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.

INSTRUCTIONS FOR USE
PERSERIS ® (risperidone) for extended-release injectable suspension
90 mg or 120 mg, sterile, single dose
For subcutaneous injection only. Do not administer by any other route.
IMPORTANT INFORMATION:
  • To be administered by a healthcare professional only.
  • Please read the instructions carefully before handling this product.
  • Allow package to come to room temperature for at least 15 minutes prior to preparation.
  • Only prepare medication when you are ready to administer the dose.
  • As a universal precaution, always wear gloves.
1 CHECK CONTENTS
  • One Liquid Syringe ( Figure
) pre-filled with the delivery system – Inspect liquid solution for foreign particles. This is the syringe you will use to inject the patient.

  • One Powder Syringe (Figure
) prefilled with Risperidone powder – Inspect syringe for consistency of powder color and for foreign particles.

  • One sterile 18-gauge, 5/8-inch safety needle
  • Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Figure
2 TAP POWDER SYRINGE
  • Hold the Powder Syringe upright and tap the barrel of the syringe to dislodge the packed powder.

Figure
Powder can become packed during shipping.

Figure
3 UNCAP LIQUID AND POWDER SYRINGES
  • Remove the cap from the Liquid Syringe , then remove the cap from the Powder Syringe.

Figure
Holding both syringes in your non-dominant hand can help with this step.

Figure
4 CONNECT THE SYRINGES
  • Place the Liquid Syringe on top of the Powder Syringe (to prevent powder spillage) and connect the syringes by twisting approximately ¾ turn. Do not over tighten.

Figure
Keep your fingers off the plungers during this step to avoid spillage of the medication.

Figure

5 MIX THE PRODUCT Figure
Failure to fully mix the medication could result in incorrect dosage.Premixing:

  • Transfer the contents of the Liquid Syringe into the Powder Syringe.
  • Gently push the Powder Syringe plunger until you feel resistance (to wet powder and avoid compacting).
  • Repeat this gentle back-and-forth process for 5 Cycles.Complete mixing:
  • Continue mixing the syringes for an additional 55 Cycles.
  • This mixing can be more vigorous than when premixing.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. The product is designed to deliver risperidone 90 mg or 120 mg.Figure
Graphic to the right illustrates a correct full cycle.

Figure

6 PREPARE INJECTION SYRINGE Figure
Failure to aspirate the liquid from the Powder Syringe may result in incorrect dosage.

  • First, transfer all contents into the Liquid Syringe.
  • Next, perform the following actions SIMULTANEOUSLY:
    • maintain slight pressure on the Powder Syringe plunger and
    • pull back gently on the Liquid Syringe plunger while twisting the syringes apart.
  • Finally, attach the safety needle by twisting until finger tight.Figure
Check that medication is uniform in color and free from foreign particles.

Figure
(click image for full-size original)

Figure

PERSERIS ® Instructions for Use
7 PREPARE THE SUBCUTANEOUS INJECTION SITE
  • This medication is to be injected subcutaneously in the abdomen (see figure) or back of upper arm (see figure).
  • Choose an injection site with adequate subcutaneous tissue that is free of skin conditions (e.g. nodules, lesions, excessive pigment).
  • Do not inject into an area where the skin is irritated, reddened, bruised, infected or scarred in any way.
  • Clean the injection site well with an alcohol pad.

Figure
To help minimize irritation, rotate injection sites following a pattern similar to the illustration. If you want to use the same injection site, make sure it is not the same spot on the injection site you used the last time.

Figure
Figure
8 REMOVE EXCESS AIR FROM SYRINGE
  • Hold the syringe upright for several seconds to allow air bubbles to rise.
  • Remove needle cover and slowly depress the plunger to push out the excess air from the syringe.
  • If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.

Figure
Due to the viscous nature of the medication, bubbles will not rise as quickly as those in an aqueous solution.

Figure
9 PINCH INJECTION SITE
  • Pinch the skin around the injection area. Be sure to pinch enough skin to accommodate the size of the needle. Lift the adipose tissue from the underlying muscle to prevent accidental intramuscular injection.
Figure
10 INJECT THE MEDICATION
  • Insert needle fully into the subcutaneous tissue.
  • Inject the medication slow and steady.Figure
PERSERIS is for subcutaneous administration only. Do not inject by any other route.Figure
Actual angle of injection will depend on the amount of subcutaneous tissue.

Figure
11 WITHDRAW NEEDLE
  • Withdraw the needle at the same angle used for insertion and release pinched skin.

Figure
Do not rub the injection area after the injection. If there is bleeding, apply a gauze pad or bandage but use minimal pressure.

Figure
12 LOCK THE NEEDLE GUARD AND DISPOSE OF SYRINGE
  • Lock the needle guard into place by pushing it against a hard surface such as a table.
  • Dispose of all syringe components in a secure sharps disposal container.
Figure
13 INSTRUCT THE PATIENT
  • Advise the patient that they may have a lump for several weeks that will decrease in size over time. It is important that the patient not rub or massage the injection site and to be aware of the placement of any belts, waistbands, sleeves, cuffs or other parts of clothing.
Figure

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 90 mg Carton Label
(click image for full-size original)

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.

Principal Display Panel -- Perseris Kit 120 mg Carton Label
(click image for full-size original)
PERSERIS risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12496-0090
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0090-1 1 KIT in 1 CARTON None
2 NDC:12496-0090-9 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 1.2 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
PERSERIS risperidone powder
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 90 mg in 0.6 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0090-2 1 SYRINGE in 1 POUCH contains a SYRINGE (12496-0090-5)
1 NDC:12496-0090-5 1.2 mL in 1 SYRINGE This package is contained within the POUCH (12496-0090-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
Part 2 of 2
DELIVERY SYSTEM poly(dl-lactic-co-glycolic acid), (50:50; 46000 mw), methylpyrrolidone liquid
Product Information
Item Code (Source) NDC:12496-0589
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Poly(DL-lactic-co-glycolic acid), (50:50; 46000 MW)
Methylpyrrolidone
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0589-2 1 SYRINGE in 1 POUCH contains a SYRINGE (12496-0589-5)
1 NDC:12496-0589-5 1 mL in 1 SYRINGE This package is contained within the POUCH (12496-0589-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
PERSERIS risperidone kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12496-0120
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0120-1 1 KIT in 1 CARTON None
2 NDC:12496-0120-9 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 SYRINGE 1.2 mL
Part 2 1 SYRINGE 1 mL
Part 1 of 2
PERSERIS risperidone powder
Product Information
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Risperidone (Risperidone) Risperidone 120 mg in 0.8 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0120-2 1 SYRINGE in 1 POUCH contains a SYRINGE (12496-0120-5)
1 NDC:12496-0120-5 1.2 mL in 1 SYRINGE This package is contained within the POUCH (12496-0120-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
Part 2 of 2
DELIVERY SYSTEM poly(dl-lactic-co-glycolic acid), (50:50; 46000 mw), methylpyrrolidone liquid
Product Information
Item Code (Source) NDC:12496-0776
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
Poly(DL-lactic-co-glycolic acid), (50:50; 46000 MW)
Methylpyrrolidone
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12496-0776-2 1 SYRINGE in 1 POUCH contains a SYRINGE (12496-0776-5)
1 NDC:12496-0776-5 1 mL in 1 SYRINGE This package is contained within the POUCH (12496-0776-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210655 11/09/2018
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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