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For Patients and Caregivers

FOR ELIGIBLE PATIENTS WITH HER2+ BREAST CANCER

Herceptin HYLECTA™ is a subcutaneous injection administered over ~2‑5 minutes that most patients preferred over IV trastuzumab*1

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PRESCRIBING INFORMATION

Herceptin HYLECTA was approved based on two Phase 3 clinical studies in HER2+ EBC: HannaH (non-inferiority study versus IV trastuzumab based on co-primary PK and efficacy endpoints) and SafeHER (safety and tolerability study).1

*In the PrefHER study, 86% (199/231) of patients preferred administration of Herceptin HYLECTA over IV trastuzumab. See data below.
EBC=early breast cancer; HER2=human epidermal growth factor receptor 2; IV=intravenous; pCR=pathological complete response; PK=pharmacokinetics.

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HannaH study1

  • In the randomized open-label HannaH trial, 596 patients with HER2+ EBC (operable or locally advanced breast cancer, including inflammatory breast cancer) received 8 cycles of either Herceptin HYLECTA or IV trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either Herceptin HYLECTA or IV trastuzumab, as treated prior to surgery for an additional 10 cycles
  • HannaH demonstrated non-inferiority between Herceptin HYLECTA and IV trastuzumab based on co-primary endpoints of pCR and PK
    • pCR was observed in 118 patients (45.4%) on the Herceptin HYLECTA arm and in 107 patients (40.7%) receiving IV trastuzumab (95% Cl for difference in pCR: -4.0; 13.4)
    • Ctrough predose Cycle 8, showed non-inferiority of Herceptin HYLECTA (78. 7 mcg/mL) compared to IV trastuzumab (57.8 mcg/mL), with a geometric mean ratio of 1.3 (90% Cl: 1.2-1.4)
  • The most common adverse reactions of any grade (occurring in ≥10% of patients) with Herceptin HYLECTA were alopecia, nausea, administration-related reactions, neutropenia, diarrhea, asthenia, fatigue, vomiting, myalgia, decreased appetite, stomatitis, arthralgia, headache, rash, constipation, radiation skin injury, pyrexia, cough, anemia, dyspnea, incision site pain, peripheral sensory neuropathy, leukopenia, mucosal inflammation, hot flush, and upper respiratory tract infection

SafeHER study1

  • SafeHER was a prospective, two-cohort, non-randomized, multinational, open-label trial assessing the overall safety and tolerability of Herceptin HYLECTA with chemotherapy in 1,864 patients with HER2+ breast cancer. Patients received a fixed dose of 600 mg/10,000 units Herceptin HYLECTA every 3 weeks for 18 cycles
  • The most common adverse reactions of Herceptin HYLECTA observed in at least 10% of patients were fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity

Patients preferred Herceptin HYLECTA administration over IV trastuzumab1

The PrefHER study was a randomized, cross-over trial conducted in 240 patients with HER2+ EBC undergoing neoadjuvant or adjuvant treatment. 121 patients in arm A received 4 cycles of Herceptin HYLECTA followed by 4 cycles of IV trastuzumab and 119 patients in arm B received 4 cycles of IV trastuzumab followed by 4 cycles of Herceptin HYLECTA. Both arms received a total of 18 cycles. After Cycle 8, 231 patients were surveyed about their preferred route of administration.

  • 86% (n=199) preferred Herceptin HYLECTA
  • 13% (n=29) preferred IV trastuzumab
  • 1% (n=3) had no preference
  • Most common reason cited for preference of Herceptin HYLECTA1
    • 77% (179/231) of patients reported that subcutaneous administration required less time (~2-5 minutes)†
  • Most common reason cited for preference of IV trastuzumab1
    • 13% (29/231) of patients reported fewer local injection reactions with IV administration
  • 3.8% (9/240) of patients withdrew from treatment prior to completion and did not complete the post-study preference questionnaire 1

†Actual time in clinic may vary.

    • Herceptin HYLECTA Prescribing Information. Genentech, Inc. 2019.

      Herceptin HYLECTA Prescribing Information. Genentech, Inc. 2019.

    Herceptin Hylecta is a subcutaneous formulation of trastuzumab designed to treat HER2-positive breast cancer by targeting HER2 receptors. This formulation combines trastuzumab with hyaluronidase to allow for a faster subcutaneous delivery compared to intravenous trastuzumab. By inhibiting the proliferation of HER2-positive cancer cells, Herceptin Hylecta facilitates the slowing or stopping of tumor growth.

    Herceptin Hylecta is administered as a 600 mg fixed-dose subcutaneous injection containing 10,000 units of hyaluronidase, delivered in approximately 2-5 minutes once every three weeks, with no loading dose required.

    Serious side effects include cardiotoxicity, infusion-related reactions, interstitial lung disease, and hypersensitivity, including severe anaphylaxis or angioedema. Regular monitoring of cardiac function (e.g., LVEF assessment) is recommended prior to and during treatment. The most common side effects were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.

    INDICATIONS & IMPORTANT SAFETY INFORMATION

    INDICATIONS

    Adjuvant Breast Cancer
    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:

    • 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 trastuzumab
    *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.

    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

    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

    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. 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

    Cardiac Monitoring

    • Evaluate cardiac function prior to and during treatment
    • 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 HYLECTA treatment
    • Monitor more frequently if Herceptin HYLECTA is withheld for significant left ventricular cardiac dysfunction

    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
    • 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

    Pulmonary Toxicity

    • 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. 
    • 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 HYLECTA in patients experiencing pulmonary toxicity

    Exacerbation of Chemotherapy-Induced Neutropenia

    • 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
    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)

    • 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 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.

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