PALIPERIDONE: Package Insert and Label Information (Page 6 of 6)

14.2 Schizoaffective Disorder

Adults

The acute efficacy of paliperidone (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 (3-12 mg once daily). In the other study, efficacy was assessed in 203 subjects who were assigned to one of two dose levels of paliperidone: 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 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 was 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 group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of paliperidone 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-D21 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 was not significantly different from placebo as measured by the PANSS.

Taking the results of both studies together, paliperidone 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 circular shaped.

1.5 mg tablets are orange-brown colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and “032” printed in black ink on other side, and are available in bottles of 30 (NDC 49252-032-10).

3 mg tablets are white to off-white colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and “033” printed in black ink on other side, and are available in bottles of 30 (NDC 49252-033-10).

6 mg tablets are beige colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and “034” printed in black ink on other side, and are available in bottles of 30 (NDC 49252-034-10).

9 mg tablets are pink colored, circular shaped, biconvex, beveled edged, coated tablet plain on one side and “035” printed in black ink on other side, and are available in bottles of 30 (NDC 49252-035-10).

Storage and Handling

Store at 20º to 25ºC (68º to 77ºF)[see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container. 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.

Orthostatic Hypotension

Patients should be advised that there is risk of orthostatic hypotension, particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions (5.9)].

Interference with Cognitive and Motor Performance

As paliperidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that paliperidone therapy does not affect them adversely [see Warnings and Precautions (5.11)].

Concomitant Medication

Patients should be advised to inform their physicians 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

Patients should be advised to avoid alcohol while taking paliperidone [see Drug Interactions (7.1)].

Heat Exposure and Dehydration

Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.17)].

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. [see Dosage and Administration (2.3)].

Paliperidone extended-release tablets

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with paliperidone. 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 palipeirdone 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 INVEGA® may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see USE IN SPECIFIC POPULATIONS (8.3) ].

Paliperidone extended-release tablets

Product of India

Manufactured By:

Inventia Healthcare Limited

Plot No.F1 & F-1/1, Additional Ambernath M.I.D.C.,

Ambernath (East)-421506,

Dist. Thane, Maharashtra, India

Revised: March 2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PALIPERIDONE EXTENDED RELEASE TABELETS

NDC 49252-032-10

1.5 mg

Rx only

30 Tablets

05e67b7a-0134-451c-b344-8d9adacbae59-1
(click image for full-size original)

PALIPERIDONE EXTENDED RELEASE TABELETS

NDC 49252-033-10

3 mg

Rx only

30 Tablets

05e67b7a-0134-451c-b344-8d9adacbae59-2
(click image for full-size original)

PALIPERIDONE EXTENDED RELEASE TABELETS

NDC 49252-034-10

6 mg

Rx only

30 Tablets

05e67b7a-0134-451c-b344-8d9adacbae59-3
(click image for full-size original)

PALIPERIDONE EXTENDED RELEASE TABELETS

NDC 49252-035-10

9 mg

Rx only

30 Tablets

05e67b7a-0134-451c-b344-8d9adacbae59-4
(click image for full-size original)
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49252-032
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE (PALIPERIDONE) PALIPERIDONE 1.5 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CELLULOSE, MICROCRYSTALLINE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
ETHYLCELLULOSES
DIBUTYL SEBACATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color ORANGE (Orange-brown) Score no score
Shape ROUND (CIRCULAR) Size 7mm
Flavor Imprint Code 032
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49252-032-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204452 09/01/2019
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49252-033
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE (PALIPERIDONE) PALIPERIDONE 3 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CELLULOSE, MICROCRYSTALLINE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
ETHYLCELLULOSES
DIBUTYL SEBACATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white) Score no score
Shape ROUND (circular) Size 7mm
Flavor Imprint Code 033
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49252-033-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204452 09/01/2019
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49252-034
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE (PALIPERIDONE) PALIPERIDONE 6 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CELLULOSE, MICROCRYSTALLINE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
MAGNESIUM STEARATE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
ETHYLCELLULOSES
DIBUTYL SEBACATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (Beige) Score no score
Shape ROUND (Circular) Size 7mm
Flavor Imprint Code 034
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49252-034-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204452 09/01/2019
PALIPERIDONE paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49252-035
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PALIPERIDONE (PALIPERIDONE) PALIPERIDONE 9 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
CELLULOSE, MICROCRYSTALLINE
BUTYLATED HYDROXYTOLUENE
SILICON DIOXIDE
MAGNESIUM STEARATE
FERRIC OXIDE RED
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)
ETHYLCELLULOSES
DIBUTYL SEBACATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Circular) Size 7mm
Flavor Imprint Code 035
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49252-035-10 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204452 09/01/2019
Labeler — Inventia Healthcare Limited (677604412)
Registrant — Inventia Healthcare Limited. (650452522)
Establishment
Name Address ID/FEI Operations
Inventia Healthcare Limited 677604412 manufacture (49252-032), manufacture (49252-033), manufacture (49252-034), manufacture (49252-035)

Revised: 06/2019 Inventia Healthcare Limited

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