The Xin Delu Sheng Recombinant Human Interleukin‑2 Injection manual provides dosage, indications, contraindications, storage, and safety information.
Recombinant Human Interleukin‑2 Injection (重组人白介素-2注射液) is an immunomodulatory drug used for the biological treatment of various malignant tumors, including kidney cancer, malignant melanoma, and malignant pleural or peritoneal effusions. The product is supplied as a clear sterile solution in glass vials or pre‑filled syringes.
The instructions detail recommended dosing (20‑100 万 IU/m² daily by intravenous, subcutaneous or intramuscular injection), contraindications, common adverse reactions such as fever and chills, storage conditions (2‑8 °C, protected from light), and handling precautions. It also includes information on use in pregnancy, pediatric and elderly patients, and emergency measures for overdose. This manual is written in Chinese.
| Dosage form | Transparent sterile solution |
|---|---|
| pH | 3.5 ~ 4.5 |
| Strength (vial) | 50万 IU/0.4 ml per vial |
| Strength (syringe) | 100万 IU/0.8 ml per pre‑filled syringe |
| Storage temperature | 2 ~ 8 °C, protected from light |
| Shelf life | 24 months |
| Packaging (vial) | Glass vial, 1 vial per box |
| Packaging (syringe) | Pre‑filled syringe, 1 per box |
| Approval number (50万 IU/vial) | 国药准字S20040007号 |
The most common adverse reactions are fever, chills, and muscle aches; other possible effects include nausea, vomiting, rash, and local injection site redness or pain.
Patients with a known allergy to any component, high fever, severe heart disease, low blood pressure, severe cardiac‑renal dysfunction, lung disease, organ transplant recipients, or a history of severe toxicity to IL‑2 should not use the product.
Store the injection at 2 ~ 8 °C, protected from light, and do not exceed 7 days at room temperature during transport.
Typical dosing is 20‑100 万 IU per square meter of body surface area once daily for four weeks; intrathoracic or intraperitoneal administration may be 50‑100 万 IU/m² 1‑2 times per week for 2‑4 weeks.