b'B:16"T:15.75"S:15.25"48Injection 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 For VIVITROL patients in emergency situations, suggestions subsequent development of necrotic tissue that required 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 Patients who develop dyspnea and hypoxemia should seek What is VIVITROL? 3,4 VIVITROL may increase the likelihood of severemedical attention immediately. Consider the possibility of injection site reactions. 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 injection Cases of urticaria, angioedema, and anaphylaxis have been Opioid antagonistPart of a comprehensive management programsite reactions should be brought to the attention of theirobserved with the use of VIVITROL. healthcare provider.Non-addictive and non-narcotic that includes psychosocial support Precipitation of Opioid Withdrawal:Patients should be warned of the risk of hypersensitivityWhen withdrawal is precipitated abruptly by administrationreactions, including anaphylaxis. IMPORTANT SAFETY INFORMATION of 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,once a month, alternating buttocks for each subsequent injection, using the carton components provided opioid-dependent patients, including those being treatedAs 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 Use An opioid-free interval of a minimum of 710 days isAlcohol Withdrawal:recommended for patients previously dependent on Use of VIVITROL does not eliminate nor diminish alcohol short-acting opioids. 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 occurringTreatment of alcohol dependence in patients who in 5% and at least twice as frequently with VIVITROL than After 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, decreasedPrevention of relapse to opioid dependence,life-threatening opioid intoxication (respiratory compromise orHepatotoxicity: appetite or other appetite disorders.following opioid detoxi cation. arrest, circulatory collapse, etc.).Cases of hepatitis and clinically signi cant liver dysfunction The adverse events seen most frequently in association withhave been observed in association with VIVITROL. WarnVIVITROL in opioid-dependent patients (ie, those occurring VIVITROL should be part of a comprehensiveCases of opioid overdose with fatal outcomes have been management program that includes psychosocialreported 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 support. interval, after missing a scheduled dose, or after discontinuinghelp if experiencing symptoms of acute hepatitis.placebo) were hepatic enzyme abnormalities, injection site 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. StronglyWith current physiologic opioid dependence consider prescribing naloxone for the emergency treatment ofPLEASE SEE BRIEF SUMMARY OF PRESCRIBINGIn acute opioid withdrawal opioid overdose. INFORMATION ON THE FOLLOWING PAGES. Who have failed the naloxone challenge test or Although VIVITROL is a potent antagonist with a prolongedReferences: 1. U.S. Department of Veterans A airs. Pharmacy Bene t Management pharmacological 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.Who have exhibited hypersensitivity toAccessed September 1, 2020. 2. U.S. Department of Veterans A airs. Department of naltrexone, polylactide-co-glycolide (PLG),attained immediately following their acute administration mayDefense. VA/DoD clinical practice guideline for the management of substance use 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 _'