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Feraheme® (ferumoxytol injection) Important Safety Information

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 as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • 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.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

A Comprehensive Access Support Program

AMAG Assist is committed to providing access support to patients and providers

AMAG Assist
Financial and prescription support*

Patient Benefits Investigation and Appeals

  • Verify your patients’ health insurance coverage for FERAHEME® and follow up with payers to ensure a timely response
  • Provide education and support on the appeals process in the event of a claim denial
  • Provide information about patient out-of-pocket costs for FERAHEME

Alternate Funding Research

  • For patients who are unable to afford their out-of-pocket costs, AMAG Assist can provide information on other resources that may be able to help with affording FERAHEME

Coding and Billing Information

  • Provide information about coding and billing and the prior authorization process (if applicable)

*Coverage and coding for FERAHEME may vary by health insurance plan. It is important to perform a benefits investigation. Upon request, AMAG Assist can help.

Sample Letter of Appeal
Patient assistance program

Uninsured and underinsured patients with no other identified source of drug coverage may be eligible to receive FERAHEME at no cost. To apply, a patient must submit a patient enrollment form through his or her healthcare provider.

An AMAG Assist Care Manager typically is able to advise the patient and physician’s office on patient eligibility within 1 business day of receiving a completed application and supporting documentation. For their eligible patients, healthcare providers can schedule a shipment of FERAHEME. A copy of a valid physician’s state license must be received before FERAHEME can be delivered to the physician’s office.

Patient Enrollment Form

Restrictions apply. Eligibility is evaluated on an individual basis.


A step-by-step guide
Getting Started

Contact AMAG Assist to request enrollment forms.

  • An AMAG Assist Care Manager will ask for basic contact and demographic information
  • The forms will be prefilled with this basic information and faxed to your office
Submitting Enrollment Forms

Review the forms and complete all remaining information.

  • Both you and your patient MUST sign the AMAG Assist release form
  • Fax all forms to AMAG Assist at 844-635-AMAG (2624)
  • You will receive a faxed confirmation upon receipt of all forms
Verifying Insurance Through AMAG Assist

For patients who are insured, you will receive a detailed insurance coverage profile. For patients who are uninsured or underinsured, eligibility for the Patient Assistance Program will be reviewed on an individualized basis.

AMAG Assist Care Managers are available to answer questions about support services at 844-635-AMAG (2624) during its hours of operation from Monday-Friday, 9:00am to 6:00pm ET.

Additional resources and access support services are available through AMAG Assist.

  • How to obtain product
  • Report an adverse event or product complaint
 
Feraheme® (ferumoxytol injection) Important Safety Information

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 as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • 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.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Indication and Dosing

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron or
  • who have chronic kidney disease (CKD)

The recommended dose of FERAHEME is an initial 510 mg dose followed by a second 510 mg dose as early as 3 days and up to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.

Contraindications

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.

Warnings and Precautions

Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.

Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.

Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.

Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.

Adverse Reactions

The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.