Airikang Camrelizumab for Injection

1. Indications and Usage
Classic Hodgkin Lymphoma (cHL):
Treatment of adult patients with relapsed or refractory cHL who have received at least two prior systemic chemotherapy regimens.
Hepatocellular Carcinoma (HCC):
Treatment of adult patients with previously treated advanced HCC who have received sorafenib and/or oxaliplatin-based systemic chemotherapy.
Esophageal Squamous Cell Carcinoma (ESCC):
Treatment of patients with locally advanced or metastatic ESCC who have progressed on or after first-line chemotherapy.
Non-Small Cell Lung Cancer (NSCLC):
Combination with paclitaxel and carboplatin for locally advanced or metastatic squamous NSCLC; combination with pemetrexed and carboplatin for EGFR/ALK-negative non-squamous NSCLC.
Nasopharyngeal Carcinoma (NPC):
Treatment of patients with locally recurrent or metastatic NPC who have progressed on at least two prior systemic therapies.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
cHL and ESCC: 200 mg administered once every 2 weeks.
HCC: 3 mg/kg administered once every 3 weeks.
NSCLC and NPC: 200 mg administered once every 3 weeks.
Duration: Continue administration until disease progression or until unacceptable toxicity occurs.
Critical Administration Instructions:
Co-administration with Chemotherapy: When administered with chemotherapy, Camrelizumab must be infused first, followed by chemotherapy after an interval of at least 30 minutes.
Infusion Time: The infusion should be completed within 30 to 60 minutes. Rapid IV injection is strictly prohibited.
Preparation: Reconstitute and dilute using aseptic technique. The product does not contain preservatives.
3. Mechanism of Action
PD-1 Blockade:
Camrelizumab is a humanized IgG4 monoclonal antibody that specifically binds to Programmed Death-1 (PD-1).
Immune Reconstitution:
By blocking the interaction between PD-1 and its ligands (PD-L1/PD-L2), it reactivates exhausted T cells, restores their immune surveillance and cytotoxicity, and facilitates the destruction of tumor cells.
4. Safety and Warnings
Immune-Mediated Adverse Reactions:
May cause severe and fatal immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroiditis, hypophysitis), or severe cutaneous adverse reactions. Monitor clinical and laboratory parameters regularly.
Infusion-Related Reactions:
Serious reactions including anaphylaxis have been reported. Monitor patients closely during and after infusion.
Reactionary Capillary Hyperplasia:
A characteristic adverse reaction of camrelizumab, occurring in 70% to 80% of patients. It typically manifests as red nodules or patches on the skin or oral mucosa.
Hepatic and Renal Impairment:
Not recommended for patients with moderate to severe hepatic or renal impairment.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Reactionary capillary hyperplasia, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), hypothyroidism, fatigue, anemia, hyperbilirubinemia, and pyrexia.
Clinical Research Highlights:
Phase 3 trials have demonstrated that camrelizumab significantly improves objective response rates (ORR) and overall survival (OS) compared to standard chemotherapy in various solid tumors.
6. Drug Interactions
Immunosuppressive Agents:
Systemic corticosteroids or other immunosuppressive agents should be avoided prior to initiating therapy, as they may interfere with the pharmacodynamic activity of camrelizumab.
Use for Adverse Events:
Systemic corticosteroids and other immunosuppressive agents may be used if required for the management of immune-mediated adverse reactions.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Camrelizumab (Humanized anti-PD-1 monoclonal antibody).
Appearance: White to off-white powder or cake.
Packaging: Single-use vial (200 mg).
Storage: Store at 2°C to 8°C. Protect from light. Do not freeze.