b'B:16"T:15.75"S:14.75"Injection Site Reactions or suicidal thoughts. Alert families and caregivers toVIVITROL must be prepared and administered by a monitor and report the emergence of symptoms ofhealthcare providerand must ONLY be administered as depression or suicidality.a deep intramuscular gluteal injection.When Reversal of VIVITROL Blockade Is RequiredAvailable on the VA National FormularyInadvertent subcutaneous/adipose layer injection of for Pain Management without entering a prior authorization request 1,2 VIVITROL may increase the likelihood of severe injection For VIVITROL patients in emergency situations,site reactions. Select proper needle size for patient body suggestions for pain management include regionalVIVITROL and counseling is recommended for appropriatehabitus and use only the needles provided in the carton. analgesia or use of non-opioid analgesics. If opioidVIVITROL injections may be followed by pain, therapy is required to reverse the VIVITROL blockade,patients according to the VA/DoD Clinical Practice Guidelinetenderness, induration, swelling, erythema, bruising, or patients should be closely monitored by trainedfor the Management of Substance Use Disorders 3 *pruritus; however, in some cases injection site reactions personnel in a setting staed and equipped for CPR.may be very severe. Eosinophilic Pneumonia VIVITROL is an MAT option to consider 4 Injection site reactions not improving may require Patients who develop dyspnea and hypoxemia should prompt medical attention, including, in some cases, seek medical attention immediately. Consider theOnce-monthly injection surgical intervention. possibility of eosinophilic pneumonia in patients whoHCP prepared and administered In the clinical trials, one patient developed an area of do not respond to antibiotics. Opioid antagonist induration that continued to enlarge after 4 weeks, with Hypersensitivity Reactions including Anaphylaxissubsequent development of necrotic tissue that required Patients should be warned of the risk of hypersensitivityRequires opioid detox for a minimum of 7-10 days surgical excision.prior to initiation Patients should be informed that any concerning reactions, including anaphylaxis, and should be injection site reactions should be brought to the advised to seek immediate medical attention in aPart of a comprehensive management program healthcare setting prepared to treat anaphylaxis shouldthat includes psychosocial support attention of their healthcare provider. a hypersensitivity reaction occur. The patient should notPretreatment with oral naltrexone is not requiredPrecipitation of Opioid Withdrawalreceive any further treatment with VIVITROL.before using VIVITROL 4 When withdrawal is precipitated abruptly by administration Intramuscular Injections of an opioid antagonist to a patient with opioid As with any intramuscular injection, VIVITROL shouldActor portrayal. dependence, the resulting withdrawal syndrome can be administered with caution to patients withbe severe. Some cases have been severe enough to thrombocytopenia or any coagulation disorder.require hospitalization and/or management in the ICU.Alkermes is here to support your work with Veterans during their recovery journeyTo prevent occurrence of precipitated withdrawal, Alcohol Withdrawal patients with opioid dependence, including those being Use of VIVITROL does not eliminate nor diminishTo learn more about VIVITROL, visit vivitrolhcp.com treated for alcohol dependence, should be opioid-free alcohol withdrawal symptoms. S:9.75" T:10.75" B:11"(including tramadol) before starting VIVITROL treatment: Interference With Laboratory Tests VIVITROL may be cross-reactive with certainAn opioid-free interval of a minimum of 7 10 days isrecommended for patients previously dependent on immunoassay methods for the detection of drugsINDICATIONS Vulnerability to Opioid Overdoseshort-acting opioids. of abuse (specically opioids) in urine. For furtherVIVITROL is indicated for:After opioid detoxi cation, patients are likely to have a reduced Patients transitioning from buprenorphine or methadone information, reference to the specic immunoassay The treatment of alcohol dependence intolerance to opioids. VIVITROL blocks the e ects of exogenous may be vulnerable to precipitated withdrawal for as longpatients who are able to abstain from alcoholopioids for approximately 28 days after administration. As theas 2 weeks. instructions is recommended.in an outpatient setting prior to initiation ofblockade wanes and eventually dissipates completely, use of If a more rapid transition from agonist to antagonist Adverse Reactionstreatment with VIVITROL. Patients should previously tolerated doses of opioids could result in potentiallytherapy is deemed necessary and appropriate by The adverse events seen most frequently in associationnot be actively drinking at the time of initiallife-threatening opioid intoxication (respiratory compromise the healthcare provider, monitor the patient closely with VIVITROL therapy for alcohol dependenceVIVITROL administration. or arrest, circulatory collapse, etc). Cases of opioid overdosein an appropriate medical setting where precipitated (occurring in 5% and at least twice as frequently with The prevention of relapse to opioidwith fatal outcomes have been reported in patients whowithdrawal can be managed. VIVITROL than placebo) include nausea, vomiting,dependence, following opioid detoxi cation. used opioids at the end of a dosing interval, after missing aPatients should be made aware of the risk associated injection site reactions (including induration, pruritus,scheduled dose, or after discontinuing treatment.with precipitated withdrawal and be encouraged to give nodules, and swelling), arthralgia, arthritis, or jointVIVITROL should be part of a comprehensive Patients and caregivers should be told of this increasedan accurate account of last opioid use, as precipitated stiness, muscle cramps, dizziness or syncope,management program that includessensitivity to opioids and the risk of overdose. opioid withdrawal has been observed in patients with somnolence or sedation, anorexia, decreased appetitepsychosocial support. Although VIVITROL is a potent antagonist with a prolongedalcohol dependence in circumstances where the or other appetite disorders.IMPORTANT SAFETY INFORMATIONpharmacological e ect, the blockade produced by VIVITROL isprescriber had been unaware of the additional use of The adverse events seen most frequently in associationVIVITROL is contraindicated in patients:surmountable. The plasma concentration of exogenous opioids opioids or co-dependence on opioids. with VIVITROL in patients with opioid dependence Receiving opioid analgesics attained immediately following their acute administration mayHepatotoxicity(occurring in 2% and at least twice as frequently With current physiologic opioid dependencebe sucient to overcome the competitive receptor blockade. Cases of hepatitis and clinically signicant liver with VIVITROL than placebo) include hepatic enzymeor in acute opioid withdrawalThis poses a potential risk to individuals who attempt, on theirdysfunction have been observed in association with abnormalities, injection site pain, nasopharyngitis,own, to overcome the blockade by administering large amountsVIVITROL. Warn patients of the risk of hepatic injury and insomnia, and toothache. Who have failed the naloxone challenge test of exogenous opioids. advise them to seek help if experiencing symptoms of PLEASE SEE BRIEF SUMMARY OF PRESCRIBINGor have a positive urine screen for opioids Any attempt by a patient to overcome the VIVITROL blockadeacute hepatitis. Discontinue VIVITROL in patients who INFORMATION ON THE FOLLOWING PAGES. Who have exhibited hypersensitivity toby taking opioids may lead to fatal overdose. Patients should exhibit signs and symptoms of acute hepatitis.References:1. Pharmacy Benets Management-Medical Advisory Panel-VISNnaltrexone, polylactide-co-glycolide (PLG), be told of the serious consequences of trying to overcome the Depression and SuicidalityPharmacist Executives Ez-Minutes. Newsletter. Department of Veterans Aairs;carboxymethylcellulose, or any otheropioid blockade. 2023. Vol 2, Issue 6. Accessed August 26, 2024. https://www.pbm.va.gov/PBM/components of the diluentPatients with alcohol dependence or opioid dependence nationalformulary/062023VANationalFormularyDecisions.pdf2.Pharmacy Discuss the availability of naloxone for the emergency treatmenttaking VIVITROL should be monitored for depression Benefits Management Services. Department of Veterans Aairs. Publishedof opioid overdose with the patient and caregiver, at the September 2024. Accessed October 23, 2024.https://www.pbm.va.gov/nationalformulary.asp 3. Department of Veterans Aairs. VA/DoD ClinicalMAT=medication-assisted treatment.initial VIVITROL injection and with each subsequent injection.ALKERMES and VIVITROL are registeredPractice Guideline for the Management of Substance Use Disorders. Published*See the VA/DoD Clinical Practice Guideline for Strongly consider prescribing naloxone for the emergencytrademarks of Alkermes, Inc.August 2021. Accessed August 26, 2024. https://www.healthquality.va.gov/2024 Alkermes, Inc. All rights reserved. guidelines/MH/sud/VADoDSUDCPG.pdf4. VIVITROL [prescribing information].the Management of Substance Use Disorders treatment of opioid overdose. VIV-007210 Printed in the U.S.A. Waltham, MA: Alkermes, Inc.for complete information.F:7.875" F:7.875"PREPARED BY12206949_VA_Journal_Ad_US_Medicine_M2FR.indd 1 12206949 vc12226236 VA Journal Ad U.S. Medicine M2FR 10/28/24 3:46 PMJob info Images FontsSpecial InstructionsDate: 10-28-2024 3:46 PM ALKE_A912219_4C.tif (CMYK; 300 ppi; 100%;Proxima Nova (Regular, Bold, Semibold, Medi- NoneClient: Alkermes 19.5MB), alks_mark_p_cmyk.ai (20%; 894KB),um, Extrabold, Extrabold Italic, Regular Italic), Product: Vivitrol QRCode-078.eps (35%; 946KB), _CMYK_Full_ Zapf Dingbats (Regular)Client Code: VIV-007210 left.ai (87.41%; 907KB)WF Issue # None Additional InformationReleasing as: PDFx1A NoneFinal Size: 15.75 x 10.75Finishing: NoneGutter: None InksColors: 4/0 & 1/0Cyan, Magenta, Yellow, BlackRename upon VIV-007210_Vivitrol VA Journal Ad_US release: Medicine Additional Comments for SizingComponent NoneDescription: NoneTeamProject Mgr: Steve BertuzziAD: Suzanne ElwardAE: Bhavish Vora Scale: 1= 1QC: LP/DY Bleed 16 w x 11 h16 w x 11 hProduction: Stacy Wichner Trim/Flat 15.75 w x 10.75 h15.75 w x 10.75 hDigital Artist: Pitagorsky, Tracy (NYC-SRX) Live/Safety 14.75 w x 9.75 h14.75 w x 9.75 h Path: NYC-SRX:PRINT & DIGITAL:PREPRESS:Alkermes:ALKERMES_VIVITROL:12206949:12206949_VA_Journal_Ad_US_Medicine_M2FR.inddPDFX1A _'