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

14.2 Schizoaffective Disorder

Adults

The acute efficacy of INVEGA (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 INVEGA (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 INVEGA : 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 INVEGA 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. INVEGA 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 INVEGA 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 INVEGA 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), INVEGA was not significantly different from placebo as measured by the PANSS. ® ® ®

Taking the results of both studies together, INVEGA 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

NDC:64725-0550-1 in a BOTTLE of 30 TABLET, EXTENDED RELEASES

Storage and Handling

Store up to 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

Physicians are advised to discuss the following issues with patients for whom they prescribe INVEGA . ®

17.1 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)

17.2 Interference with Cognitive and Motor Performance

As INVEGA 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 INVEGA therapy does not affect them adversely . ® ® [see ] Warnings and Precautions (5.11)

17.3 Pregnancy

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

17.4 Nursing

Caution should be exercised when INVEGA is administered to a nursing woman. The known benefits of breastfeeding should be weighed against the unknown risks of infant exposure to paliperidone. . ® [See ] Use in Specific Populations (8.3)

17.5 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)

17.6 Alcohol

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

17.7 Heat Exposure and Dehydration

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

17.8 Administration

Patients should be informed that INVEGA 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)

INVEGA (paliperidone) Extended-Release Tablets ®

Product of Ireland

Manufactured by: ALZA Corporation Vacaville, CA 95688 OR Janssen Cilag Manufacturing, LLC Gurabo, Puerto Rico 00778

Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560

OROS is a registered trademark of ALZA Corporation

©Janssen Pharmaceuticals, Inc. 2007

Label Image
(click image for full-size original)
INVEGA paliperidone tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0550(NDC:50458-550)
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
CARNAUBA WAX
CELLULOSE ACETATE
POLYETHYLENE GLYCOLS
PROPYLENE GLYCOL
POVIDONES
SODIUM CHLORIDE
STEARIC ACID
BUTYLATED HYDROXYTOLUENE
HYPROMELLOSES
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
TRIACETIN
LACTOSE MONOHYDRATE
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 11mm
Flavor Imprint Code PAL;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0550-1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021999 12/19/2006
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0550), REPACK (64725-0550)

Revised: 05/2014 TYA Pharmaceuticals

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