ain. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Indivior Inc. at 1-877-782-6966 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carbamazepine and other strong CYP3A4 inducers decrease plasma concentrations of risperidone. (2.3, 7.1)
Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration. (2.3, 7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1)
Renal or Hepatic Impairment: Carefully titrate on oral risperidone up to at least 3 mg before initiating treatment with PERSERIS at a dose of 90 mg. (8.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 7/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA- RELATED PSYCHOSIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Dosage Recommendations for Patients with Renal or Hepatic Impairment
2.3 Dosage Recommendations for Concomitant Use with Strong CYP2D6 Inhibitors and Strong CYP3A4 Inducers
2.4 Instructions for Use
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis
5.2 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
5.3 Neuroleptic Malignant Syndrome (NMS)
5.4 Tardive Dyskinesia
5.5 Metabolic Changes
5.6 Hyperprolactinemia
5.7 Orthostatic Hypotension
5.8 Falls
5.9 Leukopenia, Neutropenia, and Agranulocytosis
5.10 Potential for Cognitive and Motor Impairment
5.11 Seizures
5.12 Dysphagia
5.13 Priapism
5.14 Body Temperature Regulation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with PERSERIS
7.2 Drugs Having No Clinically Important Interactions with PERSERIS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
10.1 Human Experience
10.2 Management of Overdosage
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. CLOSE
1 INDICATIONS AND USAGE
PERSERISTM is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
PERSERIS is to be administered as an abdominal subcutaneous injection only. Do not administer by any other route.
Each injection must be administered by a healthcare professional using the prepackaged injection syringe and enclosed safety needle [see Dosage and Administration (2.4)].
For patients who have never taken risperidone, establish tolerability with oral risperidone prior to starting PERSERIS.
Initiate PERSERIS at a dose of 90 mg or 120 mg once monthly by sub |
