Generic Name: Prussian Blue
Class: Other Ion-removing Agents
VA Class: AD900
Chemical Name: Ferric hexacyanoferrate (II)
Molecular Formula: Fe4[Fe(CN)6]3
CAS Number: 14038-43-8
Introduction
A crystal lattice of ferric hexacyanoferrate (II); an ion-exchange medium with high affinity for cesium and thallium, including radioactive isotopes of these metals.1 3
Uses for Radiogardase
Poisoning and Radioactive Exposure
Treatment of known or suspected internal contamination with radioactive cesium and/or radioactive or nonradioactive thallium following accidental exposure and/or intentional exposure from radioactive terrorism or warfare.1 2 3 4 5 6 Reduces the risk of death and major morbidity following exposure to these metals.2 4
Treatment of radioactive exposures when the nature of the radioactive contamination is unknown.1 2
For severe thallium intoxication, may need to employ additional measures (e.g., induction of emesis followed by gastric intubation and lavage, forced diuresis, charcoal hemoperfusion, hemodialysis) to enhance thallium elimination.1 7
Radiogardase Dosage and Administration
General
Initiate therapy as soon as possible after contamination is suspected.1
Cesium poisoning: Determine baseline internalized137Cs contamination (by whole-body counting, bioassay, or urine/feces sampling) if possible.1 Measure radioactivity counts in urine and feces weekly to monitor137Cs elimination rate.1 Assess whole-body radioactivity after 30 days of therapy.1
Thallium poisoning: Determine baseline internalized thallium contamination (by whole-body counting and/or bioassay) if possible.1 Monitor CBC and serum chemistry and electrolytes weekly during therapy.1
Administration
Oral Administration
Administer orally with food to stimulate excretion of cesium or thallium.1
If patients cannot tolerate swallowing large numbers of capsules, open the capsules and mix the contents with bland food or liquids.1
Use with appropriate measures (i.e., oral fiber-based laxatives and/or a high-fiber diet) to promote regular fecal elimination.1
Can be given with 15% mannitol to prevent constipation.3 7 8
Dosage
Pediatric Patients
Poisoning and Radioactive Exposure
Cesium Poisoning
Oral
Children 2–12 years of age: 1 g 3 times daily.1
Children ≥13 years of age: 3 g 3 times daily.1 Once internal radiation has decreased substantially, reduce dosage to 1 or 2 g 3 times daily (to improve GI tolerance).1
Continue for a minimum of 30 days.1 Duration of therapy based on level of contamination and clinical judgment.1
Thallium Poisoning
Oral
Children 2–12 years of age: 1 g 3 times daily.1
Children ≥13 years of age: 3 g 3 times daily.1
Duration of therapy based on level of contamination and clinical judgment.1
Adults
Poisoning and Radioactive Exposure
Cesium Poisoning
Oral
3 g 3 times daily.1 Once internal radiation has decreased substantially, reduce dosage to 1 or 2 g 3 times daily (to improve GI tolerance).1
Continue for a minimum of 30 days.1 Duration of therapy based on level of contamination and clinical judgment.1
Thallium Poisoning
Oral
3 g 3 times daily.1
Duration of therapy based on level of contamination and clinical judgment.1
Special Populations
No special population dosage recommendations at this time.1
Cautions for Radiogardase
Contraindications
No contraindications according to manufacturer.1
Warnings/Precautions
Warnings
Radiation Exposure
Effective only in decreasing radiation exposure; does not treat complications of such exposure.1 Provide supportive treatment for radiation toxicity (e.g., for severe neutropenia and thrombocytopenia) in conjunction with prussian blue therapy.1
In radiologic emergencies, the type of elemental exposure may not be known.1 Prussian blue may not bind to all radioactive elements; therefore, may need to use other radioprotectants (e.g., potassium iodide, edetate calcium disodium, sodium alginate) in addition to prussian blue in patients contaminated with unknown or multiple radioactive elements.1 2
Major Toxicities
GI Effects
Constipation reported frequently; constipation responds to oral administration of fiber (i.e., fiber-based laxatives and/or a high-fiber diet).1 3 4
Decreased GI motility will slow the GI transit time of the prussian blue-metal complex (i.e., prussian blue-137Cs, prussian blue-thallium) and may increase exposure to the metal.1 Caution in individuals with conditions associated with decreased GI motility.1
General Precautions
Hypokalemia
Hypokalemia (serum potassium concentrations of 2.5–2.9 mEq/L) reported.1 3 Closely monitor serum electrolytes.1
Use with caution in individuals with preexisting cardiac arrhythmias or electrolyte imbalances.1
Specific Populations
Pregnancy
Category C.1
Lactation
Prussian blue is unlikely to distribute into breast milk.1
Cesium and thallium are distributed into human breast milk; women contaminated with these metals should not breast-feed.1
Pediatric Use
Safety and efficacy and dosage recommendations in pediatric patients ≥2 years of age extrapolated from adult data and supported by experience in pediatric patients (4–12 years of age).1
Dosing recommendations not established for pediatric patients <2 years of age.1
Hepatic Impairment
Use not contraindicated; however, may be less effective in these patients due to decreased excretion of cesium and/or thallium in the bile.1
Renal Impairment
Use not contraindicated.1
Common Adverse Effects
Constipation,1 3 4 GI distress,1 4 blue discoloration of sweat and tears (long-term administration).7
Interactions for Radiogardase
Orally Administered Drugs and Nutrients
Possible pharmacokinetic interaction (binding of prussian blue to drug and/or essential nutrient).1 Monitor serum concentrations and/or clinical response in patients receiving clinically important drugs.1
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Radioprotectants | Pharmacologic interaction unlikely; not expected to affect efficacy of prussian blue in the management of137Cs poisoning1 |
|
Tetracycline, oral | Possible pharmacokinetic interaction (decreased bioavailability of tetracycline)1 | Monitor serum concentrations of and/or clinical response to tetracycline1 |
Radiogardase Pharmacokinetics
Absorption
Bioavailability
Not appreciably absorbed through intact GI wall.1 7
Elimination
Elimination Route
Eliminated unchanged in feces.1 Clearance depends on GI transit time.1 7
Stability
Storage
Oral
Capsules
In the dark at 25°C (may be exposed to 15–30°C).1
ActionsActions
An ion-exchange medium with high affinity for cesium and thallium, including radioactive isotopes of these metals.1
Binds cesium and/or thallium in the GI tract, thus preventing absorption or reabsorption of these metals and increasing the rate of their elimination as insoluble complexes in feces.1
Reduces whole-body effective half-life of cesium and mean serum biologic half-life of thallium.1 4
May bind other elements (e.g., potassium).1 (See Hypokalemia under Cautions.)
Advice to Patients
Importance of taking prussian blue with food; importance of taking appropriate measures (i.e., oral fiber-based laxatives and/or a high-fiber diet) to promote regular fecal elimination.1
Importance of instructing patients on safety measures that should be used to minimize radiation exposure to others, including appropriate disposal of urine and feces.1 Clothing contaminated with blood or urine should be washed separately.1
Advise patients of possible bluish appearance of their stools.1
Advise patients who are unable to swallow capsules that their mouth and teeth might be colored blue if prussian blue capsules are opened and the contents mixed with food or liquid.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 500 mg | Radiogardase | Heyl Chemisch-pharmazeutische |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
1. Heyl Chemisch-pharmazeutische. Radiogardase (insoluble Prussian blue) capsules prescribing information. From the FDA web site (). (Accessed 7 Oct 2003).
2. US Food and Drug Administration. Questions and answers on Prussian Blue. From the FDA web site (). (Accessed 2003 Oct 7.)
3. Thompson DF, Church CO. Prussian blue for treatment of radiocesium poisoning. Pharmacotherapy. 2001; 21:1364-7. [IDIS 472544] [PubMed 11714209]
4. US Food and Drug Administration. Guidance for industry on Prussian blue for treatment of internal contamination with thallium or radioactive cesium; availability. [Docket No. 03D-0023.] Fed Regist. 2003; 68:5645-8.
5. US Food and Drug Administration Center for Drug Evaluation and Research. Guidance for industry: Prussian blue drug products—submitting a new drug application. Rockville, MD: FDA; 2003 Jan.
6. American Academy of Pediatrics. Radiation disasters and children: policy statement. Pediatrics. 2003; 111:1455-66. [PubMed 12777572]
7. Hoffman RS. Thallium toxicity and the role of Prussian blue in therapy. Toxicol Rev. 2003; 22:29-40. [IDIS 511730] [PubMed 14579545]
8. Reviewers’ comments (personal observations).
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