Classifications: immunomodulator; monoclonal antibody; antineoplastic; anti-human epidermal growth factor (anti-her); Therapeutic: antineoplastic; immunomodulator; anti-her
Pregnancy Category: B
21 mg/mL injection
Recombinant DNA monoclonal antibody (IgG1 kappa) that selectively binds to the human epidermal growth factor receptor-2 protein (HER2).
Inhibits growth of human tumor cells that overexpress HER2 proteins.
Metastatic breast cancer in those whose tumors overexpress the HER2 protein. HER2-positive breast cancer after surgery.
Concurrent administration of anthracycline or radiation; lactation during and for 6 mo following administration of trastuzumab.
Preexisting cardiac dysfunction; pulmonary disease; previous administration of cardiotoxic therapy (e.g., anthracycline
or radiation); pregnancy (category B); older adults; hypersensitivity to benzyl alcohol (preservative in bacteriostatic water).
Route & Dosage
|Metastatic Breast Cancer
Adult: IV 4 mg/kg, then 2 mg/kg qwk
PREPARE: IV Infusion: Reconstitute each vial with 20 mL of supplied diluent (bacteriostatic water) to produce a multidose vial containing 21 mg/mL.
Note: For patients with a hypersensitivity to benzyl alcohol, reconstitute with sterile water for injection; this solution
must be used immediately with any unused portion discarded. Withdraw the ordered dose and add to a 250 mL of NS and invert
bag to mix. Do not give or mix with dextrose solutions.
ADMINISTER: IV Infusion: Infuse loading dose (4 mg/kg) over 90 min; infuse subsequent doses (2 mg/kg) over 30 min. Do not give IV push or as a bolus
INCOMPATIBILITIES Solution/additive: Dextrose solution; do not mix or coadminister with other drugs.
- Store unopened vials and reconstituted vials at 2°8° C (36°46° F). Discard reconstituted
vials 28 days after reconstitution.
Adverse Effects (≥1%) Body as a Whole: Pain, asthenia, fever, chills,
, allergic reaction, bone pain, arthralgia
, hypersensitivity (anaphylaxis, urticaria, bronchospasm, angioedema, or hypotension),
of infections, infusion reaction (chills, fever,
nausea, vomiting, pain, rigors, headache, dizziness, dyspnea
, hypotension, rash). CNS: Headache, insomnia, dizziness, paresthesias, depression
, peripheral neuritis
. CV: CHF,
cardiac dysfunction (dyspnea, cough, paroxysmal nocturnal dyspnea
, peripheral edema, S3 gallop, reduced ejection fraction),
tachycardia, edema, cardiotoxicity. GI: Diarrhea, abdominal pain, nausea, vomiting,
anorexia. Hematologic: Anemia, leukopenia. Respiratory: Cough, dyspnea,
rhinitis, pharyngitis, sinusitis
. Skin: Rash,
herpes simplex, acne
may increase trastuzumab levels and toxicity
Assessment & Drug Effects
- Lab tests: Periodically monitor CBC with differential, platelet count, and Hgb and Hct.
- Monitor for chills and fever during the first IV infusion; these adverse events usually respond to prompt treatment without
the need to discontinue the infusion. Notify physician immediately.
- Monitor carefully cardiovascular status at baseline and throughout course of therapy, assessing for S&S of heart failure
(e.g., dyspnea, increased cough, PND, edema, S3 gallop). Those with preexisting cardiac dysfunction are at high risk for
Patient & Family Education
- Report promptly any unusual symptoms (e.g., chills, nausea, fever) during infusion.
- Report promptly any of the following: Shortness of breath, swelling of feet or legs, persistent cough, difficulty sleeping,
loss of appetite, abdominal bloating.