Dosing and Administration

Dosing

Feraheme is an IV iron approved for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). Feraheme offers a number of distinct dosing characteristics:

  • 510-mg undiluted IV push that may be delivered in under 1 minute1
    • Allows for goal-directed dosing
    • Deliver at a rate of up to 1 mL/sec (30 mg/sec)1
    • Second dose should be delivered 3 to 8 days after the first dose1
  • Treatment with fewer injections over a shorter period of time compared to other IV irons1,3-5
  • 1 gram of elemental iron may be provided with 2 treatments of 510 mg1
  • The recommended Feraheme dose may be readministered as needed to CKD patients with persistent or recurrent IDA1
  • No test dose or dilution necessary1

Additional considerations

  • Evaluate the hematologic response (hemoglobin [Hgb], ferritin, iron, and transferrin saturation [TSAT]) at least 1 month following the second Feraheme injection1
  • For patients receiving hemodialysis, administer Feraheme once blood pressure is stable and the patient has completed at least 1 hour of hemodialysis1
  • Monitor for signs and symptoms of hypotension following each Feraheme injection1
  • Do not administer to patients with iron overload1
  • Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection
  • Feraheme should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions
  • No head-to-head studies against other IV irons have been conducted

Feraheme dosing

Feraheme Dosing

One regimen across the spectrum of CKD

Click on sections of the table below to review the dosing and rate of administration of Feraheme and the dosing and administration of other available IV irons. Please note no head-to-head comparator trials comparing the IV irons listed here have been conducted. Please see full Prescribing Information of each IV iron listed for more details.

Feraheme and other available IV irons

  Feraheme1,2
(30 mg Fe/mL)
fewer injections over a shorter period of time
Venofer®3
(100 mg Fe/5 mL)
(200 mg Fe/10 mL)
Indication

Treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD)

Treatment of iron deficiency anemia in the following patients:

  • Non-dialysis dependent CKD (NDD-CKD) patients receiving erythropoietin
  • NDD-CKD patients not receiving erythropoietin
  • Hemodialysis dependent CKD (HDD-CKD) patients receiving erythropoietin
  • Peritoneal dialysis dependent CKD (PDD-CKD) patients receiving erythropoietin
Dose and rate
of administration
   
NDD-CKD

510-mg dose administered as a rapid IV push in under 1 minute; second dose should be delivered 3 to 8 days after the first dose (2 x 510-mg treatments within 1 week)

Five 200-mg (10-mL) treatments administered by slow IV injection (2–5 min) over 14 days. There is limited experience administering 500 mg (25 mL) diluted in ≤250 mL 0.9% NaCl, by slow infusion (3.5–4 hrs) on Day 1 and Day 14; hypotension occurred in 2 of 30 patients treated

DD-CKD Same as above

Ten 100-mg (5-mL) treatments administered by slow IV injection (2–5 min); or 100 mg (5 mL) diluted in ≤100 mL 0.9% NaCl by IV infusion (≥15 min) in consecutive dialysis sessions

PDD-CKD Same as above Two 300-mg (15-mL) treatments diluted in ≤250 mL 0.9% NaCl administered by slow IV infusion (1.5 hrs) 14 days apart, followed by one 400-mg (20-mL) treatment (same dilution) by slow infusion (2.5 hrs) 14 days later
Time to complete administration of 1 gram Within 1 week 14–28 days
  Feraheme1,2
(30 mg Fe/mL)
fewer injections over a shorter period of time
Ferrlecit®4
(62.5 mg Fe/5 mL)
Indication

Treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD)

Treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy

Dose and rate
of administration
   
NDD-CKD

510-mg dose administered as a rapid IV push in under 1 minute; second dose should be delivered 3 to 8 days after the first dose (2 x 510-mg treatments within 1 week)

Not indicated
DD-CKD Same as above

125-mg (10-mL) treatments diluted in 100 mL 0.9% NaCl administered by slow IV over 1 hr; or 10 mL undiluted by slow IV injection at a rate of up to 1 mL/min

Most patients will require a minimum cumulative dose of 1.0 gram of elemental iron, administered over 8 sessions to achieve a favorable hemoglobin or hematocrit response

PDD-CKD Same as above Not indicated
Time to complete administration of 1 gram Within 1 week ≥16 days (assuming dialysis every other day)
  Feraheme1,2
(30 mg Fe/mL)
fewer injections over a shorter period of time
INFeD®5
(50 mg Fe/mL)
Indication

Treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD)

 

Treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible

Dose and rate
of administration
   
NDD-CKD

510-mg dose administered as a rapid IV push in under 1 minute; second dose should be delivered 3 to 8 days after the first dose (2 x 510-mg treatments within 1 week)

PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given

After waiting ≥1 hr after the test dose, all subsequent daily doses should be given until the calculated total amount required has been reached

Treatments administered either as ≤100 mg (2 mL) undiluted by slow IV infusion not to exceed 1 mL/min, or intramuscularly (IM) at doses of ≤25 mg (.5 mL) for infants under 5 kg (11 lbs); ≤50 mg (1 mL) for children under 10 kg (22 lbs); or ≤100 mg (2 mL) for other patients

DD-CKD Same as above Same as above
PDD-CKD Same as above Same as above
Time to complete administration of 1 gram Within 1 week ≥10 days

 

Venofer is a registered trademark of American Regent, Inc.
Ferrlecit and INFeD are registered trademarks of Watson Pharma, Inc.

Important Safety Information
Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

Warnings and precautions

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. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. 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.

Please see full Prescribing Information for Feraheme.