Classes
DEA Class; Rx
Common Brand Names; Herceptin Hylecta, trastuzumab-hyaluronidase-oysk
- Antineoplastics, Anti-HER2;
- Antineoplastics, Monoclonal Antibody
Description
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
Indications
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
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
600 mg trastuzumab and 10,000 units of hyaluronidase (5 mL) subcutaneously once every 3 weeks.
600 mg trastuzumab and 10,000 units of hyaluronidase (5 mL) subcutaneously once every 3 weeks.
How supplied
Trastuzumab/hyaluronidase
injectable solution, single-dose vial
- (120mg/2,000 units)/mL
- Ready-to-use SC solution contains trastuzumab and hyaluronidase human