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Dosing and Administration
Treating HER2+ Cancer
Contact Herceptin Support Prescribing Information Important Safety Information
Indications & Important Safety Information
Herceptin Herceptin HYLECTA
(trastuzumab and hyaluronidase-oysk)
Herceptin: Indications
Adjuvant Breast Cancer
Herceptin is indicated for adjuvant treatment of 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 Herceptin
*High-risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
Herceptin is indicated:
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
Metastatic Gastric Cancer
Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Herceptin: Boxed WARNINGS and Additional Important Safety Information
Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens.
Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity
Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
Exposure to Herceptin 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
Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant trial, one patient who developed CHF died of cardiomyopathy
Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
Herceptin can also cause asymptomatic decline in LVEF
Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function
Cardiac Monitoring
Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of Herceptin
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
Monitor frequently for decreased left ventricular function during and after Herceptin treatment
Monitor more frequently if Herceptin is withheld for significant left ventricular cardiac dysfunction
Herceptin administration can result in serious and fatal infusion reactions
Symptoms usually occur during or within 24 hours of Herceptin administration
Interrupt Herceptin infusion for dyspnea or clinically significant hypotension
Monitor patients until symptoms completely resolve
Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
Verify the pregnancy status of females of reproductive potential prior to the initiation of Herceptin
Advise pregnant women and females of reproductive potential that exposure to Herceptin during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of Herceptin
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Herceptin treatment and any potential adverse effects on the breastfed child from Herceptin or from the underlying maternal condition
If Herceptin is administered during pregnancy, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, health care providers and patients should immediately report Herceptin exposure to Genentech at 1-888-835-2555
Pulmonary Toxicity
Herceptin administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions
Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
Discontinue Herceptin in patients experiencing pulmonary toxicity
Exacerbation of Chemotherapy-Induced Neutropenia
In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving Herceptin in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received Herceptin and those who did not
Most Common Adverse Reactions
The most common adverse reactions associated with Herceptin in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions associated with Herceptin in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including Boxed WARNINGS.
Herceptin HYLECTA
Herceptin HYLECTA: Indications
HERCEPTIN HYLECTA (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:
Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab
HERCEPTIN HYLECTA is indicated in adults:
Herceptin HYLECTA: BOXED WARNINGS and Additional Important Safety Information
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
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
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
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. In a pivotal adjuvant breast cancer trial of intravenous trastuzumab, one patient who developed CHF died of cardiomyopathy
HERCEPTIN HYLECTA can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
HERCEPTIN HYLECTA can also cause asymptomatic decline in LVEF
Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvant breast cancer therapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function
Evaluate cardiac function prior to and during treatment
Monitor frequently for decreased left ventricular function during and after HERCEPTIN HYLECTA treatment
Monitor more frequently if HERCEPTIN HYLECTA is withheld for significant left ventricular cardiac dysfunction
Verify the pregnancy status of females of reproductive potential prior to the initiation of HERCEPTIN HYLECTA
Advise pregnant women and females of reproductive potential that exposure to HERCEPTIN HYLECTA during pregnancy or within 7 months prior to conception can result in fetal harm
Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of HERCEPTIN HYLECTA
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for HERCEPTIN HYLECTA treatment and any potential adverse effects on the breastfed child from HERCEPTIN HYLECTA or from the underlying maternal condition
If HERCEPTIN HYLECTA is administered during pregnancy, or if a patient becomes pregnant while receiving HERCEPTIN HYLECTA or within 7 months following the last dose of HERCEPTIN HYLECTA, health care providers and patients should immediately report HERCEPTIN HYLECTA exposure to Genentech at 1-888-835-2555
HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis.
Discontinue HERCEPTIN HYLECTA in patients experiencing pulmonary toxicity
In randomized, controlled clinical trials with intravenous trastuzumab, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Hypersensitivity and Administration-Related Reactions
Severe administration-related reactions (ARRs), including hypersensitivity and anaphylaxis, have been reported with HERCEPTIN HYLECTA. Patients experiencing dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a severe or of a fatal ARR.
In the HannaH and SafeHER trials, 9% and 4.2% of patients experienced Grade 1-4 hypersensitivity and anaphylaxis, respectively. Grade 3-4 hypersensitivity and anaphylactic reactions occurred in 1% and <1% of the patients treated with HERCEPTIN HYLECTA, respectively. In the SafeHER trial, 2 patients required permanent treatment discontinuation with HERCEPTIN HYLECTA; 1 patient due to a hypersensitivity reaction and 1 patient due to anaphylaxis. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products
Closely monitor patients for systemic hypersensitivity reactions, especially during the first administration. Permanently discontinue HERCEPTIN HYLECTA in patients who experience anaphylaxis or severe hypersensitivity reactions. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. For patients experiencing reversible Grade 1 or 2 hypersensitivity reactions, consider pre-medication with an analgesic, antipyretic, or an antihistamine prior to re-administration of HERCEPTIN HYLECTA
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)
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 800–FDA–1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1–888–835–2555.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.1.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.2.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 13, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
Herceptin HYLECTA Prescribing Information. Genentech, Inc. February 2019.
Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.
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Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. At: https://www.nejm.org/doi/full/10.1056/NEJMoa0910383. Accessed June 24, 2019.
ClinicalTrials.gov. Combination chemotherapy with or without trastuzumab in treating women with breast cancer. NCT00021255 updated November 15, 2016. At: https://clinicaltrials.gov/ct2/show/record/NCT00021255. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
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Data on file. Genentech, Inc.
Witton CJ, Reeves JR, Going JJ, Cooke TG, Bartlett JMS. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol. 2003;200(3):290-297. At: https://onlinelibrary.wiley.com/doi/abs/10.1002/path.1370. Accessed June 24, 2019.
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Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (Herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61(12):4744-4749. At: http://cancerres.aacrjournals.org/content/61/12/4744.full-text.pdf. Accessed June 24, 2019.
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