Drug Guide
Trastuzumab
Classification
Therapeutic: Antineoplastic agent, Monoclonal antibody
Pharmacological: HER2/neu receptor antagonist
FDA Approved Indications
- HER2-positive breast cancer (adjuvant and metastatic)
- HER2-positive gastric or gastroesophageal junction adenocarcinoma
Mechanism of Action
Trastuzumab is a monoclonal antibody that binds to the extracellular domain of the HER2 receptor, inhibiting the proliferation of tumor cells that overexpress HER2 and mediating antibody-dependent cellular cytotoxicity.
Dosage and Administration
Adult: Initial dose of 8 mg/kg IV infusion over 90 minutes, then 6 mg/kg every 3 weeks; may be given as a loading dose in certain regimens.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustment, but caution in elderly due to comorbidities.
Renal Impairment: No adjustment necessary.
Hepatic Impairment: No specific data; use caution.
Pharmacokinetics
Absorption: Administered intravenously, so bioavailability is 100%.
Distribution: Volume of distribution approximately 6-8 L.
Metabolism: Metabolized via proteolytic degradation into peptides and amino acids.
Excretion: Not renally excreted; degraded by proteolytic enzymes.
Half Life: Approximately 28.5 days (steady-state).
Contraindications
- History of hypersensitivity to trastuzumab or its components.
Precautions
- Left ventricular ejection fraction (LVEF) should be measured before and during treatment.
- Use caution in patients with preexisting cardiomyopathy or who are receiving cardiotoxic chemotherapy.
Adverse Reactions - Common
- Infusion reaction (Occasional)
- Fatigue (Common)
- Nausea (Common)
- Diarrhea (Common)
- Headache (Common)
Adverse Reactions - Serious
- Cardiotoxicity, including CHF (Uncommon but serious)
- Pulmonary toxicity including interstitial pneumonitis (Rare)
- Infusion-related reactions possibly including hypotension, chills, fever, dyspnea (Uncommon)
Drug-Drug Interactions
- Cardiotoxic agents such as anthracyclines may increase risk of cardiotoxicity.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Baseline cardiac function (LVEF), monitor for infusion reactions, signs of heart failure.
Diagnoses:
- Risk for decreased cardiac output related to cardiotoxicity.
Implementation: Administer IV as prescribed, monitor cardiac status, be prepared to manage infusion reactions.
Evaluation: Assess for signs of cardiotoxicity, monitor LVEF periodically, evaluate tumor response.
Patient/Family Teaching
- Report any symptoms of shortness of breath, fatigue, or swelling.
- Inform about potential infusion reactions and need for monitoring.
- Advise on avoiding pregnancy during and for at least 7 months after treatment.
Special Considerations
Black Box Warnings:
- Cardiotoxicity, including HF and myocardial damage, which may be irreversible.
Genetic Factors: HER2 overexpression must be confirmed by testing before initiation.
Lab Test Interference: May cause falsely elevated levels of serum cardiac troponin and BNP.
Overdose Management
Signs/Symptoms: Severe infusion reactions, cardiomyopathy symptoms.
Treatment: Discontinue infusion, provide supportive care, follow cardiac function closely.
Storage and Handling
Storage: Store vials refrigerated at 2-8°C, protect from light.
Stability: Stable until expiration date on the label when stored properly.