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    Dosing & Administration

    Dosing Regimen

    Initiation regimens for select long-acting injectables (LAIs)1-6


    dosing regimen chart

    Initial injection at Day 1No loading dose or oral
    supplementation recommended

    Injection administered monthly

    First injection at Day 1


    Second initiation dose at Day 8


    Injection administered monthly

    First injection and loading dose
    at Day 1

    Oral RISPERDAL® (or another
    antipsychotic) should be given
    with the first injection and
    continued for 3 weeks

    Second injection at Day 15

    Injections administered
    every 2 weeks

    First injection and loading dose
    at Day 1

    Administer oral aripiprazole for
    21 consecutive days in conjunction
    with the first injection

    Injection administered monthly*

    First injection and loading dose
    at Day 1

    Administer the first ARISTADA injection on
    the same day or up to 10 days after ARISTADA INITIO and 1 dose of oral aripiprazole

    First injection and loading dose
    at Day 1

    14 consecutive days
    of oral aripiprazole

    Injection administered monthly


    *Depending on individual patient's needs, treatment with ARISTADA can be initiated at a dose of 441 mg, 662 mg, or 882 mg administered monthly; 882 mg administered every 6 weeks; or 1064 mg administered every 2 months.4


    Before starting an LAI, establish tolerability based on appropriate prescribing information instructions.1-7


    PERSERIS is available in 2 dosing strengths (90 mg and 120 mg)1

    • Prior to starting PERSERIS, establish tolerability with oral risperidone in risperidone-naïve patients1
    • PERSERIS must be administered by an HCP1
    • Patients who are on stable oral risperidone doses lower than 3 mg/day or higher than 4 mg/day may not be candidates for PERSERIS1
    • PERSERIS has not been studied in patients with renal or hepatic impairment and should be used with caution in these special populations1

    Corresponding average concentrations for oral risperidone and PERSERIS1

    4 mg oral risperidone 120 mg (0.8 mL) PERSERIS
    3 mg oral risperidone 90 mg (0.6 mL) PERSERIS

    Treat your patients with just 1 subcutaneous injection administered by an HCP, once a month1





    Storage & Administration

    Steps to get your patients started

    Prior to starting PERSERIS, establish tolerability with oral risperidone in risperidone-naïve patients.1

    Learn how to store and administer PERSERIS


    Selected Storage Instructions
    • PERSERIS should be refrigerated in its original carton for storage. It can remain at room temperature (68°F-77°F) for up to 7 days prior to administration. After removal from the refrigerator, use PERSERIS within 7 days or discard1
    • PERSERIS kit should be brought to room temperature for at least 15 minutes before mixing1
    Selected Administration Instructions
    • PERSERIS should be administered monthly by abdominal subcutaneous injection only. Do not administer by any other route1
    • Only a healthcare professional should administer PERSERIS1
    Instructions for Use Video

    Take the steps in the video below to start your patients on treatment without loading doses or oral supplementation1

    • Prior to starting PERSERIS, establish tolerability with oral risperidone in risperidone-naïve patients1


    Advise patients not to rub or massage the injection site and to be aware of the placement of any belts or clothing waistbands.1




    References: 1. PERSERIS [prescribing information]. North Chesterfield, VA: Indivior Inc; 2018. 2. INVEGA SUSTENNA [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2018. 3. RISPERDAL CONSTA [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2018. 4. ARISTADA [prescribing information]. Waltham, MA: Alkermes, Inc; 2018. 5. ARISTADA INITIO [prescribing information]. Waltham, MA: Alkermes, Inc; 2018. 6. ABILIFY MAINTENA [prescribing information]. Tokyo, Japan: Otsuka Pharmaceutical Co, Ltd; 2018. 7. Miyamoto S, Fleischhacker WW. The use of long-acting injectable antipsychotics in schizophrenia. Curr Treat Options Psychiatry. 2017;4(2):117-126. doi:10.1007/s40501-017-0115-z.

    INVEGA SUSTENNA® and RISPERDAL CONSTA® are registered trademarks of Janssen Pharmaceuticals, Inc.
    ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited.
    ABILIFY MAINTENA® is a registered trademark of Otsuka Pharmaceuticals, Inc.

    IMPORTANT SAFETY INFORMATION

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. PERSERIS is not approved for the treatment of patients with dementia-related psychosis and has not been studied in this population.

    INDICATIONS AND USAGE

    PERSERIS is indicated for the treatment of schizophrenia in adults.

    CONTRAINDICATIONS:

    PERSERIS is contraindicated in patients with a known hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its components. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with risperidone or paliperidone.

    WARNINGS AND PRECAUTIONS

    Cerebrovascular Adverse Reactions: In trials of elderly patients with dementia-related psychosis, there was a significantly higher incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in patients treated with oral risperidone compared to placebo. PERSERIS is not approved for use in patients with dementia-related psychosis.

    Neuroleptic Malignant Syndrome, a potentially fatal symptom complex, has been reported with antipsychotic medications. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (see full Prescribing Information). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems.

    Tardive Dyskinesia (TD): TD may develop in patients treated with antipsychotic drugs. The risk of developing TD and likelihood that it will become irreversible are believed to increase with treatment duration and total cumulative dose. Less commonly, TD can develop after relatively brief treatment periods at low doses. Elderly patients, especially elderly women, appear to be at increased risk, but it is impossible to predict which patients will develop TD. Therefore, PERSERIS should be prescribed in a manner that is most likely to minimize the occurrence of TD. Discontinue treatment if clinically appropriate.

    Metabolic Changes that may increase cardiovascular/cerebrovascular risk, have been associated with atypical antipsychotics (APs).

    • Hyperglycemia and Diabetes Mellitus (DM), in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with APs, including risperidone. Patients with DM who are started on atypical APs, including PERSERIS, should be monitored regularly for worsening of glucose control. Patients at risk for DM (e.g., obesity, family history of diabetes) who are starting treatment with atypical APs, including PERSERIS, should undergo fasting blood glucose (FBG) testing at the beginning of treatment and periodically while treated. Any patient treated with atypical APs, including PERSERIS, should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical APs, including PERSERIS, should undergo FBG testing. In some cases, hyperglycemia has resolved when risperidone was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of risperidone.

    • Dyslipidemia has been observed in patients treated with atypical APs.

    • Weight Gain has been observed with atypical AP use. Monitoring weight is recommended.

    Hyperprolactinemia: Risperidone elevates prolactin levels, and the elevation persists during chronic administration. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Hyperprolactinemia may inhibit reproductive function in female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating drugs. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in females and males.

    Orthostatic Hypotension: Risperidone may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope. Use with particular caution in patients with known cardiovascular disease, cerebrovascular disease, and conditions which predispose patients to hypotension, and in the elderly and patients with renal or hepatic impairment. Monitor such patients and consider a dose reduction if hypotension occurs.

    Falls: Somnolence, postural hypotension, motor instability, and sensory instability have been reported with the use of antipsychotics, including PERSERIS, which may lead to falls, and consequently, fractures or other fall-related injuries. Assess the risk of falls when initiating treatment and recurrently during treatment.

    Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic agents, including risperidone. In patients with a history of a clinically significant low white blood count (WBC) or a drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Consider discontinuation at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms/signs of infection and treat promptly if such symptoms/signs occur. Discontinue PERSERIS in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow WBC until recovery.

    Potential for Cognitive and Motor Impairment: Risperidone may impair judgment, thinking, or motor skills. Caution patients about operating machinery, including automobiles, until they are reasonably certain PERSERIS does not affect them adversely.

    Seizures have been observed in risperidone studies in adults with schizophrenia. PERSERIS should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.

    Dysphagia: Esophageal dysmotility and aspiration can occur. Use cautiously in patients at risk for aspiration pneumonia.

    Priapism has been reported with other risperidone products. Severe priapism may require surgical intervention.

    Disruption of Body Temperature Regulation has been attributed to antipsychotic agents. Use with caution in patients who will be exposed to temperature extremes.

    Adverse Reactions:

    The most common adverse reactions in a clinical trial (≥ 5% and greater than placebo) were increased weight, constipation, sedation/somnolence, pain in extremity, back pain, akathisia, anxiety, and musculoskeletal pain. The most common injection site reactions (≥ 5%) were injection site pain and erythema. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.

    DRUG INTERACTIONS

    • Carbamazepine and other strong CYP3A4 inducers decrease risperidone plasma concentration.

    • Fluoxetine, paroxetine, and other strong CYP2D6 inhibitors increase risperidone plasma concentration.

    • Use with other CNS drugs or alcohol may increase nervous system disorders.

    • PERSERIS may enhance hypotensive effects of hypotensive agents.

    • PERSERIS may antagonize the pharmacologic effects of dopamine agonists.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: PERSERIS may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare professional if they become or intend to become pregnant during treatment with PERSERIS. Patients exposed to PERSERIS during pregnancy may be registered with the National Pregnancy Registry for Atypical Antipsychotics (1-866-961-2388 or http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/).

    Lactation: Infants exposed to risperidone through breastmilk should be monitored for excess sedation, failure to thrive, jitteriness, and extrapyramidal symptoms.

    Pediatric Use: Safety and effectiveness of PERSERIS have not been established in pediatric patients.

    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.

    To report pregnancy or side effects associated with taking PERSERIS, please call 1-877-782-6966.

    For more information about PERSERIS, see the full Prescribing Information including BOXED WARNING.

    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.