`
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`H RESP-“9' for updates
`* View full Prescribing Information
`
`
`pp
`
`About KADCYLA
`
`Clinical
`Information
`
`Dosing and
`Administration
`
`Resources
`
`Patient Su
`
`ort
`
`Safety First!
`Before you start exploring. please read
`side effect information. In 1v’le'lrv now
`
`The first antibody-drug conjugate for the
`
`treatment of HERE-positive [HER2+]
`
`metastatic breast cancer [MBC]
`
`”Few 'r’r'JtJ'JE:+-=_I --'I-:!S.*l5.a.i553_'.|r.' u: sud-.4-
`
`Contact a Representative
`
`Tools 81 Resources
`
`Clinical Data Availabie
`
`Learn more about KADCYLA.
`Click belpwfor an appointment
`with a clinical oncology
`
`specialist.
`-- Contact as
`
`Access toots and information.
`
`Featured:
`
`'
`or
`Dosingflt
`U Administration Guide 1-
`
`Review significant survival results and the adverse reaction profile demonstrated
`in the Phase III EMILIA trial.
`
`u Learn more
`
`I?!
`
`Indication
`
`KADCYLA' "I tado—trastuzumab emtansine}, as a single agent, is indicated for the treatment of patients with HER2—positive
`tHER2+]I, metastatic breast cancer tMBC} who previously received trastuzumab and a taxane, separately or in combination.
`Patients should have either:
`
`’ Received prior therapy for metastatic disease, or
`
`1* Developed disease recurrence during or within six months of completing adjuvant therapy
`
`{,9
`
`Important Safety lnforrnation
`
`Boxed WARNINGS: HEPATDTCII'XICIT’t"r CARDIAC TOXICITY. EMBRYO-FETAL TOXICITY
`
`. Do not substitute KAD-DYLA for or with trastuzumab
`
`a Hepatotorticity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with
`KADCYLA. Monitor senlm transaminases and bilinrbin prior to initiation of KADCYLA treatment and prior to each
`KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased senlm transaminases or total
`bilimbin
`
`a Cardiac toxicity: KADEYLA administration may lead to reductions in left ventricular ejection fraction [LVEFL Evaluate left
`ventricular function in all patients prior to and during treatment with KAD-CYLA. Withheld treatment for clinically
`significant decrease in left ventricular function
`
`* Embryo-fetal toxicity: Exposure to KADCYLA can result in embryo-fetal death or birth defects. Advise patients of these
`risks and the need for effective contraception
`
`Additional Important Safety Information
`
`Left Ventricular Dysfunction [LVDJ
`
`" Patients treated with KADCYLA are at increased risk of developing L‘v'D. In EMILIA, L‘v'D occurred in 1.8% of patients in the
`KADCYLA-treated group and in 3.3% in the comparator group. Permanently discontinue KADCYLA if L‘v'EF has not
`improved or has declined further
`
`Pregnancy Registry
`
`‘ Advise patients to contact their healthcare provider immediately if they suspect they may be pregnant. Encourage
`women who may be exposed to KADCYLA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting
`1—800—890—BT2D
`
`Pulmonary Toxicity
`
`*' Cases of interstitial lung disease tILD}, including pneumonitis, some leading to acute respiratory distress syndrome or
`fatal outcome, have been reported in clinical trials with KADCYLA. In EMILIA, the overall frequency of pneumonitis was
`1.2%
`
`‘ Treatment with KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis
`
`Infusion-Related Reactions, Hypersensitivity Reactions
`
`‘ Treatment with KADCYLA has not been studied in patients who had trastuzumab permanently discontinued due to
`infusion—related reactions IlIFlR} andfor hypersensitivity reactions; treatment with KADCYLA is not recommended for these
`patients. In EMILIA, the overall frequency of IRRs in patients treated with KADCYLA was 1.4%
`
`
`
`’ In EMILIA, the incidence of a Grade 3 thrombocytopenia was 14.5% in the KADCYLA-treated group and 0.4% in the
`comparator group {overall incidence 31.2% and 3.3%, respectively}
`
`* Monitor platelet counts prior to initiation of KADCYLA and prior to each KADCYLA dose. Institute dose modifications as
`appropriate
`
`Neurotoxicity
`
`" In EMILIA, the incidence of a Grade 3 peripheral neuropathy was 2.2% in the KADCYLA—treated group and 0.2% in the
`comparator group toverall incidence 21.2% and 13.5%, respectively}
`
`‘- Monitor for signs or symptoms of neurotoxicity. KADC'YLA should be temporarily discontinued in patients experiencing
`Grade 3 or4 peripheral neuropathy until resolution to 5 Grade 2
`
`HER2 Testing
`
`‘ Detection of HEH2 protein overexpression or gene amplification is necessary for selection of patients appropriate for
`KADCYLA. Perform using FDA-approved tests by laboratories with demonstrated proficiency
`
`Extravasation
`
`‘ In KADCYLA clinical studies, reactions secondary to extravasation have been observed and were generally mild. The
`infusion site should be closely monitored for possible subcutaneous infiltration during drug administration. Specific
`treatment for KADCYLA extravasation is unknown
`
`Nursing Mothers
`
`* Discontinue nursing or discontinue KADCYLA, taking into consideration the imponance of the drug to the mother
`
`Adverse Reactions
`
`* The most common tfreouency :25%} adverse drug reactions tADFt} across clinical trials with KADCYLA were nausea,
`fatigue, musculoskeletal pain, hemorrhage, thrombocytopenia, increased transaminases, headache, constipation, and
`epistaxis. In EMILIA, the most common NCI-CTCAE tversion 3} a Grade 3 ADRs {frequency s2%} were thrombocytopenia,
`increased transaminases, anemia, hypokalemia, peripheral neuropathy, and fatigue
`
`You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1—888—835—2555.
`You may contact the FDA by visiting www.fda.govfmedwatch or calling 1—SDD—FDA—1088.
`
`Please see accompanying full Prescribing Information for additional important safety information, including Boxed WARNINGS.
`
`O
`
`KADCYLA Access Solutions
`
`2,, .1 Kadcgla’"
`atlc-t'asEIJan'atu ants-airs
`
`Access Solutions
`
`KADCYLA Access Solutions helps to resolve access and reimbursement issues for individual patients every day. Our dedicated
`specialists help bring patient treatment and practice solutions together.
`
`Our staff can:
`
`* Help confirm benefits and coverage and resolve any related issues
`
`‘ Refer underinsured patients for co-pay assistance
`
`' Provide free medicine to qualified uninsured patients who meet specific financial and medical criteria through the
`Genentech' Access to Care Foundation iGATCF}
`
`’ Individualize services to meet your patients' specific needs
`
`A permanent J-code is available for KADCYLA reimbursement. Click here for more information.
`
`To speak live with one of our specialists, call 1 (888} 249-4818. You can also visit Genentech-AccesscomeADCYLA for more
`information.
`
`Additional resources
`
`' Get KADCYLA Access Solutions information
`
`" See the latest list of distributors
`
`* Download the KADCYLA Material Safety Data Sheet
`
`The KADCYLA and Access Solutions logos are registered trademarks of Genentech, Inc.
`
`
`
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`IMMUNOGEN 2228, pg. 1
`Phigenix v. Immunogen
`|PR2014-00676
`
`' KADCYLA treatment should be interrupted in patients with severe IRRs and permanently discontinued in the event of a
`life—threatening IRH. Patients should be closely monitored for IRRs, especially during the first infusion
`
`Hemon'l'rage
`
`’ Hemorrhagic events, sometimes fatal, have been reported in clinical trials. In EMILIA, the incidence of :_- Grade 3
`hemorrhage was 1.8% in the KADCYLA-treated group and 0.8% in the comparator group toverall incidence 32.2% and
`18.4%, respectively}
`
`* In some of the observed cases the patients were also receiving anticoagulation therapy or antiplatelet therapy, or had
`thrombocytopenia; in others, there were no known additional risk factors. Use caution with these agents and consider
`additional monitoring when concomitant use is medically necessary
`
`Thrombocytcpenia
`
`IMMUNOGEN 2228, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`
`
`
`
`Indication
`KADI Register for email updates
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`I M
`
`
`Register
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`ntansinej, as a single agent, is indicated for the treatment of patients with HERZ—posifive
`1 ContactARepresentative b
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`KADCYLA‘ "l [ado-trastu your area
`agent, is indicated for the treatment of patients with HERZ—posifive
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`Financial assistance and
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`coverage support services to
`E Indicatlon
`help navigate the access and
`l(ifl.[2|E3‘i"t_fitc "l {ade—trastuzumab emtansine}, as a single age
`reimbursement precess
`.nt of patients with HEH2—positive
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`KADCYLAB '0 [adu—trastummab em‘tansinej, as a single agent, is indicated for the treatm products
`
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`Genentech Medicines
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`1 Contactfl Representative b
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`
`IMMUNOGEN 2228, pg. 2
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This ii'iioi'i'r'latiol‘i is for
`Healthoat‘e Professionals
`
`=
`
`_-
`
`-.
`
`H Go to Patients 31
`CHTEQWETS site
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`Contact a
`Representative
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`E Register for updates
`i View fuil fiescrihing Information
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`‘3 KEdCL-lla
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`Clinical
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`Dosing and
`
`About “DEVI—A
`
`Information
`
`Administration
`
`Patient Support
`
`Safetillr First!
`Eiefore vou start eiu: pioring. please read
`side effect information- an View new
`
`|PR2014-00676
`
`-
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`The first antibody-d rug conjugate for the
`treatment of HERZ-positive [HER2+]
`metastatic breast cancer [MBC]
`
`Iii'ie'iir Proposed Mechanism offiction
`
`Contact a Representative
`
`Tools 31 Resources
`
`Clinical Data Available
`
`Learn more EllIHJLIl KADCVLA.
`
`Access tools and infomi fitign 1
`
`Review significant survival results and the adverse reaction profile
`
`Ciicl: below for an
`appointment lwith a clinical
`oncology specialist.
`
`a Go ntact us
`
`' Featured:
`or
`[losing atU Administration Guide I
`
`demonstrated in the Phase Ill Ei'u'llLlA trial.
`
`1:- Learn more
`
`2E5!
`
`E Indication
`fiat-"t[3i|:12:"r"L:|'-"tE "i iado—trastuzumab emtansine}, as a single agentr is indicated for the treatment of patients with HERE-positive
`
`IMMUNOGEN 2228, pg. 3
`Phigenix v. Immunogen
`
`IMMUNOGEN 2228, pg. 3
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This ii'iioi'i'r'latiol‘i is for
`Heaithoat‘e Professionals
`
`=
`
`-.
`
`-.
`
`H Go to Patients 31
`CHTEQWETS site
`
`Contact a
`Representative
`
`E Register for updates
`i View fuil fiescrihing Information
`
`‘3 KEdCL-lia
`
`Ei'J'..l| .taiLchllti] I‘lllluilallii'
`
`Clinical
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`Dosing and
`
`About “DEVI—A
`
`Information
`
`Administration
`
`Pattent Support
`
`.
`
`flu
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`Inhibits tubolin polymerization
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`to induce cell-circle arrest and
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`Safetillr First!
`Eiefore you start e3: pioring. please read
`side effect information- an View new
`
`|PR2014-00676
`
`m The first antibody-d rug conjugate for the
`
`of DM1, a cytotoxic
`
`maflansinoid, and the stable
`
`WW
`
`treatment of HERZ-positive [HER2+]
`
`metastatic breast cancer [MBC]
`
`Iii'ieilir Proposed Mechanism of fiction
`
`Tools 31 Resources
`
`Clinical Data Available
`
`Learn more about KADCVLA.
`
`Access tools and inform fitign 1
`
`Review significant su naval results and the adve rse reaction profile
`
`Clici: below for an
`appointment lwith a clinical
`oncology specialist.
`
`a Contact us
`
`' Featured:
`or
`[losing atU Administration Guide I
`
`demonstrated in the Phase Ill El'u'ilLlA trial.
`
`1:- Learn more
`
`2E5!
`
`E Indication
`fiat-"t[3i|:12:"r"L:|'-"tE "1 iado—trastuzumab emtansine}, as a single agentr is indicated for the treatment of patients with HERE-positive
`
`IMMUNOGEN 2228, pg. 4
`Phigenix v. Immunogen
`
`IMMUNOGEN 2228, pg. 4
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This ii'riol't'r'latifli‘l is for
`Heelthmre Professionals
`
`=
`
`_
`
`“ Go to Patients B:
`CHTEEiiVETS site
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`Contact a
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`
`E HEQiStET for “Fldfltfl5
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`Clinical
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`
`About “DEVI—A
`
`Information
`
`Administration
`
`Patient Support
`
`Safety:r Firsti
`Before vou start as: pioring. please read
`side effect information- an View new
`
`The first antibody-d rug conjugate for the
`
`em t of HERZ-positive [HER2+]
`
`simulation to release DM1
`
`after entering the target cell“1Jc breast cancer [MBC]
`
`*Emtansine is the
`
`combination of DM‘I, a
`
`cytotoxic mavtansinoid,
`and the stable mcc linker.
`
`view Proposed Mechanism of fiction
`
`|PR2014-00676
`
`E Indication
`l't'ol-‘l.[liliiii"r"LJ|'-"tE "1 isdo—trastusumab emtansine}, as a single agentr is indicated for the treatment of patients with HERE-positive
`
`Contact a Representative
`
`Tools 31 Resources
`
`lillinical Data Available
`
`Learn more about KADCVLA.
`
`Access tools and inform fitign 1
`
`Review significant survival results and the adverse reaction profile
`
`Ciici: below for an
`appointment lwith a clinical
`oncology specialist.
`
`a Go ntect us
`
`' Featured:
`v
`[losing atU Administration Guide I
`
`demonstrated in the Phase Ill El'u'llLlA trial.
`
`1:- Learn more
`
`2E5!
`
`IMMUNOGEN 2228, pg. 5
`Phigenix v. Immunogen
`
`IMMUNOGEN 2228, pg. 5
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Contact a Representative
`Learn more about KADCYLA.
`Click below for an
`appointment with a clinical
`_
`.
`oncology specmilst.
`a: Contact us
`
`Dosing and administration guidelines to help with accurate dosing
`
`Tools 81 Resources
`Access. tools and information )
`
`Featured:
`
`Clinical Data Available
`Review significant survival results and the adverse reaction profile
`demonstrated in the Phase III EMILIA trial.
`n Learn more
`
`
`
`IMMUNOGEN 2228, pg. 6
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 6
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`The first antibody-d rug conjugate for the
`
`treatment of HERE-positive [HER2+]
`
`metastatic breast cancer [MBC]
`
`View Proposed Mechanism ofhction
`
`Tools 31 Flesources
`
`Clinical Data Available
`
`Learn more about KADCYLA.
`
`Access tools and inform ation 1
`
`Fieview significant so rt-ri'tral results and the adverse reaction profile
`
`Click below for an
`
`appointment with a clinical
`
`.
`.
`ancologrg.r specialist.
`
`‘
`
`a Contact us
`
`i Featured:
`[losing atU Administration Guide I
`
`a-
`
`demonstrated in the Phase III EMILIA trial.
`
`1:- Learn more
`
`|PR2014-00676
`
`Indication
`HA[ZitIZ'tr'Li'ilE "l lade—trastuzumab emtansine}, as a single agent, is indicated for the treatment of patients: with HERE-positive
`{HEFi2+i, meta
`:eived trestuzun'tah end a taxane, separately or in combination. Patients
`
`iiADCYLAIado-trastuzumah emtensine}
`
`l5 . Hear it pronounced
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`
`* Do not substitute KADC‘II'LA for or with trastuzumah
`
`‘ Hepatotoxicityr: Serious hepatotoltic'rty has been reported, including liver failure and death in patients treated with
`
`IMMUNOGEN 2228, pg. 7
`Phigenix v. Immunogen
`
`IMMUNOGEN 2228, pg. 7
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`0 Important Safety Information
`
`_.-|.
`-'_'II
`
`-j__| Info rm ation
`
`Important Safety Information
`
`_
`
`'
`
`. please read
`
`View“,
`
`Boxed WARNINGS: HEPATOTOXICITY, CARDIAC
`
`TOXICITY, EMBHYO-FETAL TOXICITY
`
`' Do not substitute KADC‘H'LA for or with trastuzumab
`
`' Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in
`
`patients treated with KADCYLA. Monitor serum transaminases and biiirubin prior to initiation of
`
`KADC‘H'LA treatment and prior to each KADC‘I’LA dose. Heduce dose or discontinue KADC‘II'LA as
`
`appropriate in cases of increased semm transaminases or total bilirubin
`
`‘ Cardiac toxicity: ILADCVLA administration may lead to reductions in left ventricular eiection
`
`fraction iL‘u’EF]. Evaluate left ventricular function in all patients prior to and during treatment
`
`with ICADCTLA. Withhold treatment for clinically significant decrease in left ventricular function
`
`' Embryo-fetal toxicity: Exposure to KADC‘I’LA can result in embryo-fetal death or birth defects.
`
`Advise patients of these risks and the need for effective contraception
`
`Additional Important Safety Information
`
`
`
`IMMUNOGEN 2228, pg. 8
`Phigenix v. Immunogen
`|PR2014-00676
`
`Contact a Fle-
`
`+..---
`
`Learn more about KADCH’LA.
`
`Access tools. and information 1
`
`Fieviev.r significant survival results and the adverse reaction profile
`
`Click below for an
`appointment with a clinical
`oncology specialist.
`H Contact "5
`
`' Featured:
`a [losing 3;
`Admmistration Gurde :
`
`demonstrated in the Phase III EMILIA trisl.
`
`:1 Learn more
`
`Indication
`ILADCYLA3 "i tado—trastuzumab emtansine}, as a single agent, is indicated for the treatment of patients with HERE-positive
`
`-M
`
`IMMUNOGEN 2228, pg. 8
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`Left Uentriculat Dysfunction {LED}
`
`' Patients treated with KADEVLA are at increased risk of developing Lift]. in EMILIA, L‘v'D occurred
`
`in 1.8% of patients in the Jrill-"u.IIIIIE't’Liili-treated group and in 3.3% in the comparator group.
`
`Permanentiy discontinue mocvm if LVEF has net improved or has declined further
`
`Pregnancy Hegistry
`
`' Advise patients to contact their healthcare provider immediately if theyr suspect theyr may be
`
`pregnant. Encourage women who may be exposed to KADCYLA during pregnancy to enroll in
`
`the MotHEFi Pregnancy Registry by contacting i—EflD-EED-EHD
`
`Puimon ary Toxicity
`
`' Cases of interstitial lung disease llLD}, including pneumonitis, some leading to acute respiratory
`
`distress syndrome or fatal outcome, have been reported in clinical trials with KADC‘ELA. In
`
`EMILlA, the overall frequency of pneumonitis was 1.2%
`
`' Treatment with EADCVLA should be permanently discontinued in patients diagnosed with ILEII
`
`or pneumonitis
`
`lnfusion-Fielated Reactions, Hypersensitivity Reactions
`
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`
`Access tools. and information 1
`
`Fieview significant survival results and the adverse reaction profile
`
`Ciici: below for an
`
`appointment with a clinical
`
`oncology specialist.
`
`‘
`
`H Contact us
`
`' Featured:
`” Dosing Er.
`
`Administration Guide =
`
`demonstrated in the Phase III El'u'llLIfi. trial.
`
`11 Learn more
`
`E:
`
`M Indication
`HDCVLAE "1 iado—trastuzumab emtansine}, as a single agent, is indicated for the treatment of patients with HERE-positive
`
`IMMUNOGEN 2228, pg. 9
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 9
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`ViEW HOW
`
`' Treatment with RADCVLQ has not been studied in patients who had trastuzumah permanentlv
`discontinued due to infusion-related reactions {IFiF-ll andr'or hvpersehsitivitv reactions; treatment
`
`
`
`with KADCVLA is not recommended for these patients. In EMILII—‘i. the overall frequency-r of lHHs
`
`in patients treated with moons was 1.4%
`
`' KADC‘ELA treatment should loe interrupted in patients with severe lFlFis and permanentlv
`
`discontinued in the event ofa life-threatening lFiFi. Patients should he closelv monitored for
`
`lF-lFts. especiallv during the first infusion
`
`Hemorrhage
`
`' Hemorrhagic eventsr sometimes fatal, have loeen reported in ctinical trials. In EMILIA, the
`
`incidence of E lGrade 3 hemorrhage was 1.8% in the KADETLA-treated group and BIBS”:- in the
`
`comparator group [overall incidence 32.2% and Edith, respectiveiv]
`
`'
`
`in some of the observed cases the patients were also receiving anticoagulation therapv or
`
`antiplatelet therapv, or had thromloocvtopenia; in othersr there were no known additional risk
`
`factors. Use caution with these agents and consider additional monitoring when concomitant
`
`use is medicallyr necessary.r
`
`Th romh ocv'to penia
`
`'
`
`in EMILIA, the incidence of 2 Grade 3 thrombocvtopenia was 14.5% in the MDCYLA-treated
`
`Contact a Fle 5
`
`Learn more about MDCYLfl.
`
`Access tools and information 1
`
`Fieview significant survival results and the adverse reaction profile
`
`Click below for en
`appointment with a clinical
`oncologyr specialist.
`H Contact "5
`
`' Featured:
`a [losing 3;
`Administration Gurde :
`
`demonstrated in the Phase ill EMELFA trial.
`
`:1 Learn more
`
`Indication
`MDCYLfiF "i iado—trastuzumab emtansine}, as a single agentr is indicated for the treatment of patients with HERE-positive
`
`-M
`
`IMMUNOGEN 2228, pg. 10
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 10
`Phigenix v. Immunogen
`IPR2014-00676
`
`

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`‘ In EMlLIA_ the incidence of 2 IGrade 3 thrombocytopenia was “14.5% in the KADCYLA-treated
`
`group and 0.4% in the comparator group {overall incidence 31.2% and 3.3%, respectively]
`
`‘ Monitor platelet counts prior to initiation of KADCYLA and prior to each KADC‘r'LA dose.
`
`Institute dose modifications as appropriate
`
`Meurotoxic'rty
`
`‘ In EMILIA, the incidence of 2 Grade 3 peripheral neuropathi.r 1iiras 2.2% in the KASCTLA-treated
`
`group and lEl.2% in the comparator group {overall incidence 21.2% and 13.5%, respectively}
`
`* Monitor for signs or symptoms of neurotoxicitir. moons shouid be temporarily discontinued
`
`in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to a Grade 2
`
`HEFi2 Testing
`
`" Detection of HEFi2 protein overexpression or gene amplification is necessary for selection of
`
`patients appropriate for KADCYLA. Perform using FDA—approved tests by laboratories with
`
`demonstrated proficiency
`
`Extraua sation
`
`
`
`Learn more about MDCVLA.
`
`Access tools and information 1
`
`Review significant so nriiral results and the adve rse reaction profile
`
`Ciicir beiow for an
`
`appointment with a ciinicai
`
`oncology specialist.
`
`‘
`
`H Contact us
`
`' Featured:
`” Dosing Er.
`
`Administration Guide :
`
`demonstrated in the Phase III EMILIA triai.
`
`11 Learn more
`
`E:
`
`M Indication
`HDCVLAE "1 iado—trastuzumab emtansine}, as a single agentr is indicated for the treatment of patients with HEH2-positive
`
`IMMUNOGEN 2228, pg. 11
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 11
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Thi
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`
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`
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`
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`
`
`
`IMMUNOGEN 2228, pg. 12
`Phigenix v. Immunogen
`|PR2014-00676
`
`'
`
`in MDCTLA clinical studies, reactions secondary.r to extravasation have been observed and were
`
`generaitv mild. The infusion site should he closetv monitored for possible subcutaneous
`
`infiltration during drug administration. Specific treatment for KADCTLA estravasation is
`
`unknown
`
`Nursing Mothers
`
`' Discontinue nursing or discontinue KADCTLA, talring into consideration the importance of the
`
`drug to the mother
`
`Adverse Heactio ns
`
`‘ The most common {frequencyr sEE'E-El adverse drug reactions lADFl] across ciinical trials with
`
`l‘Ll-‘iDC‘r'LA were nausea, fatigue, musculoslteletal pain, hemorrhage, thromhocvtopenia,
`
`increased transamirrases, headache, constipation, and epistaxis. in Ei'v'llLlA, the most common
`
`NCI-CTCAE [version 33 2 Grade 3 ADHs {frequencv flee! were thromhocvtopenia. increased
`
`transaminases. anemia, hvpoltalemia, peripheral neuropathv. and fatigue
`
`You are encouraged to report side effects to IGenentech and the FDA. "i’ou mar,-r contact Genentech lav
`
`calling 1-833-835-2555. ‘r’ou mav contact the FDA lav visiting www.fda.govfmedwatch or calling
`
`Contact a Fle i
`
`Learn more about MDCYLfl.
`
`Access tools and information 1
`
`Fleview significant survival results and the adverse reaction profile
`
`Click below for an
`appointment with a clinical
`oncologyr specialist.
`
`a Contact us
`
`' Featured:
`Dosing gta Administration Guide a
`
`demonstrated in the Phase ill El‘u'liLiA trial.
`
`:1 Learn more
`
`Indication
`MDCYLfiF "l tado—trastuzumab emtansine}, as a single agent, is indicated for the treatment of patients with HERE-positive
`
`-M
`
`IMMUNOGEN 2228, pg. 12
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`Thi
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`
`infiltration during drug administration. Specific treatment for KADC‘ELA exti'ayasation is
`unknown
`
`!
`
`. please read
`View now
`
`hiursing Mothers
`
`' Discontinue nursing or discontinue iiADC‘fLA, taking into consideration the importance of the
`
`drug to the mother
`
`Adyerse Fleastio ns
`
`' The most common {frequency 3259’Ei adyerse drug reactions [ADH] across ciinical trials with
`
`KADCTLA were nausea, fatigue, muscuioslreletal pain, hemorrhage. thi'omhocytopenia,
`
`increased transaminases. headache, constipation, and epistaxis. In EMILIA, the most common
`
`NCI-CTCAE [yersion 3i 2 Grade 3 ADHs {frequency 2-29-53 were thromhocytopenia, increased
`
`transaminases. anemia. hypoiialernia, peripheral neuropathy. and fatigue
`
`You are encouraged to repoit side effects to Genentech and the FDA. You may contact Genentech by
`
`calling 1-883-835-2555. ‘r‘ou may contact the FDA by yisiting www.fda.goyfmedwatoh or calling
`1-BDfl-FDA-ifl33.
`
`Please see accompanying full Frescn'hing Information for additional important safety information,
`
`including Boxed WARNINGS.
`
`
`
`IMMUNOGEN 2228, pg. 13
`Phigenix v. Immunogen
`|PR2014-00676
`
`Contact a Fie i
`
`Learn more about KADCH’LA.
`
`Access tools. and information 1
`
`Fieyiew significant suryiyal results and the adyerse reaction profile
`
`Click below for en
`appointment with a clinical
`oncology specialist.
`
`a Contact us
`
`' Featured:
`Dosing gta Administration Guide a
`
`demonstrated in the Phase ill EI‘u'liLiA trial.
`
`:1 Learn more
`
`Indication
`li'iAlIZIIE‘r'LA3 ":1 iado—trastuzurnab emtansine}, as a single agent, is indicated for the treatment of patients with HEHE-positiye
`
`-M
`
`IMMUNOGEN 2228, pg. 13
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

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`
`IMMUNOGEN 2228, pg. 14
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 14
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`
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`IMMUNOGEN 2228, pg. 15
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 15
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This information is for
`Healthcare Protessionals
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`IMMUNOGEN 2228, pg. 16
`Phigenix v. Immunogen
`|PR2014-00676
`
`IMMUNOGEN 2228, pg. 16
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This infnrmatSnn is in!
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`IMMUNOGEN 2228, pg. 17
`Phigenix v. lmmunogen
`lPR2014-00676
`
`IMMUNOGEN 2228, pg. 17
`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`This illlugriautiwl is FUI
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`The first antibody-drug conjugate for the
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`Phigenix v. Immunogen
`|PR2014-00676
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`
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`Phigenix v. Immunogen
`IPR2014-00676
`
`

`

`
`
`II
`
`This information IS for
`
`ii Go to Patients 5:.
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`m Caregivers site
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`i. View full Prescribing Information
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`M HEQISIE' ID" UF’EIBIES M Healthcare PfOIBSSIOI’IaIS
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`HdU'IffiSILLZiJmEIJ EITIIEIIISIII
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`About KADCYLA
`
`Clinical
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`Information
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`Dosing and
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`Administration
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`Resources
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`Patient St:
`
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`Ab o ut KA D CY LA
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`IHTHIS SEETIDH
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`Safety First!
`Before you stan exploring. please read
`
`side effect information.