KADCYLA is the first FDA-approved antibody-drug conjugate (ADC) for HER2-positive metastatic breast cancer.
`KADCYLA™ (ado-trastuzumab emtansine) injection, for intravenous use, as a single agent, is indicated for the treatment of patients
`with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
`Patients should have either:
`• Received prior therapy for metastatic disease, or
`• Developed disease recurrence during or within six months of completing adjuvant therapy.1
`
`FDA approval of KADCYLA is based on the EMILIA trial, a multicenter, open-label, randomized Phase III study conducted with 991 patients with
`locally advanced or metastatic HER2-positive mBC.1
`
`The pivotal EMILIA trial demonstrated significant improvements in overall and progression-free survival in HER2-positive mBC patients
`previously treated with trastuzumab and a taxane.1
`• KADCYLA extended median OS by 5.8 months, from 25.1 months observed in the lapatinib + capecitabine arm to 30.9 months
`in the KADCYLA arm (HR = 0.682 [95% CI: 0.548-0.849], P = 0.0006).
`• KADCYLA extended median PFS* by 3.2 months, from 6.4 months observed in the lapatinib + capecitabine arm to 9.6 months in
`the KADCYLA arm (HR = 0.650 [95% CI: 0.549-0.771], P < 0.0001).
` *As assessed by an independent review committee (IRC)
`To learn more, please visit http://www.KADCYLA.com.
`
`Select codes for your reference1-9
`
`NDC
`
`ICD-9 Codes
`
`CPT Codes
`
`HCPCS Codes
`
`50242-088-01 – 100 mg single-use vial
`50242-087-01 – 160 mg single-use vial
`
`174.0–174.9 – Malignant neoplasm of female breast
`175.0, 175.9 – Malignant neoplasm of male breast
`
`96413 – Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial
`0000000 substance/drug
`96415 – Chemotherapy administration, intravenous infusion technique, each additional hour
`
`J3490 – Unclassified drugs
`J3590 – Unclassified biologics
`J9999 – Not otherwise classified, antineoplastic drugs
`C9399 – Unclassified drugs or biologics
`
` ► KADCYLA is available through authorized specialty distributors and wholesalers via the KADCYLA distribution model. Please visit
`http://www.KADCYLA.com for more information on the network.
` ► Customers can also acquire KADCYLA through authorized specialty pharmacies and freestanding infusion centers if a patient is covered
`by a commercial healthcare plan.
` ► For information on distribution and patient access support, please contact KADCYLA Access Solutions by calling 1 -888-249-4918
`or by visiting http://www.Genentech-Access.com/KADCYLA.
`
`For more information, please contact your Account Manager or submit your inquiry at http://www.gene.com/contact-us/email-us.
`
`Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY
`• Do Not Substitute KADCYLA for or with Trastuzumab
`• Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum
`transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as
`appropriate in cases of increased serum transaminases or total bilirubin
`• Cardiac Toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in
`all patients prior to and during treatment with KADCYLA. Withhold 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
`
`Please see reverse for additional important safety information and accompanying full Prescribing Information, including Boxed WARNINGS.
`
`IMMUNOGEN 2325, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`

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`Additional Important Safety Information
`Pulmonary Toxicity
`• Cases of interstitial lung disease (ILD), 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
`(IRR) and/or 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%
`• KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR
`Thrombocytopenia
`• In EMILIA, the incidence of ≥ Grade 3 thrombocytopenia was 14.5% in the KADCYLA-treated group and 0.4% in the comparator group
`• 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 ≥ Grade 3 peripheral neuropathy was 2.2% in the KADCYLA-treated group and 0.2% in the comparator group
`• Monitor for signs or symptoms of neurotoxicity. KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4
`peripheral neuropathy until resolution to ≤ Grade 2
`HER2 Testing
`• Detection of HER2 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
`Nursing Mothers
`• Discontinue nursing or discontinue KADCYLA taking into consideration the importance of the drug to the mother
`Pregnancy Registry
`• Encourage women who may be exposed to KADCYLA during pregnancy to enroll in the MotHER Pregnancy Registry by contacting
`1-800-690-6720
`Adverse Reactions
`• The most common ADRs seen with KADCYLA in EMILIA (frequency > 25%) were nausea, fatigue, musculoskeletal pain, thrombocytopenia,
`increased transaminases, headache, and constipation. The most common NCI-CTCAE (version 3) ≥ Grade 3 ADRs (frequency >2%) 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.gov/medwatch or calling 1-800-FDA-1088.
`
`Please see accompanying full Prescribing Information for additional important safety information, including Boxed WARNINGS.
`
`References: 1. KADCYLA™ (ado-trastuzumab emtansine) full prescribing information. Genentech, Inc., February 2013. 2. ICD9Data. Malignant neoplasm of the female breast.
`http://www.icd9data.com/2013/Volume1/140-239/170-176/174/default.htm. Accessed January 29, 2013. 3. ICD9Data. Malignant neoplasm of the male breast. http://www.
`icd9data.com/2013/Volume1/140-239/170-176/175/default.htm. Accessed January 29, 2013. 4. American Medical Association. CodeManager. https://ocm.ama-assn.org/OCM/
`CPTRelativeValueSearchResults.do?locality=7&keyword=96413. Accessed January 29, 2013. 5. American Medical Association. CodeManager. https://ocm.ama-assn.org/OCM/
`CPTRelativeValueSearchResults.do? locality=7.keyword=96415. Accessed January 29, 2013. 6. ICD9Data. 2013 HCPCS J3490. http://www.icd9data.com/ HCPCS/2012/J/J3490.
`htm. Accessed January 29, 2013. 7. ICD9Data. 2013 HCPCS J3590. http://www.icd9data.com/HCPCS/2013/J/J3590.htm. Accessed January 29, 2013. 8. ICD9Data. 2013 HCPCS
`J9999. http://www.icd9data.com/HCPCS/2013/J/J9999.htm. Accessed January 29, 2013. 9. ICD9Data. 2013 HCPCS C9399. http://www.icd9data.com/HCPCS/2013/C/C9399.htm.
`Accessed January 29, 2013.
`
`©2013 Genentech, Inc., So. San Francisco, CA TDM0001305700 2/13
`
`IMMUNOGEN 2325, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
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