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TRANSCRIPT
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E;IOnsolis'".::::.tenIi¥lyI il<JIXl11 solUble ntm(j
a~,For Information Cf1 thefOcuelld ~ram.call 1-877-4€6-7654(1-877-40NSGt.JS). iy'i
P1eaee Gee fun preSCrlbing InformattonlncludlngboY.ed warnIngs by clickIng the lInk below.
Important safety InfarmationThQ mOilot SElI'loul'> adverse maotJons associated with all oplolds are ra&pl ratory depression (potentially lsadlng to apnaa or rasplratcry arral>t~. clroulatory depression, hypotension, andshock. Follow all patlQnts fOr symptoms of respiratory depressIon. In ONSOUSTM trials, thlll most common adverse rlllactfonsware: nausea, vomiting, dlz.ztnlllss, Bnlllmla, dlllhydratlon, .pllIrlpheral edGOla, dyspnea, and somnolenca •
WARNINGS: IMPORTANCE OF PROPER PATIENT seLECTION and POTENTIAL FOR ABUSEONSOLIS contains fentlll1;, ¥lI'I opioid agl:lilllat and 8 Sdledule II controlled lloUbatanCe, with aWn liability s!milarto other aplollf analgerafca. Thill lIhould be ~sidtr1lClwhen prellCliblng ar d'JapenalngONSOLIS in aitueilonl wMl9lhe PlplCian or phermaciat ia concernad about an rnclNaed"-1t Of 1IIliaus4t. abulia or divllraion. Scbedl.da II oploJd aubata_. whicb include IIIlOtpbfnll, oxycodooa,hydrOlllOfJlftOlie, Oll}IJlolIl'JIhOlie, IIRd methadone, have the highest potenlialforshun 8l1d rillk of fatal overdose due to l'8lf1inl.tory depnluion.
SIlriQU& adveraa even18, including deB!he, in patiant3 treatad with olher eral tranBmUiC>Qael fenta!1¥l procfucta have been repol1l!d Desthe accurredsa fi reeult of improper pslient lI8ec1ion {e.g., U1I6 inoploild nOMotllrant patiamsj andJor impraPll!l' doalng. The aubllliWtion of ONSOUS for any otb8f fefl!l:aflyt product may l'Nufi in fatal CMIftfoae.
ONSCUS ill indicated aNy for the mansgllment of breeldhraug/l pein in patients with cancer, 18 v-'B ofag,e and older, who are alrNdyrecaivfng and wIlo- are tolerant to opfold tnerapy tOl'1ihel:'undarMng Pllnl_lIIt. 1:BI1Cet pain. PBtientll-CClflfIlderlld oplQld mlarant Bl9 those who Sf& taklng atlee.et: 60 InlI eral fOOrphlneJday. 25 meg lranadal'lnit fentany\Jl»ur. 30mg ofri oxyo;;uwne/dsv.Bmg oral hydramorphcnelday. 26 mg cral oxymorphcmaldsy. or ErIequJsnalga8~do&iJ, of another opfcfd for Me llWlolIkorl~
ONSOLIS il ecntisindiCllled for ulle III oplold lIOII.toIill'8!rt pslientalnc1uding th01ie UIIing opic.lc!a intenninBRl:Iy, an an sa needed buifl.
ONSOLIS il contnlindiclited in !he mal18gllll\1lNlt ofa~teor postop«ative pain, inducilng bsedadtallllignW'la, cIMItaI paln, or illI8 ill1JlellI~C](mom. LIfe.threelening I8llpiratDJy depf8UIOfi couldoc:eur at any dose in opWlid non-tolerant pstlenla. Deathe hIVe occUll'lld in opic.ld nOll.tetar8l1tpatienta1r86tlld wittl ather fentanyl producta.
When~ de nat COIl....1t patWtntI OIIe IIICtJ pet' IIICtJ baaia from lII'lY ather MIl Craoemucaasl fentanyl productm ONSOUS. Piitilinta bilgfnning trMtmllnt with ONSOUS muel begin with titratIanfrom the 200 meg d08a [_DoQll'8 lind AdminilltnJliOll (2lJ.
Wh8Qdisp8f11fng.. de not euba'iitute 111 ONSQU5 pretlC'l'fptioofor 1Hl]( alb"r ffilltsn~prcr.£ucL Substantial dilferall.Cillluistin thll piJiiII'IIUI.COkinetic pratile of ONSOlIS compared tJ) otbarfentsn~pmductathat I'NUIl in clinically imllOrtanotditfllnsneel b1 thll.8'lttent of abaorPlion of ferltBl1Vi. All areaultof theBe Gift_nee,. the 8IIbs1itutiDn of QffSOLlSm,anv oth«tllllblnyl product mer l'8l1u1in Wal O'll8rdoae.
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~::::::::: Onsolis'ErI fentanyl buCUll soluble film!!!:
Prescriber Name (print):Prescriber Knowledge Assessment
5. During titration or maintenance treatment, the interval between successive doses of ONSOLlSTM should beat least:
0 A. 15 minutes
0 B. 1 hour
0 C. 2 hours
0 D. 6 hours
6. Which of the following may help assess the risk of addiction?
o A. history of personal or familial problems with alcohol or drugs
o B. history of prescription drug misuse
o C. screening instruments such as the Screener and Opioid Assessment forPatients with Pain (SOAPP)
o D. all of the above
7. TRUE OR FALSE: ONSOLlSTM must be kept out of the reach of children because it contains a medicine inan amount which can be fatal to children.
o A. True
DB. False
8. TRUE OR FALSE: Use of ONSOLlSTM with CYP3A4 inhibitors (such as erythromycin, ketoconazole, andcertain protease inhibitors) may require dosage adjustment; otherwise such use may cause potentially fatalrespiratory depression.
o A. True
DB. False
For more information about ONSOLISTM, please see Full Prescribing Information, including BOXED WARNINGS.
rlEDaPHARMACEUTlCALS3
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Informatron 'for pharmacJst6 1
f li1fQrmatronfor patle.nt5
Forlnfunnatlon Cfl thefOCU5'1M Pro.aram; call1-B77-486-7654(1--B77-40N6OCI6).
Please see full preGcrlbrng fnformatton Including boxed warnIngs by cllcklng the lInk below.
Whan dtsPlIna!ng, do not aublllitutll ..... OMSOU& presctlpUoo for lIIIyolh.rfllntBll~praducL Sublltantill ditrervllClllI elli&t IIIlhll pharmaeokllllllic pmfiIlI of ONSOUS CGIIlpllIIKt to othll,fllnhn)ll prot1uctathat rewlt in c:1in~1yifllportantQilerenc•• in the elltant ofabaorptiorl 01 fentenyl; Aa 8 realMt 01 theae dilerBncell.ttMl aubBtitutiDll of OHSOUS fOr any oU- fen'Isi¥ prcduet RIllY ,...ult infatsl oVlIrdoie,
Special C8I9 mLSt be used Ylhen doelng.ONSOUs.. If the braaldhraugh pelT! epIaoda Ie not relieved. p~\eo18 should walt at le8&t2 hwra befcr& ialdl'lg ano1her da8il~DooageWJdItdminlsftst/al(2)].
ONSOUS B htilnded 1rI bll U8Mf only In 1I1e of care of oploki tolerant patler1ia with cancer lind ontv IJlf heslthcsre profeaalona.ls Who 818 knawJedgsBble of.lind8kJ1IeQ h. ihe U80Il of6cheduIB \I oplolda to treatCBr1Ctlrpain.' ....
Patient8 end their C:aregMln mullt be Instructed that ONSOUS cantlllnaa mecflcllle in llIIl amount whicl1 can be fatJIl in c:hIklI'8ll, fn individual. feN' wl]o.. it is nal prelilCribed, and in Uloae wbo...nDtopioid taJllnint.Ali OHSOUS filma mlllltbe kept out of the _h oIchiJclren [wePiltienr COlJnaelng lnfonnatlolJ (i7l).
Thecoocomltant uae of ONSOU8 with CYP3M rnbltora mayred In an lnc:reaae In fenla1}lt p!BIlmaconcentrmlona end mayca.se pollilntIell;' ialall&6plratory depreeslonl_lJ'ug./ntslactlon& (7)].
BecaJBe of1ha risk fur mlalJael, ahuae, and averd08ti.ONSOUS B 8llBilahlecnl;' through arB!lUlclied dl&trlbutlen program. caI~ 1hefQCU8Progran. Under 1I1e FOCl..IS Progrsm, only preoscrlberal ph8lll18ClliB, andpatlenIB registered with thil program aI9 able to prl!leenbe. dl&pen!le, andr'lceJw, ONSOUe. To 8ITOillh'the FOCUS Program, c8l1 1-877-4Ql-7664 (H177-40NSOUS' arvlelt~fiIeolleFocus.mlm[eee~
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In order to enroll yourself and your patlent andInitiate ONSOUSTM prescribing, you must completethe 3-Step FOCUSTM Program Process.
Pleaoo Gee fullpreGCrlblng rnfot'mation IncludIng boxed IM:lrnlng.G by cHckln,g the link below.
:rn;:,;,t"l'it Saf~t·; :,'f), "',3,,0", ," PRESCRIBING INFORt·IATION :> ~'''''''''~i P;ky' ,'-,lED':, Ph", n-.2>'~2"li':31= ,- 1"I£i)t:I!1'101.1\.1\""1/0£1 oJlloC .\1.-\
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Information for prescribers
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Patll~f11 PrQ~,j:3.r1l
Overview
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Prescriber Education; Assessment, and Enrollment
Before you can ervoU In the FOCUSTM Program for ONSOUSTM, you must complete the prescribereducation and Knowledge Assessment. Satisfactory completlorlofthe knowledge assessment Is reqJred.RevieW the ilformatJon In eschof thEHollowlng sections to complete your education and "1Orollment.,
it Prpp-.rPatlent· S~lectlqn: Indleattor1s and ~n<tleatJOn$eDoslng.'&Admlhlstratlon: Malnten~e,tltratloni:dosage~Justments.Q~era[QPIQlduse:.~o()dm9cJl¢aJprt:ic.tlC~i:l1$k.!Us~enf'.~IsksotO,NSOUSt:M: ov~~and8<:ldICtIOn'e Prograrn:OVervlew
Proper Patient Selection
ONSOUSTM (fentanyl buccal soluble film) Is an oploldanalgeslc Indicated only for themanag&mentof brea.kthrou!1h Rain In .eatlentswl!tl cancel'j18 ¥ear8 of age and older. who arealread¥ receivingand who are tolerant to ogloldthera.P.¥ tor thelrunderl¥lng persistent cancer gain. P~tlentsconslderedoplold tolerant are those who are taking at least: 60 rng oral morphlne/dElY. 25 meg transdermal1entanyVhour. 30 mgoral oxycodone/day, 8 mg oral hydromorphonelday,25 mg oral oxymorphonelday,or an equlan'aJgeslc dose of another c;>ploldfor one weekorlonQer. '
•Preaoo see full proscrll.7Jng Informatlonlncludlng boxed warnIngs by cllcklngthe/(nk below.
:m;:~lta..,~ ~;:;f",t" :n':'lfn:;i,on ;, PRESCRIBING INFORl'lATION :- i';I ....ac/ P:Ic'i :',li:C::,; Ph3. n-,3'~",Cjtl~31: ' M£i)~l'UAI'''-4 .'"< I U tiC l\~"
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Information forpre6cribers
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Proper Patient Selectlont cont'dONSOUSTM Is contraIndicated for use In opJoId non-tolerant patients Including those using oploldsIntel'Tlllttently, on an as needed basis.
ONSOLlSTM Is contraindicated In the management 01 acute or postoperative pain, InclUdingheadac,helmlgralne, dental pail, or USG In the emergency room. Ufe-threatenlng respiratory depressioncould occur at any dose In oplold non-tolerant patients. Deaths have occurred il oplold non-tolet'antpatients treated With other fentanyl products.
Patients and thercar~lvers must belnstructedthatONSOUSTM contansa medicine In an amount whichcan be fatallnchlldren,ln ildtvlduals for whom It Isnotptescrlbed, and In those whoarenotopJoldtolerant.All ONSOUSTM films ITIJst be kept out of the reach ofchildroo. All unneeded ONSOUSTM ftlmsshould bedisposed ofby removing from the foil package and flushing down atollet.
ONSOUSTM Is Intended to be used onlyIn the care ofoplolQ tolerant patIents WIth cancer and only byhealthcare professionals who are knowledgGableof, and skilled In the use of" SchedUle IIoplolds to treat cancer paln.
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Please: Gee full prescrIbing Information IncludIng boxed warnIngs by cHcklng the [fnk below. .':rn;;:ltdr" ::::3td', i,'i.),p',.:;",:.:, 0 PRESCRIBING INFORl'lATION:> ~;T"'a':' Pc'h:,,. '·1,,[::; Pha,m.:;':e~LI:31.: • M£Dt:Il
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Information for prescribers
Dosing & AdministrationApproprlatB product closing and adminIstration
As with all oplolds, the safety of patients using SUch products Is dependent on healthcareprofesslonalsprescrtbhg them In strict conf.ormlty with their approved labeling with respect to patient selection,dosing, and proper conditions for use.
Only prescribers enrolled In the FOCUS.program may prescribe ONSOUSTM.
Dose titration
The goal of dose titration Is to find the .Indlvldual patl~'s effective and tolerable dose. The dose ofONSOUSTM Is not predicted from the dally maintenance dose of oplold used to manage the persistentcancer paln and MUST be determined by dosetltratlon.
starting Dose: Individually titrate ONSOUSTM to a dose that proVIdes·adequate analgesia with tolerablesldeetfects. Allpatients MUST begn treatment using one 200mcg ONS()USTM film.
Due to differences In pharmacoklnetlC properties and Indlvlcilal vart~lIIty,patientsswJtchlng frOm anotheroral transmueosal fentanylproduet must be started on no great&rUlan 200 meg ofONSOUSTM. Whenpreserlblng~ do notswlteh patients on a meg per meg basis· from any other oral transmueosal fentanyl
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PleaS66e6 full prescrIbing rnformat(on Including boxed ~rnrnge by cllckln,gthe.lrnk below.
'IllD:rtan'. Saf",t" 'let:" rYl3t,on " PRE~Cf{IB!NG INFORMATION:> ::': i'I"":·' Pcic" :' ;'.H:[I,':" Ph""r;',o.,:.:!wtl·:31~' MEDOf'1"Alt.M~t.1 UlIC,I\I.~
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Information for prescribers
Dosing & Administration, cont'd
product to ONSOLlSTM as ONSOUSTM Is natequivalent on a meg per meg basiS with any other1entanylproduct. ONSOLlSTM Is NOT a generic version of any other oral transmuc.osal fentanyl product.
From the. initial dose,closeIy follow patients and change the dosage Ievelllltll the patient reaches adose that provl~ adeqJateanalgesJa.
If adequate pain relief Is not achieved after one 200 meg ONSOUS™fUm, titrate using I1'lJltlpies of the200mcg ONSOLlSTM fUm (for doses of 400,600, or 800 meg). Increase the dose level by 200 meg IneaehSlJbseql!ent episode until the patient reaches a dos.ethat provides adequate analgesia With tolerable sideeffects. Do not use more than four of the 200 meg ONSOUSTM films simultaneously. When multiple 200 megONSOUSTM films are used, they should not be placed on top of each other and may be. placed on bothsides of the mouth.
If adequate pain relief is not achIeved after 800 meg ONSOUSTM ~e,four 200 meg ONSOUSTM films), andthe patlept has tolerated the 800 meg dose, treat the next: episode by usIng one 1200 meg ONSOUSTM film.Doses·atlove 1200 meg ONSOUSTM shOUld not be.U$ed.
Once adequate pain relief Jsachleved with a dose belween200 and 800 meg ONSOUSTM, the patientshould u~ or safelydtspose of all remaining 200 meg ONSOLlSTM films. PatIents who requlrs.1200 meg
.~. ~.i.·.. ·... .F'tea68 Gee fullpre6crlblng InformatIon IncludIng boxed warnrngsby cltcklne the lrnkbelow.
:mpclt"nt S,,!>"t', :d.j,P"3i.,N\ PRESCRIBING INFORNATION:> f:-,ivo';V P;·k" '·,1;:[1,'; Pho,n'.o'_2cJt,c31", M£D~"HILI\M,1,i.' LJ J Ie '\l'..
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InformatIon for preecrivere
DosIng &AdmInistration. cont'dONSOUSTM, shoUld dispose 01 all remainIng unused 200 meg ONSOUSTM films. The patlent shoUld thenget a prescription for ONSOUSTMfjlms 011hedose determIned bylltratlOn ~e, 200, 400, 600,800, or1200 meg) to treat subSequent episodes.
Single doses Should be separated by at least2 hours. ONSOUS'"" should only be used oneeperbreakthrough caneer paIn epIsode, le,ONSOUS"" shOUld not be redosed WIthIn an epIsode.
Dul1ngany episode of breakthrough eancer paIn, Ifadequate pain relief Is notachIeved atter ONSOUSTM,the patient may use a rescue medication (after 30 mInutes) as directed by their healthcare provlder.
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Pleaee Gee fuHpreGcrtblng fnformation IncludIng boxed warnIngs by cHcklng theHnk below.
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IrnPGltant 3af.~t" '"f'J'[;'13;:,O;I.' PRESCRIBING INFORt-lATION:> P:i'loc', P;CL'C'i ';- ;·,1ED,.o. Ph,an-,3c::Jti.:31,,·' MEDt:Ill.. ItAflM.... CI UlIoC ..\L"iI