Ferumoxytol (Feraheme)
Ferumoxytol is covered for the FDA-approved ages – 18 years of age and older.
a. FDA-Approved Indications
Ferumoxytol is covered for all of the following FDA-approved indications:
1. iron deficiency anemia in adult beneficiaries who are hemodialysis dependent with chronic kidney disease (HDD-CKD);
2. iron deficiency anemia in adult beneficiaries who are non-dialysis dependent with chronic kidney disease (NDD-CKD); and
3. iron deficiency anemia in adult beneficiaries who are peritoneal dialysis dependent with chronic kidney disease (PDD-CKD).
Billing Units
The appropriate procedure code(s) used determines the billing unit(s).
1. Ferumoxytol (Feraheme) and iron sucrose (Venofer): 1 billing unit = 1 mg.
2. Iron dextran (INFeD and DexFerrum): 1 billing unit = 50 mg.
3. Sodium ferric gluconate complex in sucrose (Ferrlecit): 1 billing unit = 12.5 mg.
4. Medicaid covers appropriate administration codes when billed with Q0138, Q0139, J1750, J1756, or J2916 on the same day of service.
National drug codes (NDC) 59338-0775-01 Feraheme 510 mg/17 mL, 1 vial 59338-0775-10 Feraheme 510 mg/17 mL, 10 vials
Indication and contraindication
• Feraheme® (ferumoxytol) Injection for intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.
• Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. Warnings and precautions
• Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration.
Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Anaphylactic-type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. • Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme administration.
• Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme.
• As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging. Adverse reactions
• In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in = 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%).
• In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria. Post-marketing safety experience
• The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic-type reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme
Feraheme, when added to intravenous infusion bags containing either Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately, but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours.
The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme injection. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.
For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme injection. Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme. Observe patients for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Adverse Reactions (6.1)].
Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience [see Adverse Reactions from Postmarketing Spontaneous Reports (6.2)]. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects.