b'B:16"T:15.75"S:14.75"Injection Site Reactionsor suicidal thoughts. Alert families and caregivers to Expanded VIVITROL access for VA patientsVIVITROL 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 E\x13 ective July 2023 Inadvertent subcutaneous/adipose layer injection offor Pain Management the VA removed its criteriaVIVITROL may increase the likelihood of severe injectionFor VIVITROL patients in emergency situations, 1 site reactions. Select proper needle size for patient bodysuggestions for pain management include regional for use for VIVITROL habitus and use only the needles provided in the carton.analgesia or use of non-opioid analgesics. If opioid This means:VIVITROL injections may be followed by pain,therapy is required to reverse the VIVITROL blockade, tenderness, induration, swelling, erythema, bruising, orpatients should be closely monitored by trainedpruritus; however, in some cases injection site reactionspersonnel in a setting sta ed and equipped for CPR. A VA provider or VA authorized provider can order the medicationmay be very severe.Eosinophilic Pneumonia without entering a priorInjection site reactions not improving may requirePatients who develop dyspnea and hypoxemia should authorization requestprompt medical attention, including, in some cases,seek medical attention immediately. Consider the surgical intervention.possibility of eosinophilic pneumonia in patients who In the clinical trials, one patient developed an area ofdo not respond to antibiotics. induration that continued to enlarge after 4 weeks, withHypersensitivity Reactions including Anaphylaxis Actor portrayal. subsequent development of necrotic tissue that requiredPatients should be warned of the risk of hypersensitivity surgical excision.reactions, including anaphylaxis, and should be Patients should be informed that any concerningadvised to seek immediate medical attention in a injection site reactions should be brought to the attentionhealthcare setting prepared to treat anaphylaxis should of their healthcare provider.a hypersensitivity reaction occur. The patient should not Precipitation of Opioid Withdrawalreceive any further treatment with VIVITROL. When withdrawal is precipitated abruptly by administration Intramuscular Injections of an opioid antagonist to a patient with opioid As with any intramuscular injection, VIVITROL should 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. Available on the VA National Formulary 2 require hospitalization and/or management in the ICU. Alcohol Withdrawal To prevent occurrence of precipitated withdrawal,Use of VIVITROL does not eliminate nor diminish patients with opioid dependence, including those beingalcohol withdrawal symptoms. treated for alcohol dependence, should be opioid-freeS:9.75" T:10.75" B:11"INDICATIONS Vulnerability to Opioid Overdose(including tramadol) before starting VIVITROL treatment:Interference With Laboratory TestsAn opioid-free interval of a minimum of 7 10 days isVIVITROL may be cross-reactive with certain VIVITROL is indicated for: After opioid detoxi cation, patients are likely to have a reducedrecommended for patients previously dependent onimmunoassay methods for the detection of drugs The treatment of alcohol dependence intolerance to opioids. VIVITROL blocks the e ects of exogenousshort-acting opioids. of abuse (speci cally opioids) in urine. For further patients who are able to abstain from alcoholopioids for approximately 28 days after administration. As thePatients transitioning from buprenorphine orinformation, reference to the speci c immunoassay in an outpatient setting prior to initiation ofblockade wanes and eventually dissipates completely, use ofmethadone may be vulnerable to precipitatedinstructions is recommended. treatment with VIVITROL. Patients shouldpreviously tolerated doses of opioids could result in potentiallywithdrawal for as long as 2 weeks. not be actively drinking at the time of initiallife-threatening opioid intoxication (respiratory compromiseIf a more rapid transition from agonist to antagonistAdverse ReactionsVIVITROL administration. or arrest, circulatory collapse, etc). Cases of opioid overdosetherapy is deemed necessary and appropriate byThe adverse events seen most frequently in association The prevention of relapse to opioidwith fatal outcomes have been reported in patients whothe healthcare provider, monitor the patient closelywith VIVITROL therapy for alcohol dependence dependence, following opioid detoxi cation. used opioids at the end of a dosing interval, after missing ain an appropriate medical setting where precipitated(occurring in 5% and at least twice as frequently with VIVITROL should be part of a comprehensivescheduled dose, or after discontinuing treatment.withdrawal can be managed. VIVITROL than placebo) include nausea, vomiting, management program that includesPatients and caregivers should be told of this increasedPatients should be made aware of the risk associatedinjection site reactions (including induration, pruritus, psychosocial support.sensitivity to opioids and the risk of overdose.with precipitated withdrawal and be encouraged to givenodules, and swelling), arthralgia, arthritis, or joint Although VIVITROL is a potent antagonist with a prolongedan accurate account of last opioid use, as precipitatedsti ness, muscle cramps, dizziness or syncope, IMPORTANT SAFETY INFORMATIONpharmacological e ect, the blockade produced by VIVITROL isopioid withdrawal has been observed in patients withsomnolence or sedation, anorexia, decreased appetite VIVITROL is contraindicated in patients:surmountable. The plasma concentration of exogenous opioidsalcohol dependence in circumstances where theor other appetite disorders. Receiving opioid analgesics attained immediately following their acute administration mayprescriber had been unaware of the additional use ofThe adverse events seen most frequently in association With current physiologic opioid dependencebe sucient to overcome the competitive receptor blockade.opioids or co-dependence on opioids.with VIVITROL in patients with opioid dependence This poses a potential risk to individuals who attempt, on their(occurring in 2% and at least twice as frequently or in acute opioid withdrawal own, to overcome the blockade by administering large amountsHepatotoxicitywith VIVITROL than placebo) include hepatic enzyme Who have failed the naloxone challenge testof exogenous opioids.Cases of hepatitis and clinically signi cant liverabnormalities, injection site pain, nasopharyngitis, or have a positive urine screen for opioids Any attempt by a patient to overcome the VIVITROL blockadedysfunction have been observed in association withinsomnia, and toothache. Who have exhibited hypersensitivity toby taking opioids may lead to fatal overdose. Patients should VIVITROL. Warn patients of the risk of hepatic injury andPLEASE SEE BRIEF SUMMARY OF PRESCRIBING naltrexone, polylactide-co-glycolide (PLG),be told of the serious consequences of trying to overcome the advise them to seek help if experiencing symptoms ofINFORMATION ON THE FOLLOWING PAGES.carboxymethylcellulose, or any otheropioid blockade.acute hepatitis. Discontinue VIVITROL in patients who components of the diluent exhibit signs and symptoms of acute hepatitis. References: 1. Pharmacy Bene ts Management-Medical Advisory Panel-VISN Discuss the availability of naloxone for the emergency treatmentPharmacist Executives Ez-Minutes. Newsletter. Dept of Veterans A airs; 2023. of opioid overdose with the patient and caregiver, at theDepression and SuicidalityVol 2, Issue 6. Accessed September 22, 2023. https://www.pbm.va.gov/PBM/nationalformulary/062023VANationalFormularyDecisions.pdf 2. Pharmacy initial VIVITROL injection and with each subsequent injection.Patients with alcohol dependence or opioid dependencebene ts management services. Department of Veterans A airs. Published Strongly consider prescribing naloxone for the emergencytaking VIVITROL should be monitored for depression March 2023. Accessed April 28, 2023. https://www.pbm.va.gov/treatment of opioid overdose.nationalformulary.aspALKERMES and VIVITROL are registered trademarks of Alkermes, Inc.2023 Alkermes, Inc. All rights reserved.VIV-006991 Printed in the U.S.A.F:7.875" F:7.875"12037252_VIV_2023_VA_CFU_JA_US_Med_Dir_M2FR.indd 1 11/20/23 11:27 AMPREPARED BY12037252-vc12042827 VIV 2023 VA CFU JA - US Medicine_Directory Edition M2FRJob info Images FontsSpecial InstructionsDate: 11-20-2023 11:27 AM ALKE_A092872_4C.tif (CMYK; 300 ppi; 100%;Proxima Nova (Bold, Semibold, Extrabold,Rename: VIV-006991_Vivitrol 2023 VA CFU Client: Alkermes 17.3MB), _CMYK_KO_noBkg_right.ai (108%;Medium, Regular), Zapf Dingbats (Regular) Journal Ad_US Medicine_DirectoryProduct: Vivitrol 894KB), alks_mark_p_cmyk.ai (20%; 1.0MB)Client Code: VIV-006991 Additional InformationWF Issue # 9148612 NoneReleasing as: Native + PDFx1aFinal Size: 15.75" x 10.75"Finishing: TrimGutter: None Inks Additional Comments for SizingColors: 4C + 1/0 (K)Cyan, Magenta, Yellow, Black NoneTeamProducer: Stacy WichnerAD: Suzanne ElwardAE: Bhavish Vora Scale: 1"= 1"QC: lp / dy Bleed 16" w x 11" h16" w x 11" hProduction: Steve Bertuzzi Trim/Flat 15.75" w x 10.75" h15.75" w x 10.75" hDigital Artist: YIP (NYC-SRX) Live/Safety 14.75" w x 9.75" h14.75" w x 9.75" h Path: PrePress:Alkermes:Vivitrol:12037252:12037252_VIV_2023_VA_CFU_JA_US_Med_Dir_M2FR.inddPDFX1A _'