Rockwell Medical, Inc. to Sponsor Triferic® Exhibitor Spotlight Presentation at American Society of Nephrology Conference
|Presentation Title:||Advances in Hemodialysis-Associated Anemia Management: The Benefits of Physiologic Iron Replacement Therapy|
|Presenter:||Jay B. Wish, MD, Professor of Clinical Medicine, Chief Medical Officer for Dialysis, Indiana University Health|
|Date:||Friday, November 8, 2019|
|Time:||10:00 am – 11:00 am|
|Location:||Walter E. Washington Convention Center, Exhibit Hall, Theater #1, Washington, D.C.|
In today’s clinical practice, it is very common to use traditional intravenous (IV) iron for repeated replacement of ongoing iron losses in chronic hemodialysis patients. This practice results in increased iron stores together with systemic inflammation.1 The long-range safety of such regular weekly or monthly traditional intravenous iron dosing regimens is a subject of some concern and controversy.2 Adverse effects of traditional intravenous iron may be concealed by their resemblance to common comorbidities in dialysis patients, such as infection, cardiovascular disease, and early mortality.3 Evidence of the negative effects of iron overload and other risks associated with long-term use of intravenous iron continues to build.3
Unlike traditional IV iron, Triferic replaces dialysis patients’ ongoing iron losses by providing iron with every hemodialysis treatment that is 100% bioavailable and maintains hemoglobin without increasing iron stores (ferritin). Triferic has a safety profile similar to placebo, with few Triferic-related serious adverse events reported in over 1,000,000 patient administrations.4,5
“We are very excited to have a clinician of Dr. Wish’s distinction and expertise speak on behalf of Triferic and believe this will be an extremely valuable presentation for all nephrologists who deal with issues around anemia management. Educating the medical community about the profile of Triferic through engagement with esteemed medical leaders is critical to get this important therapeutic to more patients,” said
Triferic is the only
Important Safety Information
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
For more information, including full prescribing information, visit: http://www.TRIFERIC.com.
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical’s intention to bring to market Triferic, and I.V. Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "potential," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While
Triferic® is a registered trademark of
- Monitor DP: DOPPS 6. In, 2019
- Macdougall IC, White C, Anker SD, et al. Intravenous Iron in Patients Undergoing Maintenance Hemodialysis.
The New England Journal of Medicine2019; 380: 447-458.
- Kalantar-Zadeh K, Regidor DL, McAllister CJ, Michael B, Warnock DG. Time-dependent associations between iron and mortality in hemodialysis patients. J Am Soc Nephrol. 2005;16(10):3070-3080
- Fishbane SN, Singh AK, Cournoyer SH,et al. Ferric pyrophosphate citrate (Triferic®) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015;30(12):2019-2026.
- Data on file.
Wixom, MI; Rockwell Medical, Inc.
Source: Rockwell Medical, Inc.