Anyouping Finotonlimab Injection

1. Indications and Usage
Esophageal Squamous Cell Carcinoma: Indicated for the treatment of unresectable locally advanced or metastatic esophageal squamous cell carcinoma.
Non-Small Cell Lung Cancer: Indicated for the treatment of unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC).
Gastric or Gastroesophageal Junction Cancer: Indicated for the treatment of advanced or metastatic gastric or gastroesophageal junction cancer.
Other Indications: It is also indicated for hepatocellular carcinoma and other solid tumors as approved by relevant regulatory authorities.
2. Dosage and Administration
Recommended Dosage: The recommended dosage for most indications is 400 mg or 420 mg administered intravenously.
Schedule: Infusions are typically given once every 4 weeks.
Administration: Administer as an intravenous infusion over 60 minutes. Do not administer as an intravenous bolus or injection.
Duration: Treatment continues until disease progression or unacceptable toxicity.
3. Mechanism of Action
Finotonlimab is a humanized monoclonal antibody that targets programmed cell death-1 (PD-1). By binding to PD-1, it inhibits the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby restoring the immune response against tumor cells.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: May cause immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (such as hypothyroidism, adrenal insufficiency), and dermatitis.
Infusion-Related Reactions: Monitor for hypersensitivity during and after infusion.
Complications of Allogeneic HSCT: Avoid use in patients with a history of allogeneic hematopoietic stem cell transplantation due to risk of graft-versus-host disease and fatal hepatic toxicity.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include fatigue, pyrexia, cough, nausea, decreased appetite, and rash.
Clinical Research: Efficacy and safety were established in multiple phase II and phase III clinical trials across various tumor types, demonstrating improved objective response rates and survival outcomes compared to standard chemotherapy.
6. Drug Interactions
Immunosuppressive Agents: Systemic corticosteroids or other immunosuppressive agents may reduce the efficacy of Finotonlimab.
Live Vaccines: Concomitant use with live vaccines should be avoided.
7. Pharmaceutical Information
Composition: Active ingredient is finotonlimab.
Appearance: It is a sterile, clear to slightly opalescent, colorless to pale yellow solution.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.