Genentech is excited to share the news of a new FDA-approved indication. KADCYLA®(ado-trastuzumab emtansine), as a single agent, is indicated for the

5/13/2019

Genentech is excited to share the news of a new FDA-approved indication. KADCYLA®(ado-trastuzumab emtansine), as a single agent, is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Select patients for therapy based on an FDA-approved companion diagnostic for KADCYLA.

 

Please see the attached KADCYLA Early Breast Cancer letter, as well as the KADCYLA full Prescribing Information, including the Boxed Warnings, for additional Important Safety Information. Please forward to relevant stakeholders or departments
in your organization.

 

IMPORTANT SAFETY INFORMATION

 

BOXED WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO­FETAL TOXICITY 

·       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

 

Additional Important Safety Information

·      Interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatality: Permanently discontinue KADCYLA in patients diagnosed with ILD or pneumonitis  

·      Infusion-related reactions (IRR), hypersensitivity: KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR

·      Hemorrhage: Fatal cases of hemorrhage occurred in clinical trials among patients with no known identified risk factors, as well as among patients with thrombocytopenia and those receiving anticoagulation and antiplatelet therapy. Use caution with these agents and consider additional monitoring when concomitant use is medically necessary

·      Thrombocytopenia: Monitor platelet counts prior to initiation of KADCYLA and prior to each dose. Institute dose modifications as appropriate

·      Peripheral neuropathy: Temporarily discontinue KADCYLA in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ≤ Grade 2  

·      Reactions secondary to extravasation: Closely monitor the infusion site for possible subcutaneous infiltration during drug administration

·      In early breast cancer, the most common adverse reactions seen with KADCYLA in the KATHERINE trial (frequency >25%) were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia

·      Advise women not to breastfeed during treatment and for 7 months following the last dose of KADCYLA

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 https://www.gene.com/download/pdf/kadcyla_prescribing.pdffor additional Important Safety Information and accompanying full Prescribing Information, including BOXED WARNINGS.

 

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