Baizean Tislelizumab Injection

1. Indications and Usage
Classical Hodgkin Lymphoma (cHL):
Indicated for the treatment of adult and pediatric patients (13 years of age and older) with relapsed or refractory classical Hodgkin lymphoma after failure of at least 2 prior systemic therapies.
Urothelial Carcinoma:
Indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.
Non-Small Cell Lung Cancer (NSCLC):
Indicated in combination with pemetrexed and platinum for the first-line treatment of patients with metastatic non-squamous NSCLC.
Indicated in combination with paclitaxel and carboplatin for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC.
Hepatocellular Carcinoma (HCC):
Indicated in combination with tislelizumab for the first-line treatment of patients with unresectable hepatocellular carcinoma.
Esophageal Squamous Cell Carcinoma (ESCC):
Indicated in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic ESCC.
Gastric or Gastroesophageal Junction Adenocarcinoma:
Indicated in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Solid Tumors:
Indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have progressed following prior treatment and who have no satisfactory alternative treatment options.
2. Dosage and Administration
Recommended Dosage:
Fixed Dose: 200 mg administered intravenously every 3 weeks.
Weight-Based Dose (Specific Indications): 3 mg/kg administered intravenously every 3 weeks (e.g., for certain indications or patients <60 kg depending on specific regional labeling).
Continue until disease progression or unacceptable toxicity.
Administration Instructions:
Administer as an intravenous infusion over 30 to 60 minutes.
Do not administer as an intravenous push or bolus.
Use an intravenous line with a sterile, non-pyrogenic, low-protein binding inline filter (pore size 0.2 or 0.22 µm).
Dilute in 100 mL 0.9% Sodium Chloride Injection.
3. Mechanism of Action
PD-1 Receptor Blockade:
Tislelizumab is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor.
Structural Optimization:
Tislelizumab is engineered with a modified Fc region (IgG4 backbone) to minimize binding to Fc gamma receptors (FcγR) on macrophages. This prevents Antibody-Dependent Cellular Phagocytosis (ADCP) of T cells, thereby maximizing T-cell activation and antitumor immune response compared to other anti-PD-1 antibodies.
4. Safety and Warnings
Immune-Mediated Adverse Reactions:
Tislelizumab can cause severe and life-threatening immune-mediated adverse reactions affecting organs such as the lungs (pneumonitis), intestines (colitis), liver (hepatitis), endocrine glands (thyroiditis, hypophysitis), and kidneys (nephritis).
Infusion-Related Reactions:
Monitor for signs of anaphylaxis or infusion reactions during administration.
Embryo-Fetal Toxicity:
May cause fetal harm when administered to a pregnant woman.
5. Adverse Reactions
Most Common:
Fatigue, nausea, decreased appetite, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and pruritus.
6. Drug Interactions
Immunosuppressive Agents:
Systemic corticosteroids and other immunosuppressive agents may interfere with the mechanism of action of tislelizumab. Avoid using systemic corticosteroids (prednisone >10 mg daily) prior to the first dose unless clinically necessary for autoimmune disease or symptom control.
7. Pharmaceutical Information
Storage:
Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.