Patient Enrollment Form

Transcription

1 Patiet Erollmet Form 1 HEALTHCARE PROFESSIONAL (HCP) HCP Name Facility Name Address 2489 W. BUSINESS 77 City SAN BENITO State TXZip Tel ( 956 ) Fax ( 956 ) HCP KATHLEEN SALVATORE KATHLEEN SALVATORE MD PLLC lisarodriguez.salvatore.md@gmai NPI# Facility Cotact(s)* LISA RODRIGUEZ * By icludig a facility cotact ame other tha the HCP, the HCP is authorizig the facility cotact to accurately relay HCP directios to JANSSEN CONNECT. The HCP will provide appropriate oversight to esure orders are accurately relayed ad that the HCP is iformed about all program iformatio relevat to the cliical care of the patiet. Facility Cotact Tel ( 956 ) Facility Type: Ipatiet/Hospital Outpatiet Cliic Private Practice Correctioal Telepsychiatry Other 2 SCRIPT TO BE SENT ELECTRONICALLY SIGN HERE PRESCRIPTION Patiet Name VICTORIA BENAVIDEZ DOB 01 / 19 / 1994 Sex: Male Female PO BOX 958 Patiet Address Pref. Laguage: Eglish Spaish City Elsa State TXZip Other Tel ( 956 ) Diagosis/ICD Code F31.9 Is patiet ew to this medicatio? Yes No Check here if a copy of the prescriptio is attached ad sig below INVEGA SUSTENNA (paliperidoe palmitate) 39 mg, 78 mg, 117 mg, 156 mg, 234 mg Day 1 Dose mg IM Date Needed Day 8 Dose mg IM Date Needed Directios OR INVEGA TRINZA (paliperidoe palmitate) 273 mg, 410 mg, 546 mg, 819 mg Directios OR RISPERDAL CONSTA (risperidoe) 12.5 mg, 25 mg, 37.5 mg, 50 mg Dose 12.5 mg IM every 2 weeks Qty 1 Date Needed 03/27/2017 #Refills 2 Directios IM every 2 weeks I certify that the above medicatio is medically ecessary ad that the iformatio provided is accurate to the best of my kowledge. By my sigature, I also ackowledge that I have obtaied the patiet s authorizatio to release the above iformatio ad such other iformatio as may be required by JANSSEN CONNECT to provide the offerigs selected. I appoit JANSSEN CONNECT, o my behalf, to covey this prescriptio to the dispesig pharmacy of the patiet s choice. I further certify that (a) ay offerig provided through JANSSEN CONNECT o behalf of ay patiet is ot made i exchage for ay express or implied agreemet or uderstadig that I would recommed, prescribe, or use JANSSEN CONNECT or ay other product or service for ayoe, ad that (b) my decisio to prescribe the products set forth o this page ad request JANSSEN CONNECT offerigs for my patiet was based solely o my determiatio of medical ecessity as set forth herei, ad that (c) I will ot seek reimbursemet for ay offerig provided by or through JANSSEN CONNECT from ay govermet program or third-party isurer. X / / Please list ay kow drug allergies CEFZIL (HIVES) Maiteace Dose mg IM every 4 weeks Date Needed #Refills Dose mg IM every 3 moths Date Needed #Refills X 03 / 27 / 2017 X / / Dispese as Writte Date Substitutio Accepted Date Supervisig Physicia Sigature Date Supervisig Physicia Name (if applicable) (prit ame) This prescriptio is oly valid if received by fax, meetig state regulatios. Commets: PAGE 1 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

2 3 4 5 Patiet Erollmet Form ALTERNATE PATIENT CONTACT (optioal) This cotact iformatio will be used to coordiate care services if the patiet caot be reached or is uable to maage his/her care. See full Patiet Authorizatio for JANSSEN CONNECT o page 3 of this erollmet packet for a full descriptio of what may be discussed with the alterate cotact listed below. Name Relatioship to Patiet Tel ( ) INSURANCE Primary Isurace Name UNITED HEALTHCARE Tel ( 855) VICTORIA BENAVIDEZ Cardholder Name Policy# Group# Check here if you re attachig a copy of the isurace card(s) If patiet has a separate prescriptio coverage pla, please list below. Prescriptio Pla Name Optum Rx Tel ( 800 ) U Policy Group# Bi# PCN# Istat Savigs Card: Please provide a Istat Savigs Card for my patiet. To the best of my kowledge, patiet has commercial isurace that covers medicatio costs ad is ot erolled i federal or state subsidized healthcare programs that cover prescriptio drugs, icludig Medicare, Medicaid, TRICARE, or ay other federal or state healthcare pla, icludig pharmaceutical assistace programs. We uderstad ad agree that a beefit verificatio will be performed ad a Istat Savigs Card will ot be provided if eligibility caot be verified Patiet requests that associated Istat Savigs Card iformatio be provided to pharmacy alog with their isurace iformatio if appropriate PROGRAM OFFERINGS Check the box ext to the offerigs you would like for your patiet. BENEFIT VERIFICATION Research my patiet s Jasse log-actig ijectable atypical atipsychotics coverage status Prior Authorizatio Form Assistace: By checkig this, I request that JANSSEN CONNECT assist my office i addressig the requiremets of this patiet s health pla related to prior authorizatio for treatmet with INVEGA TRINZA, INVEGA SUSTENNA, ad/or RISPERDAL CONSTA. I uderstad that assistace may iclude obtaiig the health-pla-specific prior authorizatio form, ad completig it based upo the patiet-specific iformatio provided o this form. I uderstad that the partially completed prior authorizatio form will be provided to my office by JANSSEN CONNECT for possible submissio to the health pla Prior Authorizatio Status Moitorig: By checkig this box, I request that JANSSEN CONNECT actively moitor the status of the prior authorizatio submissio. I request that JANSSEN CONNECT provide status updates to my office with respect to this CARE TRANSITION SUPPORT Provide iformatio ad assistace to help my patiet trasitio to the ext healthcare settig Facility Name Check this box if JANSSEN CONNECT should schedule patiet s iitial appoitmet, which icludes a remider alert MEDICATION SHIPMENT* Provide assistace i coordiatig my patiet s medicatio shipmet to my office Ship to HCP s secodary locatio at City State Zip INJECTION LOCATION OPTIONS WITH REMINDER ALERTS* (if available i your geography) REMINDER ALERTS ONLY Please provide remider alerts for my patiets who will be receivig ijectios i my office Facility Cotact(s) Address Tel ( ) City State Zip *By selectig Medicatio Shipmet, I uderstad that Prior Authorizatio Status Moitorig will also be provided, if applicable Fax me a list of available locatios Select a locatio closest to my patiet Cotact my patiet to select a locatio Use the followig approved JANSSEN CONNECT locatio By amig the above locatio, I attest that I do ot have a fiacial relatioship with the ijectio ceter listed *By selectig Ijectio Ceter Optios, I uderstad that Prior Authorizatio Status Moitorig will also be provided, if applicable PAGE 2 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday My patiet s ext ijectio at my office is scheduled for: Date / / at : AM PM Jasse Pharmaceuticals, Ic Jue PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994

3 Patiet Erollmet Form HIPAA Authorizatio for JANSSEN CONNECT I hereby authorize the use ad/or disclosure of my private health iformatio, described below, which icludes Protected Health Iformatio as defied i federal laws called the Privacy Regulatios developed uder the Health Isurace Portability ad Accoutability Act of 1996 (as ameded, HIPAA ). I geeral terms, I uderstad that Protected Health Iformatio is health iformatio that idetifies me or that could be used to idetify me. I uderstad that this authorizatio is volutary. The followig perso(s) or class of persos are authorized to disclose this iformatio: 1. Physicias or other healthcare providers that have provided treatmet or services to me. I uderstad that pharmacies that ship my medicatio may be paid to share this iformatio with JANSSEN CONNECT to help provide the offerigs requested for me. 2. The compay admiisterig JANSSEN CONNECT, which at the time of this authorizatio is Uited BioSource Corporatio (referred to herei as JANSSEN CONNECT ). 3. My health pla or other third-party payer. 4. Physicias ad other healthcare providers as directed by the healthcare professioal erollig me i JANSSEN CONNECT. The followig perso(s) or class of persos are authorized to receive the iformatio: 1. JANSSEN CONNECT. 2. My health pla or other third-party payer. 3. Third parties that assist JANSSEN CONNECT with the provisio of patiet offerigs for JANSSEN CONNECT. PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 Descriptio of the iformatio that may be used ad/or disclosed: My diagosis, prescribed therapy (eg, INVEGA SUSTENNA [paliperidoe palmitate], INVEGA TRINZA [paliperidoe palmitate], or RISPERDAL CONSTA [risperidoe]), ad a descriptio of the patiet offerigs I have requested or received from JANSSEN CONNECT. I uderstad that the iformatio disclosed about me may iclude metal health iformatio ad/or records. The iformatio will be used ad/or disclosed for the followig purpose(s): 1. For the provisio of the JANSSEN CONNECT patiet offerigs requested, such as ivestigatig my prescribed therapy coverage status, assistig with uderstadig prior authorizatio or appeal requiremets, providig iformatio ad assistace to help my trasitio to my ext healthcare settig, assistig i coordiatig my medicatio shipmet, helpig me PAGE 3 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

4 Patiet Erollmet Form HIPAA Authorizatio for JANSSEN CONNECT (cotiued) determie additioal ijectio ceter optios, ad providig welcome ad remider alerts. 2. I respose to a court order, subpoea, or otherwise required by law. Redisclosure: I uderstad that the Protected Health Iformatio disclosed pursuat to this authorizatio may be redisclosed by JANSSEN CONNECT, for the purposes outlied above to my health pla(s) or other third-party payer(s), my healthcare providers, JANSSEN CONNECT cotractors, ad ay idividual I desigate as a alterate cotact, ad I specifically authorize such redisclosures. Rights ad Other Terms: 1. Iability to Coditio Treatmet, Paymet, Erollmet, or Eligibility for Beefits o Provisio of Authorizatio. I uderstad that my healthcare providers ad health pla(s) may ot coditio my treatmet, paymet, eligibility for beefits, or erollmet i the health pla upo my sigig this authorizatio. 2. Copy of Authorizatio. I uderstad that I am etitled to a siged copy of this authorizatio. 3. Expiratio of Authorizatio. I uderstad that this authorizatio shall expire either whe I stop receivig JANSSEN CONNECT patiet offerigs, or 10 years from the date of this authorizatio, whichever occurs first. 4. Right to Revoke Authorizatio. I uderstad that I may revoke (ie, take back) this authorizatio at ay time except to the extet the recipiets of my iformatio have already take actio i reliace o my authorizatio. To revoke, I uderstad that I must otify JANSSEN CONNECT i writig at the followig toll-free fax umber: HIPAA. I uderstad that the persos who receive my health iformatio pursuat to this authorizatio may ot be required by federal law (such as HIPAA) to protect it, ad may share my iformatio with others if permitted by applicable law. 6. Review Iformatio Disclosed. I uderstad that I have the right to review the iformatio that has bee disclosed pursuat to this authorizatio upo writte request to JANSSEN CONNECT at the followig toll-free fax umber: By sigig this form, I represet that I have read this authorizatio form ad that I uderstad ad agree with what it says. Victoria Beavidez SIGN HERE Patiet Name Legal Authorized Represetative Name X 03 / 27 / 2017 X / / Patiet Sigature Date Legal Authorized Represetative Sigature Date PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 PAGE 4 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

5 Patiet Erollmet Form HIPAA Authorizatio for Marketig Activities I have erolled i the JANSSEN CONNECT program ad have authorized certai health iformatio about me to be disclosed to the compay that admiisters JANSSEN CONNECT, which at the time of this authorizatio is Uited BioSource Corporatio (referred to herei as JANSSEN CONNECT ). This health iformatio ( Persoal Iformatio ) icludes iformatio about: My diagosis. The therapy prescribed to me (eg, INVEGA SUSTENNA [paliperidoe palmitate], INVEGA TRINZA [paliperidoe palmitate], or RISPERDAL CONSTA [risperidoe]). The patiet offerigs I have received from JANSSEN CONNECT. This Persoal Iformatio may reveal metal-health-related iformatio about me. I ow hereby authorize JANSSEN CONNECT to use my Persoal Iformatio to: Sed me educatioal ad marketig materials regardig the JANSSEN CONNECT program, my prescribed therapy, ad other related products or offerigs i which I might be iterested. Cotact me to obtai feedback about Jasse Pharmaceuticals, Ic., Uited BioSource Corporatio or aother admiistrator of the program, the JANSSEN CONNECT program, ad my prescribed therapy. Maage ad improve the JANSSEN CONNECT program. Respod to a court order, subpoea, or as otherwise required by law. This iformatio ad cotact may occur by phoe, text, , or postal mail uless I request otherwise from JANSSEN CONNECT. I uderstad that JANSSEN CONNECT will oly share my Persoal Iformatio with third parties that provide support for JANSSEN CONNECT pursuat to cotracts where those third parties agree to use the iformatio oly as described i this authorizatio, or as required by law or legal process. PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 I uderstad that, with respect to this authorizatio: I sig this authorizatio volutarily. I uderstad that I may refuse to sig this authorizatio. I uderstad that JANSSEN CONNECT will receive paymet from Jasse Pharmaceuticals, Ic., for providig me with the iformatio ad materials described i this authorizatio. I am etitled to a siged copy of this authorizatio for my records. I may revoke this authorizatio i writig at ay time, except to the extet that actio has already bee take i reliace upo this authorizatio, ad PAGE 5 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

6 Patiet Erollmet Form HIPAA Authorizatio for Marketig Activities (cotiued) if ot earlier revoked, this authorizatio will termiate o the sooer of (i) whe I stop receivig JANSSEN CONNECT patiet offerigs, or (ii) 10 years from the date of this authorizatio. To revoke, I uderstad that I must otify JANSSEN CONNECT i writig at the followig toll-free fax umber: I uderstad that ay revocatio will ot apply to iformatio that has already bee used ad released i respose to this authorizatio. The persos who receive my health iformatio pursuat to this authorizatio may ot be required by federal law (such as HIPAA) to protect it, ad may share my iformatio with others if permitted by applicable law. I uderstad that I have the right to review ay iformatio that has bee disclosed pursuat to this authorizatio upo writte request to JANSSEN CONNECT at the followig toll-free fax umber: By sigig this form, I represet that I have read this authorizatio form ad that I uderstad ad agree with what it says. PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 Victoria Beavidez Patiet Name Legal Authorized Represetative Name SIGN HERE X 03 / 27 / 2017 X / / Patiet Sigature Date Legal Authorized Represetative Sigature Date Patiet PAGE 6 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

7 Patiet Erollmet Form HIPAA Authorizatio for Sharig JANSSEN CONNECT Patiet Data With Payer I have erolled i the JANSSEN CONNECT program ad have authorized certai health iformatio about me to be disclosed to the compay that admiisters JANSSEN CONNECT, which at the time of this authorizatio is Uited BioSource Corporatio (referred to herei as JANSSEN CONNECT ). This health iformatio ( Persoal Iformatio ) icludes iformatio about: My diagosis. The therapy prescribed to me (eg, INVEGA SUSTENNA [paliperidoe palmitate], INVEGA TRINZA [paliperidoe palmitate], or RISPERDAL CONSTA [risperidoe]). The patiet offerigs I have received from JANSSEN CONNECT. This Persoal Iformatio may reveal metal-health-related iformatio about me. I ow hereby authorize JANSSEN CONNECT to disclose this Persoal Iformatio to my health pla ad its affiliates for purposes of: My case maagemet ad care coordiatio. The health pla s ow data aalysis, icludig to help my health pla to uderstad how I ad others have used the JANSSEN CONNECT program, ad how the JANSSEN CONNECT program has impacted my healthcare ad the care of others participatig i the JANSSEN CONNECT program ad the cost of such healthcare. I uderstad that my health pla may create reports that do ot idetify me to share with JANSSEN CONNECT. I uderstad that JANSSEN CONNECT will ot share my Persoal Iformatio with ay other party for these purposes, except cotractors who provide support for JANSSEN CONNECT pursuat to cotracts where those cotractors agree to use the iformatio oly as described i this authorizatio, or as otherwise required by law. PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 I uderstad that, with respect to this authorizatio: I sig this authorizatio volutarily. I uderstad that I may refuse to sig this authorizatio. I am etitled to a siged copy of this authorizatio for my records. I may revoke this authorizatio i writig at ay time, except to the extet that actio has already bee take i reliace upo this authorizatio, ad if ot earlier revoked, this authorizatio will termiate o the sooer of (i) whe I stop receivig JANSSEN CONNECT patiet offerigs, or (ii) 10 years from the date of this authorizatio. To revoke, I uderstad that I must otify JANSSEN CONNECT i writig at the followig toll-free fax umber: I uderstad that ay revocatio will ot apply to iformatio that has already bee used ad released i respose to this authorizatio. PAGE 7 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

8 Patiet Erollmet Form HIPAA Authorizatio for Sharig JANSSEN CONNECT Patiet Data With Payer (cotiued) The persos who receive my health iformatio pursuat to this authorizatio may ot be required by federal law (such as HIPAA) to protect it, ad may share my iformatio with others if permitted by applicable law. I uderstad that I have the right to review ay iformatio that has bee disclosed pursuat to this authorizatio upo writte request to JANSSEN CONNECT at the followig toll-free fax umber: By sigig this form, I represet that I have read this authorizatio form ad that I uderstad ad agree with what it says. PATIENT VICTORIA BENAVIDEZ 01 DOB / 19 / 1994 Victoria Beavidez Patiet Name Legal Authorized Represetative Name SIGN HERE X 03 / 27 / 2017 X / / Patiet Sigature Date Legal Authorized Represetative Sigature Date PAGE 8 of 8 Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

9 Disclaimer: Iformatio ad assistace (eg, iformatio regardig access ad reimbursemet, the ipatiet/ outpatiet appoitmet gap, medicatio shipmet, additioal ijectio ceter optios, ad followthrough of healthcare professioal-directed treatmet pla) are provided by Uited BioSource Corporatio ( UBC ), uder cotract for Jasse Pharmaceuticals, Ic. ( JPI ). A Patiet Erollmet Form, with sectios completed for requested iformatio regardig assistace, must be submitted to UBC by the healthcare professioal ( HCP ) i order to activate ay JANSSEN CONNECT assistace. No other forms for request for access to JANSSEN CONNECT will be accepted. Assistace caot be directly requested by the patiet. JANSSEN CONNECT is ot available to patiets participatig i a Patiet Assistace Program. The availability of iformatio ad assistace may vary based o geography. UBC provides iformatio to HCPs regardig whether the treatmet is covered by the applicable thirdparty payer, based o the payer s coverage guidelies ad the patiet iformatio provided by the HCP. This iformatio ad assistace are made available as a coveiece to patiets, ad there is o requiremet that patiets or HCPs use ay JPI or other Johso & Johso product i exchage for this iformatio or assistace. Third-party reimbursemet is affected by may factors. This documet ad the iformatio ad assistace provided by JANSSEN CONNECT are preseted for iformatioal purposes oly. They do ot costitute reimbursemet or legal advice. JANSSEN CONNECT does ot promise or guaratee coverage, levels of reimbursemet, or paymet. Similarly, all CPT* ad HCPCS* codes are supplied for iformatioal purposes oly ad represet o statemet, promise, or guaratee expressed or implied by JPI or UBC that these codes will be appropriate or that reimbursemet will be made. The fact that a drug, device, procedure, or service is assiged a HCPCS code ad a paymet rate does ot imply coverage by the Medicare program, but idicates oly how the product, procedure, or service may be paid if covered by the Medicare program. Laws, regulatios, ad policies cocerig reimbursemet are complex ad are updated frequetly. Accordigly, the iformatio may ot be curret or comprehesive. JPI ad UBC strogly recommed you cosult your payer for its most curret coverage, reimbursemet, ad codig policies. UBC ad JPI make o represetatios or warraties, expressed or implied, as to the accuracy of the iformatio provided. I o evet shall UBC or JPI, or their employees or agets, be liable for ay damages resultig from or relatig to ay iformatio provided by or access to or through JANSSEN CONNECT. All HCPs ad other users of this iformatio agree that they accept resposibility for the use of this program. JPI assumes o resposibility for ad does ot guaratee the quality, scope, or availability of the iformatio ad assistace provided (eg, iformatio regardig access ad reimbursemet, the ipatiet/outpatiet appoitmet gap, medicatio shipmet, additioal ijectio ceter optios, ad follow-through of HCP-directed treatmet pla). UBC, ot JPI, is resposible for the iformatio ad assistace it provides uder this program. Each HCP ad patiet is resposible for verifyig or cofirmig ay iformatio provided by UBC or JPI. All claims ad other submissios to payers should be i compliace with all applicable requiremets. Aalytics (eg, data poits or statistics about the program), if provided, are as of the date oted ad may ot be represetative of future aalytics or your patiets or practice. Please cosider appropriate use of JANSSEN CONNECT iformatio ad assistace i light of your practice ad idividual patiets cliical eeds ad applicable payer requiremets. *CPT = Curret Procedural Termiology, copyright of the America Medical Associatio, HCPCS = Healthcare Commo Procedure Codig System. Questios? Call us: AM to 7 PM CT, Moday to Friday. Jasse Pharmaceuticals, Ic Jue

10 Patiet Erollmet Form FAX DATE 03/27/2017 PAGES SUBJECT JANSSEN CONNECT PATIENT ENROLLMENT FAX# PHONE# FROM KATHLEEN SALVATORE FAX# Please fid the followig attached: Page 1... Healthcare Professioal (HCP) Iformatio ad Prescriptio (REQUIRED) Page 2... Patiet Isurace Iformatio ad Program Offerigs (REQUIRED) Pages HIPAA Authorizatio for JANSSEN CONNECT (REQUIRED) Pages HIPAA Authorizatio for Marketig Activities Pages HIPAA Authorizatio for Sharig JANSSEN CONNECT Patiet Data With Payer Jasse Pharmaceuticals, Ic Jue

11 INDICATION INVEGA TRINZA (paliperidoe palmitate) a 3-moth ijectio, is a atypical atipsychotic idicated for the treatmet of schizophreia i patiets after they have bee adequately treated with INVEGA SUSTENNA (1-moth paliperidoe palmitate) for at least four moths. INVEGA SUSTENNA (paliperidoe palmitate) a 1-moth ijectio, is a atypical atipsychotic idicated for the treatmet of schizophreia. IMPORTANT SAFETY INFORMATION WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. See full Prescribig Iformatio for complete Boxed Warig Elderly patiets with demetia-related psychosis treated with atipsychotic drugs are at a icreased risk of death INVEGA TRINZA ad INVEGA SUSTENNA are ot approved for the treatmet of patiets with demetia-related psychosis Cotraidicatios: Paliperidoe is cotraidicated i patiets with a kow hypersesitivity to either paliperidoe, risperidoe, or to ay excipiets of the formulatio. Cerebrovascular Adverse Reactios: Cerebrovascular adverse reactios (e.g., stroke, trasiet ischemic attacks), icludig fatalities, were reported i placebo-cotrolled trials i elderly patiets with demetia-related psychosis takig oral risperidoe, aripiprazole, ad olazapie. The icidece of cerebrovascular adverse reactios was sigificatly higher tha with placebo. INVEGA TRINZA ad INVEGA SUSTENNA are ot approved for the treatmet of patiets with demetia-related psychosis. Neuroleptic Maligat Sydrome (NMS): NMS, a potetially fatal symptom complex, has bee reported with the use of atipsychotic medicatios, icludig paliperidoe. Cliical maifestatios iclude muscle rigidity, fever, altered metal status, ad evidece of autoomic istability (see full Prescribig Iformatio). Maagemet should iclude immediate discotiuatio of atipsychotic drugs ad other drugs ot essetial to cocurret therapy, itesive symptomatic treatmet ad close medical moitorig, ad treatmet of ay cocomitat serious medical problems. QT Prologatio: Paliperidoe causes a modest icrease i the corrected QT (QTc) iterval. Avoid the use of drugs that also icrease QTc iterval ad i patiets with risk factors for prologed QTc iterval. Paliperidoe should also be avoided i patiets with cogeital log QT sydrome ad i patiets with a history of cardiac arrhythmias. Certai circumstaces may icrease the risk of the occurrece of torsades de poites ad/or sudde death i associatio with the use of drugs that prolog the QTc iterval. Tardive Dyskiesia (TD): TD is a sydrome of potetially irreversible, ivolutary, dyskietic movemets that may develop i patiets treated with atipsychotic medicatios. The risk of developig TD ad the

12 likelihood that dyskietic movemets will become irreversible are believed to icrease with duratio of treatmet ad total cumulative dose, but ca develop after relatively brief treatmet at low doses. Elderly female patiets appeared to be at icreased risk for TD, although it is impossible to predict which patiets will develop the sydrome. Prescribig should be cosistet with the eed to miimize the risk of TD (see full Prescribig Iformatio). Discotiue drug if cliically appropriate. The sydrome may remit, partially or completely, if atipsychotic treatmet is withdraw. Metabolic Chages: Atypical atipsychotic drugs have bee associated with metabolic chages that may icrease cardiovascular/cerebrovascular risk. These metabolic chages iclude hyperglycemia, dyslipidemia, ad body weight gai. While all of the drugs i the class have bee show to produce some metabolic chages, each drug has its ow specific risk profile. Hyperglycemia ad Diabetes Mellitus: Hyperglycemia ad diabetes mellitus, i some cases extreme ad associated with ketoacidosis, hyperosmolar coma or death, have bee reported i patiets treated with all atypical atipsychotics (APS). Patiets startig treatmet with APS who have or are at risk for diabetes mellitus should udergo fastig blood glucose testig at the begiig of ad durig treatmet. Patiets who develop symptoms of hyperglycemia durig treatmet should also udergo fastig blood glucose testig. All patiets treated with atypical atipsychotics should be moitored for symptoms of hyperglycemia. Some patiets require cotiuatio of atidiabetic treatmet despite discotiuatio of the suspect drug. Dyslipidemia: Udesirable alteratios have bee observed i patiets treated with atypical atipsychotics. Weight Gai: Weight gai has bee observed with atypical atipsychotic use. Cliical moitorig of weight is recommeded. Orthostatic Hypotesio ad Sycope: INVEGA TRINZA ad INVEGA SUSTENNA may iduce orthostatic hypotesio i some patiets due to their alpha-blockig activity. INVEGA TRINZA ad INVEGA SUSTENNA should be used with cautio i patiets with kow cardiovascular disease, cerebrovascular disease or coditios that would predispose patiets to hypotesio (e.g., dehydratio, hypovolemia, treatmet with atihypertesive medicatios). Moitorig should be cosidered i patiets for whom this may be of cocer. Leukopeia, Neutropeia ad Agraulocytosis have bee reported with atipsychotics, icludig paliperidoe. Patiets with a history of cliically sigificat low white blood cell cout (WBC) or drug-iduced leukopeia/eutropeia should have frequet complete blood cell couts durig the first few moths of therapy. At the first sig of a cliically sigificat declie i WBC, ad i the absece of other causative factors, discotiuatio of INVEGA TRINZA ad INVEGA SUSTENNA should be cosidered. Patiets with cliically sigificat eutropeia should be carefully moitored for fever or other symptoms or sigs of ifectio ad treated promptly if such symptoms or sigs occur. Patiets with severe eutropeia (absolute eutrophil cout <1000/mm 3 ) should discotiue INVEGA TRINZA ad INVEGA SUSTENNA ad have their WBC followed util recovery. Hyperprolactiemia: As with other drugs that atagoize dopamie D 2 receptors, INVEGA TRINZA ad INVEGA SUSTENNA elevate prolacti levels, ad the elevatio persists durig chroic admiistratio. Paliperidoe has a prolacti-elevatig effect similar to risperidoe, which is associated with higher levels of prolacti elevatio tha other atipsychotic agets.

13 Potetial for Cogitive ad Motor Impairmet: Somolece, sedatio, ad dizziess were reported as adverse reactios i subjects treated with INVEGA TRINZA ad INVEGA SUSTENNA. INVEGA TRINZA ad INVEGA SUSTENNA have the potetial to impair judgmet, thikig, or motor skills. Patiets should be cautioed about performig activities that require metal alertess such as operatig hazardous machiery, icludig motor vehicles, util they are reasoably certai that INVEGA TRINZA ad INVEGA SUSTENNA do ot adversely affect them. Seizures: INVEGA TRINZA ad INVEGA SUSTENNA should be used cautiously i patiets with a history of seizures or with coditios that potetially lower seizure threshold. Coditios that lower seizure threshold may be more prevalet i patiets 65 years or older. Admiistratio: For itramuscular ijectio oly by a healthcare professioal. Care should be take to avoid iadvertet ijectio ito a blood vessel. Drug Iteractios for INVEGA TRINZA : Strog CYP3A4/P-glycoprotei (P-gp) iducers: Avoid usig a strog iducer of CYP3A4 ad/or P-gp (e.g., carbamazepie, rifampi, St Joh s Wort) durig a dosig iterval for INVEGA TRINZA. If admiisterig a strog iducer is ecessary, cosider maagig the patiet usig paliperidoe exteded release tablets. Drug Iteractios for INVEGA SUSTENNA : Strog CYP3A4/P-glycoprotei (P-gp) iducers: It may be ecessary to icrease the dose of INVEGA SUSTENNA whe a strog iducer of both CYP3A4 ad P- gp (e.g., carbamazepie, rifampi, St Joh s wort) is co-admiistered. Coversely, o discotiuatio of the strog iducer, it may be ecessary to decrease the dose of INVEGA SUSTENNA. Pregacy/Nursig: Patiets should be advised to otify their physicia if they become pregat/ited to become pregat or ited to urse durig treatmet with INVEGA TRINZA ad INVEGA SUSTENNA. Commoly Observed Adverse Reactios for INVEGA TRINZA : The most commo adverse reactios (icidece 5% ad occurrig at least twice as ofte as placebo) were ijectio site reactio, weight icreased, headache, upper respiratory tract ifectio, akathisia ad parkisoism. Commoly Observed Adverse Reactios for INVEGA SUSTENNA : The most commo adverse reactios i cliical trials i patiets with schizophreia ( 5% ad twice placebo) were ijectio site reactios, somolece/ sedatio, dizziess, akathisia ad extrapyramidal disorder Please see full Prescribig Iformatio, icludig Boxed WARNING, for INVEGA SUSTENNA. Please see full Prescribig Iformatio, icludig Boxed WARNING, for INVEGA TRINZA.

14 RISPERDAL CONSTA (risperidoe) log-actig ijectio is idicated as mootherapy or as adjuctive therapy to lithium or valproate for the maiteace treatmet of Bipolar I Disorder ad for the treatmet of schizophreia. IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA (risperidoe) WARNING: Icreased Mortality i Elderly Patiets with Demetia-Related Psychosis Elderly patiets with demetia-related psychosis treated with atipsychotic drugs are at a icreased risk of death. Aalyses of 17 placebo-cotrolled trials (modal duratio of 10 weeks), largely i patiets takig atypical atipsychotic drugs, revealed a risk of death i the drug-treated patiets of betwee 1.6 to 1.7 times the risk of death i placebotreated patiets. Over the course of a typical 10-week cotrolled trial, the rate of death i drug-treated patiets was about 4.5%, compared to a rate of about 2.6% i the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudde death) or ifectious (e.g., peumoia) i ature. Observatioal studies suggest that, similar to atypical atipsychotic drugs, treatmet with covetioal atipsychotic drugs may icrease mortality. The extet to which the fidigs of icreased mortality i observatioal studies may be attributed to the atipsychotic drug as opposed to some characteristic(s) of the patiets is ot clear. RISPERDAL CONSTA is ot approved for the treatmet of patiets with demetiarelated psychosis. Cotraidicatios: RISPERDAL CONSTA is cotraidicated i patiets with a kow hypersesitivity to risperidoe, paliperidoe, or to ay excipiets i RISPERDAL CONSTA. Cerebrovascular Adverse Evets (CAEs): CAEs (e.g., stroke, trasiet ischemia attacks), icludig fatalities, were reported i placebo-cotrolled trials i elderly patiets with demetiarelated psychosis takig oral risperidoe. The icidece of CAEs was sigificatly higher tha with placebo. RISPERDAL CONSTA is ot approved for the treatmet of patiets with demetia-related psychosis. Neuroleptic Maligat Sydrome (NMS): NMS, a potetially fatal symptom complex, has bee reported with the use of atipsychotic medicatios. Cliical maifestatios iclude muscle rigidity, fever, altered metal status, ad evidece of autoomic istability (see full Prescribig Iformatio). Maagemet should iclude immediate discotiuatio of atipsychotic drugs ad other drugs ot essetial to cocurret therapy, itesive symptomatic treatmet ad close medical moitorig, ad treatmet of ay cocomitat serious medical problems. Tardive Dyskiesia (TD): TD is a sydrome of potetially irreversible, ivolutary, dyskietic movemets that may develop i patiets treated with atipsychotic medicatios. The risk of developig TD ad the likelihood that dyskietic movemets will become irreversible are believed to icrease with duratio of treatmet ad total cumulative dose, but ca develop after relatively brief treatmet at low doses. Elderly wome patiets appeared to be at icreased risk for TD, although it is impossible to predict which patiets will develop the sydrome. Prescribig should be cosistet with the eed to miimize the risk of TD (see full Prescribig Iformatio). Discotiue drug if cliically appropriate. The sydrome may remit, partially or completely, if atipsychotic treatmet is withdraw.

15 Metabolic Chages: Atypical atipsychotic drugs have bee associated with metabolic chages that may icrease cardiovascular/cerebrovascular risk. These metabolic chages iclude hyperglycemia, dyslipidemia, ad body weight gai. While all of the drugs i the class have bee show to produce some metabolic chages, each drug has its ow specific risk profile. Hyperglycemia ad Diabetes Mellitus: Hyperglycemia ad diabetes mellitus, some cases extreme ad associated with ketoacidosis, hyperosmolar coma or death have bee reported i patiets treated with atypical atipsychotics (APS), icludig RISPERDAL CONSTA. Patiets startig treatmet with APS who have or are at risk for diabetes mellitus should udergo fastig blood glucose testig at the begiig of ad durig treatmet. Patiets who develop symptoms of hyperglycemia should also udergo fastig blood glucose testig. All patiets treated with atypical atipsychotics should be moitored for symptoms of hyperglycemia. Moitor glucose regularly i patiets with diabetes or at risk for diabetes. Some patiets require cotiuatio of atidiabetic treatmet despite discotiuatio of the suspect drug. Dyslipidemia: Udesirable alteratios have bee observed i patiets treated with atypical atipsychotics. Weight Gai: Weight gai has bee observed with atypical atipsychotic use. Cliical moitorig of weight is recommeded. Hyperprolactiemia: As with other drugs that atagoize dopamie D 2 receptors, risperidoe elevates prolacti levels ad the elevatio persists durig chroic admiistratio. Risperidoe is associated with higher levels of prolacti elevatio tha other atipsychotic agets. Orthostatic Hypotesio ad Sycope: RISPERDAL CONSTA may iduce orthostatic hypotesio associated with dizziess, tachycardia, ad i some patiets, sycope, especially durig the iitial dose-titratio period. RISPERDAL CONSTA should be used with cautio i patiets with kow cardiovascular disease (e.g., heart failure, history of MI or ischemia, coductio abormalities), cerebrovascular disease or coditios that would predispose patiets to hypotesio (e.g., dehydratio, hypovolemia) ad additioally elderly patiets with real or hepatic impairmet. Moitorig should be cosidered i patiets for whom this may be of cocer. Leukopeia, Neutropeia ad Agraulocytosis have bee reported with atipsychotics, icludig RISPERDAL CONSTA. Patiets with a history of cliically sigificat low white blood cell cout (WBC) or drug-iduced leukopeia/eutropeia should have frequet complete blood cell couts durig the first few moths of therapy. At the first sig of a cliically sigificat declie i WBC, ad i the absece of other causative factors, discotiuatio of RISPERDAL CONSTA should be cosidered. Patiets with cliically sigificat eutropeia should be carefully moitored for fever or other symptoms or sigs of ifectio ad treated promptly if such symptoms or sigs occur. Patiets with severe eutropeia (absolute eutrophil cout <1000/mm 3 ) should discotiue RISPERDAL CONSTA ad have their WBC followed util recovery. Potetial for Cogitive ad Motor Impairmet: Somolece was reported i multiple trials i subjects treated with RISPERDAL CONSTA. Sice RISPERDAL CONSTA has the potetial to impair judgmet, thikig, or motor skills, patiets should be cautioed about operatig

16 Powered by TCPDF ( hazardous machiery, icludig motor vehicles, util they are reasoably certai that RISPERDAL CONSTA does ot adversely affect them. Seizures: RISPERDAL CONSTA should be used cautiously i patiets with a history of seizures. Dysphagia: Esophageal dysmotility ad aspiratio have bee associated with atipsychotic drug use. Aspiratio peumoia is a commo cause of morbidity ad mortality i patiets with advaced Alzheimer s demetia. Use cautiously i patiets at risk for aspiratio peumoia. Priapism has bee reported. Severe priapism may require surgical itervetio. Thrombotic Thrombocytopeic Purpura (TTP) has bee reported. Admiistratio: For itramuscular ijectio oly. Care should be take to avoid iadvertet ijectio ito a blood vessel. Suicide: The possibility of suicide attempt is iheret i schizophreia or bipolar disorder. Close supervisio of high-risk patiets should accompay drug therapy. Icreased sesitivity i patiets with Parkiso s disease or those with demetia with Lewy bodies has bee reported. Maifestatios ad features are cosistet with NMS. Use RISPERDAL CONSTA with cautio i patiets with coditios ad medical coditios that could affect metabolism or hemodyamic resposes (e.g., recet myocardial ifarctio or ustable cardiac disease). Commoly Observed Adverse Reactios for RISPERDAL CONSTA : The most commo adverse reactios i cliical trials i patiets with schizophreia ( 5%) were headache, Parkisoism, dizziess, akathisia, fatigue, costipatio, dyspepsia, sedatio, weight icrease, pai i extremities, ad dry mouth. The most commo adverse reactios i cliical trials i patiets with bipolar disorder were weight icreased (5% i mootherapy trial) ad tremor ad Parkisoism ( 10% i adjuctive therapy trial). Please see full Prescribig Iformatio icludig Boxed WARNING for RISPERDAL CONSTA