Hanszhuang Slulituximab Injection

1. Indications and Usage
Serplulimab is a PD-1 antagonist indicated for the treatment of adult patients with unresectable or metastatic Microsatellite Instability-High (MSI-H) solid tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.
Note: It is also approved for specific indications in Small Cell Lung Cancer (SCLC) and Gastric Cancer in combination with chemotherapy.
2. Dosage and Administration
Recommended Dosage: 3 mg/kg administered as an intravenous infusion every 2 weeks until disease progression or unacceptable toxicity.
Preparation: Dilute the required volume of Serplulimab into a sterile polyvinyl chloride (PVC) or polyethylene (PE) infusion bag containing 0.9% Sodium Chloride Injection (100 mL).
Administration: Infuse over 30 to 60 minutes. Do not administer as an intravenous push or bolus.
3. Mechanism of Action
PD-1 Blockade: Serplulimab is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor.
Immune Activation: It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby reversing PD-1 pathway-mediated immune inhibition and restoring anti-tumor immunity.
4. Safety and Warnings
Immune-Mediated Adverse Reactions: Serplulimab can cause severe or life-threatening immune-mediated adverse reactions (IMARs) in any organ system, including pneumonitis, hepatitis, endocrinopathies (hypothyroidism, adrenal insufficiency), and nephritis.
Infusion-Related Reactions: Monitor patients for signs of infusion reactions during administration.
Embryo-Fetal Toxicity: May cause fetal harm. Women of reproductive potential should use effective contraception during treatment.
5. Adverse Reactions
Most Common: Increased ALT/AST (transaminases), hypothyroidism, fatigue, anemia, and proteinuria.
6. Drug Interactions
Immunosuppressants: Systemic corticosteroids and other immunosuppressive drugs may interfere with the efficacy of Serplulimab.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Serplulimab.
Storage: Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light.