High Alert
Absorption: IV administration results in complete bioavailability.
Distribution: Unknown.
Half-Life: Unknown.
Contraindicated in:
Pregnancy
;Use Cautiously in:
Exercise Extreme Caution in:
CV: ARRHYTHMIAS, edema, HF, hypertension, tachycardia
Derm: rash, acne, herpes simplex
EENT: pharyngitis, rhinitis, sinusitis
GI: abdominal pain, anorexia, diarrhea, nausea, vomiting
Hemat: anemia, leukopenia
MS: pain, arthralgia, bone pain
Neuro: depression, dizziness, headache, insomnia, neuropathy, paresthesia, peripheral neuritis, weakness
Resp: ACUTE RESPIRATORY DISTRESS SYNDROME, cough, dyspnea, INTERSTITIAL PNEUMONITIS, PULMONARY EDEMA, PULMONARY FIBROSIS
Misc: chills, fever, infection, flu-like syndrome, INFUSION REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA)
Drug-drug:
Anthracyclines, including daunorubicin, doxorubicin, or idarubicin, may ↑ risk of cardiotoxicity; if possible, avoid anthracycline-based therapy for up to 7 mo after stopping trastuzumab.

Adjuvant Treatment of Breast Cancer
Metastatic Breast Cancer
Metastatic Gastric Cancer
Assess for infusion-related symptoms (chills, fever, nausea, vomiting, pain [in some cases at tumor sites], headache, dizziness, dyspnea, hypotension, rash, asthenia) following initial infusion. Severe reactions (bronchospasm, anaphylaxis, angioedema, hypoxia, severe hypotension) may occur during or immediately following the initial infusion. May be treated with epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen. If dyspnea or severe hypotension occurs, interrupt infusion. If severe reaction occurs, permanently discontinue trastuzumab.
Assess for signs and symptoms of HF (dyspnea, ↑ cough, paroxysmal nocturnal dyspnea, peripheral edema, S3 gallop, ↓ left ventricular ejection fraction [LVEF]) prior to and frequently during therapy. Perform baseline assessment of cardiac history, physical exam, and LVEF with ECG or multiple gated acquisition (MUGA) scan. Monitor LVEF every 3 mo, at completion of therapy, and then every 6 mo for ≥2 yr. If ≥16% absolute ↓ in LVEF from pretreatment values or an LVEF value below institutional limits of normal and ≥10% absolute ↓ in LVEF from pretreatment values occurs, hold trastuzumab. Repeat LVEF measures every 4 wk if dose is held for significant left ventricular dysfunction.
Monitor patient for signs of pulmonary hypersensitivity reactions (dyspnea, pulmonary infiltrates, pleural effusion, noncardiogenic pulmonary edema, hypoxia, acute respiratory distress syndrome). Patients with symptomatic pulmonary disease or extensive lung tumor involvement are at ↑ risk. If severe symptoms occur, discontinue trastuzumab.
Lab Test Considerations:
Verify negative pregnancy test before starting therapy.
HER2 protein overexpression is used to determine whether treatment with trastuzumab is indicated. HER2 protein overexpression is detected by HercepTest (IHC assay) and PathVysion (FISH assay).IV Administration:
Advise patients to contact a health care provider 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.
May cause fetal harm. Advise women of reproductive potential to notify health care provider immediately if pregnancy is planned or suspected and to avoid breastfeeding. Caution patient to use effective contraception during therapy and for 7 mo following last dose. Monitor infants exposed to trastuzumab for oligohydramnios, pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Encourage women who may be exposed during pregnancy to report exposure to the Genentech Adverse Event Line at 1-888-835-2555.