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Radiogardase Prussian blue insoluble capsules 500 mg Capsule, 36-count — NDC 58060-0002-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Radiogardase Prussian blue insoluble capsules 500 mg Capsule, 36-count — NDC 58060-002-02 (Billing 58060-0002-02)

by Heyl Chem.-pharm. Fabrik GmbH & Co. KG · 1 BOTTLE, PLASTIC in 1 CARTON / 36 CAPSULE in 1 BOTTLE, PLASTIC

This is a package of 36 capsules of Radiogardase Prussian blue insoluble capsules 500 mg Capsule from Heyl Chem.-pharm. Fabrik GmbH & Co. KG, marketed since Mar 2010 and currently FDA-listed. It is this product's only package size.

NDC 58060-0002-02
🏷️ FDA NDC (as labeled) 58060-002-02 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 58060-002-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58060 labeler · 002 product · 02 package
Package marketed since
Mar 24, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
36 EA per package
Barcode (UPC-A, from the NDC)
3 5806000202 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58060-002-02
Product NDC 58060-002
11-digit billing NDC 58060000202
NCPDP billing unit EA — each (per item)
RxCUI 759006, 759009
UNII TLE294X33A
Application # NDA021626
SPL Set ID baa68c79-5f3d-468a-a510-58b9e978cd50
Established class (EPC) Decorporation Agent
Mechanism of action Ion Exchange Activity; Chelating Activity
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-03-24
Route ORAL
Dosage form CAPSULE
Substance FERRIC FERROCYANIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 93000072100120
GPI class Radiogardase
GCN Seq No 037484
GCN 08011
HICL code 017177
Ingredient (HICL) Prussian Blue (Insoluble)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C8
Therapeutic class — intermediate (HIC2) Antidotes To Poisons
HIC3 code C8A
Therapeutic class — specific (HIC3) Metallic Poison,Agents To Treat
AHFS code 40:18.92.00
AHFS class Other Ion-Removing Agents
FDB label name RADIOGARDASE 0.5 GM CAPSULE
FDB brand name Radiogardase
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 037484
  • GCN: 08011
  • GPI-14 (Medi-Span): 93000072100120
  • HICL (First Databank): 017177
  • AHFS class code: 40:18.92.00
  • RxCUI (RxNorm): 759006
Why two NDCs? The FDA registers this code as 58060-002-02 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 58060-0002-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Decorporation Agent class.

Pharmacologic class Decorporation Agent
Drug family (ATC) Antidotes
How it works Chelating Activity, Ion Exchange Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name RADIOGARDASE 0.5 GM CAPSULE Ingredient Prussian Blue (Insoluble)

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58060-0002-02 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 36 CAPSULE in 1 BOTTLE, PLASTIC 2010-03-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Radiogardase 500 mgthis 58060-0002-02 Heyl 36 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Mar 2010
📍
2026
Currently FDA-listed
16 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 38 mg UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 83.12 mg UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 0.67 mg UNII D3741U8K7L
    A blue colorant derived from indigo dye. It's added to tablets and capsules to provide color identification and improve the appearance of the medication.
  • 0.15 mg UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 14.21 mg UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerHeyl Chem.-pharm. Fabrik GmbH & Co. KG
Application holderHEYL CHEMISCH PHARMAZEUTISHE FABRIK
FDA applicationNDA021626 (NDA)
Labeler code58060
First marketedMar 2010
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

1 INDICATIONS AND USAGE Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium, in order to increase their rates of elimination. Radiogardase 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. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Adults and Adolescents: 3 grams orally three times a day ( 2.3 ) Pediatrics (2 – 12 years): 1 gram orally three times a day ( 2.3 ) Administer as soon as possible after internal contamination with cesium or thallium is suspected ( 2.1 )

2.1Important Administration Instructions Obtain quantitative baseline of the internalized contamination by radioactive cesium (137Cs) and/or thallium by appropriate whole-body counting and/or by bioassay (e.g., biodosimetry), or feces/urine samples, whenever possible prior to Radiogardase treatment. Initiate treatment with Radiogardase as soon as possible after contamination is suspected. Even when delayed, treatment with Radiogardase is effective and should not be withheld.

Take Radiogardase capsules with food to stimulate excretion of cesium or thallium. In patients who cannot tolerate swallowing large numbers of capsules, open the capsules and mix with bland food or liquids.

2.2Decontamination Procedures for Radioactive Cesium or Thallium Contamination Prior to initiating treatment with Radiogardase, follow radioactive decontamination safety procedures including: Use appropriate radiation protective attire and closely monitor personnel and treatment area for radiation levels using radiation detection, indication, and computation devices (RADIAC) or thermal luminescent devices (TLD). Control spread of radiation contamination through the establishment of a patient decontamination area and a contaminated material disposal site (with proper labeling, handling, and disposal of contaminated material).

2.3Recommended Dosage Adults and Adolescents : 3 grams (6 capsules) taken orally three times a day (a total daily dose of 9 grams) Pediatric Patients (2 – 12 years) : 1 gram (2 capsules) taken orally three times a day (a total daily dose of 3 grams)

2.4Treatment of Radioactive Cesium Contamination Anticipate that treatment with Radiogardase may last 30 days or longer. Base duration of Radiogardase treatment on weekly measurements of radioactivity in urine and fecal samples to monitor cesium elimination rate. Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes).

2.5Treatment of Radioactive and Non-radioactive Thallium Contamination Anticipate that treatment with Radiogardase may last 30 days or longer. For radioactive thallium: Base duration of Radiogardase treatment on weekly measurements of radioactivity inurine and fecal samples to monitor thallium elimination rate. Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter) and radiation level is acceptable.

For non-radioactive thallium: Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter). Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes). In cases of severe thallium intoxication, additional types of treatment may be necessary, such as: Induced emesis, followed by gastric intubation and lavage Forced diuresis until urinary thallium excretion is less than 1 mg/24 hours Charcoal hemoperfusion may be useful during the first 48 hours after thallium ingestion (biodistribution phase).

Hemodialysis has also been reported to be effective in thallium intoxication.

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Capsules: 0.5 grams - dark blue capsule is imprinted with the light blue inscription: PB Capsules: 0.5 grams ( 3 ) Heyl imprint image

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None ( 4 )

⚠️ Warnings and Cautions 210 words ▾

5 WARNINGS AND PRECAUTIONS Increased radiation absorbed dose to gastrointestinal mucosa : Monitor for decreased gastrointestinal motility ( 5.1 ) Constipation : Monitor and treat ( 5.2 ) Electrolyte abnormalities : Monitor serum electrolytes during treatment ( 5.3 ) Blue discoloration of stool, oral mucosa and dentition ( 5.4 )

5.1Increased Radiation Absorbed Dose to Gastrointestinal Mucosa Radiogardase can decrease gastrointestinal motility, thus slowing the transit time of radioactivity in the gastrointestinal tract. The slowed transit time can increase the radiation absorbed dose to the gastrointestinal mucosa.

5.2Constipation Radiogardase can cause constipation. Monitor and treat for signs and symptoms of constipation. Patients with disorders associated with decreased gastrointestinal motility are at higher risk.

5.3Electrolyte 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 treatement with Radiogardase. Monitor serum electrolytes during Radiogardase treatment, particularly when treating patients with pre-existing cardiac arrhythmias or electrolyte imbalances.

5.4Blue Discoloration of Feces, Oral Mucosa, and Dentition Radiogardase is excreted primarily in feces and turns stools blue. When Radiogardase capsules are opened and the contents eaten with food, the oral mucosa and dentition may also be colored blue.

🤒 Adverse Reactions 63 words ▾

6 ADVERSE REACTIONS Constipation was reported in 10 (24%) of 42 patients treated with Radiogardase. Severity of constipation was mild in 7 patients and moderate in 3 patients [see Warnings and Precautions (5.2) ]. Most common adverse reaction (incidence >24%) was constipation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [email protected], Fax +49 30 817 4049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 34 words ▾

7 DRUG INTERACTIONS Based on animal data, co-administration of Radiogardase with other decorporation agents does not affect the efficacy of Radiogardase for treatment of internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category C It is not known whether Radiogardase can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with prussian blue insoluble. However, since Radiogardase is not absorbed from the gastrointestinal tract, effects on the fetus are not expected.

Radioactive cesium ( 137 Cs) crosses the human placenta. One patient, contaminated with 0.005 mCi 137 Cs during her 4 th month of pregnancy, was not treated with Radiogardase. At birth, the concentration of 137 Cs was the same in the mother and the infant.

Thallium crosses the human placenta. Reported fetal effects include failure to thrive and death. The toxicity from untreated radioactive cesium or thallium exposure is greater than the potential reproductive toxicity of Radiogardase.

8.3Nursing Mothers Studies to determine if Radiogardase is excreted in human milk have not been conducted. Since Radiogardase is not absorbed from the gastrointestinal tract, its excretion in milk is unlikely. However, cesium and thallium are transmitted from mother to infant in breast milk. Women internally contaminated with cesium or thallium should not breastfeed.

8.4Pediatric Use Radioactive Cesium Contamination The safety and efficacy of Radiogardase in the treatment of 137 Cs in pediatric patients ages, 2 to 18 years old, was established from data from Radiogardase-treated pediatric patients exposed to 137 Cs in the Goiânia, Brazil, contamination incident and from Radiogardase-treated adults exposed to 137 Cs [see Clinical Studies (14.1) ]. Overall, 27 pediatric patients received Radiogardase in the range of 3 to 10 grams per day in divided doses (the maximum recommended adolescent dosage is 9 grams per day).

Radiogardase treatment reduced the whole body effective half-life of 137 Cs by 46% in adolescents and by 43% in children aged 4 to 12 years of age. In 12 patients for whom the rate of radiation elimination data are available, the rate was similar to that in adults treated with 3 grams three times daily and in pediatric patients treated with 1 gram three times daily. By body weight, the dose ranged from 0.32 gram/kg in the 12-year old patient (10 gram Radiogardase daily dose, 31 kg weight) to 0.21 gram/kg in the 4 year old patient (3 gram Radiogardase daily dose, 14 kg weight) [see Clinical Studies (14.1) ] .

Pediatric patients aged 2 up to 4 years are expected to have biliary and gastrointestinal function that is comparable to that of a 4-year old. The safety and efficacy of Radiogardase has not been established in the treatment of 137 Cs contamination in pediatric patients 0 to 2 years old. There are differences in the developmental maturity of the biliary system and gastrointestinal tract of neonates and infants (0 – 2 years).

The dosage-related adverse reactions of Radiogardase on an immature gastrointestinal tract are not known. Radioactive and Non-Radioactive Thallium Contamination The safety and efficacy of Radiogardase for the treatment of radioactive and non-radioactive thallium contamination in pediatric patients has not been established.

8.5Geriatric Use The safety and efficacy of Radiogardase in patients aged 65 and over have not been evaluated, to determine whether they respond differently from younger subjects.. In general, elderly patients should be monitored closely, reflecting the greater frequency of decreased cardiac function and of concomitant disease or other drug therapy.

8.6Hepatic Impairment Radiogardase is not systemically bioavailable and does not rely on hepatic metabolism for activation or inactivation. However, Radiogardase may be less effective in patients with hepatic impairment, due to decreased excretion of cesium and thallium in the bile.

🤰 Pregnancy 133 words ▾

8.1Pregnancy Pregnancy Category C It is not known whether Radiogardase can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with prussian blue insoluble. However, since Radiogardase is not absorbed from the gastrointestinal tract, effects on the fetus are not expected.

Radioactive cesium ( 137 Cs) crosses the human placenta. One patient, contaminated with 0.005 mCi 137 Cs during her 4 th month of pregnancy, was not treated with Radiogardase. At birth, the concentration of 137 Cs was the same in the mother and the infant.

Thallium crosses the human placenta. Reported fetal effects include failure to thrive and death. The toxicity from untreated radioactive cesium or thallium exposure is greater than the potential reproductive toxicity of Radiogardase.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Radioactive Cesium Contamination The safety and efficacy of Radiogardase in the treatment of 137 Cs in pediatric patients ages, 2 to 18 years old, was established from data from Radiogardase-treated pediatric patients exposed to 137 Cs in the Goiânia, Brazil, contamination incident and from Radiogardase-treated adults exposed to 137 Cs [see Clinical Studies (14.1) ]. Overall, 27 pediatric patients received Radiogardase in the range of 3 to 10 grams per day in divided doses (the maximum recommended adolescent dosage is 9 grams per day).

Radiogardase treatment reduced the whole body effective half-life of 137 Cs by 46% in adolescents and by 43% in children aged 4 to 12 years of age. In 12 patients for whom the rate of radiation elimination data are available, the rate was similar to that in adults treated with 3 grams three times daily and in pediatric patients treated with 1 gram three times daily. By body weight, the dose ranged from 0.32 gram/kg in the 12-year old patient (10 gram Radiogardase daily dose, 31 kg weight) to 0.21 gram/kg in the 4 year old patient (3 gram Radiogardase daily dose, 14 kg weight) [see Clinical Studies (14.1) ] .

Pediatric patients aged 2 up to 4 years are expected to have biliary and gastrointestinal function that is comparable to that of a 4-year old. The safety and efficacy of Radiogardase has not been established in the treatment of 137 Cs contamination in pediatric patients 0 to 2 years old. There are differences in the developmental maturity of the biliary system and gastrointestinal tract of neonates and infants (0 – 2 years).

The dosage-related adverse reactions of Radiogardase on an immature gastrointestinal tract are not known. Radioactive and Non-Radioactive Thallium Contamination The safety and efficacy of Radiogardase for the treatment of radioactive and non-radioactive thallium contamination in pediatric patients has not been established.

🧓 Geriatric Use 52 words ▾

8.5Geriatric Use The safety and efficacy of Radiogardase in patients aged 65 and over have not been evaluated, to determine whether they respond differently from younger subjects.. In general, elderly patients should be monitored closely, reflecting the greater frequency of decreased cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 56 words ▾

10 OVERDOSAGE Based on reported adverse reactions and mechanism of action, possible overdosage symptoms may include constipation, obstruction, or severe decrease in electrolytes. Gastric distress was reported in 3 patients treated with 20 gram/day of Radiogardase (approximately 2.2 times the maximum recommended dosage). In these patients, the dose was reduced to 10 gram/day for continued treatment.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Prussian blue insoluble, ferric hexacyanoferrate(II), acts by ion-exchange, adsorption, and mechanical trapping within the crystal structure, and has a high affinity for radioactive and non-radioactive cesium and thallium. Prussian blue insoluble binds cesium and thallium isotopes in the gastrointestinal tract after these isotopes are ingested or excreted in the bile by the liver, thereby reducing gastrointestinal reabsorption (enterohepatic circulation). The rate of cesium and thallium elimination is proportional to the duration and dose of prussian blue insoluble.

12.2Pharmacodynamics Cesium-137 ( 137 Cs) 137 Cs has a physical half-life of 30 years, with a beta energy peak at 174.0 keV. Following entry into the blood, it is distributed uniformly through all body tissues. Approximately 10% of 137 Cs is eliminated rapidly with a biological half-life of 2 days; 90% is eliminated more slowly, with a biological half-life of 110 days; and less than 1% of the 137 Cs is retained with a biological half-life of about 500 days.

137 Cs follows the movement of potassium and is excreted into the intestine, reabsorbed from the gastrointestinal (GI) tract into the blood, then to the bile, where it is excreted again into the GI tract by bile via enterohepatic circulation. Without Radiogardase treatment, about 80% of 137 Cs is excreted through the kidneys and about 20% in the feces. Thallium-201 ( 201 Tl) Radioactive thallium ( 201 Tl) has a physical half-life of 3 days with electron and photon emissions with a gamma energy peak at 167.4 keV.

Non-radioactive thallium has a biological half-life of 8 – 10 days.The physiologic transport of thallium follows the same route as potasium and is excreted by bile in enterohepatic circulation. Without Radiogardase treatment, the fecal to urine excretion ratio of thallium is approximately 2:1. The results of fecal analysis from patients contaminated with 137 Cs and treated with Radiogardase showed higher activities of 137 Cs in feces, and the associated whole body radioactivity counts showed a more rapid rate of elimination from the body.

The effectiveness of Radiogardase for one patient is shown in Figure 1. The whole body content of radioactive material of 137 Cs in kilo-Bequerels (kBq) is shown on the y-axis. Time in days is on the x-axis.

Line “A” represents the whole body activity of 137 Cs during prussian blue insoluble treatment at 10 g/day. The dotted line represents extrapolation of the whole body activity if treatment was continued. Line “B” represents the whole body activity of 137 Cs, after prussian blue insoluble was stopped.

Figure 1 : Comparisons of 137Cs whole body activity during and after Radiogardase treatment.

12.3Pharmacokinetics Absorption/Elimination : Prussian blue insoluble is not absorbed through the intact gastrointestinal wall. Its clearance from the body depends on the gastrointestinal tract transit time. Food Effects : Food effect studies have not been conducted. In animal studies, Prussian blue insoluble was not significantly absorbed. Food may increase the effectiveness of prussian blue insoluble by stimulating bile secretion.

🧬 Mechanism of Action 81 words ▾

12.1Mechanism of Action Prussian blue insoluble, ferric hexacyanoferrate(II), acts by ion-exchange, adsorption, and mechanical trapping within the crystal structure, and has a high affinity for radioactive and non-radioactive cesium and thallium. Prussian blue insoluble binds cesium and thallium isotopes in the gastrointestinal tract after these isotopes are ingested or excreted in the bile by the liver, thereby reducing gastrointestinal reabsorption (enterohepatic circulation). The rate of cesium and thallium elimination is proportional to the duration and dose of prussian blue insoluble.

📦 How Supplied / Storage and Handling 115 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Radiogardase is supplied as gelatin capsules containing 0.5 grams of prussian blue insoluble for oral administration. The dark blue capsule is imprinted with the light blue inscription: PB. It is packaged in white plastic containers with a child-resistant tamper-evident closure.

Each container contains 36 capsules. NDC: 58060-002-02 Storage Store at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C and 30°C (between 59 °F and 86 °F). Brief exposure to temperatures up to 40 °C (104 °F) may be tolerated, provided the mean kinetic temperature does not exceed 25 °C (77 °F); however, minimize such exposure. [see USP Controlled Room Temperature] Heyl imprint image

📋 Description 136 words ▾

11 DESCRIPTION Radiogardase (prussian blue insoluble) is a decorporation agent for oral use. Radiogardase capsules contain insoluble ferric hexacyanoferrate(II), with an empirical formula of Fe 4 [Fe(CN) 6 ] 3 and a molecular weight of 859.3 Daltons. It is supplied as 0.5 gram of blue powder in gelatin capsules with 0 – 38 mg of microcrystalline cellulose.

The dark blue capsule is imprinted with the light blue inscription: PB. The powder may vary from uniformly fine, dark granules to coarse light and dark-colored granules. The structural formula for prussian blue insoluble is shown below.

The crystal structure of prussian blue insoluble is a cubic lattice with the Fe II and Fe III atoms occupying the corners of the cube and the cyanide groups positioned on the sides. Heyl imprint image Structural formula for Prussian blue insoluble

💬 Information for Patients 166 words ▾

17 PATIENT COUNSELING INFORMATION Decreased Gastrointestinal Motility Inform patients that Radiogardase can decrease gastrointestinal motility. This can slow the transit time of cesium or thallium bound to Radiogardase and increase the radiation absorbed dose to the gastrointestinal mucosa. Alert patients to monitor for signs and symptoms of constipation and advise patients to seek medical management if symptoms develop.

Precautions to Mitigate Radiation Exposure Inform patients of safety measures to be taken to minimize radiation exposure to others or re-exposure to self. This includes instruction on appropriate use of the toilet, hand washing, and handling of items such as clothing that might get contaminated with body fluids. Discoloration of Stool, Oral Mucosa and Dentition Inform patients taking Radiogardase that their stools might be blue-colored.

Also inform patients that if the Radiogardase capsules are opened and the contents are mixed with food and eaten, the mouth and teeth may be colored blue. Manufactured by: Haupt Pharma Wülfing GmbH Distribution by: HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG, Berlin

🍼 Nursing Mothers 55 words ▾

8.3Nursing Mothers Studies to determine if Radiogardase is excreted in human milk have not been conducted. Since Radiogardase is not absorbed from the gastrointestinal tract, its excretion in milk is unlikely. However, cesium and thallium are transmitted from mother to infant in breast milk. Women internally contaminated with cesium or thallium should not breastfeed.

🧬 Pharmacokinetics 60 words ▾

12.3Pharmacokinetics Absorption/Elimination : Prussian blue insoluble is not absorbed through the intact gastrointestinal wall. Its clearance from the body depends on the gastrointestinal tract transit time. Food Effects : Food effect studies have not been conducted. In animal studies, Prussian blue insoluble was not significantly absorbed. Food may increase the effectiveness of prussian blue insoluble by stimulating bile secretion.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Cesium-137 ( 137 Cs) 137 Cs has a physical half-life of 30 years, with a beta energy peak at 174.0 keV. Following entry into the blood, it is distributed uniformly through all body tissues. Approximately 10% of 137 Cs is eliminated rapidly with a biological half-life of 2 days; 90% is eliminated more slowly, with a biological half-life of 110 days; and less than 1% of the 137 Cs is retained with a biological half-life of about 500 days.

137 Cs follows the movement of potassium and is excreted into the intestine, reabsorbed from the gastrointestinal (GI) tract into the blood, then to the bile, where it is excreted again into the GI tract by bile via enterohepatic circulation. Without Radiogardase treatment, about 80% of 137 Cs is excreted through the kidneys and about 20% in the feces. Thallium-201 ( 201 Tl) Radioactive thallium ( 201 Tl) has a physical half-life of 3 days with electron and photon emissions with a gamma energy peak at 167.4 keV.

Non-radioactive thallium has a biological half-life of 8 – 10 days.The physiologic transport of thallium follows the same route as potasium and is excreted by bile in enterohepatic circulation. Without Radiogardase treatment, the fecal to urine excretion ratio of thallium is approximately 2:1. The results of fecal analysis from patients contaminated with 137 Cs and treated with Radiogardase showed higher activities of 137 Cs in feces, and the associated whole body radioactivity counts showed a more rapid rate of elimination from the body.

The effectiveness of Radiogardase for one patient is shown in Figure 1. The whole body content of radioactive material of 137 Cs in kilo-Bequerels (kBq) is shown on the y-axis. Time in days is on the x-axis.

Line “A” represents the whole body activity of 137 Cs during prussian blue insoluble treatment at 10 g/day. The dotted line represents extrapolation of the whole body activity if treatment was continued. Line “B” represents the whole body activity of 137 Cs, after prussian blue insoluble was stopped.

Figure 1 : Comparisons of 137Cs whole body activity during and after Radiogardase treatment.

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES

14.1Cesium-137 Contamination In literature reports, 72 people received Radiogardase after exposure to radioactive cesium ( 137 Cs): 46 patients with 137Cs contamination 19 patients 137Cs contamination in other incidents 7 healthy human subjects who voluntarily ingested trace doses of 137Cs In a 1987 incident in Goiânia, Brazil, 46 patients with heavy internal contamination with 137Cs were treated with Radiogardase (Table 2). Data on the whole body effective half-life of 137Cs, during and after Radiogardase treatment, was completed on 33 of these 46 patients (see Table 2).

Radiogardase reduced the mean whole-body effective half-life of 137Cs by 69%, 46%, and 43% in adults, adolescents, and younger children, respectively. Table 2 shows the decrease in whole body effective half-life of 137Cs in patients during Radiogardase treatment compared to the half-life of 137Cs after Radiogardase discontinuation (after treatment). Table 2: Cesium-137 Effective Half-life During and After Treatment with Radiogardase Group Age (years) Radiogardase Dosage 137 Cs Effective Half Life During Radiogardase Treatment After Radiogardase Treatment Adults (n=5) > 18 10 grams/day 26 ± 6 days 80 ± 15 days (all 21 adult patients) Adults (n=10) 6 grams/day 25 ± 15 days Adults (n=6) 3 grams/day 25 ± 9 days Adolescents (n=5) 12 -14 < 10 grams/day 30 ± 12 days 62 ± 14 days Children (n=7) 4 – 9 < 3 grams/day 24 ± 3 days 42 ± 4 days Data from additional literature articles including 19 patients contaminated with 137 Cs in other incidents and a study of 7 human subjects who voluntarily ingested trace doses of 137 Cs showed a similar reduction in whole body effective half-life with Radiogardase treatment.

14.2Thallium Contamination Thirty-four patients treated with Radiogardase for non-radioactive thallium poisoning have been reported in the literature. Radiogardase treatment reduced the mean serum biologic half-life of thallium from 8 days to 3 days.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of prussian blue insoluble. No study on impairment of male or female fertility and reproductive performance has been conducted in animals.

13.2Animal Toxicology and/or Pharmacology Absorption/Elimination In an animal study (pigs, n =38), after a single dose of 40 mg of labeled prussian blue insoluble, 99% of the administered prussian blue dose was excreted unchanged in feces. Absorption from multiple doses has not been studied. In a study using rats (n = 40, mean body weight range of 188 – 219 grams) injected with 137 Cs, a dose response relationship was demonstrated for the amount of radiation elimination with prussian blue insoluble at doses of 1 to 50 mg/day (Table 1).

There is little difference in radiation elimination rate between prussian blue insoluble at doses of 50 to 100 mg/day. In Table 1, the % of Injected Radiation Dose Remaining is defined as the percentage of the total injected dose of 137 Cs remaining in the body at 96 hours post administration. Table 1: Dose Response Relationship in Rats at 96 Hours Prussian blue insoluble dose (mg/day) % Injected 137 Cs dose remaining (Range) Untreated 58.1 (63.3 – 53.4) 1 9.42 (13.2 – 6.72) 10 1.17 (1.64 – 0.84) 50 0.57 (0.80 – 0.41) 100 0.52 (0.73 – 0.37) In studies of rats, pigs, and dogs that were internally contaminated with cesium and thallium, the presence of the insoluble complexes in the gastrointestinal lumen changed the primary elimination route from the kidney to the feces and increased the rate of elimination of these two contaminants.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 40 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been performed to evaluate the carcinogenic or mutagenic potential of prussian blue insoluble. No study on impairment of male or female fertility and reproductive performance has been conducted in animals.

📄 Package Label / Principal Display Panel 4 words ▾

Package label Bottle label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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