SEVELAMER CARBONATE (Page 4 of 4)

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 Hydrochloride (N=94) Active Control (N=98)
Phosphorus Baseline Change from Baseline at Endpoint7.5 -2.17.3-1.8
Ca x 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

Powder: Sevelamer Carbonate for Oral Suspension is supplied as opaque, foil lined, heat sealed, pouches containing 0.8 g or 2.4 g of sevelamer carbonate on an anhydrous basis.
1 Carton (NDC 65862-930-90) of 90 ct 0.8 g pouches (NDC 65862-930-08)
1 Carton (NDC 65862-931-90) of 90 ct 2.4 g pouches (NDC 65862-931-08)

Storage: Store at 20° to 25°C (68° to 77°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:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
A urobindo Pharma Limited
Hyderabad-500 032, India
Revised: 11/2022

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.8 g Pouch Carton

NDC 65862-930-90
Sevelamer Carbonate
For Oral Suspension
0.8 g pouches
Orange Flavor
Rx only Containing 90 pouches
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 0.8 g Pouch Carton
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.4 g Pouch Carton

NDC 65862-931-90
Sevelamer Carbonate
For Oral Suspension
2.4 g pouches
Orange Flavor
Rx only Containing 90 pouches
AUROBINDO

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 2.4 g Pouch Carton
(click image for full-size original)

SEVELAMER CARBONATE sevelamer carbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-930
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER CARBONATE (SEVELAMER) SEVELAMER CARBONATE 800 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
ORANGE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-930-90 90 POUCH in 1 CARTON contains a POUCH (65862-930-08)
1 NDC:65862-930-08 1 POWDER, FOR SUSPENSION in 1 POUCH This package is contained within the CARTON (65862-930-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207624 06/13/2017
SEVELAMER CARBONATE sevelamer carbonate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-931
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVELAMER CARBONATE (SEVELAMER) SEVELAMER CARBONATE 2400 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW
ORANGE
SUCRALOSE
XANTHAN GUM
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65862-931-90 90 POUCH in 1 CARTON contains a POUCH (65862-931-08)
1 NDC:65862-931-08 1 POWDER, FOR SUSPENSION in 1 POUCH This package is contained within the CARTON (65862-931-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207624 06/13/2017
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Aurobindo Pharma Limited 650381903 ANALYSIS (65862-930), ANALYSIS (65862-931), MANUFACTURE (65862-930), MANUFACTURE (65862-931)

Revised: 11/2022 Aurobindo Pharma Limited

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