Radiogardase (Page 3 of 3)

14 CLINICAL STUDIES

14.1 Cesium-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.

14.2 Thallium 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.

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: Heyl imprint imagePB. 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]

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

Package label
(click image for full-size original)

Bottle label
(click image for full-size original)
RADIOGARDASE
prussian blue insoluble capsules capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58060-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERRIC FERROCYANIDE (FERRIC FERROCYANIDE) FERRIC FERROCYANIDE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 38 mg
GELATIN 83.12 mg
WATER 14.21 mg
INDIGOTINDISULFONATE SODIUM 0.67 mg
SODIUM LAURYL SULFATE 0.15 mg
Product Characteristics
Color blue (Heyl;PB) Score no score
Shape CAPSULE (Heyl;PB) Size 22mm
Flavor Imprint Code Heyl;PB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58060-002-02 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 36 CAPSULE in 1 BOTTLE, PLASTIC This package is contained within the CARTON (58060-002-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021626 03/24/2010
Labeler — Heyl Chem.-pharm. Fabrik GmbH & Co. KG (317151645)
Registrant — Heyl Chem.-pharm. Fabrik GmbH & Co. KG (317151645)
Establishment
Name Address ID/FEI Operations
Laborchemie Apolda GmbH 331821462 api manufacture (58060-002)
Establishment
Name Address ID/FEI Operations
Ostthüringische Materialprüfgesellschaft für Textil- und Kunststoffe mbH 332338250 analysis (58060-002)
Establishment
Name Address ID/FEI Operations
Haupt Pharma Wuelfing GmbH 333274975 manufacture (58060-002), analysis (58060-002), label (58060-002), pack (58060-002)
Establishment
Name Address ID/FEI Operations
SGS INSTITUT FRESENIUS GmbH 341259550 analysis (58060-002)

Revised: 10/2021 Heyl Chem.-pharm. Fabrik GmbH & Co. KG

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