• Human epidermal growth factor receptor 2 (HER2)-overexpressing node-positive or node-negative breast cancer (as part of one of the following regimens: doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or docetaxel and carboplatin) (as adjuvant therapy).
• HER2-overexpressing node-positive or node-negative breast cancer (to be used alone after multimodality anthracycline-based therapy) (as adjuvant therapy).
• HER2-overexpressing metastatic breast cancer (as first-line therapy) (in combination with paclitaxel).
• HER2-overexpressing metastatic breast cancer in patients who have already received ≥1 other chemotherapy regimens for metastatic disease (as monotherapy).

Contraindicated in:

• OB: Pregnancy.

Use Cautiously in:

• Pulmonary disease or extensive tumor involvement of lungs (↑ risk of pulmonary toxicity)
• Dyspnea at rest (↑ risk of hypersensitivity reaction)
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness in children not established
• Geri: Older adults may have ↑ risk of cardiac dysfunction.

Exercise Extreme Caution in:

• Pre-existing cardiac dysfunction.

CV: edema, ARRHYTHMIAS, HF, hypertension, SUDDEN CARDIAC DEATH.

Derm: alopecia, flushing, rash, erythema, pruritus, skin discoloration.

EENT: epistaxis.

GI: ↓ appetite, abdominal pain, constipation, diarrhea, dyspepsia, nausea, stomatitis, vomiting, ↑ liver enzymes.

GU: menstrual abnormalities, urinary tract infection.

Hemat: anemia, leukopenia, neutropenia.

Local: injection site pain.

MS: arthralgia, myalgia.

Neuro: dizziness, dysgeusia, headache, peripheral neuropathy, insomnia.

Resp: cough, upper respiratory tract infection, ACUTE RESPIRATORY DISTRESS SYNDROME, dyspnea, INTERSTITIAL PNEUMONITIS, pleural effusion, PULMONARY EDEMA, PULMONARY FIBROSIS.

Misc: fatigue, fever, hypersensitivity reactions (including anaphylaxis and angioedema).

Drug-Drug:

• Concurrent administration of myelosuppressive chemotherapy drugs may worsen degree of neutropenia.
• Concurrent anthracycline (daunorubicin, doxorubicin, or idarubicin) therapy may ↑ risk of cardiotoxicity; if possible, avoid anthracycline-based therapy for up to 7 mo after stopping trastuzumab hyaluronidase.

• Solution for injection: trastuzumab 120 mg and hyaluronidase 2,000 units/mL;

Do not substitute with or for ado-trastuzumab emtansine. Dosage and route of administration is different from trastuzumab.

• SC (Adults): Trastuzumab 600 mg/hyaluronidase 10,000 units every 3 wk for 52 wk or disease recurrence, whichever occurs first (for adjuvant therapy) or until disease progression (for metastatic disease).

Herceptin Hylecta

• Trastuzumab: A monoclonal antibody that binds to HER2 sites in breast cancer tissue and inhibits proliferation of cells that overexpress HER2 protein; Hyaluronidase: Acts locally by depolymerizing hyaluronan, which increases permeability of the SUBQ tissue.

• Regression of breast cancer and metastases.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: 77% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-life: Unknown.

Herceptin SC

(plasma concentrations)

• Explain purpose of trastuzumab hyaluronidase to patient.
• Advise patients to contact a health care professional immediately if signs and symptoms of HF (new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of face, palpitations, weight gain >5 pounds in 24 hr, dizziness, loss of consciousness) or hypersensitivity reactions (dizziness, nausea, chills, fever, vomiting, diarrhea, urticaria, angioedema, breathing problems, chest pain) occur.
• Rep: May cause fetal harm (oligohydramnios, pulmonary hypoplasia, skeletal abnormalities, neonatal death). Advise females of reproductive potential to use effective contraception during and for 7 mo after last dose. Monitor women who received trastuzumab hyaluronidase during pregnancy or within 7 mo prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing. Advise patients to notify health care professional if pregnancy is suspected or if breastfeeding. Inform patient of Pregnancy Pharmacovigilance Program. Patients who become pregnant during or with 7 mo of therapy should call immediately to report exposure to Genentech at 1-888-835-2555.

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