Sevelamer Carbonate (Page 4 of 5)

14.5 Sevelamer Hydrochloride versus Active Control in Hemodialysis Patients

Two hundred CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate-binder washout period were randomized to receive sevelamer hydrochloride 800 mg tablets (N = 99) or an active control (N = 101). At week 52, using last observation carried forward, sevelamer and active control both significantly decreased mean serum phosphorus (Table 7).

Table 7: Mean Serum Phosphorus (mg/dL) and Ion Product at Baseline and Change from Baseline to End of Treatment
Sevelamer HCl
(N = 94)
Active Control (N = 98)
Phosphorus Baseline
Change from Baseline at Endpoint


7.5

-2.1

7.3
-1.8

Ca × Phosphorus Ion Product Baseline
Change from Baseline at Endpoint


70.5

-19.4

68.4
-14.2

Sixty-one percent of sevelamer hydrochloride patients and 73% of the control patients completed the full 52 weeks of treatment. Figure 4, a plot of the phosphorus change from baseline for the completers, illustrates the durability of response for patients who are able to remain on treatment.

Figure 4: Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment

Figure 4: Mean Phosphorus Change from Baseline for Patients who Completed 52 Weeks of Treatment
(click image for full-size original)

Average daily sevelamer hydrochloride dose at the end of treatment was 6.5 g (range of 0.8 to 13 g).

14.6 Sevelamer Hydrochloride versus Active Control in Peritoneal Dialysis Patients

One hundred and forty-three patients on peritoneal dialysis who were hyperphosphatemic (serum phosphorus > 5.5 mg/dL) following a two-week phosphate binder washout period were randomized to receive sevelamer hydrochloride (N = 97) or active control (N = 46) open label for 12 weeks. Average daily sevelamer hydrochloride dose at the end of treatment was 5.9 g (range 0.8 to 14.3 g). Thirteen patients (14%) in the sevelamer group and 9 patients (20%) in the active-control group discontinued, mostly for gastrointestinal adverse reactions. There were statistically significant changes in serum phosphorus (p < 0.001) for sevelamer hydrochloride (-1.6 mg/dL from baseline of 7.5 mg/dL), similar to the active control.

14.7 Once-Daily versus Three-Times-Per-Day Dosing

Stage 5 CKD patients on hemodialysis with a serum phosphate level of > 5.5 mg/dL after washout from baseline therapies were randomized in a 2:1 ratio to receive either sevelamer carbonate powder once daily (N = 144) or sevelamer hydrochloride as a tablet with the dose divided three times per day (N = 73) for 24 weeks. The initial dose for the two groups was 4.8 g/day. At the end of the study, the total daily dose was 6.2 g/day of sevelamer carbonate powder once daily and 6.7 g/day of sevelamer hydrochloride tablets three-times-per-day. A greater percentage of subjects on the once-daily dose than three-times-per-day regimen discontinued therapy prematurely, 35% versus 15%. The reasons for discontinuation were largely driven by adverse events and withdrawal of consent in the once-daily dosing regimen. Serum phosphate levels and calcium-phosphate product were better controlled on the three-times-per-day regimen than on the once-daily regimen. Mean serum phosphorus decreased 2.0 mg/dL for sevelamer carbonate powder once daily and 2.9 mg/dL for sevelamer hydrochloride tablets three times per day.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sevelamer carbonate for oral suspension is supplied as opaque, foil-lined, heat-sealed, packets containing 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis.

1 Box (NDC 69452-126-19) of 90 ct 0.8 g packets (NDC 69452-126-60)

1 Box (NDC 69452-127-19) of 90 ct 2.4 g packets (NDC 69452-127-60)

Storage: Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Inform patients to take sevelamer carbonate for oral suspension with meals and adhere to their prescribed diets.

For patients using an oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, advise the patient to take the oral medication at least one hour before or three hours after sevelamer carbonate for oral suspension.

For sevelamer carbonate powder, brief the patient on preparation of the powder in water.

Advise patients to report new onset or worsening of existing constipation or bloody stools promptly to their physician [see Warnings and Precautions ( 5.1)] .

Distributed by:

Bionpharma Inc.

600 Alexander Road,

Princeton, NJ 08540

FDA-09

200560

Package Label — Principal Display Panel — 0.8 g Label

NDC 69452-126-60

Sevelamer Carbonate

For Oral Suspension

0.8 g

Lemon Flavor

Rx only

Front

0.8 g label front
(click image for full-size original)

Back

0.8 g label back
(click image for full-size original)

Package Label — Principal Display Panel — 0.8 g Packets, 90 per Carton

NDC 69452-126-19

Sevelamer Carbonate

For Oral Suspension

0.8 g packets

Lemon Flavor

Rx only

Contains 90 packets

0.8 g packets carton
(click image for full-size original)

Package Label — Principal Display Panel — 2.4 g Label

NDC 69452-127-60

Sevelamer Carbonate

For Oral Suspension

2.4 g

Lemon Flavor

Rx only

Front

2.4 g label front
(click image for full-size original)

Back

2.4 g label back
(click image for full-size original)

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