Formulation and specifications: Injection: 1200mg (20ml)/bottle
Indications:
1. Atelelizumab is used in combination with carboplatin and etoposide for the first-line treatment of patients with ES-SCLC.
2. Atelizumab is used for first-line monotherapy of EGFR mutation-negative and ALK-negative metastatic NSCLC with ≥50% tumor cell PD-L1 staining positivity (TC≥50%) or tumor-infiltrating PD-L1-positive immune cells (IC) covering ≥10% of the tumor area (IC≥10%) as assessed by an assay approved by the State Drug Administration.
3. atelelizumab in combination with pemetrexed and platinum-based chemotherapy for first-line treatment of patients with EGFR mutation-negative and ALK-negative metastatic nonsquamous NSCLC.
Key points for rational drug use:
1. The usage of atelelizumab is a fixed dose of 1200 mg administered by intravenous infusion lasting at least 60 minutes for the first dose and at least 30 minutes for subsequent infusions if the first infusion is well tolerated by the patient. When used in ES-SCLC, the induction phase is combined with carboplatin and etoposide regimens every 3 weeks, with a chemotherapy-free maintenance phase after 4 cycles of treatment. For first-line monotherapy in NSCLC, administer every 3 weeks. For first-line combination chemotherapy in NSCLC, the induction phase in combination with pemetrexed and platinum regimens every 3 weeks, followed by a maintenance phase of atelelizumab in combination with pemetrexed after 4 or 6 treatment cycles.
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 tumor efficacy assessments within 4 to 8 weeks.
3. For suspected immune-related adverse reactions, an adequate evaluation should be performed to confirm the etiology or to exclude other etiologies. Depending on the type and severity of immune-related adverse reactions, dosing may need to be suspended or permanently discontinued, and dose increases or reductions are not recommended.
4. The use of systemic glucocorticoids or other immunosuppressive agents should be avoided prior to the administration 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 patients are receiving glucocorticoids or other immunosuppressive agents up to immunosuppressive doses.
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 in patients with severe renal impairment have not been established and require caution under the guidance of a physician if the expected benefit of using this product outweighs the risk as assessed by the physician.
*6. The US FDA approved indications for atelelizumab also include: atelelizumab as adjuvant therapy after surgery and platinum-containing chemotherapy in patients with PD-L1 TC ≥ 1% stage II-IIIA NSCLC; in combination with albumin paclitaxel and carboplatin for EGFR/ALK-negative advanced non-squamous cell NSCLC first-line treatment; combination of bevacizumab and paclitaxel and carboplatin for EGFR/ALK-negative advanced non-squamous cell NSCLC first-line treatment; atelelizumab alone for second-line treatment of advanced NSCLC after progression on platinum-containing chemotherapy; combination of bevacizumab for unresectable hepatocellular carcinoma that has received prior systemic therapy; as adjuvant therapy for locally advanced or metastatic uroepithelial carcinoma as first-line therapy; and in combination with carbitinib and vemifenib for the treatment of unresectable or metastatic melanoma positive for the BRAF V600 mutation. These indications, except for hepatocellular carcinoma, are not currently approved in China and can be used properly with adequate communication with patients and in accordance with FDA-approved usage.