Ferric ferrocyanide

FDA label, Heyl Chem.-pharm. Fabrik GmbH & Co. KG, oral, effective 2021-10-07. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Decorporation Agent

Dosing in kidney impairment

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

Dosing in liver impairment

Hepatic 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.

Preparation and administration

Important 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.

Drug interactions

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Label text (1 paragraph)

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.

Contraindications

None None ( 4 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy 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.

Lactation

8.3 Nursing 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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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