{
 "query": "sevelamer",
 "ingredient": "sevelamer",
 "slug": "sevelamer",
 "rxcui": "214824",
 "brands": [
  "Renvela",
  "RenaGel"
 ],
 "names": [
  "sevelamer",
  "sevelamer carbonate",
  "sevelamer hydrochloride"
 ],
 "classes": [
  {
   "id": "V03AE",
   "name": "Drugs for treatment of hyperkalemia and hyperphosphatemia"
  }
 ],
 "alternatives": [
  "calcium acetate",
  "ferric citrate",
  "lanthanum carbonate",
  "polystyrene sulfonate",
  "sodium zirconium cyclosilicate",
  "sucroferric oxyhydroxide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 49,
   "PARENTERAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "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 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. ( 1 )",
  "contraindications": "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. Bowel obstruction. ( 4 ) Known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. ( 4 )",
  "warnings_and_cautions": "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 carbonate clinical studies. Cases of dysphagia and esophageal tablet retention have been reported in association with use of the tablet formulation of sevelamer, 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 carbonate discontinuation. Treatment with sevelamer carbonate should be re-evaluated in patients who develop severe gastrointestinal symptoms. 5.2 Reductions in Vitamins D, E, K (clotting factors) and Folic Acid Levels In...",
  "warnings": "",
  "adverse_reactions": "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%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-847-0069 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. There are limited clinical trial data on the safety of sevelamer carbonate. However, because it contains the same active ingredient as the hydrochloride salt, the adverse event profiles of the two salts are expected to be similar. In a cross-over study in hemodialysis patients with treatment durations of eight weeks each and no washout, and another cross-over study in hemodialysis patie...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "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) ] .",
  "spl_medguide": "",
  "clinical_studies": "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). 14.1 Cross-Over Study of Sevelamer...",
  "brand_name": "Sevelamer Carbonate",
  "manufacturer": "Sanofi-Aventis U.S. LLC",
  "application_number": "NDA022127",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251125",
  "set_id": "3abc32fe-1bfc-4759-8f7c-36095e221b06",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 13863,
  "serious": 8327,
  "death": 1664,
  "hospitalization": 4672,
  "primary_suspect": 13834,
  "top_reactions": [
   [
    "Constipation",
    2229
   ],
   [
    "Diarrhoea",
    1165
   ],
   [
    "Chronic Kidney Disease",
    926
   ],
   [
    "Pruritus",
    918
   ],
   [
    "End Stage Renal Disease",
    911
   ],
   [
    "Renal Failure",
    903
   ],
   [
    "Nausea",
    849
   ],
   [
    "Death",
    753
   ],
   [
    "Acute Kidney Injury",
    745
   ],
   [
    "Vomiting",
    559
   ],
   [
    "Off Label Use",
    425
   ],
   [
    "Nephrogenic Anaemia",
    403
   ],
   [
    "Dyspnoea",
    379
   ],
   [
    "Abdominal Pain",
    348
   ],
   [
    "Fatigue",
    330
   ]
  ],
  "by_year": {
   "2019": 1282,
   "2020": 865,
   "2021": 700,
   "2022": 526,
   "2023": 514,
   "2024": 609,
   "2025": 692,
   "2026": 269
  },
  "by_year_primary": {
   "2019": 1282,
   "2020": 864,
   "2021": 695,
   "2022": 524,
   "2023": 511,
   "2024": 600,
   "2025": 688,
   "2026": 264
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 36,
  "nda": 4,
  "anda": 32,
  "first_approval": "19981030",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 16,
  "labeling_recent": 1,
  "sponsors": [
   "AMNEAL PHARMS CO",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BIONPHARMA",
   "CHARTWELL RX",
   "DR REDDYS",
   "EPIC PHARMA LLC",
   "GENZYME"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/30/1998"
 },
 "trials": {
  "total": 98,
  "completed": 75,
  "terminated": 9,
  "with_results": 26,
  "industry": 66,
  "phase3": 31,
  "results_share": 0.3466666666666667,
  "terminated_share": 0.09183673469387756
 },
 "pubmed": {
  "rct": 96,
  "meta": 17,
  "recent_rct": 6,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "sevelamer",
   "Renvela",
   "RenaGel"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 831282,
  "beneficiaries": 221767,
  "spend": 203479684.21999997,
  "by_brand": [
   {
    "brand": "Sevelamer Carbonate",
    "claims": 767039,
    "per_claim": 184.99255467,
    "is_generic": true
   },
   {
    "brand": "Sevelamer HCl",
    "claims": 36810,
    "per_claim": 640.911906,
    "is_generic": true
   },
   {
    "brand": "Renvela",
    "claims": 27433,
    "per_claim": 1384.8727015,
    "is_generic": false
   }
  ],
  "per_claim": 244.77816699988688
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1552,
  "fills": 831282,
  "per_million": 1866.9957968535348,
  "ratio": 0.6742613491984776,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,867 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "96 randomized trials and 17 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (32 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are constipation, diarrhoea, chronic kidney disease, pruritus. How would we recognize and handle those?",
  "Why this one over calcium acetate, ferric citrate, lanthanum carbonate? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}