Radiogardase

What is Radiogardase?

Radiogardase is a medicine that is used to get rid of extra cesium or thallium from the body.

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.

Mechanism 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.

Before taking Radiogardase, tell your doctor:

• If you are allergic to Radiogardase; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Radiogardase with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Radiogardase?

• Tell all of your health care providers that you take Radiogardase. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Urine and stools may need to be checked. Talk with the doctor.
• If you have constipation, talk with your doctor. There may be ways to lower this side effect.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Radiogardase while you are pregnant.

To avoid exposing or re-exposing others:

• Use the toilet instead of a urinal.
• Flush the toilet a few times after using.
• Clean up any spilled urine, feces, or blood right away. Avoid touching.
• Wash your hands after using the toilet.
• Wash exposed clothing, bedding, and bath towels alone.
• Avoid children’s urine or feces.

How is Radiogardase best taken?

Use Radiogardase as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Radiogardase with food.
• Capsules may be opened and contents mixed with food or liquid.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Radiogardase that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad constipation.

What are some other side effects of Radiogardase?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Change in color of stool to blue.
• Change in color of mouth and teeth to blue.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Radiogardase?

• Store at room temperature.
• Protect from light.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL