AiRuiKa Camrelizumab for 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.
Hepatocellular Carcinoma (HCC):
Indicated for the treatment of patients with hepatocellular carcinoma who have previously been treated with sorafenib and/or oxaliplatin-based systemic chemotherapy.
Esophageal Squamous Cell Carcinoma (ESCC):
Indicated for the treatment of patients with locally advanced or metastatic ESCC who have progressed after or are intolerant to first-line 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) without sensitizing EGFR mutations or ALK genomic variants.
2. Dosage and Administration
Route of Administration:
Intravenous Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Fixed Dosing: 200 mg administered intravenously every 2 weeks or every 3 weeks (depending on the specific indication).
Weight-Based Dosing: 3 mg/kg administered intravenously every 3 weeks (specifically for HCC indication).
Duration: Continue until disease progression or unacceptable toxicity.
Preparation:
Dilute the required volume into a sterile infusion bag containing 0.9% Sodium Chloride Injection or 5% Glucose Injection.
3. Mechanism of Action
PD-1 Blockade:
Camrelizumab 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 evasion and restoring anti-tumor immunity.
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 2 months after the last dose.
5. Adverse Reactions
Unique Adverse Reaction:
Reactive Capillary Proliferation (RCP): A distinctive adverse reaction characterized by small, red, punctate lesions (resembling cavernous hemangiomas) on the skin or mucous membranes.
Other Common Reactions:
Hypothyroidism, Increased ALT/AST, Fatigue, Anemia, Proteinuria, Fever, Leukopenia.
6. Drug Interactions
Immunosuppressants:
Systemic corticosteroids and other immunosuppressive drugs may interfere with the efficacy of Camrelizumab. Avoid use prior to initiation unless required for managing IMARs.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Camrelizumab.
Storage:
Store in a refrigerator at 2-8°C. Do not freeze or shake. Protect from light.