Formulation and Specifications: Injection: 50mg/stem
Indications: This product is indicated for patients with HER2-positive, metastatic breast cancer who have received 1 or more chemotherapy regimens in combination with vincristine.
Key Points for Rational Use:
1. Before receiving initumumab treatment, HER2 testing should be performed in a qualified pathology laboratory, and only HER2-positive patients should be treated with initumumab.
2. The single-week dosing regimen and the three-week dosing regimen were used in the registered clinical studies of initumumab. The recommended initial loading dose of initumumab in the single-week regimen is 4 mg/kg administered intravenously over 90 minutes, and the maintenance dose is 2 mg/kg once a week. The recommended initial loading dose of initumumab in a three-week regimen is 8 mg/kg administered intravenously over 90 minutes, and the maintenance dose is 6 mg/kg every 3 weeks.
3. Caution should be exercised when used concurrently with anthracyclines, as cardiotoxicity may be increased and heart failure may occur in severe cases, and should be administered sequentially or separately.
If LVEF decreases >10% relative to baseline and decreases to less than 50%, initumomab should be suspended and LVEF should be assessed again in approximately 3 weeks. clinically significant congestive heart failure, discontinuation of initumumab is strongly recommended. Frequent monitoring (e.g., every 6 to 8 weeks) should be performed in patients who develop asymptomatic cardiac insufficiency.
5. This product is not recommended for patients with a combination of: (1) congestive heart failure. (2) High-risk, uncontrolled arrhythmias. (3) Angina pectoris requiring drug treatment. (4) Clinically significant heart valve disease. (5) Electrocardiogram suggestive of transmural myocardial infarction. (6) Poorly controlled hypertension.
6. If respiratory distress or clinically significant hypotension occurs with initumomab, the infusion should be interrupted and appropriate medications, including epinephrine, glucocorticoids, phenylephrine, bronchodilators, and oxygen, should be administered. Patients who experience severe and life-threatening infusion-related reactions should be permanently discontinued.
7. Data from the initumumab registry clinical study showed that initumumab in combination with vincristine in patients with HER2-positive metastatic breast cancer who had received 1 or more prior chemotherapy regimens significantly prolonged median progression-free survival compared with vincristine (39.1 weeks vs 14.0 weeks, HR = 0.24, p <0.0001), which resulting in clinical benefit to patients.