b'B:16"T:15.75"S:15.25"49Injection Site Reactions: Depression and Suicidality: VIVITROL must be prepared and administered by a Alcohol- and opioid-dependent patients taking VIVITROL healthcare provider. should be monitored for depression or suicidal thoughts. Alert Available on the VA National Formulary 1VIVITROL injections may be followed by pain, tenderness,families and caregivers to monitor and report the emergence induration, swelling, erythema, bruising, or pruritus; however,of symptoms of depression or suicidality.in some cases injection site reactions may be very severe. When Reversal of VIVITROL Blockade Is Required forIn the clinical trials, one patient developed an area ofPain Management:induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that requiredFor VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of AN EVIDENCE-BASED TREATMENT OPTION FORsurgical excision. non-opioid analgesics. If opioid therapy is required to reverse Injection site reactions not improving may require promptthe VIVITROL blockade, patients should be closely monitored ALCOHOL DEPENDENCE OR OPIOID DEPENDENCE medical attention, including, in some cases, surgicalby trained personnel in a setting sta ed and equipped for CPR.2intervention. Eosinophilic Pneumonia: Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severePatients who develop dyspnea and hypoxemia should seek What is VIVITROL? 3,4 injection site reactions. medical attention immediately. Consider the possibility of eosinophilic pneumonia in patients who do not respondOnce-monthly extended-release injectableNot associated with diversionSelect proper needle size for patient body habitus, and useto antibiotics. naltrexone (380 mg)Requires opioid detox for a minimum of 7-10 daysonly the needles provided in the carton.Hypersensitivity Reactions including Anaphylaxis: HCP prepared and administered prior to initiationPatients should be informed that any concerning injectionsite reactions should be brought to the attention of theirCases of urticaria, angioedema, and anaphylaxis have been Opioid antagonist Part of a comprehensive management programhealthcare provider. observed with the use of VIVITROL. that includes psychosocial support Non-addictive and non-narcotic Patients should be warned of the risk of hypersensitivity Precipitation of Opioid Withdrawal: reactions, including anaphylaxis. IMPORTANT SAFETY INFORMATIONWhen withdrawal is precipitated abruptly by administrationof an opioid antagonist to an opioid-dependent patient, theIn the event of a hypersensitivity reaction, patients should be VIVITROL must be prepared and administered by a healthcare provider resulting withdrawal syndrome can be severe. Some cases ofadvised to seek immediate medical attention in a healthcare withdrawal symptoms have been severe enough to requiresetting prepared to treat anaphylaxis. The patient should notPrior to initiating VIVITROL, an opioid-free duration of a minimum of 7-10 days is recommended for patients, to avoidhospitalization, and in some cases, management in the ICU. receive any further treatment with VIVITROL. precipitation of opioid withdrawal that may be severe enough to require hospitalizationIntramuscular Injections: The recommended dose of VIVITROL is 380 mg delivered intramuscularly (IM) as a gluteal injection, every 4 weeks orTo prevent occurrence of precipitated withdrawal,opioid-dependent patients, including those being treatedonce a month, alternating buttocks for each subsequent injection, using the carton components provided As with any intramuscular injection, VIVITROL should be for alcohol dependence, should be opioid-free (includingadministered with caution to patients with thrombocytopenia VIVITROL must not be administered intravenously or subcutaneously tramadol) before starting VIVITROL treatment: or any coagulation disorder.See Full Prescribing Information for complete Directions for UseAn opioid-free interval of a minimum of 710 days isAlcohol Withdrawal:recommended for patients previously dependent on short-acting opioids. Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.Patients transitioning from buprenorphine or methadone Their path to recovery can begin with your help.may be vulnerable to precipitated withdrawal for as long asInterference with Laboratory TestsS:10.25" T:10.75" B:11"Visit vivitrolhcp.com to learn more two weeks.VIVITROL may be cross-reactive with certain immunoassayIf a more rapid transition from agonist to antagonistmethods for the detection of drugs of abuse (speci cally therapy is deemed necessary and appropriate by theopioids) in urine.healthcare provider, monitor the patient closely in an For further information, reference to the speci c immunoassay IMPORTANT SAFETY INFORMATIONappropriate medical setting where precipitated withdrawalinstructions is recommended. can be managed. ADVERSE REACTIONSINDICATIONS WARNINGS AND PRECAUTIONS Patients should be made aware of the risk associated withprecipitated withdrawal and be encouraged to give anThe adverse events seen most frequently in association with VIVITROL is indicated for: Vulnerability to Opioid Overdose: accurate account of last opioid use. VIVITROL therapy for alcohol dependence (ie, those occurringin 5% and at least twice as frequently with VIVITROL than Treatment of alcohol dependence in patients whoAfter opioid detoxi cation, patients are likely to have a reducedPrecipitated opioid withdrawal has been observed in are able to abstain from alcohol in an outpatienttolerance to opioids. VIVITROL blocks the e ects of exogenousalcohol-dependent patients in circumstances where theplacebo) include nausea, vomiting, injection site reactions setting prior to initiation of treatment withopioids for approximately 28 days after administration. As theprescriber had been unaware of the additional use of(including induration, pruritus, nodules, and swelling), VIVITROL. Patients should not be actively drinkingblockade wanes and eventually dissipates completely, use ofopioids or co-dependence on opioids. arthralgia, arthritis, or joint sti ness, muscle cramps, dizziness at the time of initial VIVITROL administration. previously tolerated doses of opioids could result in potentiallyor syncope, somnolence or sedation, anorexia, decreased life-threatening opioid intoxication (respiratory compromise orHepatotoxicity: appetite or other appetite disorders.Prevention of relapse to opioid dependence,arrest, circulatory collapse, etc.).Cases of hepatitis and clinically signi cant liver dysfunction following opioid detoxi cation. The adverse events seen most frequently in association withhave been observed in association with VIVITROL. WarnVIVITROL in opioid-dependent patients (ie, those occurringCases of opioid overdose with fatal outcomes have been VIVITROL should be part of a comprehensivereported in patients who used opioids at the end of a dosingpatients of the risk of hepatic injury; advise them to seekin 2% and at least twice as frequently with VIVITROL than management program that includes psychosocialinterval, after missing a scheduled dose, or after discontinuinghelp if experiencing symptoms of acute hepatitis.placebo) were hepatic enzyme abnormalities, injection site support. treatment. Patients and caregivers should be told of thisDiscontinue use of VIVITROL in patients who exhibitpain, nasopharyngitis, insomnia, and toothache.CONTRAINDICATIONS increased sensitivity to opioids and the risk of overdose. Discussacute hepatitis symptoms.You are encouraged to report side e ects to the FDA. the availability of naloxone for the emergency treatment of VIVITROL is contraindicated in patients: opioid overdose with the patient and caregiver, at the initialVisit www.fda.gov/medwatch or call 1-800-FDA-1088. Receiving opioid analgesics VIVITROL injection and with each subsequent injection. Strongly consider prescribing naloxone for the emergency treatment ofPLEASE SEE BRIEF SUMMARY OF PRESCRIBING With current physiologic opioid dependence INFORMATION ON THE FOLLOWING PAGES.opioid overdose.In acute opioid withdrawal Although VIVITROL is a potent antagonist with a prolongedReferences: 1. U.S. Department of Veterans A airs. Pharmacy Bene t Management Who have failed the naloxone challenge test orpharmacological e ect, the blockade produced by VIVITROL isStrategic Health Group. VHA national formulary. https://www.pbm.va.gov/PBM/have a positive urine screen for opioids surmountable. The plasma concentration of exogenous opioidsnationalformulary/VANationalFormulary-July2020.xls. Published July 2020. Accessed September 1, 2020. 2. U.S. Department of Veterans A airs. Department of Who have exhibited hypersensitivity toattained immediately following their acute administration mayDefense. VA/DoD clinical practice guideline for the management of substance use naltrexone, polylactide-co-glycolide (PLG),be sucient to overcome the competitive receptor blockade.disorders. https://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGcarboxymethylcellulose, or any other componentsThis poses a potential risk to individuals who attempt, on theirRevised22216.pdf. Published December 2015. Accessed September 1, 2020. of the diluent 3. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; March 2021. own, to overcome the blockade by administering large amounts4. Center for Drug Evaluation and Research. Accessed September 1, 2020. of exogenous opioids. https://www.fda.gov/media/116739/download Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should ALKERMES and VIVITROL are registered trademarks of Alkermes, Inc.be told of the serious consequences of trying to overcome the 2021 Alkermes, Inc. All rights reserved.opioid blockade. VIV-005849FS:7.125" FS:7.125"F:7.875" F:7.875"11552134_VIV005849_VA_AdSpread_Resize_M3FR.indd 1 12/6/21 1:38 PMPREPARED BY11552134 VIV005849_VA_AdSpread_Print_15.75x10.75 M3FRJob info Images FontsSpecial InstructionsDate: 12-6-2021 1:38 PM ALKE_A072194_4C.tif (CMYK; 977 ppi; 30.68%;Gotham (Book, Bold), Zapf Dingbats (Regular),NoneClient: ALKERMES 37.6MB), alks_mark_p_ko.ai (21.81%; 1.0MB),Symbol Std (Medium)Product: ALKERMES VIVITROL VIVITROL_Logo_White.eps (123.15%; 1.0MB), Client Code: VIV005849 NY_ALKE_A057713_4C.tif (CMYK; 633 ppi;Additional InformationWF Issue # 10659621 47.33%; 24.5MB) NoneReleasing as: PDFx1AFinal Size: 15.75 (w) x 10.75 (h) - InchesFinishing: Trim Gutter: .5" each side Inks Additional Comments for SizingColors: 4CCyan, Magenta, Yellow, Black NoneTeamProducer: Miles Cornman, Jarrett NewmanAD: Suzanne ElwardAE: Tanisha Makker Scale: 1"= 1"QC: LW Bleed 16" w x 11" h16" w x 11" hProduction: Michael Patrissi, Bryant Santana Trim/Flat 15.75" w x 10.75" h15.75" w x 10.75" hDigital Artist: Agosto, Victor (NYC-FCB) Live/Safety 15.25" w x 10.25" h15.25" w x 10.25" h FR Spellcheck:NonePath: PrePress:Alkermes:ALKERMES_VIVITROL:11552134:11552134_VIV005849_VA_AdSpread_Resize_M3FR.inddPDFX1A _'