Lanthanum Carbonate

Lanthanum carbonate is a phosphate binder that reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the GI tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption.

• Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.

• Contraindicated in patients with: hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. bowel obstruction, including ileus and fecal impaction.contraindicated

Divide the total daily dose of lanthanum carbonate chewable tablets and take with or immediately after meals. The recommended initial total daily dose of lanthanum carbonate chewable tablets is 1,500 mg. Titrate the dose every 2 to 3 weeks until an acceptable serum phosphate level is reached. Monitor serum phosphate levels as needed during dose titration and on a regular basis thereafter. Lanthanum Carbonate chewable Tablets has the potential to bind other orally administered drugs: consider separating the administration of other oral medications [ see Drug Interactions (7) ] . In clinical studies of patients with ESRD, lanthanum carbonate chewable tablets doses up to 4,500 mg were evaluated. Most patients required a total daily dose between 1,500 mg and 3,000 mg to reduce plasma phosphate levels to less than 6.0 mg/dL. Doses were generally titrated in increments of 750 mg/day. Information for lanthanum carbonate chewable tablets Chew or crush lanthanum carbonate chewable tablets completely before swallowing. Do not swallow intact lanthanum carbonate chewable tablets. Consider using the oral powder formulation in patients with poor dentition or who have difficulty chewing tablets. The recommended initial total daily dose of lanthanum carbonate chewable tablets are 1,500 mg in divided doses. Titrate every 2 to 3 weeks based on serum phosphate level. ( 2 ) Take lanthanum carbonate chewable tablets with or immediately after meals. ( 2 ) Lanthanum carbonate chewable tablets: Chew or crush tablet completely before swallowing. ( 2 )

Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction. Risks include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications. Advise patients to chew or crush the tablet completely. ( 5.1 ) Lanthanum carbonate has radio-opaque properties and, therefore, may give the appearance typical of an imaging agent during abdominal X-ray procedures. ( 5.2 ) 5.1 Gastrointestinal Adverse Effects Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal perforation, and fecal impaction have been reported in patients taking lanthanum, some requiring surgery or hospitalization. Consider discontinuing lanthanum carbonate in patients without another explanation for severe gastrointestinal symptoms. Risk factors for gastrointestinal obstruction and gastrointestinal perforation identified from post-marketing reports in patients taking lanthanum carbonate chewable tablets include abnormal gastrointestinal anatomy (e.g., diverticular disease, peritonitis, history of gastrointestinal surgery, gastrointestinal cancer, gastrointestinal ulceration), hypomotility disorders (e.g., constipation, ileus, subileus, diabetic gastroparesis) and the use of medications known to potentiate these effects. Some cases were reported in patients with no history of gastrointestinal disease.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1) ] In controlled trials, the most common adverse reactions that were more frequent (≥ 5% difference vs. placebo) in lanthanum carbonate were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of lanthanum carbonate: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Exelan pharmaceutical,Inc. at 1-866-604-3268 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. Overall, the safety profile of Lanthanum carbonate chewable tablets has been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for Lanthanum carbonate chewable tablets were gastrointestinal events,such as nausea,vomiting and abdominal pain and they generally abated over time with continued dosing.

8.1 Pregnancy Risk Summary Available data from case reports with use of lanthanum carbonate in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (MRHD), resulted in no adverse developmental effects. In rabbits, lanthanum carbonate doses 5 times the MRHD was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see Data ) . Deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see Use in Specific Populations (8.4) ] . Use a non-lanthanum containing phosphate binder in a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Absorption and Distribution - Following single- or multiple- dose oral administration of lanthanum carbonate to healthy subjects, the concentration of lanthanum in plasma was very low (bioavailability <0.002%). Following oral administration in patients, the mean lanthanum C max was 1.0 ng/mL.

The symptoms associated with overdose are adverse reactions such as headache, nausea and vomiting. In clinical trials in healthy adults, gastrointestinal (GI) symptoms were reported with daily doses up to 6,000 mg/day of lanthanum carbonate administered with food. Given the topical activity of lanthanum in the gut, and the excretion of the majority of the dose in feces, supportive therapy is recommended for overdosage. Lanthanum carbonate was not acutely toxic in animals by the oral route. No deaths and no adverse effects occurred in mice, rats, or dogs after single oral doses of 2,000 mg/kg (1.7, 3.4, and 11.3 times the MRHD, respectively, on a mg/m 2 basis).

• Oct 26, 2004NDANDA021468Takeda Pharms Usa
• Sep 24, 2014NDANDA204734Takeda Pharms Usa
• Aug 11, 2017ANDAANDA090978Natco Pharma Ltd
• Jan 24, 2022ANDAANDA206868Invagen Pharms
• Jan 27, 2022ANDAANDA090977Barr
• Mar 13, 2025ANDAANDA202329Alkem Labs Ltd

1. 1Death67113%
2. 2Nausea4749.4%
3. 3Vomiting4619.2%
4. 4Constipation3557.1%
5. 5Sepsis3496.9%
6. 6Abdominal Pain3476.9%
7. 7General Physical Health Deterioration3146.2%
8. 8Off Label Use3126.2%
9. 9Abdominal Distension2905.8%
10. 10Hyponatraemia2755.5%
11. 11Anaemia2665.3%
12. 12Multiple Organ Dysfunction Syndrome2665.3%
13. 13Stress2635.2%
14. 14Ascites2605.2%
15. 15Appendicitis2505.0%

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

• Application potential of hierarchically porous La(2)O(2)CO(3) for arsenic-containing wastewater purification: rapid adsorption behavior and La-O-As coordination mechanism.
  Environmental research · 2026 · Han Y, Si Y, Wang D, et al.
  PMID 42103255DOI 10.1016/j.envres.2026.124687
• Adsorption and recovery of phosphate using sodium carbonate as co-precipitant synthesized La&Zr dual-metal modified material: Adsorption mechanism and practical application.
  Chemosphere · 2024 · Hu Y, Li Y, Du Y, et al.
  PMID 39032732DOI 10.1016/j.chemosphere.2024.142878
• Effects of lanthanum carbonate and calcium carbonate on cardiovascular calcification in hemodialysis patients: A systematic review and meta-analysis.
  Clinical nephrology · 2022 · Yang J, Zhang X, Wang L, et al.
  PMID 34448696DOI 10.5414/CN110522
• Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial.
  JAMA · 2021 · Ogata H, Fukagawa M, Hirakata H, et al.
  PMID 34003226DOI 10.1001/jama.2021.4807
• La-based-adsorbents for efficient biological phosphorus treatment of wastewater: Synergistically strengthen of chemical and biological removal.
  Chemosphere · 2020 · Liu B, Nan J, Zu X, et al.
  PMID 32416397DOI 10.1016/j.chemosphere.2020.127010
• Comparison of the effects of lanthanum carbonate and calcium carbonate on the progression of cardiac valvular calcification after initiation of hemodialysis.
  BMC cardiovascular disorders · 2020 · Watanabe K, Fujii H, Kono K, et al.
  PMID 32000687DOI 10.1186/s12872-020-01343-1
• A comparison between the combined effect of calcium carbonate with sucroferric oxyhydroxide and other phosphate binders: an in vitro and in vivo experimental study.
  BMC nephrology · 2019 · Yaguchi A, Akahane K, Tsuchioka K, et al.
  PMID 31830936DOI 10.1186/s12882-019-1655-9
• Effects of oral activated charcoal on hyperphosphatemia and vascular calcification in Chinese patients with stage 3-4 chronic kidney disease.
  Journal of nephrology · 2019 · Gao Y, Wang G, Li Y, et al.
  PMID 30588573DOI 10.1007/s40620-018-00571-1

The 10 most recently updated of 52 ClinicalTrials.gov registrations naming Lanthanum Carbonate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
  Completed · Phase 4 · Interventional · 44 enrolled · SIGA Technologies
  NCT04485039updated 2024-12-27
• Healthy Combine Study
  Completed · Phase 1 · Interventional · 39 enrolled · Northwestern University
  NCT03136705updated 2024-02-23
• The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
  Completed · Interventional · 19 enrolled · Endeavor Health
  NCT01002872updated 2023-09-21
• Phosphate Lowering in CKD Trial
  Completed · Phase 4 · Interventional · 66 enrolled · VA Office of Research and Development
  NCT02209636updated 2022-08-26
• The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE
  Completed · Phase 2 · Interventional · 205 enrolled · The Cleveland Clinic
  NCT02258074updated 2021-08-02
• To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder
  Unknown · Phase 1 · Phase 2 · Interventional · 48 enrolled · Grand Life Science (Liaoning) Co., Ltd.
  NCT04440696updated 2021-07-28
• Different Effects of Non-calcium Phosphate Binders on Serum Calcium
  Completed · Phase 4 · Interventional · 34 enrolled · Medical University of Lodz
  NCT03451019updated 2021-07-27
• Long-term Effect of Lanthanum Carbonate on Bone
  Completed · Observational · 34 enrolled · Shire
  NCT00557323updated 2021-07-13
• Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
  Completed · Phase 3 · Interventional · 48 enrolled · Shire
  NCT00151918updated 2021-07-06
• Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease
  Completed · Phase 4 · Interventional · 2,500 enrolled · Shire
  NCT00160121updated 2021-07-02

Frequently asked questions

How does Lanthanum Carbonate work?

Lanthanum carbonate is a phosphate binder that reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the GI tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption.

What is Lanthanum Carbonate used for?

According to FDA labeling, Lanthanum Carbonate carries indications including: Lanthanum carbonate chewable tablets are phosphate binder indicated to reduce serum phosphate in patients with end- stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lanthanum Carbonate?

Lanthanum Carbonate is classified as Drugs for treatment of hyperkalemia and hyperphosphatemia.

What are the brand names for Lanthanum Carbonate?

Lanthanum Carbonate is marketed under brand names including Fosrenol.

What are the contraindications for Lanthanum Carbonate?

Lanthanum Carbonate labeling lists contraindications including: Contraindicated in patients with: hypersensitivity to Lanthanum carbonate or to any ingredient in the formulation. bowel obstruction, including ileus and fecal impaction.. Always consult the full prescribing information and a clinician.