RADIOGARDASE(Heyl Chem.-pharm. Fabrik GmbH & Co. KG)(三)
aired and/or compromised liver function patients were not identified in the literature. Prussian blue insoluble is not systemically bioavailable and does not rely on renal elimination or hepatic metabolism; therefore, the use of Prussian blue insoluble is not contraindicated in these groups of patients. However, Prussian blue insoluble may be less effective in patients with impaired liver function due to decreased excretion of cesium and thallium in the bile.
Clinical Trials
Epidemiological studies and literature review data were reported in 106 subjects who received Prussian blue insoluble after excessive exposure to 137 Cs or non-radioactive thallium.
Overall, in literature reports, 65 patients and 7 normal human volunteers received Prussian blue insoluble after internal contamination with 137 Cs.
In a 1987 incident in Goiânia, Brazil, 46 persons with heavy internal contamination with 137 Cs were treated with Prussian blue insoluble. Data on the whole body effective half-life of 137 Cs, during and after Prussian blue insoluble treatment was completed on 33/46 of these patients. The untreated mean whole body effective half-life of 137 Cs is 80 days in adults, 62 days in adolescents, and 42 days in children. Prussian blue insoluble reduced the mean whole-body effective half-life of 137 Cs by 69% in adults, by 46% in adolescents and by 43% in children. The following table shows the decrease in whole body effective half-life of 137 Cs in patients during Prussian blue insoluble treatment as compared to being off treatment.
Table 2: Cesium-137 Effective Half-life During and After Treatment with Prussian blue Insoluble (In Days, by Age, and Dose of Prussian blue Insoluble)
Group Age (Years) Prussian blue insoluble dose (grams/day) No. of Pts. During Prussian blue insoluble Treatment – 137 Cs T1/2 Off Prussian blue insoluble Treatment – 137 Cs T1/2
Adults > 18 10 5 26 ± 6 days 80 ± 15 days (all 21 adult patients)
Adults > 18 6 10 25 ± 15 days
Adults > 18 3 6 25 ± 9 days
Adolescents 12 -14 ≤ 10 5 30 ± 12 days 62 ± 14 days
Children 4 — 9 ≤ 3 7 24 ± 3 days 42 ± 4 days
Data from additional literature articles including a study of 7 human volunteers contaminated with trace doses of 137 Cs and reports on 19 patients contaminated with 137 Cs in other incidents show a similar reduction in whole body effective half-life after Prussian blue insoluble treatment.
Thallium Contamination
Thirty-four patients treated with Prussian blue insoluble for non-radioactive thallium poisoning are reported in the literature. Prussian blue insoluble treatment reduced the mean serum biologic half-life of thallium from 8 days to 3 days.
Radiogardase Indications and Usage
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.
CONTRAINDICATIONSNone
WARNINGS
Prussian blue insoluble is administered to decrease radiation exposure. It does not treat the complications of radiation exposure. Patients contaminated with high doses of 137 Cs 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.
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