 Daboshu Sintilimab Injection Application Scope

A fully human IgG4 anti‑PD‑1 monoclonal antibody for treatment of relapsed or refractory classical Hodgkin’s lymphoma after ≥2 lines of systemic chemotherapy.

Also approved in China for various solid tumors including non‑small cell lung cancer (NSCLC), hepatocellular carcinoma, esophageal squamous cell carcinoma, gastric and gastroesophageal junction adenocarcinoma, and EGFR‑mutated NSCLC post‑TKI progression.

 Daboshu Sintilimab Injection Application Scope Characteristics

Ingredients: Active: sintilimab 100 mg/10 mL (10 mg/mL)
Excipients: mannitol, histidine, sodium citrate dihydrate, sodium chloride, edetate disodium, polysorbate 80, citric acid (monohydrate), water for injection
Properties: Clear to slightly opalescent colorless to pale yellow solution. Molecularly fully human IgG4 monoclonal antibody
Packaging Specification: 100 mg/10 mL per vial; typically marketed in boxes containing two vials
Storage: Refrigerate 2 – 8 °C. After opening or dilution, use immediately; diluted product stable for up to 24 hours at 2–8 °C or 6 hours at room temp
Expiry Date: See printed label per batch. Clinical sites record shelf-life as specified per batch
Executive Standard: Meets Chinese pharmacopeia and national standards; class I biological product
Approval Number: Approved by NMPA on December 24, 2018 (first indication: Hodgkin’s lymphoma) under priority review
Date of Revision: Refer to the latest official product label (e.g., October 2022 by CDE); revision dates vary by update
Manufacturer: Innovent Biologics (Suzhou) Co., Ltd., in collaboration with Eli Lilly

Guidelines for the Use of Sintilimab Injection

Dosage and Administration:
- Recommended Dose: 80 mg administered subcutaneously once every 4 weeks.
- Administration: Administer via subcutaneous injection using the single-dose autoinjector.
- Missed Dose: If a dose is missed, administer as soon as possible. Resume monthly dosing from the date of the most recently administered dose.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Injection site reactions (19%)
  - Decreased platelet count (12%)
  - Arthralgia (9%)
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.
Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Drug Interactions

No formal interaction studies; caution when co-administered with bevacizumab, pemetrexed, cisplatin—label advises sequencing with sintilimab first, followed by bevacizumab ≥5 min later, then chemotherapy agents.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.