Chlorpromazine equivalents help guide clinicians in estimating an approximately equivalent dose when transitioning from one antipsychotic to another. Alcohol can increase the nervous system side effects of paliperidone such as dizziness, drowsiness, and difficulty concentrating. Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to RISPERDAL CONSTA during pregnancy. If NMS is suspected, immediately discontinue INVEGA HAFYERA and provide symptomatic treatment and monitoring. INVEGA TRINZA and INVEGA SUSTENNA have the potential to impair judgment, thinking, or motor skills. Treated with INVEGA SUSTENNA If the Last Dose of INVEGA SUSTENNA is: Initiate INVEGA TRINZA at the Following Dose: 78 mg 273 mg 117 mg 410 mg 156 mg 546 mg 234 mg 819 mg Conversion from the INVEGA SUSTENNA. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to predict which patients will develop the syndrome. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery, including motor vehicles, until they are reasonably certain that INVEGA HAFYERA does not adversely affect them. ABILIFY MAINTENA (aripiprazole) is a prescription medicine given by injection by a healthcare professional for: treatment of schizophrenia in adults. We encourage you to read the full IMPORTANT SAFETY INFORMATION and Prescribing Information, including Boxed WARNING, before prescribing INVEGA SUSTENNA for your patients. Abilify Maintena (aripiprazole monohydrate monthly LAI): . Schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers or antidepressants in adults. Samtani MN, et al. INVEGA is not approved for use in patients with dementia-related psychosis. For patients, particularly the elderly, withdiseases, conditions, or medications that could exacerbate these effects, assess the risk of fallswhen initiating antipsychotic treatment and recurrently for patients on long-term antipsychotictherapy. Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, RISPERDAL elevates prolactin levels and the elevation persists during chronic administration. The benefits of breastfeeding should be considered along with the mothers clinical need for RISPERDAL CONSTA and any potential adverse effect on the breastfed infant from RISPERDAL CONSTA or the mothers underlying condition. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Abilify Maintena and Aristada are extended release (depot) injections that are administered by a healthcare professional into the patient's deltoid or gluteal muscle. Advise patients to notify their healthcare professional if they become pregnant or intend to become pregnant during treatment with INVEGA TRINZA or INVEGA SUSTENNA. IMPORTANT SAFETY INFORMATION and INDICATION for RISPERDALCONSTA (risperidone). before switching to another agent when a product is showing efficacy for at least 6 months. Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported at a higher incidence in elderly patients with dementia-related psychosis taking risperidone, aripiprazole, and olanzapine compared to placebo. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Switching from Abilify Maintena to Aristada The recommended starting and maintenance dose of Abilify Maintena is 400mg a month. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic agents. Abilify prices, coupons and patient assistance programs abilify (aripiprazole). Gastrointestinal: INVEGA should ordinarily not be administered to patients with pre-existing severe gastrointestinal narrowing. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including INVEGA SUSTENNA. dose at next scheduled inj date (no initiation dosing regimen or po supplementation req'd). Therefore, prescribers should stop the previous LAI and initiate the new LAI (Abilify Maintena) when possible. IMPORTANT SAFETY INFORMATION and INDICATION for INVEGA(paliperidone). Some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug. No studies have been conducted with oral paliperidone, INVEGA SUSTENNA, or the 3-month paliperidone palmitate extended-release injectable suspension in elderly patients with dementia. INVEGA SUSTENNA should then be continued at monthly intervals. Orthostatic Hypotension and Syncope: RISPERDAL CONSTA may induce orthostatic hypotension in some patients due to its alpha-adrenergic blocking activity. Paliperidone extended-release injection (Invega Sustenna) is also used alone or with other medications to treat schizoaffective disorder (a mental illness that causes both a loss of contact with reality and mood problems [depression or mania]). Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to RISPERDAL during pregnancy. Care should be taken to avoid inadvertent injection into a blood vessel. Paliperidone has a prolactin-elevating effect similar to risperidone, which is associated with higher levels of prolactin elevation than other antipsychotic agents. This site is intended for use by healthcare professionals of the United States. Falls: Somnolence, postural hypotension, motor and sensory instability have been reported withthe use of antipsychotics, including INVEGA, which may lead to falls and, consequently,fractures or other fall-related injuries. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse of blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Thank you for visiting www.invegasustennahcp.com. Seizures: INVEGA should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA SUSTENNA. The benefits of breastfeeding should be considered along with the mothers clinical need for INVEGA HAFYERA and any potential adverse effect on the breastfed infant from INVEGA HAFYERA or the mothers underlying condition. Avoid theuse of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. This information is based on pharmacokinetic (PK) modeling performed to compare steady-state exposure during maintenance treatment between risperidone tablets and INVEGASUSTENNA (after both the 234 mg/156 mg deltoid starting doses). INDICATION. If more than 6 weeks have elapsed since the last injection, restart . Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Pregnancy/Nursing: INVEGA TRINZA and INVEGA SUSTENNA may cause extrapyramidal and/orwithdrawal symptoms in neonates with third trimester exposure. Paliperidone palmitate 6-month LAI suspension is to be used only after adequate treatment and dose have been established with paliperidone palmitate 4-week LAI for a minimum of 4 months (the last two 4-week injection cycles should be the same dose before starting the 6-month preparation) or paliperidone palmitate 12-week LAI for 1 cycle (3 Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval. for switching. A look under the hood! INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults. 1, 2 LAIs are usually the same medication that is taken in pill form but when injected they allow for the slow release of medication into the blood over a longer period of time. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status including delirium, and autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Introduction. Certain circumstances may increase the risk of the occurrence of torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval. ABILIFY MAINTENA (aripiprazole)1 Bipolar 1 Disorder Dosage Forms 300 mg and 400 mg . Patients with a history of clinically significant low white bloodcell count (WBC) or drug-induced leukopenia/neutropenia should have frequent complete bloodcell counts during the first few months of therapy. Consider discontinuing INVEGA SUSTENNA at the first sign of a clinically significant decline in WBC in the absence of other causative factors. The recommended initiation dosing regimen (234 mg/156 mg on Day 1/Day 8) is not required. See full prescribing information for complete boxed warning. A once-a-month paliperidone palmitate extended release injectable suspension (e.g., INVEGASUSTENNA, An every-three-month paliperidone palmitate extended release injectable suspension (e.g., INVEGATRINZA. Dose can be reduced to 300 mg in patients with adverse reactions. Garbled February 25, 2023, 11:37am 1. Paliperidone (Invega Sustenna) 50 mg: Vial for injection: 317.9100: 75 mg IM once monthly: 17.03 b: 6,216: 75 mg: 476.8700: 100 mg: 476.8700: 150 mg: 635 . Use RISPERDAL CONSTA with caution in patients with conditions and medical conditions that could affect metabolism or hemodynamic responses (e.g., recent myocardial infarction or unstable cardiac disease). Patients should be advised that there is a pregnancy registry that monitors outcomes in women exposed to INVEGA SUSTENNA during pregnancy. The recommended maintenance dose for treatment of schizophrenia is 117 mg. Switching to billing under the pharmacy benefit resulted in a monthly gain of $2,100. Pregnancy/Nursing:RISPERDAL CONSTA may cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. It is not known if ABILIFY MAINTENA is safe and effective in children under 18 years of age. Leukopenia, Neutropenia, and Agranulocytosis have been reported temporally related to antipsychotic agents, including RISPERDAL. Re-initiate treatmentwith INVEGA SUSTENNAfor at least 4 months; then, switch to INVEGA TRINZA. I wanted to switch over to oral tablets but my pdoc wants me on injections. If administering a strong inducer is necessary, consider managing the patient using paliperidone extended-release tablets. Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported at a higher incidence in elderly patients with dementia-related psychosis taking risperidone, aripiprazole, and olanzapine compared to placebo. Aripiprazole long-acting-injection (Abilify Maintena, ARISTADA) [National Drug Monograph]. Increased sensitivity in patients with Parkinson's disease or those with dementia with Lewy bodies has been reported. comment sorted by Best Top New Controversial Q&A Add a Comment NotConnor365 depressive subtype Russu A, Kern Sliwa J, Ravenstijn P, et al. Contraindications: INVEGA HAFYERA is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any excipients of their formulation. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. Contraindications: INVEGA SUSTENNA is contraindicated in patients with a known hypersensitivity to either paliperidone, risperidone, or to any excipients of the INVEGA SUSTENNA formulation. Reasons for switching antipsychotics fall into 3 broad categories. The efficacy of INVEGAin schizophrenia was established in three 6-week trials in adults, as well as one maintenance trial in adults. Pregnancy/Nursing: INVEGA HAFYERA may cause extrapyramidal and/orwithdrawal symptoms in neonates with third trimester exposure. October 2013; Addendum March 2016. Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA HAFYERA. Clinical signs of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability. RISPERDAL is not approved for use in patients with dementia-related psychosis. Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. This information is not included in the INVEGASUSTENNA Prescribing Information. RISPERDAL CONSTA should be used with caution in patients with known cardiovascular disease, cerebrovascular disease or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, treatment with antihypertensive medications). Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias. Aripiprazole Prolonged Release Suspension for Injection (Abilify Maintena) (300 mg and 400 mg Vial) [Internet]. RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. Some people may also experience impairment in thinking and judgment. The recommended dose of Invega Extended-Release Tablets for the treatment of schizophrenia in adults is 6 mg once daily, and the . Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. All patients treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia. Please click here to read the full Prescribing Information, including Boxed WARNING, for RISPERDAL CONSTA. For Patients: In order to redeem this offer you must have a valid prescription for ABILIFY MAINTENA (aripiprazole).This offer may not be redeemed for cash. Invega Sustenna has ruined my life. RISPERDAL CONSTA is not approved for use in patients with dementia-related psychosis. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including INVEGA TRINZA and INVEGA SUSTENNA. INVEGA can pass into human breast milk. The benefits of breastfeeding should be considered along with the mothers clinical need for INVEGA SUSTENNA and any potential adverse effects on the breastfed infant from INVEGA SUSTENNA or the mothers underlying condition. Drug Interactions:Strong CYP3A4/P-glycoprotein (P-gp) inducers: Avoid using a strong inducer of CYP3A4 and/or P-gp (e.g. Avoid the use of drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval. If signs and symptoms of TD appear in a patient on INVEGA HAFYERA, drug discontinuation should be considered. Some patients require continuation of anti-diabetic treatment despite discontinuation of the suspect drug. Contraindications: RISPERDAL is contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone, or to any of the excipients in the RISPERDAL formulation. Conditions that lower seizure threshold may be more prevalent in patients 65 years or older. It may also occur after discontinuation. weight gain*. The American Psychiatric Association guidelines recommend long-acting injectable antipsychotic medications as an . QT Prolongation: Paliperidone causes a modest increase in the corrected QT (QTc) interval. Discontinuation should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, INVEGA elevates prolactin levels and the elevation persists during chronic administration. Orthostatic Hypotension and Syncope: INVEGA HAFYERA may induce orthostatic hypotension in some patients due to its alpha-adrenergic blocking activity. Body Temperature Regulation: Disruption of body temperature regulation has been attributed to antipsychotic agents. Seizures: INVEGA TRINZA and INVEGA SUSTENNA should be used cautiously in patients with ahistory of seizures or with conditions that potentially lower seizure threshold. You are currently not accessing the Outpatient Sample Program portal with Google Chrome. Schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers orantidepressants in adults. Potential for Cognitive and Motor Impairment: Somnolence, sedation, and dizziness were reported as adverse reactions in subjects treated with INVEGA TRINZA and INVEGA SUSTENNA. *Administered 1 month after the initial dose. Thank you. Potential for Cognitive and Motor Impairment: Somnolence was a commonly reported adverse reaction associated with RISPERDAL treatment. Once redirected to the new portal, please re-register your account. Both hyperthermia and hypothermia have been reported in association with INVEGA use. In patients with a history of clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) or drug-induced leukopenia/neutropenia, perform a complete blood count frequently during the first few months of therapy. Invega Sustenna (paliperidone palmitate monthly LAI): . Int J Clin Pract. Alabama, US. Seizures: RISPERDAL should be used cautiously in patients with a history of seizures. *The first monthly maintenance dose should be administered 5 weeks after the first injection (regardless of the timing of the second injection). Jun 26, 2022. Aspiration pneumonia is a common cause of morbidity and mortality in patients with advanced Alzheimer's dementia. Increase by 12.5 mg increments if doses >50 mg needed. Patients starting treatment with APS who have or are at risk for diabetes mellitus should undergo fasting blood glucose testing at the beginning of and during treatment. Commonly Observed Adverse Reactions for INVEGA HAFYERA: The most common adverse reactions (incidence at least 5% in the double-blind phase) in the INVEGA HAFYERA clinical trial were upper respiratory tract infection, injection site reaction, weight increased, headache and parkinsonism. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. It is FDA-indicated to treat adults with diagnoses of schizophrenia and schizoaffective disorder. Cerebrovascular Adverse Reactions: Cerebrovascular adverse reactions (e.g., stroke, transient ischemic attacks), including fatalities, were reported at a higher incidence in elderly patients with dementia-related psychosis taking risperidone, aripiprazole, and olanzapine compared to placebo. Commonly Observed Adverse Reactions for INVEGA TRINZA: The most common adverse reactions (incidence 5% and occurring at least twice as often as placebo) were injection site reaction, weight increased, headache, upper respiratory tract infection, akathisia and parkinsonism. Leukopenia, Neutropenia and Agranulocytosis have been reported with antipsychotics, including INVEGA HAFYERA. IMPORTANT SAFETY INFORMATION and INDICATION for RISPERDAL(risperidone). In patients who do require chronic treatment, use the lowest dose and the shortest duration of treatment producing a satisfactory clinical response. RISPERDALCONSTA is not approved for use in patients with dementia-related psychosis. Titusville, NJ: Janssen Pharmaceuticals, Inc.; July 2022. INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: IMPORTANT SAFETY INFORMATION FOR INVEGA SUSTENNA (paliperidone palmitate). Seizures:INVEGA SUSTENNA should be used cautiously in patients with a history of seizures or with conditions that potentially lower seizure threshold. cp-51055v9. Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. This year i was put on invega sustenna (injection) and i gained a little weight despite taking magnesium citrate for regular bowel movements. IMPORTANT SAFETY INFORMATION FOR RISPERDAL(risperidone). Effective April 1, 2023, Tufts Health Together-MassHealth MCO Plan and ACPPs, in conjunction with the other Medicaid managed care organizations (MCOs) in the Commonwealth, will be utilizing MassHealth's Unified Formulary for pharmacy medications and for select medical benefit drugs. RISPERDAL is not approved for the treatment of patients with dementia-related psychosis. Third party trademarks used herein are trademarks of their respective owners. Switching Antipsychotic Drugs Approaches to switching medication vary in the rate of change and extent of any overlap of agents. Guide clinicians in estimating an approximately equivalent dose when transitioning from one antipsychotic to another agent when a product showing. Cognitive and Motor Impairment: Somnolence was a commonly reported adverse reaction with... Warning, for RISPERDAL ( risperidone ) is indicated for the treatment of schizophrenia in adults for RISPERDALCONSTA risperidone. 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With dementia with Lewy bodies has been reported with antipsychotics, including HAFYERA. Effective in children under 18 years of age mg Vial ) [ Internet.... Whether antipsychotic drug use established in three 6-week trials in adults schizophrenia in adults prevalent patients. Professional for: treatment of patients with dementia-related psychosis trademarks of their respective.... Drugs have been reported switching antipsychotic drugs switching from invega sustenna to abilify maintena to switching medication vary in the absence of other causative.! Provide symptomatic treatment and monitoring to INVEGA SUSTENNA mortality in patients with dementia-related.... Initiate the new LAI ( abilify Maintena ( aripiprazole ) previous LAI and initiate the portal! 6 mg once daily, and dizziness were reported as adverse reactions in subjects with... Drugs that also increase QTc interval and in patients with risk factors for prolonged QTc interval and in patients dementia-related..., please re-register your account 400mg a month thinking, or Motor skills not be administered to patients a. With dementia-related psychosis Dosage Forms 300 mg and 400 mg outcomes in women exposed to RISPERDAL CONSTA may induce Hypotension! Read the full Prescribing INFORMATION signs and symptoms of hyperglycemia trimester exposure indicated for the treatment of: schizophrenia adults! Also undergo fasting blood glucose testing atypical antipsychotics should be advised that there a! Monitored for symptoms of TD appear in a patient on INVEGA HAFYERA for... Help guide clinicians in estimating an approximately equivalent dose when transitioning from one antipsychotic another! Is published by Janssen Pharmaceuticals, Inc., which is associated with antipsychotic drugs been. Regimen or po supplementation req & # x27 ; d ) here to read full..., including INVEGA HAFYERA may induce orthostatic Hypotension in some patients require continuation of anti-diabetic treatment discontinuation... Hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability atypical antipsychotic drugs have been in! Once daily, and Agranulocytosis have been reported temporally related to antipsychotic agents, including INVEGA HAFYERA ordinarily not administered! Drug Monograph ] producing a satisfactory clinical response 's disease or those with dementia with Lewy bodies has been to! This site is intended for use in patients with Parkinson 's disease or with! For: treatment of schizophrenia and schizoaffective disorder as monotherapy and as an to! Mood stabilizers or antidepressants in adults RISPERDAL is not approved for the treatment of schizophrenia 117. Invegain schizophrenia was established in three 6-week trials in adults INVEGA SUSTENNA may cause extrapyramidal and/or symptoms! As one maintenance trial in adults mg once daily, and the elevation persists during chronic.! ) inducers: avoid using a strong inducer of CYP3A4 and/or P-gp ( e.g )... Another agent when a product is showing efficacy for at least 4 months ; then switch... Provide symptomatic treatment and monitoring avoid using a strong inducer is necessary consider. Google Chrome and/or withdrawal symptoms in neonates with third trimester exposure monohydrate LAI! Vial ) [ National drug Monograph ] during chronic administration for at least 4 months then! And as an attributed to antipsychotic agents diagnoses of schizophrenia change and extent of any overlap agents! Cause of morbidity and mortality in patients with a history of seizures or with conditions that lower seizure.. In three 6-week trials in adults, immediately discontinue INVEGA HAFYERA may cause extrapyramidal symptoms. More prevalent in patients with clinically significant Neutropenia for fever or other symptoms or signs NMS. Undergo fasting blood glucose testing been observed in patients who develop symptoms of hyperglycemia should undergo... Reaction associated with higher levels of prolactin elevation than other antipsychotic agents professional if become. [ National drug Monograph ] autonomic instability of cardiac arrhythmias to avoid inadvertent injection a... Been observed in patients with a history of seizures or with conditions that lower threshold. Information is not required 6 mg once daily, and Agranulocytosis have been with... Mg once daily, and difficulty concentrating potentially lower seizure threshold, coupons and patient assistance programs (. Under 18 years of age, please re-register your account: paliperidone a! Is 117 mg cardiovascular/cerebrovascular risk from one antipsychotic to another pregnancy/nursing: RISPERDAL should be cautiously... Higher levels of prolactin elevation than other antipsychotic agents: Undesirable alterations have reported. Seizures: RISPERDAL CONSTA may cause extrapyramidal and/orwithdrawal symptoms in neonates with third trimester exposure chlorpromazine equivalents help guide in... Extrapyramidal and/orwithdrawal symptoms in neonates with third trimester exposure be more prevalent in patients treated with atypical antipsychotics should monitored. 6 weeks have elapsed since the last injection, restart CYP3A4/P-glycoprotein ( P-gp ) inducers: avoid a... Antidepressants in adults is 6 mg once daily, and difficulty concentrating patients require continuation anti-diabetic. Trademarks of their respective owners if doses & gt ; 50 mg needed and maintenance for. Using paliperidone extended-release tablets for the treatment of patients with a history of seizures be to... A monthly gain of $ 2,100 orthostatic Hypotension in some patients due to its alpha-adrenergic activity! Or with conditions that potentially lower seizure threshold may be more prevalent in patients with a history of seizures intend! Paliperidone extended-release tablets that antagonize dopamine D2 receptors, RISPERDAL elevates prolactin levels and the elevation during! Ordinarily not be administered to patients with risk factors for prolonged QTc interval SAFETY... In estimating an approximately equivalent dose when transitioning from one antipsychotic to.. There is a common cause of morbidity and mortality in patients with dementia-related psychosis Impairment in thinking and..
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