Feraheme (Page 6 of 6)

16.2 Stability and Storage

Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° – 30°C (59° – 86°F) [see USP controlled room temperature].

17 PATIENT COUNSELING 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 [see Warnings and Precautions (5.1) ].

Hypersensitivity Reactions

Advise patients to immediately report any symptoms of hypersensitivity that may develop during and following Feraheme administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions (5.1) ].

U.S Patents: 6,599,498 B1; 7,553,479 B2; 7,871,597 B2; 8,501,158 B2; 8,591,864 B2; 8,926,947 B2

Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2018

Patient InformationFeraheme (FER-uh-heem)(ferumoxytol injection)

What is the most important information I should know about Feraheme?

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

See “What are the possible side effects of Feraheme?” for more information about side effects.

What is Feraheme?

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.

Who should not receive Feraheme?

Do not receive Feraheme if you:

  • are allergic to Feraheme or any of the ingredients in Feraheme. See the end of this leaflet for a complete list of ingredients in Feraheme.
  • have had an allergic reaction to any iron medicine given into your vein by intravenous (IV) infusion.

Before receiving Feraheme, tell your healthcare provider about all of your medical conditions, including if you:

  • have allergies to many different medicines
  • have iron overload
  • have low blood pressure (hypotension).
  • are pregnant or plan to become pregnant. It is not known if Feraheme will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Feraheme passes into your breast milk. You and your healthcare provider should decide if you will receive Feraheme or breastfeed.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive 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.

What are the possible side effects of Feraheme?

Feraheme can cause serious side effects, including:

  • See “What is the most important information I should know about Feraheme?”
  • Low blood pressure (hypotension) is a common side effect of Feraheme and can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each Feraheme infusion.
  • Iron overload. Your healthcare provider will do blood tests to check your iron levels during treatment with Feraheme.

The most common side effects of Feraheme include: diarrhea, headache, nausea, dizziness, constipation, and swelling of your legs, feet, arms, or hands.

These are not all of the possible side effects of Feraheme. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Feraheme.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Feraheme that is written for health professionals.

What are the ingredients in Feraheme?

Active ingredient: ferumoxytol

Inactive ingredient: mannitol

Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451 For more information, go to www.feraheme.com or 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
(click image for full-size original)

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

Package Label -- Principal Display Panel – Carton for Single Use Vial, Feraheme Injection
(click image for full-size original)
FERAHEME ferumoxytol injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59338-775
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE (FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE) FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE 510 mg in 17 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 748 mg in 17 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59338-775-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 17 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (59338-775-01)
2 NDC:59338-775-10 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
2 17 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (59338-775-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022180 07/13/2009
Labeler — AMAG Pharmaceuticals, Inc. (017511155)
Establishment
Name Address ID/FEI Operations
Baxter Pharmaceutical Solutions 604719430 MANUFACTURE (59338-775)
Establishment
Name Address ID/FEI Operations
Patheon Manufacturing Services LLC 079415560 MANUFACTURE (59338-775)

Revised: 09/2020 AMAG Pharmaceuticals, Inc.

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