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`1 of 3
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`IMMUNOGEN 2233, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`Indicaticin
`
`i'leZtCVLa! [adc trastugun‘ab en‘tansine}. as a single agent. is indicated fer the treatn‘ent cfpatients with HERE ppsitive [HEFt2+';.
`n*etastatic breast cancer [ME-C} whp previpuslv received trastuaun*ab and a tasane. separatelv er in cpn*binatipn. Patients shculd have
`either. received pricr therapv fer n‘etastatic disease. pr develpped disease recurrence during prwithin sir. n‘pnths pfccn‘pleting
`adjuvanttherapv.
`
`safety for right side of banner
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`Irnpcirtant Safety Infbrm aticin
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`Etcxed WflRNINGS: HEPATUTDIIEICITW', CA RDIAC TflxlClT‘r', EMER‘r’D-FETflL TflxlElT‘r'
`
`- [in Net Substitute MDEYLA fer c-r with Trastuzurnab
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`- Hepatc-tcnticitv: Serieus hepatetexicitv has been reperted, including liver failure and death in patients treated with MDEYLA.
`fulcin'rtcir serurn transarninases and bilirubin pricr tci initiaticn cif HADEYLA treatment and pricir tci each HADCYLA dcse. Reduce
`dcse c-r discpntinue fUtDC‘r'LA as apprcpriate in cases cif increased serum transarninases c-r tetal bilirubin
`
`- E ardia c Tcut ic itv: full. DE tr'Ltil. administratien rnav le a d tci re ductiens in left ventric ula r eje cticin fra cticin iL'v'EF}. Evaluate left
`ventricular functic-n in all patients pricr-r tci and during treatment with HADEYLA. Withheld treatment fer clinicallv significant
`decrease in left ventricular functicin
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`- Ernbrv ci-Fetal Texic itv: Ex pesure tc- f'UtDC‘r'LA can result in ernbrvci-fetal death c-r birth defects. Itdvise patients cif these risks
`and the need fer effective centraceptici-n
`
`The fellewing addftienal seribus adverse reactions have been reperted in clinicaltrials with HADCYLA:
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`- Interstitial Lung Disease [ILD]. including pneun‘cnitis. scn‘e leading tc acute respiratcrv distress svndrcn*e pr fatalitv. HADCULH
`shculd be pern‘anentlv discpntinued in patients diagncsed with ILD pr pneun‘cnitis
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`- Infusicn related reacticns IIFtFt}. vaersensitivitv. HADCULatreatnent shculd be interrupted in patientswith severe IRFI and
`pern‘anentlv discpntinued in the event pfa life threatening IRE
`
`- Thrcn‘bccvtcpenia. I'vlcnitcr platelet ccunts pricr tc initiaticn cfi'EADEULH and pricr tc each dcse. Institute dcse n‘cdificaticns as
`apprcpriate
`
`- Peripheral neurppathv. i-‘LHDEULashpuld be ten~pprarilv discpntinued in patients experiencing Grade 3 er a peripheral neurppathv
`until resplutipn tp s Grade 2
`
`- Reacticns seccndarv tc eatravasaticn. The infusicn site shculd be clcselv n‘cnitcred fcr pcssible subcutanecus infiltraticn during drug
`adn‘inistratipn
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`It. ddfticinal Impprtant Safety- Inferrn a ticin:
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`- Detecticn cfHEHE prctein cverertpressicn pr gene an‘plificaticn is necessarv fcr selecticn cfpatients apprcpriate fcr MDCULH
`therapv
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`- Nursing n‘pthers. Etiscpntinue nursing pr discpntinue HADCULataIting intp cpnsideratipn the in‘pprtance pfthe drug tp the nether
`
`- The nest cpnncn adverse drug reacticns ifreguencv a 25%} acrcss clinical trials with HADEULHwere fatigue. nausea.
`n‘usculcslteletal pain. thrcn‘bccvtcpenia. headache. increased transan‘inases. and ccnstipaticn
`
`Ucu are encpuraged tp repprt side effects tp Genentech and the FDA. Ucu n‘av cpntact Genentech bv calling 1-833-835-2555. Ucu n‘av
`cpntact the FDabv visiting mrwjdagcivimedwatcb pr calling *I-EtZItZI-Fljfl-WBE.
`
`IMMUNOGEN 2233, pg. 2
`Phigenix v. Immunogen
`|PR2014—00676
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`2 of3
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`2 of 3
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`IMMUNOGEN 2233, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`audif easrh Flashoblckedo For patients with HER2+ MBC
`ibascklupst
`xx Overall and progression-free
`w survival data are available
`
`r":
`
`LEARN MORE HERE
`
`Phigenixv. mmmmmmmmm
`lPR2014-00676
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`3 of 3
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`IMMUNOGEN 2233, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
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