Prussian blue

Prussian blue was originally developed as a dye for use in paints and ink. It is used in medicine to help speed up the body's elimination of certain metals or chemical elements. It works by binding to the metals in the digestive tract to keep the body from absorbing them.

Prussian blue is used to treat people who have been contaminated with radioactive cesium or thallium, or non-radioactive thallium.

Prussian blue may also be used for other purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

To make sure Prussian blue is safe for you, tell your doctor if you have:

• a digestive disorder;
• chronic constipation;
• a blockage in your stomach or intestines;
• a heart rhythm disorder; or
• an electrolyte imbalance (such as low levels of potassium in your blood).

FDA pregnancy category C. It is not known whether Prussian blue will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether Prussian blue passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Exposure to radiation could cause a man to have low sperm counts up to several years later. Talk with your doctor if you have concerns about how radiation may affect your fertility.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prussian Blue falls into category C:

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

OR

There are no well-controlled studies that have been done in pregnant women. Prussian Blue should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

OR

No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Prussian Blue should be given to a pregnant woman only if clearly needed.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Other drugs may interact with Prussian blue, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Contraindications

• No contraindications according to manufacturer.1

Warnings/Precautions

Warnings

Effective only in decreasing radiation exposure; does not treat complications of such exposure.1 Provide supportive treatment for radiation toxicity (e.g., for severe neutropenia and thrombocytopenia) in conjunction with prussian blue therapy.1

In radiologic emergencies, the type of elemental exposure may not be known.1 Prussian blue may not bind to all radioactive elements; therefore, may need to use other radioprotectants (e.g., potassium iodide, edetate calcium disodium, sodium alginate) in addition to prussian blue in patients contaminated with unknown or multiple radioactive elements.1 2

Major Toxicities

Constipation reported frequently; constipation responds to oral administration of fiber (i.e., fiber-based laxatives and/or a high-fiber diet).1 3 4

Decreased GI motility will slow the GI transit time of the prussian blue-metal complex (i.e., prussian blue-137Cs, prussian blue-thallium) and may increase exposure to the metal.1 Caution in individuals with conditions associated with decreased GI motility.1

General Precautions

Hypokalemia (serum potassium concentrations of 2.5–2.9 mEq/L) reported.1 3 Closely monitor serum electrolytes.1

Use with caution in individuals with preexisting cardiac arrhythmias or electrolyte imbalances.1

Specific Populations

Category C.1

Prussian blue is unlikely to distribute into breast milk.1

Cesium and thallium are distributed into human breast milk; women contaminated with these metals should not breast-feed.1

Safety and efficacy and dosage recommendations in pediatric patients ≥2 years of age extrapolated from adult data and supported by experience in pediatric patients (4–12 years of age).1

Dosing recommendations not established for pediatric patients <2 years of age.1

Use not contraindicated; however, may be less effective in these patients due to decreased excretion of cesium and/or thallium in the bile.1

Use not contraindicated.1

Common Adverse Effects

Constipation,1 3 4 GI distress,1 4 blue discoloration of sweat and tears (long-term administration).7

• Importance of taking prussian blue with food; importance of taking appropriate measures (i.e., oral fiber-based laxatives and/or a high-fiber diet) to promote regular fecal elimination.1

• Importance of instructing patients on safety measures that should be used to minimize radiation exposure to others, including appropriate disposal of urine and feces.1 Clothing contaminated with blood or urine should be washed separately.1

• Advise patients of possible bluish appearance of their stools.1

• Advise patients who are unable to swallow capsules that their mouth and teeth might be colored blue if prussian blue capsules are opened and the contents mixed with food or liquid.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

Prussian blue is used to treat radioactive cesium or thallium, or non-radioactive thallium poisoning. It works by combining with thallium and cesium in the intestines. The combination is then removed from the body through the stools. By removing the thallium or radiocesium, the medicine lessens damage to your body's organs and tissues.

prussian blue is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Convulsions
• decreased urine
• difficulty having a bowel movement (stool)
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• shortness of breath
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blue colored stools

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.