DexFerrum

Iron dextran is used to treat patients with iron deficiency anemia that cannot be adequately treated with oral iron supplements.

Iron dextran is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Iron dextran must be given slowly. Injecting this medicine too quickly can cause serious side effects.

Your doctor may want to give your first dose of this medicine in a hospital to quickly treat any serious side effects that occur.

If you use this medicine at home, prepare your dose only when you are ready to give the injection. Do not mix iron dextran with other medicines or liquid (diluent) in the same syringe or IV container. Do not use iron dextran if it has changed colors or has particles in it. Call your pharmacist for new medicine.

Tell your doctor if you have any changes in height or weight. Iron dextran doses are based on these measures.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with iron dextran.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using iron dextran.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store at room temperature away from moisture and heat.

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

Overdose symptoms may include joint pain, chills, dizziness, fever, headache, muscle aches, nausea, and vomiting.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Iron dextran can cause severe and sometimes fatal allergic reactions or severely low blood pressure. Tell your caregiver right away if you feel light-headed or if you suddenly have trouble breathing.

Call your doctor at once if you have:

• fast or slow heartbeats. chest pain, wheezing, trouble breathing;

• a light-headed feeling, like you might pass out;

• flushing (warmth, redness, or tingly feeling);

• blue-colored lips or fingernails;

• red or pink urine;

• weak or shallow breathing (breathing may stop);

• seizure (convulsions);

• swelling, warmth, redness, or itching where the medicine was injected; or

• delayed effect (1-2 days after injection)--fever, chills, dizziness, headache, general ill feeling, nausea and vomiting, joint or muscle pain, back pain.

Common side effects may include:

• mild itching or rash;

• body aches, numbness or tingly feeling;

• nausea, vomiting, stomach pain, diarrhea;

• mild dizziness or weakness, low fever; or

• brown discoloration of your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with iron dextran, 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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Dexferrum.
• Do not take other iron products with this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Dexferrum while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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:

• Loose stools (diarrhea).
• Headache.
• Dizziness.
• Belly pain.
• Upset stomach or throwing up.
• Change in taste.
• Feeling tired or weak.
• Pain where the shot was given.
• Irritation or swelling where the shot was given.
• Brown skin where the shot was given.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Animal studies have shown teratogenic and embryocidal outcomes at about 3 times the maximum human dose. No consistent adverse fetal effects were seen at doses of 50 mg/kg or less in animal models. Animal models were not iron deficient. There are no controlled data in human pregnancy. It appears that some iron does cross the placenta, but the form of the iron that crosses is not clear. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is recommended only if clearly needed and the benefit outweighs the risk. Use is not recommended during the first trimester of pregnancy. US FDA pregnancy category: C Comments: -Iron deficiency anemia during the first trimester can frequently be treated with oral iron.