Sevelamer

Sevelamer hydrochloride tablets contain sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. It contains multiple amines separated by one carbon from the polymer backbone.

• 1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.ICD-10: N18.9

• 4. CONTRAINDICATIONS Sevelamer hydrochloride is contraindicated in patients with bowel obstruction.contraindicated

2. DOSAGE AND ADMINISTRATION Patients Not Taking a Phosphate Binder . The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, which can be administered as one or two 800 mg sevelamer hydrochloride tablets or two to four 400 mg sevelamer hydrochloride tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer hydrochloride tablets for patients not taking a phosphate binder. Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Hydrochloride Tablets 800 mg Sevelamer Hydrochloride Tablets 400 mg >5.5 and <7.5 mg/dL 1 tablet three times daily with meals 2 tablets three times daily with meals ≥7.5 and <9 mg/dL 2 tablets three times daily with meals 3 tablets three times daily with meals ≥9 mg/dL 2 tablets three times daily with meals 4 tablets three times daily with meals Patients Switching from Calcium Acetate . In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride tablets and calcium acetate. Table 2 gives recommended starting doses of sevelamer hydrochloride tablets based on a patient’s current calcium acetate dose.

5. 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. ( 5.1 ) 5.1 Gastrointestinal Adverse Events Patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders, including severe constipation, or major GI tract surgery were not included in the sevelamer hydrochloride clinical studies. Dysphagia and esophageal tablet retention have been reported in association with use of sevelamer tablets, some requiring hospitalization and intervention. Consider using sevelamer suspension in patients with a history of swallowing disorders. Cases of bowel obstruction, bleeding gastrointestinal ulcers, colitis, ulceration, necrosis, and perforation have also been reported with sevelamer use [see Adverse Reactions (6.2)] . Inflammatory disorders may resolve upon sevelamer hydrochloride discontinuation. Treatment with sevelamer hydrochloride should be re-evaluated in patients who develop severe gastrointestinal symptoms. 5.2 Monitor Serum Chemistries Bicarbonate and chloride levels should be monitored. 5.3 Monitor for Reduced Vitamins D, E, K (clotting factors) and Folic Acid Levels In preclinical studies in rats and dogs, sevelamer hydrochloride reduced vitamins D, E, and K (coagulation parameters) and folic acid levels at doses of 6 to 10 times the recommended human dose. In short-term clinical trials, there was no evidence of reduction in serum levels of vitamins.

6. ADVERSE REACTIONS • The most common reasons for discontinuing treatment were gastrointestinal adverse reactions. ( 6.1 ) • In a parallel design study of 12 weeks duration, treatment-emergent adverse reactions to sevelamer hydrochloride tablets in peritoneal dialysis patients included dyspepsia (12%), peritonitis (8%), diarrhea (5%), nausea (5%), constipation (4%), pruritus (4%), abdominal distension (3%), vomiting (3%), fatigue (3%), anorexia (3%), and arthralgia (3%). ( 6.1 ) • Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride (n=99) were similar to those reported for the active-control group (n=101). Overall adverse reactions among those treated with sevelamer hydrochloride occurring in >5% of patients included: vomiting (22%), nausea (20%), diarrhea (19%), dyspepsia (16%), abdominal pain (9%), flatulence (8%), and constipation (8%).

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Sevelamer hydrochloride is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. Clinical Considerations Sevelamer hydrochloride may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [ see Clinical Pharmacology ( 12.2 )] . Consider supplementing with these vitamins. Data Animal data In pregnant rats given dietary doses of 0.5, 1.5, or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred at 7-21 times the maximum human equivalent dose of 13 g based on 60 kg body weight. In pregnant rabbits given oral doses of 100, 500, or 1000 mg/kg/day of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurredin the high-dose group (human equivalent dose approximately 5 times the maximum clinical trial dose based on 60 kg body weight). 8.2 Lactation Risk Summary Sevelamer hydrochloride is not absorbed systemically by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to sevelamer hydrochloride.

Metabolism

A mass balance study using 14 C-sevelamer hydrochloride in 16 healthy male and female volunteers showed that sevelamer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease.

10. OVERDOSAGE Sevelamer hydrochloride has been given to normal healthy volunteers in doses of up to 14 g per day for eight days with no adverse effects. Sevelamer hydrochloride has been given in average doses up to 13 g per day to hemodialysis patients. There are no reports of overdosage with sevelamer hydrochloride in patients. Since sevelamer hydrochloride is not absorbed, the risk of systemic toxicity is low.

• Oct 19, 2007NDANDA022127Sanofi
• Aug 12, 2009NDANDA022318Genzyme
• Jun 13, 2017ANDAANDA207624Aurobindo Pharma
• Jul 17, 2017ANDAANDA207179Aurobindo Pharma
• Sep 29, 2017ANDAANDA206094Dr Reddys
• Oct 26, 2017ANDAANDA203860Invagen Pharms
• Nov 28, 2017ANDAANDA207288Amneal Pharms Co
• Mar 20, 2018ANDAANDA200959Arthur Grp

1. 1Constipation2,55321%
2. 2Diarrhoea1,0568.9%
3. 3Pruritus1,0198.6%
4. 4Nausea8367.0%
5. 5Chronic Kidney Disease6805.7%
6. 6Renal Failure6765.7%
7. 7End Stage Renal Disease6755.7%
8. 8Death6415.4%
9. 9Vomiting5454.6%
10. 10Acute Kidney Injury5134.3%
11. 11Abdominal Pain3192.7%
12. 12Dyspnoea3072.6%
13. 13Nephrogenic Anaemia2992.5%
14. 14Fatigue2742.3%
15. 15Pneumonia2572.2%

Recent PubMed references pinned to Sevelamer as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Real-World Evidence for Sevelamer vs Calcium-Containing Phosphate Binders in Long-Term Effectiveness and Safety Among Patients with Non-Dialysis CKD: The REVEAL Study.
  Advances in therapy · 2026 · Li P, Li C, Liang S, et al.
  PMID 41984313DOI 10.1007/s12325-026-03572-w
• Effect of Cinacalcet Combined With Sevelamer Hydrochloride on the Incidence of Urolithiasis in Maintenance Hemodialysis Patients With Diabetic Kidney Disease.
  Archivos espanoles de urologia · 2026 · Zhang D, Lu J, Jiang S, et al.
  PMID 41943702DOI 10.56434/j.arch.esp.urol.20267902.39
• Assessing the real-world drug safety of sevelamer for hyperphosphatemia: Insights from a comprehensive analysis of the FDA adverse event reporting system (FAERS) database.
  Medicine · 2026 · Shao X, Yang H, Tan C, et al.
  PMID 41760019DOI 10.1097/MD.0000000000047807
• Phosphate binders suppress glutaminase activity for treatment of cirrhosis and hepatic encephalopathy murine models.
  Biochemical pharmacology · 2026 · Chen ZN, Liu ZX, Huang CK, et al.
  PMID 41587593DOI 10.1016/j.bcp.2026.117752
• Pharmacologic deprivation of serum inorganic phosphate ameliorates renal fibrosis via the modulation of systemic inflammation.
  European journal of pharmacology · 2026 · Kang MD, Deng Q, Zhang YY, et al.
  PMID 41344535DOI 10.1016/j.ejphar.2025.178430
• [Sevelamer vs. Calcium Acetate for Treating Hyperphosphatemia in Maintenance Hemodialysis Patients].
  Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2025 · Liu K, Zhao J, Wang F, et al.
  PMID 40964123DOI 10.12182/20250560605
• The effects of resins added to the milk of children suffering from chronic kidney disease: a clinical relevance to control potassium and phosphate levels?
  Nephrologie & therapeutique · 2025 · Bechara R, Chambon V, Naud C, et al.
  PMID 40232162DOI 10.1684/ndt.2025.118
• Gastrointestinal Mucosal Cell Injury Caused by Sevelamer Crystals: Case Series and Literature Review.
  Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation · 2025 · Elkalashy A, Rainwater RR, Ali U, et al.
  PMID 39920980DOI 10.1053/j.jrn.2025.01.008

The 10 most recently updated of 97 ClinicalTrials.gov registrations naming Sevelamer as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Observational · 5,000 enrolled · Duke University
  NCT04278404updated 2026-04-06
• Role of Combination Therapy of Glucose Insulin Potassium Infusion (GIK), Intravenous Hydrocortisone and Oral Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Cases Admitted to Intensive Care Unit (ICU) at Sohag University Hospitals.
  Not yet recruiting · Interventional · 74 enrolled · Sohag University
  NCT07451561updated 2026-03-05
• A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
  Completed · Phase 3 · Interventional · 336 enrolled · Tanabe Pharma Corporation
  NCT00416520updated 2026-01-08
• A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
  Completed · Phase 3 · Interventional · 632 enrolled · Tanabe Pharma Corporation
  NCT00542815updated 2026-01-07
• AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia
  Completed · Phase 3 · Interventional · 474 enrolled · Alebund Pharmaceuticals
  NCT07030595updated 2025-11-17
• FGF23 Reduction : Efficacy of a New Phosphate Binder in CHronic Kidney Disease
  Completed · Phase 3 · Interventional · 98 enrolled · Centre Hospitalier Universitaire, Amiens
  NCT01220843updated 2025-09-19
• Activated Charcoal Use in Chronic Kidney Disease Patients
  Recruiting · Phase 2 · Interventional · 40 enrolled · Mansoura University
  NCT06906874updated 2025-08-08
• Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
  Recruiting · Phase 2 · Interventional · 50 enrolled · Jemincare
  NCT06664125updated 2025-02-03
• Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
  Completed · Phase 4 · Interventional · 44 enrolled · SIGA Technologies
  NCT04485039updated 2024-12-27
• Calcium-Phosphorus Regulation Therapy on Heart Valve Disease
  Recruiting · Phase 4 · Interventional · 196 enrolled · China National Center for Cardiovascular Diseases
  NCT06660524updated 2024-10-28

Frequently asked questions

How does Sevelamer work?

Sevelamer hydrochloride tablets contain sevelamer hydrochloride, a non-absorbed binding crosslinked polymer. It contains multiple amines separated by one carbon from the polymer backbone.

What is Sevelamer used for?

According to FDA labeling, Sevelamer carries indications including: 1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sevelamer?

Sevelamer is classified as Drugs for treatment of hyperkalemia and hyperphosphatemia, Phosphate Binder, Phosphate Chelating Activity, Decreased Inorganic Ion Absorption, Inhibition Large Intestine Fluid/Electrolyte Absorption, Inhibition Small Intestine Fluid/Electrolyte Absorption.

What are the brand names for Sevelamer?

Sevelamer is marketed under brand names including RenaGel, Renvela.

What are the contraindications for Sevelamer?

Sevelamer labeling lists contraindications including: 4. CONTRAINDICATIONS Sevelamer hydrochloride is contraindicated in patients with bowel obstruction.. Always consult the full prescribing information and a clinician.