Formulation and specifications: Injection: 50 mg (10 ml)/vial
Indications: This product is used in combination with navulizumab in adult patients with non-surgically resectable, primary non-epithelial malignant pleural mesothelioma.
Rational dosing points:
1. The recommended dose of this product is 1 mg/kg every 6 weeks by intravenous infusion over 30 minutes, in combination with 360 mg of nabumetinumab every 3 weeks, or in combination with 3 mg/kg of nabumetinumab every 2 weeks by intravenous infusion over 30 minutes until disease progression or intolerable toxicity occurs, or until 24 months in patients without disease progression.
2. Atypical reactions have been observed. For patients who are clinically stable and have preliminary evidence of disease progression, continued treatment with this product in combination with navulizumab is recommended until disease progression is confirmed.
3. Liver function and thyroid function should be assessed at baseline and prior to each dose of this product. In addition, any signs or symptoms of immune-related adverse reactions (including diarrhea and colitis) must be evaluated during treatment with this product.
4. This product may be administered by intravenous infusion without dilution or by infusion using sodium chloride solution for injection (9 mg/ml, 0.9%) or glucose solution for injection (50 mg/ml, 5%) diluted to a concentration of 1 to 4 mg/ml. This product should not be administered by intravenous push or single rapid intravenous injection.
5. When used in combination with nabumetinumab, nabumetinumab should be infused first and then this product should be infused on the same day. A separate infusion bag and filter should be used for each infusion.
6. The most common adverse reactions to ibritumomab in combination with nabumetumab are rash, fatigue, diarrhea, pruritus, hypothyroidism and nausea. Most adverse reactions were mild to moderate.
7. When Grade 4 or recurrent Grade 3 adverse reactions occur, or Grade 2 or 3 adverse reactions persist despite therapeutic modifications, the combination of this product with nabumetinumab should be permanently discontinued
8. When this product is administered in combination with nabumetinumab, if either drug is suspended, the other drug should be suspended at the same time. If dosing is restarted after the suspension, either combination therapy or nabumetinumab monotherapy should be restarted based on the individual patient’s assessment.
*9. The U.S. FDA and EU EMA approved ibritumomab in combination with nabumetinumab for the treatment of advanced and metastatic NSCLC, as described in section 18 of the “Nabumetinumab” Rational Drug Use Guideline.