Breast cancer:

Indications for HERCEPTIN HYLECTA:

Adjuvant treatment in HER2-overexpressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin). HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel for first line treatment.

Adult:

Do not substitute for or with ado-trastuzumab emtansine. Give as SC inj in left or right thigh; rotate inj sites. 600mg/10,000 Units over 2–5mins once every 3 weeks. Adjuvant treatment: treat for 52 weeks or until disease recurrence, whichever occurs first; extending treatment beyond 1year: not recommended. Metastatic treatment: treat until disease progression. Dose modification for cardiomyopathy: see full labeling.

Children:

Not established.

Boxed Warning:

Cardiomyopathy. Pulmonary toxicity. Embryo-fetal toxicity.

Warnings/Precautions:

Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy or every 6 months for ≥2yrs after therapy (if adjuvant); repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Discontinue if anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome occurs. Monitor for hypersensitivity reactions; permanently discontinue if occur. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests specific for breast cancer. Embryo-fetal toxicity (eg, oligohydramnios); monitor during pregnancy or within 7 months prior to conception. Advise females of reproductive potential to use effective contraception during and for 7 months after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.

Pharmacologic Class:

Human epidermal growth factor receptor (HER2) inhibitor + endoglycosidase.

Interactions:

Increased cardiomyopathy with anthracycline-based chemotherapy; if possible, avoid for up to 7 months after discontinuing Herceptin Hylecta; if used, monitor carefully.

Adverse Reactions:

Fatigue, arthralgia, diarrhea, inj site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, pain in extremity; cardiac dysfunction, exacerbation of chemotherapy-induced neutropenia, pulmonary toxicity, hypersensitivity.

Note:

Report pregnant women with breast cancer exposed to Herceptin Hylecta in the pharmacovigilance program (888) 835-2555.
Testing considerations: HER2 protein overexpression or HER2 gene amplification

Generic Availability:

NO

How Supplied:

Single-dose vial—1