Iodine [131I] Metuximab Injection

The primary hepatocellular carcinoma (HCC) cannot be removed by surgery or recur after surgery, and the advanced HCC is not suitable for transcatheter arterial chemoembolization (TACE), or cannot be cured by TACE treatment, or recurs after surgery.
药品名称
Product Name: Licartin
English Name: Iodine [131I] Metuximab Injection
Pinyin: Dian [131I] Meituoxi Dankang Zhusheye
成 份
This product is radioactive iodine [131I] labeled monoclonal antibody (McAb) produced by HAb18 hybridoma – Metuximab Injection.
Molecular weight: Under non-reducing conditions, the molecular weight of Metuximab is 96,000 ~ 110,000 Da, and that of 131I is 127.
Accessory: Human Albumin
性 状
Iodine [131I] Metuximab skin test preparations are white loose block solid;
Iodine [131I] Metuximab Injection is a colorless clear liquid.
功能主治
The primary hepatocellular carcinoma (HCC) cannot be removed by surgery or recur after surgery, and the advanced HCC is not suitable for transcatheter arterial chemoembolization (TACE), or cannot be cured by TACE treatment, or recurs after surgery.
规格
5mg in 1 bottle
用法用量
Method of administration:
Skin test: Before the administration, the skin test should be carried out first, and a negative result means the injection can be given.
Method: Take 1 bottle of skin test preparations, dissolve in 1ml normal saline, extract 0.1ml dissolved solution, give a forearm intradermal injection, and observe the result after 15min. If the diameter of the skin rash at the injection site>0.5cm, or pseudopodia appear around the injection site, it refers to a positive reaction.
Blocking thyroid: orally take Lugol’s solution 3 days before the treatment, 0.5ml every time, 3 times a day for 10 days.
Vascular administration: interventional administration by intravenous or hepatic arterial injection. Inject designated dose of Iodine [131I] Metuximab Injection after reaching the proper artery or the tumor feeding artery by hepatic artery catheterization. Complete the injection within 5~10min. Immediately flush the cannula with 10ml of 0.9% normal saline, to ensure that the therapeutic drug is fully accessible.
Dosage:
The dosage of Iodine [131I] is calculated depending on the patient’s weight. The generally recommended dosage is 27.75 MBq/kg (0.75mCi/kg). There should be an interval of no less than 4 weeks before each dose.
In Phase I study of clinical tolerability, 29 patients with primary hepatocellular carcinoma were given the four doses of 9.25 MBq/kg, 18.5 MBq/kg, 27.75 MBq/kg and 37 MBq/kg, and the results have shown that the patients can still be tolerated at the maximum dose of 37 MBq/kg. Doses in Phase II non-controlled open clinical study: 27.75MBq/kg for tumor diameter of less than 8cm; 37MBq/kg for tumor diameter of more than 8cm. The medication cycle is 28 days. If the patient is in stable or partial remission condition, and the general circumstances permit, then increase medication once.
The best frequency of administration of this product is not clear. The results of Phase II clinical study show that most patients have not seen any significant change in tumor size in the second cycle compared with that of the first cycle. The radionuclide imaging, AFP qualitative change and KPS score of the two cycles are basically the same.
不良反应
29 patients with primary hepatocellular carcinoma were given the four doses of 9.25 MBq/kg, 18.5 MBq/kg, 27.75 MBq/kg and 37 MBq/kg respectively.
In the course of the trial, no subject suspended the test due to serious adverse events. There was no allergy, fever, chill, fatigue or other adverse reactions. The subjects’ weight decreased compared with the baseline. The difference was statistically significant
说明书下载
Instruction of Licartin.pdf (仅供专业人士参考) 下载
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