Sevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
Tablets: 800 mg white oval, film-coated, compressed tablets, engraved with RV800 on one side Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packets
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
Tablets: Sevelamer carbonate tablets for oral use is supplied as white oval, film-coated, compressed tablets, engraved with RV800 on one side, containing 800 mg of sevelamer carbonate on an anhydrous basis. 1 Bottle of 270 ct 800 mg tablets (NDC 0955-1057-30) Powder: 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 0955-1054-90) of 90 ct 2.4 g packets (NDC 0955-1054-01) 1 Box (NDC 0955-1052-90) of 90 ct 0.8 g packets (NDC 0955-1052-01)
NDC 0955-1050-27 Rx only Winthrop A SANOFI COMPANY Sevelamer Carbonate Tablets 800 mg 270 Film-Coated Tablets SANOFI
Winthrop A SANOFI COMPANY SANOFI NDC 0955- 1052 -90 Rx only Sevelamer Carbonate For Oral Suspension Citrus Flavor 0.8 g Contains 90 packets
Winthrop A SANOFI COMPANY SANOFI NDC 0955- 1054 -90 Rx only Sevelamer Carbonate For Oral Suspension Citrus Flavor 2.4 g Contains 90 packets
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 861375 | sevelamer carbonate 0.8 GM Powder for Oral Suspension | PSN | 20 |
| 861370 | sevelamer carbonate 2.4 GM Powder for Oral Suspension | PSN | 20 |
| 749206 | sevelamer carbonate 800 MG Oral Tablet | PSN | 20 |
| 861370 | sevelamer carbonate 2400 MG Powder for Oral Suspension | SCD | 20 |
| 749206 | sevelamer carbonate 800 MG Oral Tablet | SCD | 20 |
| 861375 | sevelamer carbonate 800 MG Powder for Oral Suspension | SCD | 20 |
| 861375 | sevelamer carbonate 0.8 GM Powder for Oral Suspension | SY | 20 |
| 861370 | sevelamer carbonate 2.4 GM Powder for Oral Suspension | SY | 20 |
| Class | Version | Type | Effective |
|---|---|---|---|
| SEVELAMER Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5085f16b-f856-182d-a646-425b62d3f565 | Product name | 6 | 20251118 |
| 86e7ef73-ca63-701e-e952-6c80aa5122b8 | Product name | 9 | 20210309 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0955-1050-27 | Sevelamer Carbonate | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | 20 | |
| 0955-1052-01 | Sevelamer Carbonate | 1 in 1 PACKET | POWDER, FOR SUSPENSION | 1 | 20 | |
| 0955-1052-90 | Sevelamer Carbonate | 90 in 1 BOX | POWDER, FOR SUSPENSION | 90 | 20 | |
| 0955-1054-01 | Sevelamer Carbonate | 1 in 1 PACKET | POWDER, FOR SUSPENSION | 1 | 20 | |
| 0955-1054-90 | Sevelamer Carbonate | 90 in 1 BOX | POWDER, FOR SUSPENSION | 90 | 20 | |
| 0955-1057-30 | Sevelamer Carbonate | 270 in 1 BOTTLE | TABLET, FILM COATED | 270 | 20 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0955-1050-27 | EA - Each | 0955-1050 | 4ab1951a-d2bb-414b-852d-c8133fb7ce5b | 1 | 2017-11-06 |
| 0955-1052-01 | EA - Each | 0955-1052 | dcad97b7-dee7-42c3-8524-f7b68839179d | 1 | 2018-02-20 |
| 0955-1052-90 | EA - Each | 0955-1052 | b5de286b-ebc3-4788-8949-930135c2120f | 1 | 2018-02-20 |
| 0955-1054-01 | EA - Each | 0955-1054 | b52b59aa-2aaf-4d81-a040-56c82a937150 | 1 | 2018-02-20 |
| 0955-1054-90 | EA - Each | 0955-1054 | 386f9b27-fd9b-4563-8b6e-e27e93a1ced4 | 1 | 2018-02-20 |
Sevelamer carbonate is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.
Tablets: 800 mg white oval, film-coated, compressed tablets, engraved with RV800 on one side Powder: 0.8 g and 2.4 g pale-yellow powder packaged in an opaque, foil-lined, heat-sealed packets
Sevelamer carbonate is contraindicated in patients with bowel obstruction. Sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.
There are no empirical data on avoiding drug interactions between Sevelamer carbonate and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology (12.3) ] . The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate-release or an extended-release product. Where possible consider monitoring clinical responses and/or blood levels of concomitant drugs that have a narrow therapeutic range. Table 5: Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer carbonate Dosing Recommendations Ciprofloxacin Take at least 2 hours before or 6 hours after sevelamer Mycophenolate mofetil Take at least 2 hours before sevelamer
In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
The active ingredient is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine- co -N,N′-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network
The ability of sevelamer to control serum phosphorus in CKD patients on dialysis was predominantly determined from the effects of the hydrochloride salt to bind phosphate. Six clinical trials used sevelamer hydrochloride and three clinical trials used sevelamer carbonate. The sevelamer hydrochloride studies include one double-blind, placebo-controlled 2-week study (sevelamer N=24); two open-label, uncontrolled, 8-week studies (sevelamer N=220); and three active-controlled open-label studies with treatment durations of 8 to 52 weeks (sevelamer N=256). The sevelamer carbonate studies include one double-blind, active-controlled, cross-over study with two 8-week treatment periods using sevelamer carbonate tablets (N=79); one open-label, active-controlled, cross-over study with two 4-week treatment periods using sevelamer carbonate powder (N=31); and one randomized, parallel, open-label study using sevelamer carbonate powder (N=144) dosed once daily or sevelamer hydrochloride tablets (N=73) dosed three times daily for 24 weeks. Six of the active-controlled studies are described here (three sevelamer carbonate and three sevelamer hydrochloride studies).
Tablets: Sevelamer carbonate tablets for oral use is supplied as white oval, film-coated, compressed tablets, engraved with RV800 on one side, containing 800 mg of sevelamer carbonate on an anhydrous basis. 1 Bottle of 270 ct 800 mg tablets (NDC 0955-1057-30) Powder: 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 0955-1054-90) of 90 ct 2.4 g packets (NDC 0955-1054-01) 1 Box (NDC 0955-1052-90) of 90 ct 0.8 g packets (NDC 0955-1052-01)
Inform patients to take sevelamer carbonate 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) ] .
Manufactured for: Winthrop U.S., a business of sanofi-aventis U.S. LLC Bridgewater, NJ 08807 A SANOFI COMPANY ©2022 sanofi-aventis U.S. LLC
NDC 0955-1050-27 Rx only Winthrop A SANOFI COMPANY Sevelamer Carbonate Tablets 800 mg 270 Film-Coated Tablets SANOFI
Winthrop A SANOFI COMPANY SANOFI NDC 0955- 1052 -90 Rx only Sevelamer Carbonate For Oral Suspension Citrus Flavor 0.8 g Contains 90 packets
Winthrop A SANOFI COMPANY SANOFI NDC 0955- 1054 -90 Rx only Sevelamer Carbonate For Oral Suspension Citrus Flavor 2.4 g Contains 90 packets
NDC0955-1057-30 Rx only Winthrop A SANOFI COMPANY Sevelamer Carbonate Tablets 800 mg 270 Film-Coated Tablets SANOFI