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Molecule

Sevelamer

Also known as sevelamer carbonate, sevelamer hydrochloride
Available on requestNephrology and urology
Presentations
9
Brands
1
Manufacturers
1
Available from stock
0

Sevelamer is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. MedsAcross supplies Sevelamer for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Phosphate Binder, Phosphate Chelating Activity
ATC classification
V03AE02 Sevelamer · Antihyperkalemic agents
US FDA first approval
30 October 1998
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Parenteral
Dosage forms
Tablet, Powder for oral suspension
Identifiers
UNII 9YCX42I8IURxCUI 214824CAS 52757-95-6DrugBank DB00658Q904153

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Renvela ® (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. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis.

Source: US FDA prescribing information

How it works

Renvela contains sevelamer carbonate, a non-absorbed phosphate-binding cross-linked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

Source: US FDA prescribing information

Dosing overview

Starting dose of Renvela is 0.8 or 1.6 grams administered orally three times per day with meals based on serum phosphorus levels for adult patients and based on body surface area (BSA) category for pediatric patients. Titrate by 0.8 g per meal in two-week intervals for adult patients as needed to obtain serum phosphorus target. Titrate based on BSA category for pediatric patients in two-week intervals for 6 weeks and then every 4 weeks as needed to obtain serum phosphorus target.

Source: US FDA prescribing information

Contraindications

Renvela is contraindicated in patients with bowel obstruction. Renvela is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. Bowel obstruction. Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients.

Source: US FDA prescribing information

Warnings and precautions

Serious cases of dysphagia, bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have been associated with sevelamer use, some requiring hospitalization and surgery.

Source: US FDA prescribing information

Side effects

Most of the safety experience is with sevelamer carbonate tablets and sevelamer hydrochloride. In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%), and constipation (8%).

Source: US FDA prescribing information

Interactions

There are no empirical data on avoiding drug interactions between Renvela 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. 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.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

9 presentations of Sevelamer, sorted by availability.

MedicineManufacturerRegisterAvailability
Sevelamer 800 mg tabletOralGeneric name—US FDAAvailable on request
Sevelamer 800 mg powder for oral suspensionOralGeneric name—US FDAAvailable on request
Sevelamer 2400 mg powder for oral suspensionOralGeneric name—US FDAAvailable on request
Sevelamer 400 mg tabletOralGeneric name—US FDAAvailable on request
Sevelamer 800 mg tabletParenteralGeneric name—US FDAAvailable on request
Sevelamer 2400 mg/2790 mg powder for oral suspensionOralGeneric name—US FDAAvailable on request
Renvela 2400 mg powder for oral suspensionOralGenzymeUS FDAAvailable on request
Renvela 800 mg tabletOralGenzymeUS FDAAvailable on request
Renvela 800 mg powder for oral suspensionOralGenzymeUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 30 October 1998Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Sevelamer in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Sevelamer available for export from India?

Yes, on request. MedsAcross lists 9 presentations of Sevelamer and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Sevelamer have?

The catalogue lists 1 brand names for Sevelamer, including Renvela.

Is Sevelamer approved by the US FDA?

Yes. The US FDA first approved Sevelamer on 30 October 1998, according to Drugs@FDA.

Is Sevelamer authorised in the European Union?

Yes. Sevelamer has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Sevelamer need cold chain shipping?

No listed presentation of Sevelamer is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Sevelamer in?

Sevelamer is classified under ATC code V03AE02 (Sevelamer).

References

  1. Renvela prescribing information (Genzyme). U.S. National Library of Medicine, DailyMed. Retrieved 25 November 2025
  2. Renagel: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 January 2025
  3. Renvela: European public assessment report (EPAR). European Medicines Agency. Retrieved 8 January 2025

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