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In situations such as nuclear accidents, the release of radioactive materials, or deliberate attacks involving radioactive substances – whether through accidents at nuclear power plants, the use of nuclear weapons, or the improper handling of radioactive materials – radioactive isotopes like cesium-134 and cesium-137 can enter the human body. These isotopes accumulate in tissues and can cause significant health damage.
Short-term symptoms of radioactive exposure include nausea, vomiting, diarrhea, and weakness, followed by hair loss and skin changes. Depending on the radiation dose, acute radiation sickness can occur, severely affecting the bone marrow, lungs, and digestive system. Long-term effects of radiation exposure increase the risk of developing cancers such as thyroid cancer, leukemia, and other malignancies, as well as genetic damage that may manifest years or even decades later.
Radiogardase® (Prussian Blue) can play a critical role in treating this type of contamination. It is administered orally and binds to radioactive cesium and thallium in the gut, which can allow them to be excreted more rapidly through the stool. This can reduce the duration that radioactive materials remain in the body, thereby possibly lowering the overall radiation exposure and minimizing the risk of long-term health effects.
Medical Information about Prussian Blue (the following refers to the medicinal product authorised in the US)
Active Pharmaceutical Ingredient (API): Prussian Blue insoluble
Brand Name: Radiogardase®
Chemical Name: Ferric(III) hexacyanoferrate(II) (Insoluble Prussian Blue)
ATC Code: V03AB31
Dosage Form: Hard capsules
Indications:
Mechanism of Action:
Prussian Blue is not absorbed by intact mucosa after oral administration. It binds to radioactive cesium and thallium in the gastrointestinal tract after these isotopes are ingested or excreted in the bile by the liver thereby reducing reabsorption (enterohepatic circulation). In this way, Prussian Blue, facilitates the excretion of cesium and/or thallium through the stool. This reduces the duration the radioactive element remains in the body, minimizing overall radiation exposure.
Recommended Dosage:
The typical dose for cesium intoxication is 9 grams per day, divided into 3 grams every 8 hours. Treatment duration is generally 30 to 90 days, depending on the level of contamination. Doses up to 20 grams per day have been considered safe in certain cases.
Important Notes:
Stability and Storage:
Radiogardase® is stable at room temperature, with a shelf life of 4 years. In some cases, shelf-life extension may be possible.
Prussian blue insoluble is administered to decrease internal radiation exposure. It does not treat the complications of radiation exposure. Patients contaminated with high doses of cesium-137 may develop radiation toxicity including bone marrow suppression with severe neutropenia and thrombocytopenia. Supportive treatment for radiation toxicity symptoms should be given concomitantly with Prussian blue insoluble treatment. In radiological emergencies, the type of elemental exposure may not be known. Prussian blue insoluble may not bind to all radioactive elements and some radioactive elements may not undergo enterohepatic circulation, which is needed for Prussian blue insoluble binding and elimination. In patients who have contamination with multiple or unknown radioactive isotopes, additional decontamination and treatment procedures may be needed.
Prussian blue insoluble can cause constipation. Decreased gastrointestinal motility will slow the transit time of cesium-137 bound to Prussian blue insoluble in the gastrointestinal tract, and may increase the radiation absorbed dose to the gastrointestinal mucosa. Constipation occurring during Prussian blue insoluble treatment may be treated with a fiber based laxative and/or a high fiber diet. Prussian blue insoluble should be used with caution in patients with disorders associated with decreased gastrointestinal motility.
Radiogardase® is excreted primarily in feces and turns stools blue in color. When Radiogardase® capsules are opened and the contents eaten with food, the oral mucosa and dentition may also be colored blue.
Electrolyte Abnormalities
Radiogardase® may bind to electrolytes found in the gastrointestinal tract. Hypokalemia, with serum potassium values of 2.5 – 2.9 (normal 3.5 – 5.0), was reported in 3 (7%) of 42 patients during treatment with Radiogardase®. Serum electrolytes should be monitored during Radiogardase® treatment, particularly when treating patients with pre-existing cardiac arrhythmias or electrolyte imbalances.
Prussian blue insoluble is approved for HEYL Chem.-pharm. Fabrik GmbH & Co. KG in several countries:
USA: NDA # 21-626, NDC 58060-002-01
Brand Name: Radiogardase®
Date approved by the FDA: October 2, 2003
Prescription state: Prescription only
Indication: Prussian blue insoluble is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination
Germany: Marketing authorisation number. 6813163.00.00
Brand Name: Radiogardase®-Cs
Date of authorsation by the BfArM: September 24, 1997
Prescription state: Prescription only
Indication: Decorporation or avoidance of absorption of radioactive cesium (e.g., 134Cs, 137Cs)