Feraheme

Last updated on RxList: 9/28/2020
Feraheme Side Effects Center

What Is Feraheme?

Feraheme (ferumoxytol) Injection is a type of iron used to treat iron deficiency anemia in people with chronic kidney disease. Anemia is a lack of red blood cells caused by having too little iron in the body.

What Are Side Effects of Feraheme?

Common side effects of Feraheme include:

  • dizziness,
  • fainting,
  • low blood pressure (hypotension),
  • injection site reactions (pain, swelling, or redness),
  • nausea,
  • vomiting,
  • stomach pain,
  • diarrhea,
  • constipation,
  • headache,
  • swelling in your hands or feet,
  • chest pain, or
  • cough.

Tell your doctor if you have unlikely but serious side effects of Feraheme including:

  • unusual bruising,
  • skin darkening (bronze tone),
  • swelling of lower legs, or
  • chest pain.

Dosage for Feraheme?

The recommended dose of Feraheme is an initial 510 mg intravenous injection followed by a second 510 mg intravenous injection 3 to 8 days later.

What Drugs, Substances, or Supplements Interact with Feraheme?

Feraheme may interact with oral iron supplements (including ferrous gluconate, ferrous fumarate, or ferrous sulfate), making it harder for your body to absorb those iron supplements. Other drugs can interact with Feraheme. Tell your doctor all medications and supplements you use.

Feraheme During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Feraheme; it is unknown if it will harm a fetus. It is unknown if Feraheme passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Feraheme is not recommended.

Additional Information

Our Feraheme (ferumoxytol) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

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Feraheme Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Watch for signs of allergic reaction for at least 30 minutes after your injection.

Older adults who have other health problems may be more likely to have a severe allergic reaction to ferumoxytol.

Call your doctor at once if you have:

  • severe dizziness or light-headed feeling;
  • slow heart rate, weak pulse, slow breathing; or
  • worsening symptoms of kidney failure.

Common side effects may include:

  • headache, dizziness;
  • diarrhea, constipation;
  • nausea; or
  • swelling in your arms, hands, legs, or feet.

Read the entire detailed patient monograph for Feraheme (Ferumoxytol Injection)

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Feraheme Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Serious Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypotension [see WARNINGS AND PRECAUTIONS]
  • Iron Overload [see WARNINGS AND PRECAUTIONS]
  • Magnetic Resonance (MR) Imaging Test Interference [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical studies, 3,968 subjects were exposed to Feraheme. Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years).

The data described below reflect exposure to Feraheme in 997 patients exposed to a 1.02 g course of ferumoxytol administered as two 510 mg intravenous (IV) doses: 992 subjects (99.5%) received at least 1 complete dose of ferumoxytol and 946 subjects (94.9%) received 2 complete doses. The mean cumulative IV Iron exposure was 993.80 ±119.085 mg.

The safety of Feraheme was studied in a randomized, multicenter, double-blind clinical trial in patients with IDA (IDA Trial 3), [see Clinical Studies]. In this trial, patients were randomized to two intravenous infusions of 510 mg (1.02 g) of Feraheme (n=997), or two intravenous infusions of 750 mg (1.500 g) of ferric carboxymaltose (FCM) (n=1000). Both intravenous irons were infused over a period of at least 15 minutes. Most patients received their second infusion of Feraheme and FCM 7(+1) days after Dose 1.

The mean (SD) age of the study population (N=1997) was 55.2 (17.16) years. The majority of patients were female (76.1%), white (71.4%) and non-Hispanic (81.8%). The mean (SD) hemoglobin at baseline for all patients was 10.4 (1.5) g/dl.

Serious adverse events were reported in 3.6% (71/1997) of ferumoxytol- and FCM- treated patients. The most common (≥2 subjects) serious AEs reported in Feraheme-treated patients were syncope, gastroenteritis, seizure, pneumonia, hemorrhagic anemia, and acute kidney injury. In FCM-treated patients the most common (≥2 subjects) serious AEs were syncope, cardiac failure congestive, angina pectoris, and atrial fibrillation.

Adverse reactions related to Feraheme and reported by ≥1% of Feraheme-treated patients in IDA Trial 3 are listed in Table 1.

Table 1: Adverse Reactions to Feraheme Reported in ≥1% of IDA Patients in IDA Trial 3

Adverse ReactionsFeraheme
2 x 510 mg
(N = 997)
%
Ferric Carboxymaltose
2 x 750 mg
(N = 1000)
%
Headache3.43.1
Nausea1.83.4
Dizziness1.51.6
Fatigue1.51.2
Diarrhea10.8
Back Pain10.4

In IDA Trial 3, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included arthralgia (0.3%), dyspnea (0.3%), flushing (0.2%), chest discomfort (0.2%), chest pain (0.2%), nausea (0.2%), back pain (0.2%), dizziness (0.2%) and headache (0.2%).

Across two clinical trials in patients with IDA (IDA Trial 1 and 2), [see Clinical Studies], patients were randomized to: two injections (rapid intravenous injection - prior method of administration no longer approved) of 510 mg of Feraheme (n=1,014), placebo (n=200), or five injections/infusions of 200 mg of iron sucrose (n=199). Most patients received their second Feraheme injection 3 to 8 days after the first injection. Adverse reactions related to Feraheme and reported by ≥ 1% of Feraheme-treated patients in these trials were similar to those seen in Trial 3.

In Trials 1 and 2, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypersensitivity (0.6%), hypotension (0.3%), and rash (0.2%).

In addition, a total of 634 subjects enrolled in and completed participation in a Phase 3 open label extension study. Of these, 337 subjects met IDA treatment criteria and received Feraheme. Adverse reactions following this repeat Feraheme dosing were generally similar in type and frequency to those observed after the first two intravenous injections.

Across three randomized clinical trials in patients with IDA and CKD (CKD Trials 1, 2, and 3), [see Clinical Studies], a total of 605 patients were exposed to two injections of 510 mg of Feraheme and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days. Most patients received their second Feraheme injection 3 to 8 days after the first injection.

Adverse reactions related to Feraheme and reported by ≥ 1% of Feraheme-treated patients in the CKD randomized clinical trials are listed in Table 2 . Diarrhea (4%), constipation (2.1%) and hypertension (1%) have also been reported in Ferahemetreated patients.

Table 2: Adverse Reactions to Feraheme Reported in ≥1% of Patients with IDA and CKD Trials 1, 2 and 3

Adverse ReactionsFeraheme
2 x 510 mg
(n = 605) %
Oral Iron
(n = 280)
%
Nausea3.17.5
Dizziness2.61.8
Hypotension2.50.4
Peripheral Edema23.2
Headache1.82.1
Edema1.51.4
Vomiting1.55
Abdominal Pain1.31.4
Chest Pain1.30.7
Cough1.31.4
Pruritus1.20.4
Pyrexia10.7
Back Pain10
Muscle Spasms11.4
Dyspnea11.1
Rash10.4

In these clinical trials in patients with IDA and CKD, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension (0.4%), chest pain (0.3%), and dizziness (0.3%).

Following completion of the controlled phase of the trials, 69 patients received two additional 510 mg intravenous injections of Feraheme (for a total cumulative dose of 2.04 g). Adverse reactions following this repeat Feraheme dosing were similar in character and frequency to those observed following the first two intravenous injections.

Postmarketing Experience

Because adverse 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 experience with Feraheme: fatal, lifethreatening, and serious 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 usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.

Read the entire FDA prescribing information for Feraheme (Ferumoxytol Injection)

© Feraheme Patient Information is supplied by Cerner Multum, Inc. and Feraheme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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