Kantanni Cadonilimab Injection

1. Indications and Usage
Cadonilimab is indicated for the treatment of recurrent or metastatic cervical cancer in patients who have failed platinum-based chemotherapy. It is also indicated in combination with fluoropyrimidine and platinum-based chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
2. Dosage and Administration
Cervical Cancer Dosage: The recommended dose is 6 mg/kg administered via intravenous infusion every 2 weeks until disease progression or unacceptable toxicity.
Gastric Cancer Dosage: The recommended dose is 10 mg/kg administered via intravenous infusion every 3 weeks until disease progression or unacceptable toxicity.
Administration: Infusion should be completed over approximately 60 minutes. The solution must be diluted in 100 mL of 0.9% sodium chloride injection and administered using a sterile, low-protein binding infusion filter (0.22 or 0.2 μm). Do not administer as an intravenous push or bolus.
3. Mechanism of Action
Cadonilimab is a recombinant humanized fusion protein monoclonal antibody that targets PD-1 and CTLA-4. It simultaneously binds to PD-1 on T cells and CTLA-4 on T cells and antigen-presenting cells, thereby blocking their interaction and enhancing anti-tumor immune responses.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: Severe or fatal immune-mediated pneumonitis, colitis, hepatitis, and endocrinopathies (such as hypothyroidism, hyperthyroidism, and adrenal insufficiency) may occur.
Infusion-Related Reactions: Reactions ranging from fever to anaphylaxis may occur during or after infusion.
Hepatic and Renal Impairment: The drug is not recommended for patients with moderate to severe hepatic or renal impairment due to lack of data.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions (incidence ≥10%) include rash, anemia, hypothyroidism, elevated AST, elevated ALT, pruritus, fatigue, and proteinuria.
Clinical Research: In pivotal clinical trials, cadonilimab demonstrated significant clinical response rates in patients with recurrent or metastatic cervical cancer and gastric cancer, with a manageable safety profile consistent with other immune checkpoint inhibitors.
6. Drug Interactions
Immunosuppressants: Concomitant use of immunosuppressants (other than for managing immune-mediated adverse reactions) may reduce the efficacy of cadonilimab.
Vaccines: Live vaccines should be avoided during treatment with cadonilimab.
7. Pharmaceutical Information
Composition: Active ingredient is cadonilimab. Excipients include histidine, hydrochloric acid, sucrose, polysorbate 80, and water for injection.
Appearance: Clear to slightly yellow liquid, which may be slightly opalescent.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.