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Cefepime / Enmetazobactam

Extended indication Treatment of the following infections in adults: - Complicated urinary tract infections (cUTI), inc
Therapeutic value No estimate possible yet
Registration phase Registered

Product

Active substance Cefepime / Enmetazobactam
Domain Infectious diseases
Reason of inclusion New medicine (specialité)
Main indication Infectious diseases other
Extended indication Treatment of the following infections in adults: - Complicated urinary tract infections (cUTI), including pyelonephritis - Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Manufacturer Allecra
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Beta lactamase remmer.

Registration

Registration route Centralised (EMA)
ATMP No
Submission date January 2023
Expected Registration March 2024
Orphan drug No
Registration phase Registered
Additional remarks Geregistreerd maart 2024

Therapeutic value

Current treatment options Meropenem.
Therapeutic value No estimate possible yet
Substantiation Dit geneesmiddel zou in plaats van meropenem ingezet kunnen gaan worden. Cefepime/enmetazobactam is een antibioticum dat werkzaam is tegen ESBL en AMPc . Hiermee is het een carbapenem-sparend antibioticum. De verwachting is dat het in de praktijk nauwelijks ingezet zal worden. Door de intraveneuze toediening en het bijwerkingenprofiel zullen artsen waarschijnlijk eerder voor meropenem of een ander carbapenem-sparend antibioticum kiezen.
Duration of treatment Minimal 7 day / days
Frequency of administration 3 times a day
Dosage per administration Cefepime 2 g/enmetazobactam 0,5 g
References ALLIUM Trial (NCT03687255)
Additional remarks Cefepime 2 gram/enmetazobactam 0,5 gram every eight hours as a two-hour continuous intravenous infusion.

Expected patient volume per year

References Nethmap 2017(1); Nivel (2); Expert opinie (3);
Additional remarks Afgelopen jaren is het meropenem gebruik verviervoudigd, mede gedreven door ESBL infecties, met name urineweginfecties. Incidentie urineweginfecties is 40 tot 60 per 1.000 volwassen inwoners (1). In de Nederlandse huisartsenpraktijk bedraagt de incidentie van nierbekkenontsteking 30 tot 40 per 1.000 personen per jaar (2). Er wordt verwacht dat dit geneesmiddel nauwelijks zal worden ingezet in de praktijk (3).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.