b'B:16"T:15.75"S:14.75"Injection Site Reactionsor suicidal thoughts. Alert families and caregivers toVIVITROL must be prepared and administered by amonitor and report the emergence of symptoms of healthcare provider and must ONLY be administered as depression or suicidality.a deep intramuscular gluteal injection. When Reversal of VIVITROL Blockade Is Required Available on the VA National FormularyInadvertent subcutaneous/adipose layer injection offor 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 bodysuggestions for pain management include regional VIVITROL and counseling is recommended for appropriate habitus 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 Guideline tenderness, induration, swelling, erythema, bruising, orpatients should be closely monitored by trainedfor the Management of Substance Use Disorders 3 *pruritus; however, in some cases injection site reactionspersonnel in a setting sta ed and equipped for CPR.may be very severe. Eosinophilic Pneumonia VIVITROL is an MAT option to consider 4Injection site reactions not improving may require Patients who develop dyspnea and hypoxemia should Once-monthly injection prompt medical attention, including, in some cases,seek medical attention immediately. Consider thesurgical intervention. possibility of eosinophilic pneumonia in patients whoHCP prepared and administeredIn the clinical trials, one patient developed an area ofdo not respond to antibiotics.Opioid antagonist induration that continued to enlarge after 4 weeks, withHypersensitivity Reactions including AnaphylaxisRequires opioid detox for a minimum of 7-10 days subsequent development of necrotic tissue that required Patients should be warned of the risk of hypersensitivity prior to initiation surgical excision. reactions, including anaphylaxis, and should bePatients should be informed that any concerningadvised to seek immediate medical attention in aPart of a comprehensive management program injection site reactions should be brought to thehealthcare setting prepared to treat anaphylaxis should that includes psychosocial support attention of their healthcare provider. a hypersensitivity reaction occur. The patient should not Pretreatment with oral naltrexone is not required Precipitation 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 opioidAs with any intramuscular injection, VIVITROL should Actor portrayal. dependence, the resulting withdrawal syndrome canbe administered with caution to patients with be severe. Some cases have been severe enough tothrombocytopenia 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 diminish To learn more about VIVITROL, visit vivitrolhcp.com treated for alcohol dependence, should be opioid-freealcohol withdrawal symptoms. S:9.75" T:10.75" B:11"(including tramadol) before starting VIVITROL treatment:Interference With Laboratory Tests 10 days isAn opioid-free interval of a minimum of 7VIVITROL may be cross-reactive with certain recommended for patients previously dependent on immunoassay methods for the detection of drugs INDICATIONS Vulnerability to Opioid Overdoseshort-acting opioids. of abuse (speci cally opioids) in urine. For furtherVIVITROL is indicated for: After opioid detoxication, patients are likely to have a reducedPatients transitioning from buprenorphine or methadoneinformation, reference to the speci c immunoassayThe treatment of alcohol dependence in tolerance to opioids. VIVITROL blocks the eects of exogenous may be vulnerable to precipitated withdrawal for as longpatients who are able to abstain from alcohol opioids for approximately 28 days after administration. As the as 2 weeks. instructions is recommended.in an outpatient setting prior to initiation of blockade wanes and eventually dissipates completely, use ofIf a more rapid transition from agonist to antagonistAdverse Reactionstreatment with VIVITROL. Patients should previously tolerated doses of opioids could result in potentially therapy is deemed necessary and appropriate by The adverse events seen most frequently in association not be actively drinking at the time of initial life-threatening opioid intoxication (respiratory compromise the healthcare provider, monitor the patient closelywith VIVITROL therapy for alcohol dependence VIVITROL administration. or arrest, circulatory collapse, etc). Cases of opioid overdose in an appropriate medical setting where precipitated(occurring in 5% and at least twice as frequently with The prevention of relapse to opioid with fatal outcomes have been reported in patients who withdrawal can be managed. VIVITROL than placebo) include nausea, vomiting, dependence, following opioid detoxication. used opioids at the end of a dosing interval, after missing aPatients should be made aware of the risk associatedinjection site reactions (including induration, pruritus, scheduled dose, or after discontinuing treatment. with precipitated withdrawal and be encouraged to givenodules, and swelling), arthralgia, arthritis, or joint VIVITROL should be part of a comprehensive Patients and caregivers should be told of this increased an accurate account of last opioid use, as precipitated sti ness, muscle cramps, dizziness or syncope,management program that includes sensitivity to opioids and the risk of overdose. opioid withdrawal has been observed in patients withsomnolence or sedation, anorexia, decreased appetite psychosocial support. Although VIVITROL is a potent antagonist with a prolonged alcohol dependence in circumstances where the or other appetite disorders. IMPORTANT SAFETY INFORMATION pharmacological eect, the blockade produced by VIVITROL is prescriber had been unaware of the additional use of The adverse events seen most frequently in association VIVITROL 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 may Hepatotoxicity(occurring in 2% and at least twice as frequently With current physiologic opioid dependence be sucient to overcome the competitive receptor blockade.Cases of hepatitis and clinically signi cant liver with VIVITROL than placebo) include hepatic enzyme or in acute opioid withdrawal This poses a potential risk to individuals who attempt, on their dysfunction have been observed in association withabnormalities, injection site pain, nasopharyngitis, own, to overcome the blockade by administering large amounts VIVITROL. Warn patients of the risk of hepatic injury andinsomnia, and toothache.Who have failed the naloxone challenge test of exogenous opioids. advise them to seek help if experiencing symptoms ofPLEASE SEE BRIEF SUMMARY OF PRESCRIBING or have a positive urine screen for opioids Any attempt by a patient to overcome the VIVITROL blockade acute hepatitis. Discontinue VIVITROL in patients whoINFORMATION ON THE FOLLOWING PAGES.Who have exhibited hypersensitivity to by taking opioids may lead to fatal overdose. Patients should exhibit signs and symptoms of acute hepatitis.References: 1. Pharmacy Bene ts Management-Medical Advisory Panel-VISN naltrexone, 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 A airs; carboxymethylcellulose, or any other opioid 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.pdf 2. Pharmacy Discuss the availability of naloxone for the emergency treatment taking VIVITROL should be monitored for depressionBenefits Management Services. Department of Veterans A airs. Published of 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 A airs. VA/DoD Clinical MAT=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 emergency trademarks of Alkermes, Inc.August 2021. Accessed August 26, 2024. https://www.healthquality.va.gov/2024 Alkermes, Inc. All rights reserved. guidelines/MH/sud/VADoDSUDCPG.pdf 4. 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 _'