sodium zirconium cyclosilicate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5225	242800-27-7

Description:

Molecule	Description
Synonyms: sodium zirconium cyclosilicate lokelma ZS-9 UXSi-9	Sodium zirconium cyclosilicate selectively binds potassium in exchange for hydrogen and sodium cations throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen. This lowers serum potassium levels by drawing potassium into the GI tract and increasing faecal potassium excretion to resolve hyperkalaemia. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

sodium zirconium cyclosilicate
lokelma
ZS-9
UXSi-9

Sodium zirconium cyclosilicate selectively binds potassium in exchange for hydrogen and sodium cations throughout the gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen. This lowers serum potassium levels by drawing potassium into the GI tract and increasing faecal potassium excretion to resolve hyperkalaemia.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
7.50	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company
March 22, 2018	EMA	AstraZeneca AB
May 18, 2018	FDA	ASTRAZENECA PHARMS
March 25, 2020	PMDA	AstraZeneca K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	163.05	47.89	61	239	374320	63114402

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	249.18	44.69	115	386	397934	34558496

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	319.38	42.77	131	546	566383	79177328
Blood potassium increased	42.83	42.77	14	663	29261	79714450

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AE10	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia
MeSH PA	D007475	Ion Exchange Resins

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hyperkalemia	indication	14140009

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10398730	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	8808750	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9844567	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9861658	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10335432	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10398730	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	8808750	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9844567	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9861658	Feb. 10, 2032	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9913860	Oct. 22, 2033	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9913860	Oct. 22, 2033	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10300087	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9592253	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	10300087	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	9592253	Oct. 14, 2035	TREATMENT OF HYPERKALEMIA IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	April 24, 2023	ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	April 24, 2023	ADDITIONAL INFORMATION ADDED TO THE LABELING REGARDING THE USE IN PATIENTS ON CHRONIC HEMODIALYSIS
10GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	May 18, 2023	NEW CHEMICAL ENTITY
5GM/PACKET	LOKELMA	ASTRAZENECA	N207078	May 18, 2018	RX	FOR SUSPENSION	ORAL	May 18, 2023	NEW CHEMICAL ENTITY

Bioactivity Summary:

None

External reference:

ID	Source
D652ZWF066	UNII
4037731	VANDF
C4045824	UMLSCUI
CHEMBL3301592	ChEMBL_ID
DB14048	DRUGBANK_ID
D10727	KEGG_DRUG
279467	MMSL
34257	MMSL
d08797	MMSL
017557	NDDF
17141-74-1	SECONDARY_CAS_RN
91799284	PUBCHEM_CID
2047628	RXNORM
C000597310	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1105	POWDER, FOR SUSPENSION	5 g	ORAL	NDA	25 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1105	POWDER, FOR SUSPENSION	5 g	ORAL	NDA	25 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1110	POWDER, FOR SUSPENSION	10 g	ORAL	NDA	25 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	0310-1110	POWDER, FOR SUSPENSION	10 g	ORAL	NDA	25 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6501	POWDER, FOR SUSPENSION	10 g	ORAL	NDA	25 sections
LOKELMA	HUMAN PRESCRIPTION DRUG LABEL	1	50090-6502	POWDER, FOR SUSPENSION	5 g	ORAL	NDA	25 sections