Following completion of Study-05A, 658 patients (597 on hemodialysis and 61 on peritoneal dialysis) were treated in the 28-week extension study (Study-05B) with either Velphoro (N=391) or sevelamer carbonate (N=267) according to their original randomization.
Serum phosphorus levels declined rapidly during the first few weeks of treatment and remained relatively constant thereafter. The phosphorus lowering effect of Velphoro was consistently maintained through 12 months of treatment (shown in FIGURE 1). Age, gender, race, or dialysis modality did not affect the efficacy of Velphoro.
Serum iron level increases from baseline were not clinically meaningful and did not differ significantly compared to the active control. There was no evidence of accumulation of iron during one year treatment.
There were no clinically meaningful changes for vitamins (A, D, E and K) with Velphoro.
Mean change (±SEM) from baseline in serum phosphorus over time in Study-05A and extension Study-05B
Figure 1
Mean change (±SEM) from baseline in serum phosphorus over time in Study-05A and extension Study-05B. Insert showing the mean change (±SEM) from baseline in serum phosphorus during the withdrawal phase of the study (Weeks 24 to 27) for Velphoro non-effective low dose control (250 mg/day) versus Velphoro maintenance dose.CLOSE
16 HOW SUPPLIED/STORAGE AND HANDLING
Velphoro are chewable tablets supplied as brown, circular, bi-planar tablets, embossed with "PA 500" on 1 side. Each tablet of Velphoro contains 500 mg iron as sucroferric oxyhydroxide. Velphoro tablets are packaged as follows:
NDC 49230-645-51 Bottle of 90 chewable tablets
Storage
Store in the original package and keep the bottle tightly closed in order to protect from moisture.
Store at 25°C (77°F) with excursions permitted to 15 to 30°C (59 to 86°F).
17 PATIENT COUNSELING INFORMATION
Inform patients that Velphoro tablets must be chewed and not swallowed whole. To aid with chewing and swallowing, the tablets may be crushed [see Dosage and Administration (2)].
Velphoro should be taken with meals.
Instruct patients on concomitant medications that should be dosed apart from Velphoro [see Drug Interactions. (7)]
Inform patients that Velphoro can cause discolored (black) stool.
Distributed by:
Fresenius Medical Care North America
920 Winter Street
Waltham, MA 02451
US Patent Nos. 6174442 and pending, comparable and/or related patents.
© 2014 Fresenius Medical Care North America. All rights reserved.
PRINCIPAL DISPLAY PANEL
Principal Display Label - Bottle Label - NDC 49230-645-51
Principal Display Label - Bottle Label
PRINCIPAL DISPLAY PANEL
Principal Display Label - Bottle Carton - NDC 49230-645-51
Principal Display Label – Bottle Carton
INGREDIENTS AND APPEARANCE
VELPHORO
sucroferric oxyhydroxide tablet, chewable
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49230-645
Route of Administration ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) (IRON - UNII:E1UOL152H7) IRON 500 mg
PRODUCT CHARACTERISTICS
Color BROWN Score no score
Shape ROUND&nb |
