Tyvyt Sintilimab Injection

1. Indications and Usage
Relapsed or Refractory Classical Hodgkin Lymphoma (cHL):
Indicated for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma who have received at least two prior lines of systemic chemotherapy.
Non-Small Cell Lung Cancer (NSCLC):
Indicated in combination with platinum-based chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC (both squamous and non-squamous).
Esophageal Squamous Cell Carcinoma (ESCC):
Indicated in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of locally advanced, recurrent, or metastatic ESCC.
Hepatocellular Carcinoma (HCC):
Indicated in combination with bevacizumab biosimilar for the first-line treatment of unresectable or metastatic HCC.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Dose: 200 mg administered intravenously every 3 weeks.
Duration: Continue until disease progression or unacceptable toxicity.
Preparation:
Dilute the required volume into a sterile infusion bag containing 0.9% Sodium Chloride Injection. The final concentration should range from 0.5 to 5.0 mg/mL.
Administration:
Infuse over 30 to 60 minutes.
3. Mechanism of Action
PD-1 Blockade:
Sintilimab is a recombinant 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 inhibiting the PD-1 pathway-mediated immune suppression and restoring anti-tumor immune responses.
4. Safety and Warnings
Immune-Mediated Adverse Reactions (IMARs):
Can cause severe or fatal immune-mediated adverse reactions in any organ system, including pneumonitis, hepatitis, nephritis, myocarditis, and endocrinopathies. Monitor patients with baseline and periodic labs.
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 and for at least 5 months after the last dose.
5. Adverse Reactions
Most Common:
Pyrexia, anemia, fatigue, increased ALT/AST, decreased white blood cell count, and thyroid dysfunction (hypothyroidism).
6. Drug Interactions
Immunosuppressants:
Systemic corticosteroids and other immunosuppressive drugs may interfere with the efficacy of Sintilimab. Avoid use prior to initiation unless required for managing IMARs.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sintilimab.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light.