Patients on Velphoro took fewer tablets than those on sevelamer carbonate2

Sevelamer carbonate
10.1 tablets per day (mean) (n=260)
Velphoro
4.0 tablets per day (mean) (n=384)
Tablets not actual size.
Sevelamer carbonate
10.1 tablets
per day

(mean) (n=260)
Velphoro
4.0 tablets
per day

(mean) (n=384)
Tablets not actual size.
Tablets per day during the maintenance phase of the study

In a separate retrospective study (N=8,616), low pill burden was associated with better adherence and improved lab goal achievement‡3

In a separate retrospective study (N=8,616), low pill burden was associated with better adherence and improved lab goal achievement‡3

See why low pill burden matters

Dr. Sprague discusses the impact of high pill burden on adherence.

Stuart M. Sprague, DO
Chief of the Division of Nephrology and Hypertension
NorthShore University HealthSystem, University of Chicago, Evanston, Illinois
Give patients flexible administration options

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*Over the course of the 52-week study, patients on Velphoro took an average of 5.4 fewer tablets per day: 5.4 x 365 = 1,971.
A 52-week, open-label, active-controlled, phase 3 study evaluated the safety and efficacy of Velphoro in lowering serum phosphorus levels in patients (N=1,054) with chronic kidney disease on hemodialysis or peritoneal dialysis. In the titration phase (first 24 weeks), patients were randomized to receive either Velphoro or sevelamer carbonate to establish the noninferiority of Velphoro to sevelamer carbonate in lowering serum phosphorus at 12 weeks (secondary endpoint). The following withdrawal phase (weeks 24 to 27, n=93) established the superiority of Velphoro with an effective maintenance dose over a placebo-like low dose (primary endpoint). During a final long-term maintenance phase (weeks 28-52, n=658), patients continued phosphate binder treatment according to their original randomization for the assessment of long-term efficacy, safety, and tolerability.1
Study to assess the association of phosphate binder pill burden and adherence with phosphorus goal attainment. Adherence was estimated by the medication possession ratio (MPR), defined as the proportion of time a patient had sufficient medication to have taken it as prescribed. Using pharmacy management program data, hemodialysis patients on phosphate binder monotherapy were tracked from first phosphate binder prescription fill for 1 year or until patients were censored. Censoring occurred if patients switched phosphate binder type, received prescriptions for multiple phosphate binders, enrolled in the automatic refill management system, had a gap of 180 days between fills of all medications in the pharmacy management program, had two consecutive serum phosphorus levels <3.0 mg/dL, discontinued hemodialysis, or died.3

References:
1. Velphoro® [package insert]. Waltham, MA: Fresenius Medical Care North America; 2014. 2. Floege J, Covic AC, Ketteler M, et al; on behalf of the Sucroferric Oxyhydroxide Study Group. Long-term effects of the iron-based phosphate binder, sucroferric oxyhydroxide, in dialysis patients. Nephrol Dial Transplant. 2015;30(6):1037-1046. 3. Wang S, Alfieri T, Ramakrishnan K, Braunhofer P, Newsome BA. Serum phosphorus levels and pill burden are inversely associated with adherence in patients on hemodialysis. Nephrol Dial Transplant. 2014;29(11):2092-2099.

INDICATION

Velphoro® (sucroferric oxyhydroxide) is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

IMPORTANT SAFETY INFORMATION

  • Velphoro must be administered with meals. Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed.
  • Patients with peritonitis during peritoneal dialysis, significant gastric or hepatic disorders, following major gastrointestinal (GI) surgery, or with a history of hemochromatosis or other diseases with iron accumulation have not been included in clinical studies with Velphoro. Monitor effect and iron homeostasis in such patients.
  • In a parallel design, fixed-dose study of 6 weeks duration, the most common adverse drug reactions to Velphoro chewable tablets in hemodialysis patients included discolored feces (12%) and diarrhea (6%).
  • Velphoro can be administered concomitantly with oral calcitriol, ciprofloxacin, digoxin, enalapril, furosemide, HMG-CoA reductase inhibitors, hydrochlorothiazide, losartan, metoprolol, nifedipine, omeprazole, quinidine and warfarin. Take doxycycline at least 1 hour before Velphoro. Velphoro should not be prescribed with oral levothyroxine.

For additional important safety information, please see the full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at
1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is intended for use by US healthcare professionals only.
 

Distributed by:
Fresenius Medical Care North America
Waltham, MA 02451