Sevelamer Carbonate For Oral Suspension (Page 4 of 4)

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 grams (range 0.8 to 14.3 grams). 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 grams/day. At the end of the study, the total daily dose was 6.2 grams/day of sevelamer carbonate powder once daily and 6.7 grams/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 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, packets containing 0.8 grams or 2.4 grams of sevelamer carbonate, colloidal silicon dioxide, iron oxide yellow, lemon spray dry flavour, mannitol, propylene glycol, PHA vanilla flavour, PHA orange flavour, and sucralose.

1 Box of 90 ct 0.8 grams packets NDC 43598-478-90

1 Box of 90 ct 2.4 grams packets NDC 43598-479-90

Storage: Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]

Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Dosing

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 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)].

RX only

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton NJ 08540, USA

Made in India

Issued: 0520

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

0.8 grams — Packet Label:

packet1
(click image for full-size original)

0.8 grams-Carton Label:

carton1
(click image for full-size original)

2.4 grams-Packet Label:

packet2
(click image for full-size original)

2.4 grams-Carton Label:

carton2
(click image for full-size original)
SEVELAMER CARBONATE FOR ORAL SUSPENSION sevelamer carbonate for oral suspension powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-478
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
Silicon Dioxide
Ferric Oxide Yellow
Mannitol
Propylene Glycol
Sucralose
Vanilla
Lemon
Orange
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-478-90 90 PACKET in 1 CARTON contains a PACKET (43598-478-01)
1 NDC:43598-478-01 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (43598-478-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210464 10/25/2018
SEVELAMER CARBONATE FOR ORAL SUSPENSION sevelamer carbonate for oral suspension powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-479
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
Silicon Dioxide
Ferric Oxide Yellow
Mannitol
Propylene Glycol
Sucralose
Vanilla
Lemon
Orange
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-479-90 90 PACKET in 1 CARTON contains a PACKET (43598-479-01)
1 NDC:43598-479-01 1 POWDER, FOR SUSPENSION in 1 PACKET This package is contained within the CARTON (43598-479-90)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210464 10/25/2018
Labeler — Dr. Reddys Laboratories Inc (802315887)
Establishment
Name Address ID/FEI Operations
DR. REDDY’S LABORATORIES LIMITED (FTO-Sez-Process Unit-01) 860037244 analysis (43598-478), manufacture (43598-478), analysis (43598-479), manufacture (43598-479)

Revised: 05/2020 Dr. Reddys Laboratories Inc

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