PERSERIS (Page 8 of 8)
16 HOW SUPPLIED/STORAGE AND HANDLING
PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use is, when fully mixed a viscous suspension that, varies from white 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°C to 8°C (36°F 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 30 days prior to administration. After removal from the refrigerator, use PERSERIS within 30 days or discard.
17 PATIENT COUNSELING INFORMATION
General Instructions
Advise patients not to rub or massage the injection site and to be aware of the placement of any belts or clothing waistbands, sleeves, cuffs, or other parts of clothing [see Dosage and Administration (2.4)].
Neuroleptic Malignant Syndrome
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 the healthcare provider or report to the emergency room if they experience signs and symptoms of NMS [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 (5.4)].
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 (5.5)].
Hyperprolactinemia
Counsel patients on signs and symptoms of hyperprolactinemia that may be associated with chronic use of PERSERIS. 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 (5.6)].
Orthostatic Hypotension and Syncope
Educate patients of 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 (5.7)].
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 PERSERIS [see Warnings and Precautions (5.9)].
Potential for Cognitive and Motor Impairment
Inform patients that PERSERIS has the potential to impair judgment, thinking, and motor skills. Caution patients about performing activities requiring mental alertness, such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that PERSERIS does not affect them adversely [see Warnings and Precautions (5.10)].
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 [Warnings and Precautions (5.13)].
Heat Exposure and Dehydration
Educate patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions (5.14)].
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)].
Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with PERSERIS. Advise patients that PERSERIS may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) 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, 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 PERSERIS may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible [see Use in Specific Populations (8.3)].
Manufactured for:
Indivior Inc., North Chesterfield, VA 23235.
© 2022, Indivior UK Limited. All Rights Reserved.
PERSERIS is a registered trademark of Indivior UK Limited.
Powder syringe manufactured by Patheon Manufacturing Services, Greenville, NC 27834.
Liquid syringe manufactured by Curia, Burlington, MA 01803.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. | Revised 12/2022 |
FREQUENTLY ASKED QUESTIONS Q What is the mixture supposed to look like? A When fully mixed, the product should be a cloudy suspension that is uniform in color. It can vary from white to yellow-green in color. If you see any clear areas in the mixture, continue to mix until the distribution of the color is uniform.Q Why is it important to put the liquid syringe on top? A The liquid is viscous and will not fall out when placing on top. However, powder may be lost if the powder syringe is inverted, which could affect the ultimate dosage.Q What do I do if there is residual left in the powder syringe? A A small ring of residual powder may be observed in the end of the powder syringe barrel after mixing. This is normal. If you have followed the instructions carefully and the rest of the mixture is a cloudy suspension that is uniform in color, proceed with the injection.Q What do I do if a foreign particle is found in either of the syringes? A Do not use if you suspect foreign particles in either of the syringes.Q How soon must I inject after mixing PERSERIS ® ? A This product should be used immediately following preparation.Q Can I inject into the leg? A This injection is only approved for injection into the subcutaneous tissue of abdomen and back of the upper arm.Q How do I get rid of large air gaps? A Small bubbles, also known as champagne bubbles, are not a problem and common with this medication. Large air gaps, however, can be minimized by pulling back on the plunger rod to pop air bubbles prior to expelling the air very slowly. Air should be expelled very carefully to avoid loss of medication.Q Should I massage or put my finger on the injection site following the injection? A It is not advisable to palpate or massage the area following the injection.Q Will the deposit be palpable? A Depending on the patient’s subcutaneous tissue, the deposit may be more or less palpable. Patients should be advised that a bump may be palpable (decreasing in size) for several weeks. | |
Manufactured for: Indivior Inc., North Chesterfield, VA 23235.© 2022, Indivior UK Limited. All Rights Reserved.PERSERIS is a registered trademark of Indivior UK Limited.Powder syringe manufactured by Patheon Manufacturing Services, Greenville, NC 27834.Liquid syringe manufactured by Curia, Burlington, MA 01803. | |
Principal Display Panel — Perseris Kit 90 mg Carton Label
NDC 12496-0090-1
once-monthly
PERSERIS ®
(risperiDONE)
for extended-release
injectable suspension
90 mg
Liquid
Syringe
+
Mix
Powder Syringe
1 Injection
Rx only
Sterile
Single-dose only
For subcutaneous injection only. Please read complete instructions prior to use.
Principal Display Panel — Perseris Kit 120 mg Carton Label
NDC 12496-0120-1
once-monthly
PERSERIS®
(risperiDONE)
for extended-release
injectable suspension
120 mg
Liquid
Syringe
+
Mix
Powder Syringe
1 Injection
Rx only
Sterile
Single-dose only
For subcutaneous injection only. Please read complete instructions prior to use.
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Labeler — Indivior Inc. (797408549) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Curia Massachusetts, Inc. | 556991748 | ANALYSIS (12496-0090), MANUFACTURE (12496-0090), ANALYSIS (12496-0120), MANUFACTURE (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Curia Global, Inc. | 080046430 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Assia Chemical Industries Ltd (Teva Tech site) | 649323474 | API MANUFACTURE (12496-0090), API MANUFACTURE (12496-0120), ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Eurofins Lancaster Laboratories, Inc | 069777290 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Indivior Inc. | 080660711 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Isomedix Operations Inc | 004303926 | STERILIZE (12496-0090), STERILIZE (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Nelson Laboratories, LLC | 151663234 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Patheon Manufacturing Services LLC | 079415560 | ANALYSIS (12496-0090), MANUFACTURE (12496-0090), ANALYSIS (12496-0120), MANUFACTURE (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
SGS North America Inc | 049859261 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Sharp Packaging Services, LLC | 143696495 | PACK (12496-0090), LABEL (12496-0090), PACK (12496-0120), LABEL (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Spectral Data Services, Inc. | 144318722 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
SYNERGY HEALTH AST, LLC | 044622190 | STERILIZE (12496-0090), STERILIZE (12496-0120) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Teva API India Private Ltd. | 677604388 | ANALYSIS (12496-0090), ANALYSIS (12496-0120) |
Revised: 08/2023 Indivior Inc.
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