started - alk-viv · work directly with vivitrol2gether for assistance in fulfilling vivitrol...

GETTING STARTED

PROGRAM OVERVIEW

PATIENT SUPPORT SERVICES AND RESOURCES

ORDERING FOR YOUR PATIENTS

DEDICATED CASE MANAGER SUPPORT

CONTINUING PATIENT CARE

CO-PAY SAVINGS PROGRAM

PATIENT ENROLLMENT FORM

FREQUENTLY ASKED QUESTIONS

IMPORTANT SAFETY INFORMATION FOR VIVITROL® (NALTREXONEFOREXTENDED-RELEASEINJECTABLESUSPENSION)

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MEDICATION GUIDEPRESCRIBING INFORMATION

WHAT’S INSIDE

Please see Important Safety Information on page 12. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.

https://www.vivitrol.com/content/pdfs/medication-guide.pdf


https://www.vivitrol.com/content/pdfs/prescribing-information.pdf



PROGRAM OVERVIEW

Along with VIVITROL® (naltrexone for extended-release injectable suspension), we offer Vivitrol2getherSM—a customized support services program to help you and your patients in their recovery journey from opioid or alcohol dependence throughout fulfillment, transition of care, and during VIVITROL treatment.

WithVivitrol2gether,youchoosetheVIVITROLfulfillmentfeaturesthatworkbesttosupport

yourpatients.Ifyouprefertoworkdirectlywithpharmacies,weprovidetheresourcesyouneed,

withVIVITROLteammembersavailabletoansweryourquestionsquickly.Youcanalsochoose

tosignuptoworkwithadedicatedcasemanagertohelpassistyouinthefulfillmentprocess,as

wellasuseanonlinetrackingportaltofindVIVITROLfulfillmentdetailsandpatientservices.

Whichever option you choose, Vivitrol2gether provides the resources to support patient access:

§ Specialtyorotherpharmacyselectionoptionsbasedonapatient’shealthplancoverage

§ Educationabouthealthplanandpharmacyrequirements,includingpriorauthorizationsand

coveragerequirements

§ EasyaccesstoresourcestohelpfacilitateVIVITROLdelivery







IMPORTANT SAFETY INFORMATION FOR VIVITROL®

PROGRAM OVERVIEW

PROGRAM OVERVIEW

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First VIVITROL prescription

§ Determinethespecialtyorotherpharmacyoptionsavailablebasedonthepatient’shealthplancoverage

§ DiscusstheVIVITROLCo-paySavingsProgramwiththepatient;eligiblepatientscansignupandprovidetherequiredinformationtothepharmacy

§ Remindyourpatientstoexpectacallfromthepharmacyand/ornursecoordinatortoreviewimportantinformationaboutthefirstpharmacyorder

Insurance, Co-pay Savings and Prescription Verification

§ Specialtyorotherpharmacyperformsabenefitverificationonbehalfofthepatientandconfirmsprescriptionverificationandpriorauthorizationwiththehealthplan

§ Co-paysavingsareappliedforeligiblepatients

§ Patientauthorizespayment

Schedule shipping and delivery

§ Patientiscontactedtoscheduleorconfirmdeliverydate

§ Patientiscalledaboutnextstepsandfollow-ups

Rx is filled and ready to ship

§ Pharmacycontactspatientandprovider’sofficetoauthorizeshipment

– Afterpatientauthorization,pharmacywillcontactyourofficetosetupdelivery

§ Prescriptionisfilledbypharmacyandshippedtoyouroffice

Delivery of VIVITROL

§ OfficereceivesVIVITROL

§ PatientreceivesinjectionofVIVITROL

§ Yourpatient’sfollow-upappointmentisscheduled

Follow-up for next injection

§ Schedulefollow-upappointmentforthenextinjection

Work directly with Vivitrol2gether for assistance in fulfilling VIVITROL prescriptions. Our team is ready to support you and your patients. Call 1-800-VIVITROL (1-800-848-4876), 9am–8pm (EST) and visit VIVITROLHCP.com to access a variety of helpful resources.

Whetheryouhaveselectedtosendtheprescriptiondirectlytothepharmacy(specialtyorother)

orhavechosentoworkwithaVivitrol2getherdedicatedcasemanager,thefollowingsteps

provideanunderstandingoftheorderingprocessforVIVITROL.

Follow these steps with your patients to facilitate the delivery of VIVITROL to your office once a month.


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https://www.vivitrol.com/










PROGRAM OVERVIEW


§ An800 number for patientsconsideringVIVITROLtolearnaboutVIVITROL,howto

getstartedandwhat’snecessaryduringtreatment

§ A dedicated Nurse Coordinator,onceapatientisreceivingVIVITROLtreatment,whocan

providepatientsupportservicesduringtreatmentwithVIVITROL

§ Aidincoordinating carefromaresidentialfacilityorothersettingsforfollow-upVIVITROL

injection

§ Assistancewiththelogisticsof obtaining, starting, and scheduling VIVITROLtreatment

§ Help with finding counselorsandinpatientandoutpatientservicesintheirarea

§ InformationabouttheVIVITROL® Co-pay Savings Program,eligibilityrequirementsand

enrollmentinstructions

§ Online resourcesfortherecoveryjourney

§ Helparrangingappointments and follow-up reminders

The VIVITROL Provider Locator isanonlineresourcethatconnectspatientstohealthcare

providerswhocanprescribeand/oradministerVIVITROLnationally.

IfyouprovideVIVITROL,consideraddingyourfacilitytotheProviderLocatorsopatients

andreferringhealthcareprofessionalscanfindyou.Visit VIVITROL.com/Locator.

IfyouhavepatientstransitioningtoanewsiteofcareforVIVITROL,usethelocatortofind

VIVITROLprovideroptionsinaspecificareaaspartoftheirdischargeortransitionplan.

Visit VIVITROL.com to access these resources.

Your VIVITROL® (naltrexone for extended-release injectable suspension) patients also have the support of Vivitrol2getherSM. We understand the recovery journey from opioid or alcohol dependence is a challenge. Vivitrol2gether provides a variety of patient support services:

Provider Locator:

PATIENT SUPPORT SERVICESANDRESOURCES

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—Kurt,father,counselor,recoveringopioidaddict*

I’m choosing to move forward, and if there’s something out there that’s going to help me, then I’m going to use it.

*Patientstoriesreflectpersonalexperiences.Individualexperiencesmayvary.

Watch Kurt’s story on VIVITROL.com/Kurt to learn how he used VIVITROL along with a drug counseling program to help reinforce his recovery process.





http://www.VIVITROL.com/Locator

http://www.VIVITROL.com/Patient-Support

http://www.VIVITROL.com/Kurt




VIVITROL® (naltrexone for extended-release injectable suspension) is widely accessible for your patients

Pharmacyoptions,approvalrequirements,andthe

costforVIVITROLprescriptionsvarybyhealthplan.

HealthplanstypicallycoverVIVITROLaseithera

medicalorpharmacybenefit.TheVivitrol2getherSM

teamwilllookintoyourpatient’shealthplancoverage

andcommunicateanyrequirements.

§ Network pharmacy:SomehealthplansallowanynetworkpharmacytofillVIVITROL

§ Specialty pharmacy: Often,healthinsuranceprovidersallowpatientstoobtaininjectable

medicationsthroughaspecialtypharmacy.Thesepharmacieswillobtainandshipapatient-

specificprescriptiontoyouroffice.Theybillthepatient’sinsurancedirectlyandcollectany

co-payfromthepatient.Ifapatient’sinsurancecoversVIVITROLunderthemedicalbenefit

portionofthehealthplan,theplanmayallowanetworkpharmacytoshipVIVITROLdirectly

totheprovider’sofficeandbillthepatient’shealthplandirectlyonbehalfoftheprovider

§ Buy-and-bill: AnotheroptionifVIVITROLiscoveredthroughthemedicalbenefitisforthe

doctortobuyunitsofVIVITROLfromaspecialtydistributorandbillthepatient’sinsurance

directlywhenitisadministered

Pharmacy and fulfillment options

HowhealthcareprovidersobtainVIVITROLusuallydependsonhowitiscoveredbythepatient’s

healthplan.

Nationally more than 90%

of patients have insurance

coverage for VIVITROL1

Reference: 1. DataderivedfrominsuredpatientsenrolledintheVIVITROL®Co-paySavingsProgramfromMarch2016throughFebruary2017.








PROGRAM OVERVIEW


The Vivitrol2gether Enrollment Form gathersalltheinformationneededtoprocess

anorderincludingallpatientandprovidersignatures.Theform,alongwithother

necessarydocuments,isfaxedtoVivitrol2gethersotheteamcanhelpexpeditethe

approvalandshipmentprocess.(Seeformonpage9.)

These are the 3 primary resources you use when working with a dedicated case manager.

Viewthestatusofapatient’sprescriptionontheProvider Online Portal.Tosignup,

obtainthePortalAuthorizationFormfromyourofficecontactordirectlyfrom

Vivitrol2gether.Oncetheauthorizationisprocessed,youwillbeabletoviewupdates

onanyVIVITROLprescriptionsyousubmitted.

A dedicated Nurse Coordinatorwhoprovidespatientsupportservicestopatients

throughoutfulfillment,transitionofcare,andduringtreatmentwithVIVITROL.

Suggestions to speed up pharmacy fill timeItisimportanttotrytoavoid delaysinthefulfillmentofVIVITROL.

Submit any Prior Authorization Formstothehealthplanatthestartoftheprocess.Thepharmacycannotshipuntiltheyreceiveapprovalfromthehealthplan.

Create a connection with the pharmacy. Establishingarelationshipandcommunicatingurgencycanhelptoexpediteshipments.Determinethebestwayforyoutocommunicatewiththepharmacy(e.g.,phone,email,orfax).

Follow up with the pharmacy regularlyandbesuretocommunicatetherequiredinjectiondateforeachpatient.

View ordering steps on the following page.

ORDERINGFORYOURPATIENTS


DEDICATED CASE MANAGER SUPPORT

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PROGRAM OVERVIEW

VIVITROL prescription: CompleteandfaxallnecessaryformstoVivitrol2gether.Ifyour

patientsareeligible,*theycansignupfortheVIVITROL®Co-paySavingsProgramto

helpsaveonprescriptionout-of-pocketexpenses. (Seepage8forfulldetails.)

How Vivitrol2gether Can Help: Vivitrol2gether will provide you with pharmacy options

(specialty or other) based on your patient’s health plan and Vivitrol2gether pharmacy

experience. If you have a preferred pharmacy, include it on the Vivitrol2gether Enrollment

Form for triage. Vivitrol2gether may also assist in determining the proper Prior

Authorization Form for a specific payer.

Prescription processing: OncetheVivitrol2getherEnrollmentFormisenteredintothe

pharmacydatabase,thepharmacyperformsabenefitverificationonbehalfofyour

patientsandconfirmspriorauthorizationapprovalwiththehealthplan(ifapplicable).

How Vivitrol2gether Can Help: If information is missing, Vivitrol2gether can

troubleshoot and coordinate the retrieval of missing information. If there are any obstacles

at this stage, Vivitrol2gether informs you as it helps get the prescription back on track.

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*Toseefulleligibilityrequirements,pleaserefertopage8.

To authorize patient enrollment for Vivitrol2gether, 4 signatures are required on the enrollment form.

§ 1 signature from the provider § 3 signatures from the patient

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Follow these steps for ordering VIVITROL® (naltrexone for extended-release injectable suspension), and learn how a dedicated Vivitrol2getherSM case manager can help.


Next Steps Card: ReviewtheinformationontheNextStepsCardwithyourpatients

andhandthecardtothem.RemindyourpatientsthataNurseCoordinatorand

pharmacistwillbecallingtoreviewimportantinformationaboutthefirstpharmacy

order.Itisimportantthattheyanswerthesecalls.

How Vivitrol2gether Can Help: Vivitrol2gether provides a dedicated Nurse Coordinator

for every patient who signs up. Nurse Coordinators can help guide patients through the

process of starting and continuing VIVITROL treatment.

Shipment authorization: Thepharmacywillneedtocallyourpatients—eventhose

stayinginaresidentialfacility—toauthorizeshipmentbeforesettingupdeliveryto

yourlocation.Onthecall,patientsmaybeaskedto:

§ Authorizeshipment

§ GivetheirVIVITROL®Co-paySavingsProgramID#

§ Provideacreditcard#foranyco-payresponsibility

Once patients have authorized shipment, the pharmacy will contact your office to set up VIVITROL delivery.

Without this authorization, VIVITROL will not be shipped. If patients are residential

and do not have phone access, the pharmacy will be notified, but they will still attempt to

reach patients. Have a process in place to get patients in contact with their pharmacy.

How Vivitrol2gether Can Help: Nurse Coordinators will attempt to reach your patients

and their authorized contact(s) when the prescription is ready to ship. They also remind

patients of their injection appointment dates and times. If there are obstacles at this stage,

Vivitrol2gether informs you and troubleshoots to get the prescription back on track.

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DEDICATED CASE MANAGER SUPPORT (CONTINUED)

ORDERINGFORYOURPATIENTS


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PROGRAM OVERVIEW


§ When filling their first prescription ofVIVITROL,patientsarerequiredtoworkwithyoutofillout

theappropriateVivitrol2getherSMforms.It’simportantto:

ReviewtheNext Steps Cardwithyourpatient.

Askthepatienttoaddaminimumof2 authorized contacts forVivitrol2getherandthepharmacy.

Informyourpatientsthat they will receive a phone callfromthespecialtyspecialtyorotherpharmacyforapprovaltoshipVIVITROL.

§ Patients need to authorize the shipment of their prescription to ensure it gets to your office,

for every appointment. BecauseyourofficeisnotacquiringVIVITROLdirectlyandVIVITROLis

beingbilledtothepatient,thepharmacywillalsohavetocollectanyout-of-pocketexpenses.It’s

importanttoemphasizethiscommunication,aspharmacieshavereportedthatreachingpatients

toauthorizeshipmentisachallenge.

§ If patients are transitioning to an outpatient program andthepresentfacilityisnotwherethey

willreceivefutureVIVITROLinjections,workwiththemtocreateadischargeplanandfindan

injectionprovider.Vivitrol2getherwillcoordinatewiththepharmacyandtheintendedinjection

providertoensuretheprescriptionisdeliveredtothecorrectlocation.

To support your patients on their recovery journey with VIVITROL® (naltrexone for extended-release injectable suspension), it’s important they’re aware of the following:


Schedule their next appointment: Yourpatientshouldunderstandyourscheduling

proceduresandanyactionneededtoschedulethenextappointment.

Stay in touch with their Nurse Coordinator: UponenrollinginVivitrol2gether,your

patientwillbeassignedaVIVITROLNurseCoordinator.TheassignedNurse

Coordinatorwillhelpcoordinatetheirfirstinjectionandwillcontinuetoworkwith

themduringVIVITROLtreatment.NurseCoordinatorswillprovideinjection

appointmentremindersandfollow-upcalls.Itisimportanttoremindyourpatientsto

alwaysreturntheirNurseCoordinator’scalls.

Continue psychosocial support: Yourpatientsshouldcontinuereceivingcounseling

supporttohelpthemworkthroughtheirrecoveryjourneywhiletheyareonVIVITROL.

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Always remind your patients to:

Nurse Coordinators will contact patients within a week of receiving a completed Vivitrol2gether Enrollment Form from your office. Patients can call 1-800-VIVITROL (1-800-848-4876) 9am–8pm (EST) to reach their Nurse Coordinator.

CONTINUINGPATIENT CARE


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http://www.VIVITROLHCP.com


CO-PAY SAVINGSPROGRAM

* Eligibility for Alkermes-Sponsored Co-pay Assistance: OffervalidonlyforprescriptionsforFDA-approvedindications.Patientsmustbeatleast18yearsold.IfpatientsarepurchasingtheirVIVITROLprescriptionswithbenefitsfromMedicare,includingMedicarePartDorMedicareAdvantageplans;Medicaid,includingMedicaidManagedCareorAlternativeBenefitPlans(“ABPs”)undertheAffordableCareAct;Medigap;VeteransAdministration(“VA”);DepartmentofDefense(“DoD”);TRICARE®;oranysimilarstate-fundedprogramssuchasmedicalorpharmaceuticalassistanceprograms,theyarenoteligibleforthisoffer.Voidwhereprohibitedbylaw,taxed,orrestricted.Alkermes,Inc.reservestherighttorescind,revoke,oramendtheseofferswithoutnotice.

†DataderivedfrominsuredpatientsenrolledintheVIVITROL®Co-paySavingsProgramfromMarch2016throughFebruary2017.

The VIVITROL® (naltrexoneforextended-releaseinjectable

suspension) Co-pay Savings Program

TheVIVITROL®Co-paySavingsProgramispartofthecomprehensivepatientsupport

servicesfromVivitrol2getherdesignedtohelpyoureligiblepatients*without-of-pocket

expensesassociatedwiththeirVIVITROLprescriptions.

The VIVITROL® Co-pay Savings Program:

§ Coversupto$500/monthofVIVITROLco-payordeductibleexpensesforeligiblepatients.*

Thismaymean$0co-payordeductibleexpensesforyourpatients.

§ Hasnoincomeeligibilityrequirements.

§ Hasnopresetdurationlimitsorexpiration.TheVIVITROL®Co-paySavingsProgramcardcanbe

usedmultipletimes.Itneverexpiresandremainsactivethroughoutthedurationoftreatment.

§ Allowspatientstoprintco-paycardsdirectlyfromVIVITROLCopay.com.Patientscancutoutthe

cardandkeepitintheirwallet,sothattheyalwayshavetheirIDnumberhandytogivetoa

healthcareproviderorpharmacy.

90%† of insured patients using the program had no

out-of-pocket expenses for VIVITROL.†








PROGRAM OVERVIEW

Who is eligible*?

AnypatientwithaprescriptionforVIVITROLforalcoholoropioiddependence

whois18yearsorolderwith:

§ Commercialhealthinsurance

§ Noinsuranceorelectingnottouseinsurance

Who is not eligible?

PatientsusingfederalorstatehealthcareprogramstopurchasetheirVIVITROL

prescription,suchas:

§ Medicare,includingMedicarePartDorMedicareAdvantageplans–Medicaid,

includingMedicaidManagedCareorAlternativeBenefitPlansunderthe

AffordableCareAct

§ Medigap

§ VeteransAdministration

§ DepartmentofDefense

§ TRICARE®

§ State-fundedprogramssuchasmedicalorpharmaceuticalassistanceprograms

Additional Financial Assistance OptionsIf your patient is unable to cover a co-pay for VIVITROL or has no insurance, Vivitrol2gether may be able to help identify additional financial assistance options. Please contact Vivitrol2gether for more information.

Your eligible patients* can sign up for the VIVITROL® Co-pay Savings Program by visiting VIVITROLCopay.com


CO-PAYSAVINGSPROGRAM


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http://www.VIVITROLCopay.com











PROGRAM OVERVIEW

Fax ALL of the following documents to Vivitrol2gether Support Services at 1-877-329-8484:

§Vivitrol2getherSupportServicesEnrollmentForm

§Photocopyofthefrontandbackofthepatient’sinsurancecard(enlargedtoensurelegibility)

§PriorAuthorizationForm(ifapplicable)

EResidential facilities, enter your patient’s next provider followingdischarge.ThisallowsthepharmacyandNurseCoordinatortocoordinateduringtreatment.

§Besureyourpatientunderstandsyourdischargeplanforcontinuedtreatment.

Ifyoudon’tknowwhothenextproviderwillbe,Vivitrol2gethercanhelpyoulocateone.

BEnter a working phone number for your patient.Thepharmacytypicallymustspeakwithyourpatienttoauthorizeshipment.Patientsinresidentialfacilitieswillalsoneedtobereachablebythepharmacy.Includeinformationforalternatecontactsinsection7incasethepatientisunavailable.

COutpatientproviderswhowillbeadministeringinjectionsgoingforward,select“yes.”

DFillintheestimateddischargedatetoensuretimelycoordinationduringtreatment.

FInclude an enlarged copy of your patient’s insurance card (front and back)orfilloutthissection. The card copy is preferred. Pharmacyselectionandprocessingcannottakeplacewithoutyourpatient’shealthplaninformation.

GProvide your signature ontheEnrollmentFormtoverifyyouasthehealthcareproviderprescribingVIVITROL.



PATIENTENROLLMENTFORM

Please see Important Safety Information on page 12. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients. MEDICATION GUIDEPRESCRIBING INFORMATION

PATIENTENROLLMENTFORM: FRONT PAGE

ItisimportanttotrytoavoiddelaysinVIVITROL®(naltrexoneforextended-releaseinjectable

suspension)fulfillmentforyourpatients.Takingthetimewithyourpatienttocompletethe

Vivitrol2getherSMEnrollmentFormandcheckoffallthesestepswillconfirmaccuracyandhelp

yourpatientwithanybarrierstoreceivingVIVITROL.


An editable PDF version of the Vivitrol2gether Support Services patient enrollment form can be downloaded at VIVITROLHCP.com/Support.

Complete all fields to avoid delays in your treatment plan

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http://www.VIVITROLHCP.com/Support









PROGRAM OVERVIEW

PATIENTENROLLMENTFORM

All fields on this page must be filled out with your patient and require your patient’s name and signature.

KYour patient must check both boxes and sign and date the co-pay sectiontoconfirmeligibilityandinterestintheVIVITROL®Co-paySavingsProgram.*If missing, the prescription request will be sent to the specialty or other pharmacy without a co-pay card included. YoucanalsoenrollyourpatientonlineatVIVITROLCopay.com.Ifyourpatienthasaco-paycardalready,includethecardID#wherenoted.Patientsignatureisrequiredifeligible.

IIncluding two contacts will help expedite the process.Theseindividualswillbecontactedifthepatientisnotavailableorifthepatient’sphonenumberhaschanged.

JPatient authorization including signature, print name, and date are required for the enrollment to process. Amissingsignaturewilldelayprocessing.

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ItisimportanttotrytoavoiddelaysinVIVITROL®(naltrexoneforextended-releaseinjectable

suspension)fulfillmentforyourpatients.Takingthetimewithyourpatienttocompletethe

Vivitrol2getherSMEnrollmentFormandcheckoffallthesestepswillconfirmaccuracyandhelp

yourpatientwithanybarrierstoreceivingVIVITROL.


Helpful Hint:

To enroll, 4 signatures are required on this form

§ 1 from you (bottom of front page)

§ 3 from your patient

Complete all fields to avoid delays in your treatment plan

PATIENTENROLLMENTFORM: BACK PAGE


*Toseefulleligibilityrequirements,pleaserefertopage8.

An editable PDF version of the Vivitrol2gether Support Services patient enrollment form can be downloaded at VIVITROLHCP.com/Support.

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http://www.VIVITROLHCP.com/Support









PROGRAM OVERVIEW

FREQUENTLY ASKEDQUESTIONS

FREQUENTLY ASKEDQUESTIONS

How long does it take for a pharmacy to fill VIVITROL® (naltrexoneforextended-releaseinjectablesuspension)?

Pharmacyandhealthplanapprovaltimesvary:theycanshipasquicklyas48hoursortakeaslongas

2weeks.Asyoustarttoenrollpatients,youwillstarttobetterunderstandthetimingofthepharmacies

youworkwith.

How can I help expedite the prescription fill process?

Yourofficehasaroleinexpeditingaprescription.Belowaretipsthatcanhelp:

§Submit a complete Vivitrol2getherSM Enrollment Form. Besuretoincludeanenlargedfront-and-back

copyofthepatient’sinsurancecard,patientauthorization,andaminimumoftwoauthorizedcontacts

forthepatient.

§Complete any health plan Prior Authorization Form andsubmitittothehealthplanatthebeginningof

theprocess.Vivitrol2getheroryourofficecontactcanprovidegeneralhealthplancoverageinformation

andcopiesofPriorAuthorizationFormstoyourofficeifneeded.

§Follow up with the pharmacy. WhileVivitrol2getherwillworkonpharmacyfollow-up,itisabestpractice

forproviderstoalsocontactthepharmacy.Vivitrol2getherwillsendyouafaxalertwhenyourpatient’s

prescriptionhasbeensenttoapharmacy.Thisfaxwillincludethepharmacy’snameandphonenumber.

Youcancontactthepharmacytorequestthattheyexpeditetheprescription.

Why does the pharmacy need to speak with my patient to ship VIVITROL?

PharmaciesdeliveringVIVITROLhaveinternalprocessesorexternalaccreditationguidelinesrequiringpatient

authorizationtobilltheirinsurance.BecauseyourofficeisnotacquiringVIVITROLdirectlyandVIVITROLis

beingbilledtothepatient,thepharmacywillalsohavetocollectanyco-pay.Pharmacies have reported that

reaching patients to authorize shipment is a challenge.

Whatyoucando:

§GiveyourpatienttheprovidedNextStepsCard,containingimportantinformationaboutall

necessaryactions.Includeaworkingphonenumberforthepatientonimportantforms,includingthe

Vivitrol2getherEnrollmentForm.

§Askthepatienttoaddaminimumof2authorizedcontactsforVivitrol2getherandthepharmacy.

§ Informyourpatientsthattheywillbecalledbythespecialtypharmacy.Thepharmacyneedsthepatient’s

approvalbeforetheyshipVIVITROL.

Are there services for patients to learn more about VIVITROL (before patient enrollment)?

Yes,thereisan800 number for patientswhoareconsideringVIVITROLtocallforanswerstoquestions

aboutVIVITROL,howtogetstarted,andwhat’snecessaryduringtreatment.


Please see Important Safety Information on page 12. Also see Prescribing Information and Medication Guide. Review the Medication Guide with your patients. MEDICATION GUIDEPRESCRIBING INFORMATION

Office staff notes:

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PROGRAM OVERVIEW

IMPORTANT SAFETY INFORMATION FOR VIVITROL® (NALTREXONE FOR EXTENDED-RELEASE INJECTABLE SUSPENSION)

Please see Prescribing Information and Medication Guide. Review the Medication Guide with your patients.


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INDICATIONSVIVITROL is indicated for:

§TreatmentofalcoholdependenceinpatientswhoareabletoabstainfromalcoholinanoutpatientsettingpriortoinitiationoftreatmentwithVIVITROL.PatientsshouldnotbeactivelydrinkingatthetimeofinitialVIVITROLadministration.

§Preventionofrelapsetoopioiddependence,followingopioiddetoxification.

§VIVITROLshouldbepartofacomprehensivemanagementprogramthatincludespsychosocialsupport.

CONTRAINDICATIONS

VIVITROL is contraindicated in patients:

§Receivingopioidanalgesics

§Withcurrentphysiologicopioiddependence

§ Inacuteopioidwithdrawal

§Whohavefailedthenaloxonechallengetestorhaveapositiveurinescreenforopioids

§Whohaveexhibitedhypersensitivitytonaltrexone,polylactide-co-glycolide(PLG),carboxymethylcellulose,oranyothercomponentsofthediluent

WARNINGS AND PRECAUTIONSVulnerability to Opioid Overdose:

§Afteropioiddetoxification,patientsarelikelytohaveareducedtolerancetoopioids.VIVITROLblockstheeffectsofexogenousopioidsforapproximately28daysafteradministration.Astheblockadewanesandeventuallydissipatescompletely,useofpreviouslytolerateddosesofopioidscouldresultinpotentiallylife-threateningopioidintoxication(respiratorycompromiseorarrest,circulatorycollapse,etc.).

§Casesofopioidoverdosewithfataloutcomeshavebeenreportedinpatientswhousedopioidsattheendofadosinginterval,aftermissingascheduleddose,orafterdiscontinuingtreatment.Patientsandcaregiversshouldbetoldofthisincreasedsensitivitytoopioidsandtheriskofoverdose.

§AlthoughVIVITROLisapotentantagonistwithaprolongedpharmacologicaleffect,theblockadeproducedbyVIVITROLissurmountable.Theplasmaconcentrationofexogenousopioidsattainedimmediatelyfollowingtheiracuteadministrationmaybesufficienttoovercomethecompetitivereceptorblockade.Thisposesapotentialrisktoindividualswhoattempt,ontheirown,toovercometheblockadebyadministeringlargeamountsofexogenousopioids.

§AnyattemptbyapatienttoovercometheVIVITROLblockadebytakingopioidsmayleadtofataloverdose.Patientsshouldbetoldoftheseriousconsequencesoftryingtoovercometheopioidblockade.

Injection Site Reactions:

§VIVITROLinjectionsmaybefollowedbypain,tenderness,induration,swelling,erythema,bruising,orpruritus;however,insomecasesinjectionsitereactionsmaybeverysevere.

§ Injectionsitereactionsnotimprovingmayrequirepromptmedicalattention,including,insomecases,surgicalintervention.

§ Inadvertentsubcutaneous/adiposelayerinjectionofVIVITROLmayincreasethelikelihoodofsevereinjectionsitereactions.

§Selectproperneedlesizeforpatientbodyhabitus,anduseonlytheneedlesprovidedinthecarton.

§Patientsshouldbeinformedthatanyconcerninginjectionsitereactionsshouldbebroughttotheattentionoftheirhealthcareprovider.

Precipitation of Opioid Withdrawal:

§Whenwithdrawalisprecipitatedabruptlybyadministrationofanopioidantagonisttoanopioid-dependentpatient,theresultingwithdrawalsyndromecanbesevere.Somecasesofwithdrawalsymptomshavebeensevereenoughtorequirehospitalization,andinsomecases,managementintheICU.

§Topreventoccurrenceofprecipitatedwithdrawal,opioid-dependentpatients,includingthosebeingtreatedforalcoholdependence,shouldbeopioid-free(includingtramadol)beforestartingVIVITROLtreatment:

–Anopioid-freeintervalofaminimumof7–10daysisrecommendedforpatientspreviouslydependentonshort-actingopioids.

–Patientstransitioningfrombuprenorphineormethadonemaybevulnerabletoprecipitatedwithdrawalforaslongastwoweeks.

§ Ifamorerapidtransitionfromagonisttoantagonisttherapyisdeemednecessaryandappropriatebythehealthcareprovider,monitorthepatientcloselyinanappropriatemedicalsettingwhereprecipitatedwithdrawalcanbemanaged.

§Patientsshouldbemadeawareoftheriskassociatedwithprecipitatedwithdrawalandbeencouragedtogiveanaccurateaccountoflastopioiduse.

Hepatotoxicity:

§CasesofhepatitisandclinicallysignificantliverdysfunctionhavebeenobservedinassociationwithVIVITROL.Warnpatientsoftheriskofhepaticinjury;advisethemtoseekhelpifexperiencingsymptomsofacutehepatitis.DiscontinueuseofVIVITROLinpatientswhoexhibitacutehepatitissymptoms.

Depression and Suicidality:

§Alcohol-andopioid-dependentpatientstakingVIVITROLshouldbemonitoredfordepressionorsuicidalthoughts.Alertfamiliesandcaregiverstomonitorandreporttheemergenceofsymptomsofdepressionorsuicidality.

When Reversal of VIVITROL Blockade Is Required for Pain Management:

§ForVIVITROLpatientsinemergencysituations,suggestionsforpainmanagementincluderegionalanalgesiaoruseofnon-opioidanalgesics.IfopioidtherapyisrequiredtoreversetheVIVITROLblockade,patientsshouldbecloselymonitoredbytrainedpersonnelinasettingstaffedandequippedforCPR.

Eosinophilic Pneumonia:

§Casesofeosinophilicpneumoniarequiringhospitalizationhavebeenreported.Warnpatientsoftheriskofeosinophilicpneumoniaandtoseekmedicalattentioniftheydevelopsymptomsofpneumonia.

Hypersensitivity Reactions:

§Patientsshouldbewarnedoftheriskofhypersensitivityreactions,includinganaphylaxis.

Intramuscular Injections:

§AswithanyIMinjection,VIVITROLshouldbeadministeredwithcautiontopatientswiththrombocytopeniaoranycoagulationdisorder.

Alcohol Withdrawal:

§UseofVIVITROLdoesnoteliminatenordiminishalcoholwithdrawalsymptoms.

ADVERSE REACTIONS

§SeriousadversereactionsthatmaybeassociatedwithVIVITROLtherapyinclinicaluseincludesevereinjectionsitereactions,eosinophilicpneumonia,seriousallergicreactions,unintendedprecipitationofopioidwithdrawal,accidentalopioidoverdose,anddepressionandsuicidality.

§TheadverseeventsseenmostfrequentlyinassociationwithVIVITROLtherapyforalcoholdependence(ie,thoseoccurringin≥5%andatleasttwiceasfrequentlywithVIVITROLthanplacebo)includenausea,vomiting,injectionsitereactions(includinginduration,pruritus,nodules,andswelling),musclecramps,dizzinessorsyncope,somnolenceorsedation,anorexia,decreasedappetiteorotherappetitedisorders.

§TheadverseeventsseenmostfrequentlyinassociationwithVIVITROLinopioid-dependentpatients(ie,thoseoccurringin≥2%andatleasttwiceasfrequentlywithVIVITROLthanplacebo)werehepaticenzymeabnormalities,injectionsitepain,nasopharyngitis,insomnia,andtoothache.

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.




http://www.fda.gov/medwatch


ALKERMES and VIVITROL are registered trademarks of Alkermes, Inc. Vivitrol2gether is a service mark of Alkermes, Inc. ©2017 Alkermes, Inc. All rights reserved. VIV-003344

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