Pronunciation:

EYE-urn DEX-tran

Brand Names:

• Dexferrum
• Infed

Dosage Forms:

• Solution

Warnings:

Anaphylactic-type reactions, including fatalities, have followed the parenteral use of iron dextran. Have resuscitation equipment and personnel readily available during administration. Administer a test dose, and only administer full dose in the absence of signs or symptoms of anaphylactic-type reaction. Observe patients during administration for anaphylactic-type reaction. Use iron dextran only in patients no amenable to oral iron therapy. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic reactions .

Classifications:

Therapeutic—

Parenteral Mineral-Trace Mineral

Uses of This Medicine:

Iron dextran is an iron replacement product that is used to treat iron deficiency, such as anemia (not enough iron in the blood) or blood loss in patients with certain conditions (eg, hemophilia, gastrointestinal bleeding).

Iron is a mineral that the body needs to produce red blood cells. When the body does not get enough iron, it cannot produce the number of normal red blood cells needed to keep you in good health. This condition is called iron deficiency (iron shortage) or iron deficiency anemia.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use of iron dextran is not recommended in children younger than 4 months of age.

Older adults—

No information is available on the relationship of age to the effects of iron dextran in geriatric patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving iron dextran.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Baloxavir Marboxil
• Bictegravir
• Dimercaprol
• Eltrombopag
• Erdafitinib
• Magnesium Sulfate
• Raltegravir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Delafloxacin
• Minocycline
• Zinc

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Phytic Acid Containing Food

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergies, history of or
• Asthma, history of or
• Heart or blood vessel disease or
• Kidney infection or
• Liver disease or
• Rheumatoid arthritis—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in a vein or as a shot into a muscle (usually in the buttock).

You may be given a small test dose of this medicine to make sure you or your child are not allergic to it. The rest of your dose will be given at least one hour after the test dose.

Do not use iron supplements while you or your child are being given iron dextran shots unless your doctor tells you to.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects (eg, too much iron in the blood).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Tell your doctor right away if you have the following symptoms after receiving this medicine: chills, backache, dizziness, headache, moderate to high fever, joint or muscle pain, nausea, or vomiting.

Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

Incidence not known

Backache

blood in the urine

bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

chest pain or discomfort

chills

cold, clammy skin

confusion

cough

difficulty with moving

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast, slow, pounding, or irregular heartbeat or pulse

fast, weak pulse

feeling of warmth

fever

headache

hives or welts, itching, or rash

lightheadedness, dizziness, or fainting

muscle pain or stiffness

nausea

nervousness

no blood pressure or pulse

pain in the joints

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the face, neck, arms, and occasionally, upper chest

redness of the skin

seizures

stopping of heart

sweating

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

unconsciousness

unusual tiredness or weakness

vomiting

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:

Incidence not known

Abdominal or stomach pain

change in taste

diarrhea

soreness or pain at the injection site

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.