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HEYL Radiogardase®

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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:

  • Elimination (decorporation) or prevention of absorption (resorption) of radioactive cesium isotopes, such as cesium-134 and cesium-137
  • Known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium

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:

  • Treatment should begin as soon as possible for maximum efficacy. However, clinical studies have shown that treatment remains effective even if initiated weeks after exposure.
  • Regular monitoring of cesium levels is recommended during treatment to assess the effectiveness of the therapy.
  • Radiogardase® is not absorbed by the gastrointestinal tract and acts directly in the intestines to bind cesium ions, which enhances fecal excretion of radioactive materials.

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.

WARNINGS and PRECAUTIONS

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)