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Radiogardase

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Radiogardase

Radiogardase

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Adults and Adolescents

The recommended dose of Prussian blue insoluble is 3 grams orally three times a day.

Pediatrics (2 – 12 years)

The recommended dose of Prussian blue insoluble is 1 gram orally three times a day.

In patients who cannot tolerate swallowing large numbers of capsules, the capsules may be opened and mixed with bland food or liquids. This may result in blue discoloration of the mouth and teeth.

Prussian blue insoluble capsules may be taken with food to stimulate excretion of cesium or thallium.

Treatment with Prussian blue insoluble for radioactive cesium (137Cs) contamination

Treatment with Prussian blue insoluble should be initiated as soon as possible after contamination is suspected. Contamination should be verified as soon as possible. However, even when treatment cannot be started right away, patients should be given Prussian blue insoluble as soon as it becomes available. Treatment with Prussian blue insoluble is still effective even after time has elapsed since exposure.

Treatment should continue for a minimum of 30 days and then the patient should be reassessed for the amount of residual whole body radioactivity. The duration of treatment after exposure is dictated by the level of contamination and the judgment of the attending physician. Before, during and after therapy, pertinent measurements for radioactivity should be made to help determine when to terminate treatment.

During treatment, the following information should be collected:

  • the radioactivity counts in urine and fecal samples should be measured and recorded weekly to monitor 137 Cs elimination rate, and
  • the occurrence of any adverse events from Prussian blue insoluble (i.e., constipation, which can be treated by increasing the amount of fiber in the diet).

When the internal radioactivity is substantially decreased, the Prussian blue insoluble dose may be decreased to 1 or 2 grams TID to improve gastrointestinal tolerance.

Treatment with Prussian blue insoluble for thallium contamination

Treatment with Prussian blue insoluble should be initiated as soon as possible after contamination is suspected. Contamination should be verified as soon as possible. However, even when treatment cannot be started right away, treatment with Prussian blue insoluble is effective and should not be withheld.

Further considerations for radioactive cesium contamination

  1. Health professionals should follow appropriate radiation protective attire and procedures at all times. Protect health professionals handling patients from unnecessary radiation exposure and monitor health professionals and the area of operation 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 triage site, patient decontamination area, and a contaminated or “dirty” material dumpsite. Proper labeling, handling, and disposal of contaminated material needs to be established and followed.
  2. Manage the patient to minimize further injury and to stabilize before external decontamination.
  3. Establish if the patient suffers from a single or combined injury (e.g., radiation, burns, trauma, chemical, biological, etc.) and whether the contaminant may be internalized.
    The route of entry of the radiation contaminant needs to be identified and recorded. The route of entry will determine other treatment methods needed (e.g., wound debridement or stomach lavage if ingested). Patients need to be triaged based on their injuries and the level and type of contamination.
  4. A quantitative baseline of the internalized contamination of 137Cs should be obtained by appropriate whole-body counting and/or by bioassay (e.g., Biodosimetry), or feces/urine sample whenever possible to obtain the following type of information to establish an elimination curve:
    • Estimated internalized radiation contamination of 137Cs, and
    • Rate of measured elimination of radiation in the feces.

Further considerations for thallium contamination (radioactive and non-radioactive)

General therapy guidelines for thallium contamination should follow the radioactive decontamination procedures listed above for 137 Cs, except that there is no need for radiation safety precautions when treating patients contaminated with non-radioactive thallium. For both radioactive and non-radioactive thallium contamination, a quantitative baseline of the internalized thallium contamination should be ascertained by appropriate whole body counting and/or by bioassay whenever possible.

Patients should also have weekly CBC, serum chemistry and electrolytes while under treatment. The response to other orally administered medications should be closely monitored. (See Drug-Drug Interactions.)

In cases of severe thallium intoxication, additional types of elimination 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/24h.
  • 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.

Considerations for multiple contaminant exposure (radioactive and non-radioactive)

In patients who have contamination with multiple or unknown radioactive isotopes, additional decontamination and treatment procedures may be needed.

HOW SUPPLIED

Radiogardase® (insoluble prussian blue) is supplied as 0.5 gram blue powder in gelatin capsules for oral administration. The dark blue capsules are imprinted with the light blue inscription: PB. It is packaged in white plastic containers (HDPE) with a child-proof closure and tamper-evident seal. The containers contain 36 capsules each.

Instruction for opening the container

Open the container as shown on the picture:

Open the container as shown on this picture

Step 1: Press firmly on the closure.

Step 2: Twist the closure while pressing.

Step 3: Remove seal from plastic container before first use.

The product is manufactured by Haupt Pharma Berlin GmbH for distribution by HEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KG, Berlin.

NDC 58060-002-02

Storage

Store in the dark at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Patient Treatment Data

To develop long-term response data, detailed information on patient treatment should be provided to the manufacturer whenever this drug is administered. These data should include a record of the radioactive body burden and bioassay results at defined time intervals, a description of measurement methods to facilitate analysis of data, and adverse events (see attached patient data form). In cases where exposure is limited in terms of number of patients, it may be possible to collect more detailed patient information. Please see the following website, www.heyltex.com for additional suggested data collection.

Questions regarding patient treatment data collection and the use of Prussian blue insoluble for the treatment of patients exposed to radioactive cesium and/or radioactive or nonradioactive thallium may be submitted to Dr. Johann Ruprecht, Email: info@heyl-berlin.de. Fax +49 30 8174049. HEYL Chem.-pharm. Fabrik GmbH & Co. KG. Rev. 03/2008. FDA revision date: 8/25/2008

Last reviewed on RxList: 10/1/2008
This monograph has been modified to include the generic and brand name in many instances.

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