)].

Metabolic Changes

Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions (5.6)].

Orthostatic Hypotension

Educate patients about the risk of orthostatic hypotension and syncope, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.9)].

Leukopenia/ Neutropenia

Advise patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia they should have their CBC monitored while taking paliperidone extended-release tablets [see Warnings and Precautions (5.11)].

Hyperprolactinemia

Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of paliperidone extended-release tablets. Advise them to seek medical attention if they experience any of the following: amenorrhea or galactorrhea in females, erectile dysfunction or gynecomastia in males [see Warnings and Precautions (5.7)].

Interference with Cognitive and Motor Performance

Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery, or operating a motor vehicle, until they are reasonably certain that paliperidone extended-release tablets therapy does not affect them adversely [see Warnings and Precautions (5.12)].

Priapism

Advise patients of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Warnings and Precautions (5.15)].

Heat Exposure and Dehydration

Counsel patients on the importance of avoiding overheating and dehydration [see Warnings and Precautions (5.16)].

Concomitant Medication

Advise patients to inform their healthcare providers if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions [see Drug Interactions (7)].

Alcohol

Advise patients to avoid alcohol while taking paliperidone extended-release tablets [see Drug Interactions (7.1)].

Administration

Patients should be informed that paliperidone extended-release tablets should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice something that looks like a tablet in their stool [see Dosage and Administration (2.3)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paliperidone extended-release tablets. Advise patients that paliperidone may cause extrapyramidal and/or withdrawal symptoms in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to paliperidone during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding women using paliperidone extended-release tablets to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Infertility

Advise females of reproductive potential that paliperidone may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].

The brands listed are trademarks of their respective owners.

Manufactured by:

CSPC Ouyi Pharmaceutical Co., Ltd.

Shijiazhuang, Hebei, China, 052160

Manufactured for:

Tris Pharma, Inc.

Monmouth Junction, NJ 08852

www.trispharma.com

LB8649 Rev.00 06/2021

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