We are encouraged by the number of patients and families supported by our products and services. It motivates us to continue to seek ways to improve the patient and provider experience with these products and to deliver our therapies to more people who could benefit from them.
In collaboration with research physicians, we are conducting a large clinical trial that will add to the body of knowledge provided by the NICHD MFMU Network study of hydroxyprogesterone caproate (HPC) injection (Meis NEJM 2003), now available as FDA-approved Makena. This is the largest randomized controlled trial to date assessing the impact of progestogen therapy on reducing the risk of recurrent singleton preterm birth. In April 2018, AMAG completed enrollment of more than 1,700 women into the PROLONG study. These patients will need to complete their course of therapy, including a 28-day neonatal follow-up. Primary results are expected in early 2019.1,3
Feraheme® (ferumoxytol injection) For Intravenous (IV) Use
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 3 to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.
Feraheme® (ferumoxytol injection) Important Safety Information
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.
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.
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 email@example.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
Please click here to see full Prescribing Information, including Boxed Warning.
[footnote]References: 1. AMAG Pharmaceuticals, Inc.; Confirmatory Study of 17P Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery (PROLONG). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2016 May 05]. Available from: https://clinicaltrials.gov/show/NCT01004029 NLM Identifier: NCT01004029. 3. Data on file, AMAG Pharmaceuticals, Inc.
PP-FRH-US-00073 – Updated October 2018