July 4, 2015
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Feraheme

"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...

Feraheme

FERAHEME®
(ferumoxytol) Injection




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].
  • 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].
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

Feraheme, an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme is Fe5874O8752C11719H18682O9933Na414 with an apparent molecular weight of 750 kDa.

Feraheme Injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme Injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.

What are the possible side effects of ferumoxytol (Feraheme)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have serious side effects such as:

  • feeling like you might pass out;
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
  • easy bruising;
  • swelling where the medicine was injected; or
  • worsening symptoms of kidney failure...

Read All Potential Side Effects and See Pictures of Feraheme »

What are the precautions when taking ferumoxytol injection (Feraheme)?

Before taking ferumoxytol, tell your doctor or pharmacist if you are allergic to it; or if you have had a reaction to other types of injectable iron; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

During use and for 3 months after your last injection, tell X-ray staff that you use or used this medication. This medication can interfere with the results of an MRI...

Read All Potential Precautions of Feraheme »

Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.

Feraheme - User Reviews

Feraheme User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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