Iodine131I Metuximab Application Scope

Indicated for primary hepatocellular carcinoma (HCC) that is:

Unresectable or recurrent after surgery.
Unsuitable for or unresponsive to Transcatheter Arterial Chemoembolization (TACE).
For the prevention of postoperative recurrence in high-risk patients.

Iodine131I Metuximab Characteristics

Ingredients: Iodine131I Metuximab.
Properties:

Non-reducing molecular weight: 96,000 – 110,000 Da.
- Skin-test formulation: white loose solid.
- Injection: colorless, clear solution.
Packaging Specification: 5 mg/vial (1 patient dose/box).
Storage:
- Store at 2 – 8 °C, protected from light.
- Keep in a lead container during storage and transport.
- Do not freeze or shake.
Expiry Date:
- Skin test formulation: 24 months.
- Injection: 48 hours after preparation.
Executive Standard: To be confirmed (per NMPA).
Approval Number:
- Iodine-131 Metuximab Injection: Guo Yao Zhun Zi S20060064
- Skin Test Preparation: Guo Yao Zhun Zi S20060065
Date of Revision: To be confirmed.
Manufacturer: Huashen Group (Chengdu) in collaboration with The Fourth Military Medical University, China.

Guidelines for the Use of Iodine131I Metuximab

Dosage and Administration:
- Recommended Dose:
  1. Dosage is calculated by body weight.
  - 27.75 MBq/kg (0.75 mCi/kg) for tumors < 8 cm.
  - 37 MBq/kg (1.0 mCi/kg) for tumors ≥ 8 cm.
  - Minimum interval between doses: 4 weeks or greater.
- Administration:
  - Administer via hepatic artery catheterization into the proper hepatic or tumor-feeding artery—complete injection within 5–10 minutes, followed by 10 mL saline flush.
- Missed Dose: No double dosing. Reschedule based on the physician’s evaluation.
Adverse Reactions:
- Common Adverse Reactions:
  
  Observed in clinical studies (n = 103):
  - Thrombocytopenia (25.2%)
  - Elevated ALT (21.4%) / AST (21.4%)
  - Leukopenia (18.4%)
  - Elevated bilirubin (14.6%)
  - Anemia (13.6%)
  - Neutropenia (8.7%)
  - Proteinuria (8.7%)
  - HAMA reaction (3.9%)
  - Mild fever (2.9%)
- Serious Adverse Reactions:
  - Rare; may include transient Grade III hematologic or hepatic toxicity.
  - Usually reversible within 28 days.
  - No severe allergic or anaphylactic events reported.
Contraindications:
- Known hypersensitivity to Metuximab, iodine compounds, or any excipients.
- Positive HAMA (human anti-mouse antibody) test.
- Inability to tolerate thyroid-blocking medication (e.g., Lugol’s solution).
- Child-Pugh C liver function classification.
Precautions:
- Must be administered in certified facilities with nuclear medicine capability and trained personnel.
- Strictly follow radiation safety regulations (GB 8703-88):
  - Minimize exposure time.
  - Increase operator distance.
  - Use appropriate shielding and lead containers.
- Maintain accurate usage log and radiation monitoring records.
- Handle spills or leaks per emergency radiation protocols.
- Dispose of radioactive waste only after adequate decay.
- Monitor hematologic and hepatic functions during treatment.
- Avoid use in pregnant or lactating women; may cause fetal thyroid injury.
- Pediatric and elderly use is not recommended due to insufficient data.

Iodine131I Metuximab Interactions

No confirmed drug interaction studies.
Avoid concurrent radiotherapy or radiopharmaceuticals without medical supervision.
May interfere with radioiodine thyroid imaging or therapy.
Use caution with immunosuppressive agents or recent monoclonal antibody therapy.

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.