Patients with iron deficiency anemia in a hospital or clinic setting now have access to an important IV iron medicine at a more affordable price
Iron deficiency anemia occurs when there is a lower than normal number of oxygen-carrying red blood cells because of too little iron1
Immediate availability of Ferumoxytol Injection bolsters Sandoz portfolio and delivers another high-quality generic medicine to US patients
Princeton, New Jersey, July 16, 2021 — Sandoz, a global leader in generic and biosimilar medicines, today announced the immediate US availability of generic Ferumoxytol, an intravenous medicine used to treat iron deficiency anemia (IDA).
Ferumoxytol, a generic equivalent to AMAG Pharmaceuticals’ Feraheme®* (ferumoxytol injection), is approved to treat IDA in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease.2 The overall global IV iron market is over a one billion dollar market and continues to grow.3
“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,” said Keren Haruvi, President, Sandoz Inc. “This launch delivers on our strategy to continue to build our hospital and clinic portfolio and provide US patients access to affordable generic medicines that work as well as brand-name products.”
Sandoz initially plans to make its generic Ferumoxytol medicine available to patients in the hospital and clinic setting. Intravenous administration of iron has been shown to be more effective, more rapidly, than a prolonged course of oral iron therapy in patients with IDA.4
*Feraheme is a registered trademark of Covis Pharma GMBH Limited Liability Company.
IMPORTANT SAFETY INFORMATION
Ferumoxytol is contraindicated in patients with:
Known hypersensitivity to ferumoxytol or any of its components
History of allergic reaction to any intravenous iron product
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity for at least 30 minutes following the administration of Ferumoxytol.
Hypotension: May cause hypotension. Monitor for signs and symptoms of hypotension following the administration of Ferumoxytol.
Iron Overload: Regularly monitor hematologic responses during Ferumoxytol therapy. Do not administer Ferumoxytol to patients with iron overload.
Magnetic Resonance Imaging: Ferumoxytol can alter magnetic resonance imaging (MRI) studies.
The most common adverse reactions following the administration of Ferumoxytol are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.
Drug-drug interaction studies with Ferumoxytol were not conducted. Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no studies of Ferumoxytol in pregnant women. In animal studies, Ferumoxytol caused decreased fetal weights and fetal malformations at maternally toxic doses of 13-15 times the human dose. Use Ferumoxytol during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Ferumoxytol is present in human milk. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to avoid Ferumoxytol, taking into account the importance of Ferumoxytol to the mother and the known benefits of nursing.
Pediatric Use: The safety and effectiveness of Ferumoxytol in pediatric patients have not been established.
Geriatric Use: In controlled clinical trials, 330 patients ≥ 65 years of age were treated with Ferumoxytol. No overall differences in safety and efficacy were observed between older and younger patients in these trials, but greater sensitivity of older individuals cannot be ruled out. In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Iron replacement product 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).
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Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2020 sales of USD 9.6 billion.
Das SN, Devi A, Mohanta BB, Choudhury A, Swain A, Thatoi PK. Oral versus intravenous iron therapy in iron deficiency anemia: An observational study. J Family Med Prim Care. 2020;9(7):3619-3622. Published 2020 Jul 30. doi:10.4103/jfmpc.jfmpc_559_20