Yuancexin Recombinant Human Interleukin-2 for Injection

1. Indications and Usage
Malignant Tumors: Treatment of renal cell carcinoma, melanoma, breast cancer, bladder cancer, liver cancer, colorectal cancer, lymphoma, and lung cancer. It is also used for the control of malignant pleural and ascitic effusions.
Immune Enhancement: Treatment of postoperative, post-radiotherapy, and post-chemotherapy tumor patients to enhance immune function.
Immunodeficiency: Treatment of congenital or acquired immunodeficiency diseases to improve cellular immune function and anti-infection ability.
Autoimmune Diseases: Treatment of various autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and Sjögren’s syndrome.
Infectious Diseases: Has certain therapeutic effects on viral, bacillary, and intracellular parasitic infections, such as Hepatitis B, leprosy, tuberculosis, and Candida albicans infections.
2. Dosage and Administration
Administration: Must be used under the guidance of an experienced specialist. Dissolve with sterile water for injection or physiological saline before use. The solution should be clear; do not use if cloudy or precipitated. Use immediately after opening.
General Systemic Administration:
Subcutaneous or Intramuscular Injection: 500,000 to 1,000,000 IU/m², 2-3 times per week, for a course of 4-6 weeks.
Regional and Local Administration:
Intrapleural/Intraperitoneal Injection: For malignant effusions, after draining the fluid, inject 300,000 to 1,000,000 IU/m² per dose, 1-2 times per week, for 2-4 weeks (or until effusion disappears).
Intravenous Drip: 200,000 IU/m² (adults approx. 300,000 IU) added to 100-500 mL of normal saline, dripped over 2-3 hours, once daily, for 4-6 weeks.
Note: Dosage varies by manufacturer and specific patient condition. Treatment should start with a low dose and gradually increase.
3. Mechanism of Action
Lymphokine: Recombinant Human Interleukin-2 (rhIL-2) is a lymphokine that promotes the proliferation of cytotoxic T cells, natural killer (NK) cells, and lymphokine-activated killer (LAK) cells.
Immune Activation: It enhances the killing activity of these cells and promotes lymphocytes to secrete antibodies and interferons, thereby exerting antiviral, anti-tumor, and immune-enhancing effects.
4. Safety and Warnings
Contraindications:
Patients with a history of hypersensitivity to any component of the product (including human albumin).
Patients with high fever, severe heart disease, hypotension, severe cardiac or renal insufficiency, abnormal pulmonary function, or those who have undergone organ transplantation.
History of specific severe toxic reactions to IL-2 (e.g., sustained ventricular tachycardia, uncontrolled arrhythmias, cardiac tamponade, renal failure requiring dialysis >72 hours, coma, or gastrointestinal bleeding requiring surgery).
Capillary Leak Syndrome (CLS): Overdose or high doses may cause CLS, characterized by hypotension, peripheral edema, and transient renal insufficiency. Discontinue immediately and provide symptomatic treatment if this occurs.
Special Populations: Use with caution in pregnant and lactating women.
5. Adverse Reactions
Most Common: Fever and chills, which are dose-related. Usually transient (around 38°C), but high fever with chills may occur. Body temperature typically returns to normal 3-4 hours after stopping the drug.
Other Common Reactions: Nausea, vomiting, and flu-like symptoms.
Local Reactions: Subcutaneous injection may cause local redness, swelling, induration, and pain.
Severe Reactions: Capillary Leak Syndrome (hypotension, edema, renal dysfunction) with high doses.
6. Drug Interactions
Reliable reference data on drug interactions is currently unavailable. Concomitant use with other drugs should be approached with caution.
7. Pharmaceutical Information
Chemical Name: Recombinant Human Interleukin-2 (derived from recombinant E. coli). Some formulations (e.g., 125Ser) are modified for enhanced thermal stability.
Excipients: Typically contains Human Albumin and/or Mannitol.
Storage: Store and transport at 2-8°C, protected from light.