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Adjuvant Breast Cancer Treatment
This section provides health care professionals with data on the proposed mechanisms of action, indications and usage, efficacy, and important safety information for Herceptin (trastuzumab) in adjuvant use.
- Treatment Guidelines
- In response to emerging evidence, guidelines from the National Comprehensive Cancer Network® (NCCN) have been revised to support the adjuvant use of Herceptin, regardless of nodal status.
- Pivotal Studies and Efficacy
- Four phase III trials involving more than 10,000 patients demonstrated a significant reduction in the risk of recurrence when 52 weeks of Herceptin were used with standard adjuvant therapy.
- Dosing and Administration
- Read more in this section to assist you in the proper administration of Herceptin.
- Treatment Duration
- Labeling indicates use in combination with chemotherapy, and then as a single agent, for a total of 52 weeks.
- Cardiac Safety Profile
- Patients receiving Herceptin therapy should be frequently monitored for heart function decline before, during and after treatment.
- Possible Side Effects
- There are serious side effects associated with Herceptin.
- Proposed Mechanisms of Action
- How does Herceptin work? Read this section for answers.
- Full Prescribing Information
- A link to the Full Prescribing Information
Boxed WARNINGS and Additional Important Safety Information
- Cardiotoxicity and Cardiac Monitoring
- Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF).
- The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens.
- Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.
- Patients should undergo monitoring for decreased left ventricular function before Herceptin treatment, and frequently during and after Herceptin treatment.
- More frequent monitoring should be employed if Herceptin is withheld in patients who develop significant left ventricular cardiac dysfunction.
- In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.
- Infusion Reactions, Pulmonary Toxicity and Neutropenia
- Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported.
- In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
- Patients should be monitored until signs and symptoms completely resolve.
- Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
- Exacerbation of chemotherapy-induced neutropenia has also occurred.
Pregnancy Category D
Herceptin can cause oligohydramnios and fetal harm when administered to a pregnant woman.
Most Common Adverse Events
The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.
