b'B:16"T:15.75"S:14.75"Injection 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. AlertVIVITROL injections may be followed by pain, tenderness,families and caregivers to monitor and report the emergence Available on the VA National Formulary 1 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 requiredfor pain management include regional analgesia or use of surgical excision. non-opioid analgesics. If opioid therapy is required to reverseInjection site reactions not improving may require promptthe VIVITROL blockade, patients should be closely monitored medical attention, including, in some cases, surgicalby trained personnel in a setting sta ed and equipped for CPR.AN EVIDENCE-BASED TREATMENT OPTION FOR intervention. Eosinophilic Pneumonia:2Inadvertent subcutaneous/adipose layer injection of ALCOHOL DEPENDENCE OR OPIOID DEPENDENCEVIVITROL may increase the likelihood of severe Cases of eosinophilic pneumonia requiring hospitalization injection site reactions. have been reported. Warn patients of the risk of eosinophilic pneumonia and to seek medical attention if they developSelect proper needle size for patient body habitus, and usesymptoms of pneumonia.only the needles provided in the carton. Hypersensitivity Reactions including Anaphylaxis:VIVITROL is a once-monthly, non-narcotic treatment option that is FDA-approved to treat alcohol dependence and Patients should be informed that any concerning injection Cases of urticaria, angioedema, and anaphylaxis have been prevent relapse to opioid dependence following opioid detoxi cation, in combination with psychosocial counseling.site reactions should be brought to the attention of theirobserved with use of VIVITROL in the clinical trial setting and healthcare provider. in postmarketing use. Things to know about VIVITROL 3 :Precipitation of Opioid Withdrawal:Patients should be warned of the risk of hypersensitivity Monthly extended-release injectable Non-narcoticWhen withdrawal is precipitated abruptly by administration reactions, including anaphylaxis. of an opioid antagonist to an opioid-dependent patient, theIn the event of a hypersensitivity reaction, patients should be naltrexone (380 mg) Not associated with diversion resulting withdrawal syndrome can be severe. Some cases ofadvised to seek immediate medical attention in a healthcareHCP-administered* withdrawal symptoms have been severe enough to requiresetting prepared to treat anaphylaxis. The patient should not Requires opioid detoxi cation hospitalization, and in some cases, management in the ICU. receive any further treatment with VIVITROL. Opioid antagonistTo prevent occurrence of precipitated withdrawal,Part of a comprehensive management programopioid-dependent patients, including those being treatedIntramuscular Injections:Non-addictive that includes psychosocial support for alcohol dependence, should be opioid-free (including As with any intramuscular injection, VIVITROL should betramadol) before starting VIVITROL treatment: administered with caution to patients with thrombocytopenia *VIVITROL is delivered via intramuscular gluteal injection, alternating buttocks for each subsequent injection.An opioid-free interval of a minimum of 710 days isor any coagulation disorder. recommended for patients previously dependent onAlcohol Withdrawal:short-acting opioids.Use of VIVITROL does not eliminate nor diminish alcohol Patients transitioning from buprenorphine orwithdrawal symptoms.Their path to recovery can begin with your help.methadone may be vulnerable to precipitated withdrawalInterference with Laboratory Tests for as long as two weeks. S:9.75" T:10.75" B:11"Visit vivitrolhcp.com to learn moreIf a more rapid transition from agonist to antagonist VIVITROL may be cross-reactive with certain immunoassay therapy is deemed necessary and appropriate by themethods for the detection of drugs of abuse (speci cally healthcare provider, monitor the patient closely in anopioids) in urine.appropriate medical setting where precipitated withdrawal For further information, reference to the speci c immunoassay can be managed. instructions is recommended.Patients should be made aware of the risk associated with IMPORTANT SAFETY INFORMATION precipitated withdrawal and be encouraged to give anADVERSE REACTIONSaccurate account of last opioid use.The adverse events seen most frequently in association with INDICATIONS WARNINGS AND PRECAUTIONSPrecipitated opioid withdrawal has been observed inVIVITROL therapy for alcohol dependence (ie, those occurring alcohol-dependent patients in circumstances where thein 5% and at least twice as frequently with VIVITROL than VIVITROL is indicated for: Vulnerability to Opioid Overdose: prescriber had been unaware of the additional use ofplacebo) include nausea, vomiting, injection site reactionsTreatment of alcohol dependence in patients who After opioid detoxi cation, patients are likely to have a reducedopioids or co-dependence on opioids. (including induration, pruritus, nodules, and swelling), are able to abstain from alcohol in an outpatienttolerance to opioids. VIVITROL blocks the e ects of exogenousarthralgia, arthritis, or joint sti ness, muscle cramps, dizziness setting prior to initiation of treatment withopioids for approximately 28 days after administration. As theHepatotoxicity: or syncope, somnolence or sedation, anorexia, decreased VIVITROL. Patients should not be actively drinkingblockade wanes and eventually dissipates completely, use of Cases of hepatitis and clinically signi cant liver dysfunctionappetite or other appetite disorders.at the time of initial VIVITROL administration. previously tolerated doses of opioids could result in potentiallyhave been observed in association with VIVITROL. Warn The adverse events seen most frequently in association withPrevention of relapse to opioid dependence,life-threatening opioid intoxication (respiratory compromise orpatients of the risk of hepatic injury; advise them to seekVIVITROL in opioid-dependent patients (ie, those occurring following opioid detoxi cation. arrest, circulatory collapse, etc.). help if experiencing symptoms of acute hepatitis.in 2% and at least twice as frequently with VIVITROL thanVIVITROL should be part of a comprehensive Cases of opioid overdose with fatal outcomes have beenDiscontinue use of VIVITROL in patients who exhibitplacebo) were hepatic enzyme abnormalities, injection site management program that includes psychosocialreported in patients who used opioids at the end of a dosingacute hepatitis symptoms.pain, nasopharyngitis, insomnia, and toothache.support. interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of thisYou are encouraged to report side e ects to the FDA. CONTRAINDICATIONS increased sensitivity to opioids and the risk of overdose. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.VIVITROL is contraindicated in patients:Although VIVITROL is a potent antagonist with a prolonged pharmacological e ect, the blockade produced by VIVITROL isPLEASE SEE BRIEF SUMMARY OF PRESCRIBINGReceiving opioid analgesics surmountable. The plasma concentration of exogenous opioidsINFORMATION ON THE FOLLOWING PAGES. With current physiologic opioid dependence attained immediately following their acute administration mayIn acute opioid withdrawal be sucient to overcome the competitive receptor blockade.Who have failed the naloxone challenge test orThis poses a potential risk to individuals who attempt, on theirReferences: 1. U.S. Department of Veterans A airs. Pharmacy Bene t Management have a positive urine screen for opioids own, to overcome the blockade by administering large amountsStrategic Health Group. VHA national formulary. https://www.pbm.va.gov/PBM/of exogenous opioids. nationalformulary/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), Any attempt by a patient to overcome the VIVITROL blockadeDefense. VA/DoD clinical practice guideline for the management of substance use by taking opioids may lead to fatal overdose. Patients should disorders. https://www.healthquality.va.gov/guidelines/MH/sud/VADoDSUDCPGcarboxymethylcellulose, or any other componentsbe told of the serious consequences of trying to overcome the Revised22216.pdf. Published December 2015. Accessed September 1, 2020. of the diluent opioid blockade. 3. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; July 2020.ALKERMES and VIVITROL are registered trademarks of Alkermes, Inc.2021 Alkermes, Inc. All rights reserved.VIV-005589FS:7.125" FS:7.125"F:7.875" F:7.875"11508764_VIV_VA_HOSP_US_MED_AD_M1.indd 1 1/12/21 2:20 PMPREPARED BY11508764 Ad for compendium of US Medicine M1Job info Images FontsSpecial InstructionsDate: 1-12-2021 2:20 PM VIVITROL_Logo_White.eps (127%; 1.0MB),Minion Pro (Regular), Gotham (Book, Bold),NoneClient: ALKERMES ALKE_A059870_4C.tif (CMYK; 384 ppi; 78.1%;Arial (Regular), Symbol Std (Medium)Product: ALKERMES VIVITROL 33.0MB), ALKE_A060010_4C.tif (CMYK; 977 ppi; Client Code: VIV-005589 30.68%; 37.6MB), alks_mark_p_ko.ai (21.81%;Additional InformationWF Issue # 8016332 1.0MB) NoneReleasing as: PDFx1AFinal Size: 15.75"w x 10.75"hFinishing: TrimGutter: Gutter clearance = .5" across Inks Additional Comments for SizingColors: 4/C spread + B&W Brief SummaryCyan, Magenta, Yellow, Black NoneTeamProducer: Denzyl AmankwahAD: Kristine SoAE: Denzyl Amankwah Scale: 1"= 1"QC: Lynwood Bleed 16" w x 11" h16" w x 11" hProduction: Emily O\'Loane Trim/Flat 15.75" w x 10.75" h15.75" w x 10.75" hDigital Artist: Pitagorsky, Tracy (NYC-FCB) Live/Safety 14.75" w x 9.75" h14.75" w x 9.75" h FR Spellcheck:NonePath: PrePress:Alkermes:Vivitrol:11508764:11508764_VIV_VA_HOSP_US_MED_AD_M1.indd_ _'