FLASCO

Announcing a New Genentech Therapy

  • Katrina Williams
  • April 17, 2019

Genentech is excited to share the news of a new FDA-approved therapy.

Herceptin Hylecta Indication and Usage

Adjuvant Breast Cancer  HERCEPTIN HYLECTATM (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for trastusumab

*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2cm, age <35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer  HERCEPTIN HYLECTA is indicated in adults:

  • In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab

Please see the attached Herceptin HYLECTA Day 1 Letter, as well as the Herceptin HYLECTA full Prescribing Information, for additional Important Safety Information. Please forward to relevant stakeholders or departments in your organization.

 

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS and Additional Important Safety Information 

Cardiomyopathy 

  • HERCEPTIN HYLECTA administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN HYLECTA with anthracycline-containing chemotherapy regimens
  • Evaluate left ventricular function in all patients prior to and during treatment with HERCEPTIN HYLECTA. Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvant therapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function

 Pulmonary Toxicity 

  • HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity. Symptoms usually occur during or within 24 hours of HERCEPTIN HYLECTA administration. Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve

 Embryo-Fetal Toxicity 

  • Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception 
  • Exacerbation of chemotherapy-induced neutropenia has also occurred
  • Hypersensitivity and severe Administration-Related Reactions (ARRs) including anaphylaxis, have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products

Most Common Adverse Reactions 

  • Adjuvant Breast Cancer: Most common adverse reactions for HERCEPTIN HYLECTA are fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity
  • Metastatic Breast Cancer (based on intravenous trastuzumab): The most common adverse reactions are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash 

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

 

Please see accompanying full Prescribing Information, including BOXED WARNINGS, for additional information or go to https://www.gene.com/download/pdf/HerceptinHylecta_prescribing.pdf.

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