A generic version of the iron replacement therapy Feraheme® (ferumoxytol injection) has been made available by Sandoz.
Ferumoxytol injection is approved for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease.
The product is supplied as single-dose vials containing 510mg of elemental iron per 17mL in 1- and 10-count cartons. The Company initially plans to make the product available to patients in the hospital and clinic setting.
Commenting on the approval, Keren Haruvi, President, Sandoz Inc., said, “As the first generic high dose IV iron available in the US, Ferumoxytol provides patients with iron deficiency anemia a more cost-effective treatment option.”
Ferumoxytol injection carries a Boxed Warning associated with the risk for serious hypersensitivity and anaphylaxis reactions. The most common adverse reactions associated with treatment include diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.
- Sandoz launches first generic high dose intravenous iron, Ferumoxytol Injection, to treat US patients with iron deficiency anemia. News release. Sandoz, Inc. Accessed July 16, 2021. https://www.prnewswire.com/news-releases/sandoz-launches-first-generic-high-dose-intravenous-iron-ferumoxytol-injection-to-treat-us-patients-with-iron-deficiency-anemia-301335349.html.
- Ferumoxytol injection [package insert]. Princeton, NJ: Sandoz, Inc.; 2020.