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Trastuzumab/​Hyaluronidase

    Brands

    DEA Class; Rx

    Common Brand Names; Herceptin Hylecta, trastuzumab-hyaluronidase-oysk

    • Antineoplastics, Anti-HER2; 
    • Antineoplastics, Monoclonal Antibody
    •  

    Trastuzumab is a HER2/neu receptor antagonist; hyaluronidase is an endoglycosidase
    Used for the treatment of HER2-overexpressing breast cancer
    Do not substitute trastuzumab; hyaluronidase with other trastuzumab-based products; both administration and dosing recommendations are different

    Indicated for adjuvant treatment of HER2-overexpressing breast cancer for the following:

    In combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel OR

    In combination with docetaxel and carboplatin OR

    As a single agent following multimodality anthracycline-based therapy

    Indicated for HER2-overexpressing metastatic breast cancer in combination with paclitaxel for first-line treatment or as a single agent in patients who have received ≥1 chemotherapy regimens for metastatic disease

    —

    • Alopecia (63%)
    • Nausea (49%)
    • Fatigue (46%)
    • Neutropenia (44%)
    • Diarrhea (34%)
    • Rash (26%)
    • Upper respiratory tract infection (24%)
    • Vomiting (23%)
    • Stomatitis (21%)
    • Myalgia (21%)
    • Peripheral neuropathy (20%)
    • Decreased appetite (20%)
    • Arthralgia (18%)
    • Headache (17%)
    • Nail disorder (14%)
    • Abdominal pain (14%)
    • Flushing (14%)
    • Edema (14%)
    • Pyrexia (13%)
    • Anemia (12%)
    • Cough (12%)
    • Dyspepsia (11%)
    • Leukopenia (11%)
    • Back pain (11%)
    • Incision site complication (11%)

    Left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death may occur as well as asymptomatic decline in LVEF (see Black Box Warnings)

    Fetal harm may occur when administered to a pregnant woman (see Black Box Warnings and Pregnancy)

    Pulmonary toxicity (eg, dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis) reported; 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 (see Black Box Warnings)

    Chemotherapy-induced neutropenia may be exacerbated

    Severe administration-related reactions (ARRs), including hypersensitivity and anaphylaxis, reported; patients experiencing dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a severe or fatal ARR

    Fetal harm when administered to a pregnant woman

    Verify pregnancy status of females of reproductive potential before initiation

    Female: Use effective contraception during treatment and for 7 months following the last dose

    There is no information regarding the presence of trastuzumab or hyaluronidase in human milk, the effects on the breastfed infant, or the effects on milk production

    Adults

    600 mg trastuzumab and 10,000 units of hyaluronidase (5 mL) subcutaneously once every 3 weeks.

    Geriatric

    600 mg trastuzumab and 10,000 units of hyaluronidase (5 mL) subcutaneously once every 3 weeks.

    Trastuzumab/hyaluronidase

    injectable solution, single-dose vial

    • (120mg/2,000 units)/mL
    • Ready-to-use SC solution contains trastuzumab and hyaluronidase human