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FERAHEME- ferumoxytol injection


  1. Patient Information
  2. Feraheme May Cause Serious Side Effects Including:
  3. Tell Your Healthcare Provider Or Get Medical Help Right Away If You Get Any Of These Signs Or Symptoms:
  4. Feraheme Is A Prescription Medicine Used To Treat Iron Deficiency Anemia In Adults Who Have:
  5. Do Not Receive Feraheme If You:
  6. Active Ingredient:
  7. Inactive Ingredient:
  8. Revised: 2/2018document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Prior History of Allergies to Parenteral Iron Products

Question patients regarding any prior history of allergies to parenteral iron products [

Feraheme May Cause Serious Side Effects Including: 

  • Serious allergic reactions that can lead to death.Serious allergic reactions have happened in people after receiving the first dose of Feraheme or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to Feraheme.

Tell Your Healthcare Provider Or Get Medical Help Right Away If You Get Any Of These Signs Or Symptoms: 

  • rash
  • itching
  • dizziness or lightheadedness
  • swelling of the tongue or throat
  • wheezing or trouble breathing

Feraheme Is A Prescription Medicine Used To Treat Iron Deficiency Anemia In Adults Who Have: 

  • intolerance to oral iron or who have not responded well to treatment with oral iron or
  • chronic kidney disease (CKD)

It is not known if Feraheme is safe and effective in children less than 18 years of age.

Do Not Receive Feraheme If You: 

  • are allergic to Feraheme or any of the ingredients in Feraheme.

    • Feraheme will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive Feraheme in 2 doses 3 to 8 days apart.
    • Your healthcare provider will watch you during and for at least 30 minutes after you receive Feraheme.

Active Ingredient: 

ferumoxytol

Inactive Ingredient: 

mannitol

Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451
For more information, go towww.feraheme.comor call 1--877-411-2510.


Package Label - Principal Display Panel 17 mL Vial, Feraheme Injection

Package Label - Principal Display Panel     17 mL Vial, Feraheme Injection



Package Label - Principal Display Panel Carton for Single Use Vial, Feraheme Injection

Package Label - Principal Display Panel     Carton for Single Use Vial, Feraheme Injection



FERAHEME
ferumoxytol injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59338-775
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE(UNII: CLH5FT6412) (FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE - UNII:CLH5FT6412)FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE510 mg in 17 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL(UNII: 3OWL53L36A)748 mg in 17 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59338-775-011 in 1 CARTON07/13/2009
117 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:59338-775-1010 in 1 CARTON07/13/2009
217 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02218007/13/2009
Labeler -AMAG Pharmaceuticals, Inc. (017511155)
Establishment
NameAddressID/FEIBusiness Operations
AMAG Pharmaceuticals, Inc.017511155MANUFACTURE(59338-775)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Manufacturing Services LLC079415560MANUFACTURE(59338-775)

Revised: 2/2018document Id: 

d790b0a1-e9ff-4b56-b7e1-ff4637ebd333Set id: 32b0e320-a739-11dc-a704-0002a5d5c51bVersion: 18Effective Time: 20180205AMAG Pharmaceuticals, Inc.



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