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Label Changes for:

Feraheme (ferumoxytol) Injection

March 2015

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  

March 2015

BOXED WARNING (new)

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

  • Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
  • Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions (5.1)].
  • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [see Warnings and Precautions (5.1)].
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [see Warnings and Precautions (5.1)].

CONTRAINDICATIONS

Feraheme is contraindicated in patients with:

  • bullet added...History of allergic reaction to any intravenous iron product

WARNINGS AND PRECAUTIONS

  • 'Serious' added to Hypersensitivity Reactions section.
  • ...Section edited with new clinical data and monitoring recommendations including advice that patients should be closely monitored for signs and symptoms of hypersensitivity reactions, including monitoring of blood pressure and pulse during administration and for at least 30 minutes following each infusion of Feraheme and advice that Elderly patients (> 65 years of age) or patients with multiple comorbidities who experience a serious  hypersensitivity reaction due to Feraheme may have more severe outcomes. The potential risks and benefits of Feraheme administration should be carefully considered in these patients.

ADVERSE REACTIONS

Postmarketing Experience
  • ...fatal and serious added

USE IN SPECIFIC POPULATIONS

Geriatric Use
  • ...added: Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes. The potential risks and benefits of Feraheme administration should be carefully considered in these patients.

PATIENT COUNSELING INFORMATION

Prior to Feraheme administration:

  • bullet edited...Question patients regarding a history of allergy to intravenous iron or any medications.

 

June 2011 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • 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 postmarketing 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 these subjects.

 

November 2010

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • Feraheme may cause serious life-threatening hypersensitivity reactions including anaphylaxis and/or anaphylactoid reactions. Anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience.
Hypotension
  • Severe adverse reactions of clinically significant hypotension have been reported.

ADVERSE REACTIONS

Postmarketing Experience
  • ...The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic/anaphylactoid 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….
     

 

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