Cefepime - PharmaKB

Cefepime

Cefepime, Exblifep (cefepime) is a small molecule pharmaceutical. Cefepime was first approved as Maxipime on 1996-01-18. It is used to treat acinetobacter infections, bacterial infections, bacterial pneumonia, bacterial skin diseases, and bacteroides infections amongst others in the USA.

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Events

FDA approval date

EMA approval date

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Study first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
musculoskeletal diseases	D009140
respiratory tract diseases	D012140
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
skin and connective tissue diseases	D017437
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Combinations

Exblifep

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Cefepime hydrochloride

Tradename	Company	Number	Date	Products
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	B. Braun Medical	N-050821 RX	2010-05-06	2 products
CEFEPIME IN PLASTIC CONTAINER	Baxter	N-050817 RX	2008-08-05	2 products, RLD, RS

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Cefepime hydrochloride

Enmetazobactam

Tradename	Company	Number	Date	Products
EXBLIFEP	ALLECRA THERAPS	N-216165 RX	2024-02-22	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
cefepime	New Drug Application	2024-03-29
cefepime cefepime	ANDA	2023-09-30
cefepime hydrochloride	ANDA	2022-05-09
cefepime hydrochloride and dextrose	New Drug Application	2022-03-18

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
sepsis	HP_0100806	D018805	A41.9
neutropenia	—	D009503	D70
fever	HP_0001945	D005334	R50.9
urinary tract infections	EFO_0003103	D014552	N39.0
bacterial infections	—	D001424	A49
pseudomonas infections	EFO_0001076	D011552	A41.52
bacterial skin diseases	—	D017192	—
escherichia coli infections	EFO_1001318	D004927	B96.20
soft tissue infections	—	D018461	—
streptococcal infections	EFO_1001476	D013290	—

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Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

J: Antiinfectives for systemic use

— J01: Antibacterials for systemic use

— J01D: Other beta-lactam antibacterials in atc

— J01DE: Fourth-generation cephalosporins

— J01DE01: Cefepime

— J01R: Combinations of antibacterials

— J01RA: Combinations of antibacterials

— J01RA06: Cefepime and amikacin

HCPCS

Code	Description
J0692	Injection, cefepime hydrochloride, 500 mg
J0701	Injection, cefepime hydrochloride (baxter), not therapeutically equivalent to maxipime, 500 mg
J0703	Injection, cefepime hydrochloride (b braun), not therapeutically equivalent to maxipime, 500 mg

Clinical

Clinical Trials

100 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Infections	D007239	EFO_0000544	—	—	5	13	2	10	30
Communicable diseases	D003141	—	—	—	4	12	1	6	23
Pneumonia	D011014	EFO_0003106	—	—	—	4	4	7	15
Neutropenia	D009503	—	D70	1	2	3	4	4	14
Febrile neutropenia	D064147	—	—	1	2	1	4	3	11
Fever	D005334	HP_0001945	R50.9	—	2	3	3	2	10
Sepsis	D018805	HP_0100806	A41.9	—	—	—	2	7	9
Hyperthermia	D000084462	—	—	—	2	1	3	2	8
Bacteremia	D016470	EFO_0003033	R78.81	—	—	1	1	4	6
Ventilator-associated pneumonia	D053717	EFO_1001865	J95.851	—	—	3	1	—	4

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Urinary tract infections	D014552	EFO_0003103	N39.0	—	4	9	—	3	16
Bacterial infections	D001424	—	A49	2	1	1	—	2	6
Pyelonephritis	D011704	EFO_1001141	N10-N16	—	—	6	—	—	6
Neoplasms	D009369	—	C80	1	2	1	—	—	4
Healthcare-associated pneumonia	D000077299	—	—	—	—	1	—	2	3
Bacterial pneumonia	D018410	EFO_1001272	J15.9	—	—	3	—	—	3
Enterobacteriaceae infections	D004756	EFO_1001313	—	—	1	1	—	—	2
Septic shock	D012772	—	A48.3	—	—	1	—	1	2
Respiratory tract infections	D012141	—	J06.9	—	—	1	—	1	2
Intraabdominal infections	D059413	—	—	—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Methicillin-resistant staphylococcus aureus	D055624	—	—	—	1	—	—	1	2
Pseudomonas aeruginosa	D011550	NCBITaxon_287	—	—	2	—	—	—	2
Gastrointestinal microbiome	D000069196	—	—	—	1	—	—	—	1
Reinfection	D000084063	—	—	—	1	—	—	—	1
Anaphylaxis	D000707	—	T88.6	—	1	—	—	—	1
Hypersensitivity	D006967	HP_0012393	T78.40	—	1	—	—	—	1
Drug hypersensitivity	D004342	EFO_0009482	T88.7	—	1	—	—	—	1
Cephalosporin resistance	D018550	—	Z16.19	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	5	—	—	—	—	5
Renal insufficiency	D051437	HP_0000083	N19	4	—	—	—	—	4
Pharmacokinetics	D010599	—	—	2	—	—	—	1	3
Syndrome	D013577	—	—	1	—	—	—	1	2
Gram-negative bacterial infections	D016905	—	—	1	—	—	—	1	2
Mycoses	D009181	—	B35-B49	1	—	—	—	—	1
Myelodysplastic syndromes	D009190	—	D46	1	—	—	—	—	1
Myeloid leukemia acute	D015470	—	C92.0	1	—	—	—	—	1
Breast neoplasms	D001943	EFO_0003869	C50	1	—	—	—	—	1
Myeloproliferative disorders	D009196	—	D47.1	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	2	2
Heart failure	D006333	HP_0001635	I50	—	—	—	—	2	2
Hypertension	D006973	EFO_0000537	I10	—	—	—	—	2	2
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	2	2
Hemophilia a	D006467	EFO_0007267	D66	—	—	—	—	2	2
Pain	D010146	EFO_0003843	R52	—	—	—	—	2	2
Hyperaldosteronism	D006929	HP_0011736	E26	—	—	—	—	2	2
Pulmonary arterial hypertension	D000081029	—	—	—	—	—	—	2	2
Hypokalemia	D007008	HP_0002900	E87.6	—	—	—	—	2	2
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	—	—	—	2	2

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Cefepime
INN	cefepime
Description	Cefepime is a cephalosporin bearing (1-methylpyrrolidinium-1-yl)methyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. It has a role as an antibacterial drug. It is a cephalosporin and an oxime O-ether. It is a conjugate base of a cefepime(1+).
Classification	Small molecule
Drug class	cephalosporins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CO/N=C(\C(=O)N[C@@H]1C(=O)N2C(C(=O)[O-])=C(C[N+]3(C)CCCC3)CS[C@H]12)c1csc(N)n1