Lanthanum carbonate

Overview

Lanthanum carbonate is a phosphate binder commonly used in clinical practice. It is marketed under the trade name Fosrenol by Shire Pharmaceuticals. It is the largest of all pills filled in community pharmacies. Sometimes patients forget that Fosrenol is not swallowed whole, but instead should be chewed. This has led to severe choking. It is prescribed for treating high phosphate levels, mainly found in patients with chronic kidney disease. Lanthanum should be taken with meals and binds to phosphate in the diet, preventing phosphate absorption in the intestine.

Background

Indication

Used to reduce serum phosphate in patients with end stage renal disease (ESRD).

Associated Conditions

Hyperphosphataemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Different Effects of Non-calcium Phosphate Binders on Serum Calcium	2018/03/01	NCT03451019	Phase 4	Completed	Medical University of Lodz
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis	2017/11/17	NCT03346369	Phase 3	UNKNOWN	Universitair Ziekenhuis Brussel
Healthy Combine Study	2017/05/02	NCT03136705	Phase 1	Completed	Northwestern University
Bioequivalence Study of BAY 77-1931 Orally Disintegrating Tablet	2017/03/08	NCT03074058	Phase 1	Completed	Bayer
The COMBINE Study: The CKD Optimal Management With BInders and NicotinamidE	2014/10/07	NCT02258074	Phase 2	Completed	The Cleveland Clinic
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia	2014/09/11	NCT02237534	Phase 4	UNKNOWN	Osaka University
Phosphate Lowering in CKD Trial	2014/08/06	NCT02209636	Phase 4	Completed	VA Office of Research and Development
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23	2013/05/03	NCT01845090	Phase 4	UNKNOWN	Camillians Saint Mary's Hospital Luodong
A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis	2012/10/01	NCT01696279	Phase 2	Completed	Shire
Fosrenol and Phosphorus Balance - Lanthanum Carbonate	2012/04/20	NCT01581996	Not Applicable	Completed	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Lanthanum carbonate	Teva Pharmaceuticals USA, Inc.	0093-5938	ORAL	500 mg in 1 1	2/7/2024
Fosrenol	Takeda Pharmaceuticals America, Inc.	54092-252	ORAL	500 mg in 1 1	12/20/2023
Lanthanum carbonate	Exelan Pharmaceuticals, Inc.	76282-477	ORAL	750 mg in 1 1	6/13/2023
Fosrenol	Takeda Pharmaceuticals America, Inc.	54092-254	ORAL	1000 mg in 1 1	12/20/2023
Fosrenol	Takeda Pharmaceuticals America, Inc.	54092-253	ORAL	750 mg in 1 1	12/20/2023
Lanthanum carbonate	Exelan Pharmaceuticals, Inc.	76282-476	ORAL	500 mg in 1 1	6/13/2023
Lanthanum Carbonate	Lupin Pharmaceuticals, Inc.	68180-819	ORAL	500 mg in 1 1	1/22/2024
Lanthanum carbonate	Teva Pharmaceuticals USA, Inc.	0093-5940	ORAL	1000 mg in 1 1	2/7/2024
Lanthanum carbonate	Cipla USA Inc.	69097-936	ORAL	1000 mg in 1 1	6/13/2023
Lanthanum carbonate	Prasco Laboratories	66993-422	ORAL	500 mg in 1 1	12/26/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Fosrenol Chewable Tablets 500mg	Hamol Limited	SIN13594P	TABLET, CHEWABLE	500mg	1/23/2009
Fosrenol Chewable Tablets 1000mg	Hamol Limited	SIN13596P	TABLET, CHEWABLE	1000mg	1/23/2009

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Lanthanum Carbonate Chewable Tablets	青岛百洋制药有限公司	国药准字H20244877	化学药品	片剂	9/10/2024
Lanthanum Carbonate Chewable Tablets	杭州安元生物医药科技有限公司	国药准字H20253619	化学药品	片剂	3/11/2025
Lanthanum Carbonate Chewable Tablets	南京正大天晴制药有限公司	国药准字H20223690	化学药品	片剂	9/20/2022
Lanthanum Carbonate Chewable Tablets	山东齐都药业有限公司	国药准字H20244466	化学药品	片剂	7/16/2024
Lanthanum Carbonate Chewable Tablets	温州海鹤药业有限公司	国药准字H20244505	化学药品	片剂	7/30/2024
Lanthanum Carbonate Chewable Tablets	TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH	国药准字HJ20171353	化学药品	片剂	4/8/2021
Lanthanum Carbonate Chewable Tablets	TAKEDA PHARMACEUTICALS INTERNATIONAL AG IRELAND BRANCH	国药准字HJ20171356	化学药品	片剂	4/8/2021
Lanthanum Carbonate Chewable Tablets	沈阳福宁药业有限公司	国药准字H20233125	化学药品	片剂	2/7/2023
Lanthanum Carbonate Chewable Tablets	MYLAN LABORATORIES LIMITED	国药准字HJ20230116	化学药品	片剂	10/18/2023
Lanthanum Carbonate Chewable Tablets	沈阳华泰药物研究有限公司	国药准字H20233126	化学药品	片剂	2/7/2023

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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