Tevrida Camrelinib Hydrochloride Tablets

1. Indications and Usage
Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC):
Indicated in combination with platinum-doublet chemotherapy for the first-line treatment of patients with locally advanced or metastatic squamous NSCLC .
Hepatocellular Carcinoma (HCC):
Indicated in combination with apatinib for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma .
Classic Hodgkin Lymphoma (cHL):
Indicated for the treatment of adult and pediatric patients with relapsed or refractory classic Hodgkin lymphoma after two or more prior therapies .
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY. Do not administer as an IV push or bolus.
Recommended Dosage:
Standard Dose: 200 mg every 2 weeks (for monotherapy).
Combination: Dosage varies when combined with chemotherapy or apatinib (e.g., 3 mg/kg every 3 weeks).
Administration Instructions:
Infuse over 30 to 60 minutes through an IV line with an in-line sterile, non-pyrogenic, low-protein binding filter.
3. Mechanism of Action
PD-1 Blockade:
Camrelizumab is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1)receptor.
Immune Activation:
It blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2). This reverses T-cell exhaustion, restoring the immune system’s ability to recognize and kill tumor cells .
4. Safety and Warnings
Immune-Mediated Adverse Reactions:
Can cause severe and fatal immune-mediated adverse reactions in any organ system (e.g., pneumonitis, colitis, hepatitis, endocrinopathies). Monitor patients regularly.
Infusion-Related Reactions:
Severe reactions (anaphylaxis) can occur during or within 24 hours of infusion. Interrupt or discontinue infusion if severe reactions occur.
Embryo-Fetal Toxicity:
Exposure to camrelizumab may cause fetal harm due to potential disruption of maternal PD-1 pathway signaling.
5. Adverse Reactions
Most Common:
General: Fatigue, pyrexia (fever).
Dermatologic: Pruritus, rash.
Unique Toxicity: Reactionary Capillary Proliferation (RCPE): Often manifests as small, bright red papules on the skin (distinct from Kaposi sarcoma) .
6. Drug Interactions
Immunosuppressants:
Systemic corticosteroids and other immunosuppressive drugs can interfere with the pharmacodynamic activity of camrelizumab. Avoid use unless necessary for managing immune-mediated adverse reactions.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Camrelizumab.
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid for injection.
Storage: Store at 2°C–8°C (36°F–46°F). Do not freeze or shake.