Ferumoxytol (Feraheme) is a unique intravenous preparation of iron that can be infused relatively rapidly compared to iron sucrose. Furthermore, compared to other iron preparations, it has got a low immunogenicity, is infused in isotonic fluid, and is stable when binds to its carrier proteins. It is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.

Ferumoxytol (Feraheme) Uses:

• Iron-deficiency anemia:

  • It is indicated for the treatment of iron deficiency anemia in adults who are intolerant to have an unsatisfactory response to oral iron.
  • It is also indicated for the intravenous treatment of iron deficiency anemia in patients with chronic kidney disease.

Ferumoxytol (Feraheme) Dose in Adults

Note:

• In the manufacturer's labeling, the need for a test dose is not indicated.
• Doses expressed here are in mg of elemental iron.

Ferumoxytol (Feraheme) Dose in the treatment of Iron-deficiency anemia:

• IV:

  • 510 mg as an intravenous infusion.
  • The second infusion is administered after 3 to 8 days of the initial dose as 510 mg IV infusion.
  • The response to therapy may be assessed a month after the second dose.
  • Patients with recurrent or persistent iron deficiency anemia may be advised re-administration of the dose.

Use in Children:

Not indicated.

Ferumoxytol (Feraheme) Pregnancy Risk Category: N

• Iron requirements for mothers increase during pregnancy.
• Except in extreme cases, the iron content of the foetus is not affected by maternal iron deficiency.
• Anemia due to iron deficiency is often associated with poor fetal outcomes, such as low birth weight, preterm births, and higher fetal deaths.
• Iron deficiency during pregnancy can be treated in the same way as for the general population.
• Although oral iron preparations can be sufficient, intravenous iron may also be useful in cases of severe iron deficiency, patients who are allergic to oral iron or patients with gastrointestinal disease.
• Due to limited data, intravenous Iron should be administered in the second or third trimester.

Ferumoxytol use during breastfeeding:

• Breastmilk is usually rich in iron, even when there is a maternal iron deficiency. 
• The iron content in breastmilk can decrease in severe or moderate iron deficiency anemia.
• It has not been determined whether maternal use of ferrumoxytol affects iron content in breastmilk.
• Manufacturers recommend weighing the risks to the child from drug exposure and the benefits for the mother.

Ferumoxytol (Feraheme) Dose in Kidney Disease:

Adjustment in the dose is not necessary.

• Hemodialysis:
  • The drug is not removed by hemodialysis.
  • The dose should be administered at least one hour after hemodialysis and after the blood pressure has stabilized.

Dose in Liver disease:

Adjustment in the dose has not been provided in the manufacturer's labeling.

Side Effects of Ferumoxytol (Feraheme):

• Cardiovascular:

  • Hypotension
  • Edema
  • Peripheral Edema
  • Chest Pain
  • Hypertension

• Central Nervous System:

  • Dizziness
  • Headache
  • Fatigue

• Dermatologic:

  • Pruritus
  • Skin Rash

• Gastrointestinal:

  • Diarrhea
  • Nausea
  • Constipation
  • Vomiting
  • Abdominal Pain

• Hypersensitivity:

  • Hypersensitivity Reaction

• Neuromuscular & Skeletal:

  • Back Pain
  • Muscle Spasm

• Respiratory:

  • Cough
  • Dyspnea

• Miscellaneous:

  • Fever

Contraindications to Ferumoxytol (Feraheme):

• Allergy reactions to ferumoxytol or other intravenous iron products or any component of this formulation

Warnings and precautions

• Hypersensitivity reactions: [US Boxed Warning]

  • Intranasal iron formulations can cause serious allergic reactions. Anaphylactic reactions can include hypotension, shock and syncope as well as cardiac and cardiorespiratory arrest.
  • Infusions should be given slowly for at least 15 minutes. You should have resuscitation equipment and measures available at the infusion site.
  • Hypersensitivity reactions, including pulse and blood pressure, must be closely monitored by patients during and after infusion.
  • Itching, wheezing and urticaria may also be symptoms.
  • Anaphylaxis is more common in patients who have had previous allergic reactions to drugs.
  • Patients in their 80s and older may experience severe hypersensitivity reactions, such as shock or hypotension.

• Hypotension

  • Hypotension can occur after and during the administration of the drug. Hypotension must be closely monitored.

Ferumoxytol: Drug Interaction

Note: Drug Interaction Categories:

• Risk Factor C: Monitor When Using Combination
• Risk Factor D: Consider Treatment Modification
• Risk Factor X: Avoid Concomitant Use

Monitoring parameters:

• Hemoglobin,
• serum ferritin, serum iron, and transferrin saturation at least one month after the second injection and periodically thereafter.
• Signs and symptoms of hypersensitivity reactions,
• blood pressure and pulse during the infusion and for at least 30 minutes after the infusion.

How to administer Ferumoxytol (Feraheme)?

IV:

• It is administered as a slow intravenous infusion over at least fifteen minutes.
• While infusing it, make the patient lie down in a supine position.
• Monitor for signs and symptoms of hypersensitivity reactions including pulse and blood pressure during and for at least 30 minutes after the infusion.
• With rapid intravenous bolus injection, serious hypersensitivity reactions have been observed.
• It is important to keep an interval of at least thirty minutes between administering ferumoxytol and other intravenous drug that may cause serious allergic reactions such as the administration of chemotherapeutic agents and monoclonal antibodies.
• In patients who undergo hemodialysis, the dose should be administered at least one hour after the hemodialysis session and when the blood pressure has stablized.

Mechanism of action of Ferumoxytol (Feraheme):

• It is a superparamagnetic Iron Oxide that has been coated with a semisynthetic carbohydrate of low molecular weight.
• Iron is released from the carbohydrate compound that enters the retinal system macrophages, liver, and bone-marrow.
• The iron is either incorporated in hemoglobin, or transported into storage facilities.

Metabolism:

• After iron-carbohydrate compound uptake, the iron is released.

Half-life elimination:

• About 15 hours
• It is not removed by hemodialysis

International Brand Names of Ferumoxytol:

• Feraheme
• Rienso

Ferumoxytol Brand Names in Pakistan:

No Brands Available in Pakistan.