Feraheme

Pregnancy Category: C

Lactation: excretion in milk unknown; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Ferumoxytol is injected into a vein through an IV. A healthcare provider will give you this injection, which can take up to 15 minutes to complete.

You will be watched closely for at least 30 minutes after receiving ferumoxytol, to make sure you do not have an allergic reaction to the medicine.

Ferumoxytol is usually given as a single injection followed by a second injection 3 to 8 days later.

You may need frequent medical tests to help your doctor determine how long to treat you with ferumoxytol.

Ferumoxytol can cause unusual results with magnetic resonance imaging (MRI) tests for up to 3 months after you receive this medication. After you receive a ferumoxytol injection, you should wait at least 4 weeks before having an MRI. Tell any doctor who treats you that you have received a ferumoxytol injection.

Ferumoxytol will not affect other types of X-rays, CT scans, ultrasounds, or nuclear radiation imaging.

Iron Deficiency Anemia in Patients with Chronic Kidney Disease

Treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).1 2 3

National Kidney Foundation guidelines recommend use of IV iron in patients undergoing hemodialysis and either oral or IV iron in patients undergoing peritoneal dialysis and in those with chronic kidney disease not on dialysis.4

No formal drug interaction studies to date.1

Oral Iron Preparations

Ferumoxytol expected to reduce absorption of concomitantly administered oral iron.1

Absorption

Bioavailability

Time to peak plasma concentrations is 0.32 hours.1

Elimination

Elimination Route

Not removed by dialysis.1 3

Half-life

15 hours.1

• Risk of serious hypersensitivity reactions.1 5 6 Importance of patient informing clinician of prior hypersensitivity reactions to parenteral iron preparations or other drugs.1 5 6 Importance of patient alerting clinician or seeking immediate medical attention if any symptoms of allergic reaction occur during or after infusion of the drug (e.g., rash, itching, dizziness, lightheadedness, swelling of the tongue or throat, wheezing, breathing difficulty).1 5 6

• Risk of hypotension.1 5 6

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or conditions (e.g., hypotension, multiple drug allergies).1 6

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 6

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

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ferumoxytol injection is an iron replacement product that is used to treat iron deficiency anemia (not enough iron in the blood) in patients with chronic kidney disease (CKD).

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.

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

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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

Animal studies showed fetal malformations and decreased fetal weights at maternally toxic doses; lower doses (approximately twice the human dosage) did not show maternal or fetal effects. No effects on fertility were seen in animal studies. There are no controlled data in human pregnancy. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Iron deficiency anemia during the first trimester can often be treated with oral iron. -Use is not recommended in women not using adequate contraception. -Treatment with this product should be confined to the second and third trimester if benefit outweighs risk. (UK)