Formulation and specifications: Injection: 1200 mg (20 ml)/vial
Indications: Atelelizumab in combination with bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic systemic therapy.
Rational dosing points:
1. atelelizumab in combination with bevacizumab based on the IMBrave150 study: first intravenous infusion of atelelizumab at the recommended dose of 1200 mg, followed by intravenous infusion of bevacizumab at 15 mg/kg. this regimen was administered every 3 weeks. The first dose should last at least 60 minutes and subsequent doses may last at least 30 minutes.
2. Patients may be treated with atelelizumab until no clinical benefit or intolerable toxicity occurs. If the patient is clinically stable, continued treatment with this product may be considered based on a judgment of overall clinical benefit, even if there is preliminary evidence of disease progression. Close monitoring should be conducted in patients who continue treatment with atelelizumab after disease progression, with repeat oncologic efficacy assessments within 4 to 8 weeks.
3. Baseline tests including thyroid function and cardiac enzymes are recommended prior to treatment and regular follow-up during treatment for early detection of immune-related adverse reactions, while it should be noted that immune-related adverse reactions may also occur after the end of treatment. For suspected immune-related adverse reactions, adequate evaluation should be performed to confirm the etiology or exclude other etiologies. Depending on the type and severity of the immune-related adverse reaction, dosing may need to be suspended or permanently discontinued, and no dose increases or reductions are recommended. In severe cases or those with doubtful diagnosis, a multidisciplinary comprehensive treatment (MDT) of immune adverse reactions consisting of gastroenterology, rheumatology, dermatology, respiratory medicine, oncology, etc. may be consulted.
4. Systemic glucocorticoids or other immunosuppressive agents should be avoided prior to the use of this product, as they may affect the pharmacodynamic activity and efficacy of this product. However, systemic glucocorticoids or other immunosuppressive agents may be used to treat immune-related adverse reactions after administration of this product has been initiated. Retreatment with atelelizumab is not recommended while the patient is receiving immunosuppressive doses of glucocorticoids or other immunosuppressive agents.
5. The safety and efficacy of atelizumab in pediatric and adolescent patients under 18 years of age have not been established. No dose adjustment is required in elderly patients (≥65 years of age), patients with mild hepatic impairment, or patients with mild to moderate renal impairment. The safety and efficacy of use in patients with moderate to severe hepatic impairment, and patients with severe renal impairment have not been established and should be used with caution under the guidance of a physician if the expected benefit of using this product outweighs the risk as assessed by the physician.