This information is for Healthcare
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`a. Kadcyla”
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`Important Safety Inforn'lation
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`
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`About KADCYLA
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`III THESEETHJII
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`n KADCVLA Structure
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`11 Pro osed ”DA
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`Multiple antitumor
`activities from a single
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`agent
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`Proposed mechanism of action for
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`KADG‘I'LA, based on preclinical
`models‘*2
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`11 VIEW THE FULL ANIMATIGN EIELGW
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`.I-
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`Proposed Mfls
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`[TDM0001956700
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`HAD E't" LA
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`PLAY
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`+ Click to interact
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`SELECT WI] El]
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`/—Updated video -
`TDM0001424701
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`Next: See Clinical Information
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`a Want to discuss the
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`KADGYLA proposed
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`Tallr to a representative about getting the
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`HADG‘I'LA M'DA Brochure
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`1 Contact Us
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`Indication
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`KADGYLAE "I [ado—trastuzumab emtansineI, as
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`a single agent, is indicated for the treatment of
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`patients with HEH2—positive [HER2+I, metastatic
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`breast cancer {MEG} who previouslv received
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`trastuzumab and a taxane, separater or in
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`combination. Patients should have either.
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`* Received prior therapv for metastatic
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`disease, or
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`* Developed disease recunence during or
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`within six months of completing adjuvant
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`theraprlir
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`Important Safety Infom'ration
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`Boxed WARNINGS:
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`HEPATIIIIITIIIIIZIIIIItl:IT"'|‘Ir GARDIAG
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`TtIllll'llltlilT'li‘Ir EMBRVfl-FEI'AL
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`TtCllllllllltlilT‘ir“r
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`* Do Not Substitute WLA for or with
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`Trastuzu mab
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`* Hepatotoxicitv: Serious hepatotoxicitv has
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`been reported, including liver failure and
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`death in patients treated with IEADG'I'LA.
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`Monitor semm transaminases and
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`bilinrbin priorto initiation of HADE‘I'LA
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`treatment and priorto each WLA
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`dose. Reduce dose or discontinue
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`KADIDVLA as appropriate in cases of
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`increased serum transaminases or total
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`bilinrbin
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`* Gardiac Toxicitv: HADE‘I'LA administration
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`mlavllr lead to reductions in left ventricular
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`eiection fraction {LUEFL Evaluate left
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`ventricular function in all patients prior to
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`and during treatment with IEADG'l'LA.
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`With hold treatment for clinicallv
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`significant decrease in left ventricular
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`function
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`* Emhrvo-Fetal Toxicitv: Exposure to
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`KADID‘VLA can resultin embrvo-fetal death
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`or birth defects. Advise patients of these
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`risks and the need for effective
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`contraception
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`Additional Important Safety
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`Infomration:
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`Leftlferrtr'icrlerD'vsfrlrctirerIIJr'Di
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`* Patients treated with KAD-G‘r'LA are at
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`increased rislr of developing LVD. In
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`EMILIA, LUD occuned in 1.3% of patients in
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`the KADGTLA—treated group and in 3.3% in
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`the comparator group. Pennanentlrlir
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`discontinue HADGYLA if L'v'EF has not
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`improved or has declined further
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`Preslmmvflesistrv
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`* Advise patients to contact their healthcare
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`provider immediatelv if thev suspect thev
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`mailr be pregnant. Encourage women who
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`mav be exposed to HADGYLA during
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`pregnancv to enroll in the MotHEFI
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`Pregnancvllr Flegistrvllr bv contacting
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`1 [Slit]! 590-5220
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`Primrv'lirxicitv
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`* Gases of interstitial lung disease [ILDL
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`including pneumonitis, some leading to
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`acute respiratorv distress svndrome or
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`fatal outcome have been reported in
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`clinical trials with KADGYLA. In EMILIA, the
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`overall freouencrlir of pneumonitis was
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`1.2%
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`* Treatment with KADGYLA should be
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`perrnanentlv discontinued in patients
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`diagnosed with ILD or pneumonitis
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`him-Related Reactions. Hypersensitivity Reactions
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`* Treatment with HADGYLA has not been
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`studied in patients who had trastuzurnab
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`perrnanentlv discontinued due to
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`infusion—related reactions [IFIFII andlor
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`hvpersensitivitv reactions; treatment with
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`KADE‘I’LA is not recommended for these
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`patients. In EMILIA, the overall frecluencrlir
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`of lFlFls in patients treated with KADG‘r'LA
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`was 1.4%
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`* KADE‘I’LA treatment should be intenupted
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`in patients with severe IFIFI and
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`perrnanentlv discontinued in the event of
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`a life—threatening IHH. Patients should be
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`closet-IIr monitored for IFIFI reactions,
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`especiallyr during the first infusion
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`Tll'orrlrecvteperl'a
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`* In EMILIA, the incidence of 2 Grade 3
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`thrombocvtopenia was 14.5% in the
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`KADGYLA—treated group and 3.11% in the
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`comparator group [overall incidence 31.2%
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`and 3.3%, respectivele
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`* Monitor platelet counts prior to initiation
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`of KADEYLA and prior to each KADGYLA
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`dose. Institute dose modifications as
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`appropriate
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`I'll
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`I "I
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`t In EMILIA, the incidence of 2 Grade 3
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`peripheral neuropathv was 2.2% in the
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`KADGYLA—treated group and 3.2% in the
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`comparator group [overall incidence 21.2%
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`and 13.5%, respectivele
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`* Monitor for signs or svmptoms of
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`neurotoxicitv. HADG‘fLA should be
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`temporarilv discontinued in patients
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`experiencing Grade 3 ortl peripheral
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`neuropathv until resolution to 5 Grade 2
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`HEIEEstir-g
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`* Detection of HER2 protein overexpression
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`or gene amplification is necessaryr for
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`selection of patients appropriate for
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`KADG‘I’LA. Perform using FDA approved
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`tests bv laboratories with demonstrated
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`proficiencv
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`Extravesetierr
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`* In HADGTLA clinical studies, reactions
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`secondarv to extravasation have been
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`observed and were generallv mild. The
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`infusion site should be closelv monitored
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`for possible subcutaneous infiltration
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`during drug administration. Specific
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`treatment for HADEYLA extravasation is
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`unknown
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`flisirgflotlrers
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`* Discontinue nursing ordiscontinue
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`KADE‘I’LA taking into consideration the
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`importance of the dnrg to the mother
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`AdverseRe-ections
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`* The most common ADHs seen with
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`HADGYLA in EMILIA [frequencv 3:- 25%}
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`were nausea, fatigue, musculoslreletal
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`pain, thrombocvtopenia, increased
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`transaminases, headache, and
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`constipation. The most common
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`NGl—GTGAE [version 31 2 Grade 3 ADHs
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`[frequencyr 2:. 2%} were thrombocvtopenia,
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`increased transaminases, anemia,
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`hvpolralemia, peripheral neurepathv and
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`fatigue
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`You are encouraged to report side effects to
`
`Genentech and the FDA. You rnav contact
`
`Genentech bv calling 1 [3331 335-2555. ‘I’ou mav
`
`contact the FDA bv visiting
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`www.fda.govfmedwatch or calling
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`1 [30111 FEE-1033.
`
`Please see accompanying full Prescribing
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`Information for additional important salietvllr
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`infomration, including Boxed WARNINGS.
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`References: 1. ICADC‘II'LA Prescribing Information-
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`Genentech, Inc- Ellery:r 2&13- 2. Scheue r W, Friess T Eurtscher
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`H, Doses nmaier E, Endl J, Hassma nn Iu'l- Stronglyr enha need
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`a ntitumor flflti‘fil‘f of trastuzuma b a nd pe rtuzuma b
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`combination treatment on HEH2—positive human xe nograft
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`tumor models. fence-r Hes. soossssssossss.
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`Genentech
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`IMMUNOGEN 2227, pg. 1
`Phgienix v. Immunogen
`|PR2014-00676
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`1
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`IMMUNOGEN 2227, pg. 1
`Phgienix v. Immunogen
`IPR2014-00676
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`

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`IMMUNOGEN 2227, pg. 2
`Phgienix v. Immunogen
`|PR2014-00676
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`2
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`IMMUNOGEN 2227, pg. 2
`Phgienix v. Immunogen
`IPR2014-00676
`
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