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【INDICATIONS AND USAGE】
This product is a bispecific antibody directed against the EGF and MET receptors,indicated for the treatment of adult patients with:
Locally advanced or metastatic non-small cell lung cancer(NSCLC)harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations,in combination with lazertinib,for first-line treatment.
Locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations,in combination with carboplatin and pemetrexed,for first-line treatment.
Locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations,as monotherapy,in patients whose disease has progressed on or after platinum-based chemotherapy.
【RECOMMENDED DOSAGE】
The recommended dosage is based on baseline body weight and is administered as a diluted intravenous infusion.
Administer premedication as recommended prior to each infusion.
Administer via a peripheral vein during Weeks 1 and 2.
When used with chemotherapy:administer once weekly for 4 weeks,with the initial dose split across Day 1 and Day 2 of Week 1;subsequently,administer every 3 weeks beginning with Week 7.
When used as monotherapy or with lazertinib:administer once weekly for 5 weeks,with the initial dose split across Day 1 and Day 2 of Week 1;subsequently,administer every 2 weeks beginning with Week 7.
When coadministered with lazertinib,provide prophylactic anticoagulation during the first four months of treatment to reduce the risk of venous thromboembolic(VTE)events.
Administer the infusion at the rates specified in Tables.
【ADVERSE REACTIONS】
In combination with lazertinib:
The most common adverse reactions(≥20%)were rash,nail toxicity,infusion-related reactions,musculoskeletal pain,stomatitis,edema,venous thromboembolic events,paresthesia,fatigue,diarrhea,constipation,COVID-19,hemorrhage,dry skin,decreased appetite,pruritus,nausea and ocular toxicity.
The most common Grade 3 or 4 laboratory abnormalities(≥2%)were decreased albumin,decreased sodium,increased ALT,decreased potassium,decreased hemoglobin,increased AST,increased GGT,and increased magnesium.
In combination with carboplatin and pemetrexed:
The most common adverse reactions(≥20%)were rash,nail toxicity,stomatitis,infusion-related reactions,fatigue,edema,constipation,decreased appetite,nausea,COVID-19,diarrhea and vomiting.
The most common Grade 3 or 4 laboratory abnormalities(≥2%)were decreased albumin,increased ALT,increased GGT,decreased sodium,decreased potassium,decreased magnesium,and decreased white blood cells,hemoglobin,neutrophils,platelets and lymphocytes.
As monotherapy:
The most common adverse reactions(≥20%)were rash,infusion-related reactions,paronychia,musculoskeletal pain,dyspnea,nausea,fatigue,edema,stomatitis,cough,constipation and vomiting.
The most common Grade 3 or 4 laboratory abnormalities(≥2%)were decreased lymphocytes,decreased albumin,decreased phosphate,decreased potassium,increased alkaline phosphatase,increased glucose,increased GGT,and decreased sodium.
【MECHANISM OF ACTION】
This product is a bispecific antibody that binds the extracellular domains of EGFR and MET.In vitro and in vivo studies show that it disrupts EGFR and MET signaling function by blocking ligand binding and,in exon 20 insertion mutation models,by degrading EGFR and MET.The presence of EGFR and MET on the tumor cell surface also permits targeting of these cells for destruction by immune effector cells such as natural killer cells and macrophages,through antibody-dependent cellular cytotoxicity(ADCC)and trogocytosis,respectively.
【STORAGE】
Store refrigerated at 2°C to 8°C(36°F to 46°F)in the original carton to protect from light.Do not freeze.