ite to yellow-green and is available in dosage strengths of 90 mg and 120 mg.
PERSERIS 90 mg is supplied in a single-dose kit, packaged in a carton (NDC 12496-0090-1), containing the following:
One pouch with a sterile syringe (labelled ‘P') prefilled with risperidone powder
One pouch with a sterile syringe (labelled ‘L') prefilled with the delivery system, and desiccant.
One 18-gauge, 5/8-inch sterile safety needle.
PERSERIS 120 mg is supplied in a single-dose kit, packaged in a carton (NDC 12496-0120-1), containing the following:
One pouch with a sterile syringe (labelled ‘P') prefilled with risperidone powder.
One pouch with a sterile syringe (labelled ‘L') prefilled with the delivery system, and desiccant.
One 18-gauge, 5/8-inch sterile safety needle.
Storage and Handling
Store in refrigerator at 2° to 8°C (36° to 46°F). Allow PERSERIS kit to come to room temperature, 20°C to 25°C (68°F to 77°F), for at least 15 minutes prior to mixing.
PERSERIS may be stored in its unopened original packaging at room temperature, 20°C to 25°C (68°F to 77°F), for up to 7 days prior to administration. After removal from the refrigerator, use PERSERIS within 7 days or discard.
17 PATIENT COUNSELING INFORMATION
Physicians are advised to discuss with patients for whom they prescribe PERSERIS all relevant safety information including, but not limited to, the following:
Instructions for General Use
Advise patients not to rub or massage the injection site and to be aware of the placement of any belts or clothing waistbands [see Dosage and Administration (2.4)].
Orthostatic Hypotension
Advise patients of the risk of orthostatic hypotension and instruct in nonpharmacologic interventions that help to reduce the occurrence of orthostatic hypotension (e.g., sitting on the edge of the bed for several minutes before attempting to stand in the morning and slowly rising from a seated position) [see Warnings and Precautions (5.7)].
Potential for Cognitive and Motor Impairment
Inform patients that PERSERIS has the potential to impair judgment, thinking, or motor skills. Advise caution about operating hazardous machinery, including automobiles, until they are reasonably certain that treatment with PERSERIS does not affect them adversely [see Warnings and Precautions (5.10)].
Concomitant Medication
Advise patients 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 interaction [see Drug Interactions (7)].
Alcohol
Advise patients to avoid alcohol during treatment with PERSERIS [see Drug Interactions (7.1)].
Metabolic Changes
Advise patients that treatment with PERSERIS can be associated with diabetes mellitus and hyperglycemia, dyslipidemia and weight gain [see Warning and Precautions (5.5)].
Pregnancy
Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during treatment with PERSERIS. Advise patients that PERSERIS 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 PERSERIS during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise breastfeeding women using PERSERIS to monitor infants for somnolence, failure to thrive, |
