IIBG, 123I (MIBG, 123-I)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceJoenguang [123I]Joenguang [123I]
Dosage form: & nbspsolution for intravenous administration
Composition:

In 1 ml of the drug contains:

Iodine-123

150-300 MBq

M-iodobenzylguanidine sulfate (yobenguane sulfate)

0.30 mg

Sodium acetate

not more than 3.0 mg

Sodium chloride

9.0 mg

Water for injections

up to 1.0 ml
Description:Colorless, clear liquid.
Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp

V.09   Diagnostic radiopharmaceuticals

Pharmacodynamics:
Physicochemical characteristics
IIBG, 123I radiopharmaceutical diagnostic drug is a chemical compound of m-iodobenzylguanidine sulfate in which part of the stable iodine atoms is replaced by radioactive iodine-123, in the form of a sterile and apyrogenic solution ready for use, pH 5-7. Volumetric activity of iodine-123 from 150 to 300 MBq / ml at the date and time of preparation. The radiochemical purity of the preparation is not less than 95.0%. Radionuclide 123I with a half-life of 13.31 hours emits gamma quanta with energy 159 keV (83.4%) during the decay. The average energy of conversion electrons and Auger electrons is 28 keV per decay.

Pharmacological action

Yobenguang [123I] has a similar structure to norepinephrine. The distribution of the radiopharmaceutical is similar to the distribution of norepinephrine. Accumulating in the endings of neurons and competing with norepinephrine, but not having its mediator properties, the drug does not have a pharmacological effect on the activity of the sympathetic nervous system and does not cause a hemodynamic effect.

Yobenguang [123I] is an indicator used as a diagnostic tool for visualization of the state of the sympathetic nervous system, by means of which the integrity and functional state of the adrenergic nerve endings in various organs and tissues is assessed.

Pharmacokinetics:

After intravenous administration, the maximum concentration of the drug Joenguang [123I] is observed in the liver, heart, salivary glands, lungs and is (percentage of dose / g) in: liver - 0.76 (for 60 min), heart - 0.64 (20-30 min), light - 0.17 (for 40 min), muscles - 0.02 (for 60 min), blood - 0.02 (for 10 min). The drug is excreted by the kidneys: 40-55% - for 24 hours and 70-90% - for 96 hours, mostly unchanged.

Accumulation of the drug in the adrenergic nerve endings of various organs and tissues is described immediately by two mechanisms: 1. sodium-dependent pathway, 2. by mechanical diffusion.In radionuclide diagnostics, the administered doses are so small that the capture mechanism dominates - the sodium-dependent pathway. After getting the drug into the cell, most of it remains with neuroblastomas in a free form in the cytoplasm; with pheochromocytoma and paragangliome, the drug is actively transported into granules of catecholamines, but not metabolized by enzymes that metabolize catecholamines. It is accumulated by cells of neuroendocrine sympatomedullary tumors of various localizations.

Indications:

In the study of adults:

localization of the primary tumor and its metastases, evaluation of the effectiveness of treatment and identification of relapses in patients:

- pheochromocytoma and paraganglioma;

- carcinoids of the small intestine and lung;

- medullary thyroid cancer;

- neuroblastoma;

- tumors from Merkel cells;

- diagnosis of violations of sympathetic innervation of the myocardium with myocardial infarction, arrhythmias, chronic heart failure, cardiomyopathy of various origins (including diabetic, ischemic and stress damage to the myocardium).

When studying children:

- confirmation of the sympatoadrenal nature of the tumor in neuroblastoma, pheochromocytoma and ganglioneuroma;

- staging of the tumor process;

- assessment of the radical nature of surgical treatment of the primary tumor;

- assessment of the effectiveness of chemotherapy in neuroblastoma, especially in patients with IV and IVs stage;

- follow-up after treatment for the timely detection of subclinical recurrence of neuroblastoma and dissemination in the bone marrow.

Contraindications:

Pregnancy, the period of breastfeeding.

General clinical contraindications for radionuclide studies.

Hypersensitivity.

Dosing and Administration:

The drug is administered intravenously in the patient's position "lying" or "sitting". Mandatory preliminary blockade of the thyroid gland by lugol 2 drops 2 times a day for 3 days before the study and 2 days after. To exclude allergies to iodine Before the test, a skin test should be performed with an alcohol solution of iodine applied to the skin of the back surface of the forearm. Redness in place of the application indicates the presence of allergies to iodine.

Recommended single doses: adults and children - 4 MBq / kg body weight.

Given the high adhesiveness of iodine-123, which causes the concentrated preparation to adhere to the endothelium of the walls of blood vessels, it is recommended to dilute the drug in a vial with saline solution of sodium chloride (up to 10.0 ml).For the same reason, it is not recommended to administer the drug to the central venous catheters. The drug should be administered slowly (for at least 5 minutes). As the diagnostic equipment, a gamma camera is used, planar or rotary (SREST), with a round (not less than 400 mm in diameter) or a rectangular crystal.

Scintigraphy of the myocardium is carried out in 20-30 minutes and 4 hours after intravenous administration of the drug in the planar or rotational modes.

Visualization of the adrenal glands and the entire body is performed 24 hours after intravenous administration of the drug.

Normally, the whole body is visualized as a shadow. Increased accumulation of the drug is observed in salivary glands, in the heart, in the liver, in the bladder; poor accumulation in the intestine; the skeleton is not visualized.

The visualization of the thyroid gland is carried out 10 minutes after the administration of the drug on the gamma camera in the patient's position "lying on the back" according to the standard procedure. The presence of a radiologist during intravenous administration of the drug "MIBG, 123I"The patient is strictly required.

Radiation loads on the organs and body of the patient when using the drug "MIBG, 123I"

Organs and Systems

Absorbed dose, mGy / MBq

Bladder

0,06

Adrenal glands

0,007

Red marrow

0,007

Thyroid

0,19

Kidneys

0,024

A heart

0,016

Ovaries

0,032

Spleen

0,006

Whole body (effective equivalent dose) mSv / MBq

0,09
Side effects:

Allergic reactions are possible.

Overdose:

Overdose of the drug is unlikely, due to careful monitoring of injected activity in a specialized hospital in the presence of a radiologist.

Interaction:

Sympatholytic and other antihypertensive medications (including blockers of "slow" calcium channels and beta-adrenoblockers) reduce the accumulation of the drug in the myocardium and catecholamine tumors.

The list of medicinal products and the terms of their cancellation before the study by MIBG,123I

Medicinal products

The mechanism of violation

Recommended Cancellation Time

Opioid analgesics

Suppression of inclusion

7-14 days

Tricyclic antidepressants

Suppression of inclusion

7-21 days

Sympathomimetics

Pellet depletion

7-14 days

Neuroleptics

Suppression of inclusion

21-28 days

Antihypertensive and cardiovascular agents

Beta1-adrenoblockers,

antiarrhythmic

drugs

Suppression of inclusion and depletion of granules

21 day

Reserpine

Depletion of granules and suppression of transport

14 days

Bretilia tosylate, guanethidine

Depletion of granules and suppression of transport

14 days

Blocks of "slow" calcium channels

Increase in inclusion and delay in excretion

14 days

Inhibitors angiotensin-converting enzyme

Increase in inclusion and delay in excretion

14 days

In addition, before the study with MIBG, 123I it is recommended to exclude chocolate and blue molded cheese from the diet, containing vanillin and catecholamine such compounds, which also have cross-interaction, causing depletion of the granules.

Special instructions:

Work with the drug should be carried out in accordance with the requirements of the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010), "Radiation Safety Standards" (NRB-99/2009) and the Guidelines "Hygienic Requirements for Radiation Safety in Radionuclide diagnostics with the help of radiopharmaceuticals "(MU 2.6.1, 1892-04).

Form release / dosage:Solution for intravenous administration, portions of 100, 150 and 300 MBq for the set date and time of delivery.
Packaging:

In hermetically ukuporennyh bottles for medicines with a capacity of 10 or 20 ml.

A vial with a passport and instruction for medical use in a package transport packaging for radioactive substances.

Storage conditions:

The drug is stored in compliance with the requirements of OSPORB-99/2010, NRB-99/2009, MU 2.6.1. 1892-04.

Shelf life:

30 hours from the date and time of manufacture.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals
Registration number:P N003220 / 01
Date of registration:20.02.2009 / 20.12.2012
Expiration Date:Unlimited
The owner of the registration certificate:Federal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of RussiaFederal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of Russia Russia
Manufacturer: & nbsp
Information update date: & nbsp12.05.2018
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