cefepime and taniborbactam (pending for FDA approval)

Action and Spectrum

Actions and spectrum: 

Cefepime binds to the penicillin-binding proteins and inhibits the synthesis of bacterial cell walls. Bacterial cell wall biosynthesis is essentially inhibited by this binding, which stops the last transpeptidation of peptidoglycan synthesis. Cefepime basically causes bacterial death by rupturing the bacterial cell wall’s structural integrity. 

Taniborbactam, an inhibitor of bicyclic boronate β-lactamase (BLI), is formerly known as VNRX-5133. 

It selectively targets and inhibits a wide range of enzymes, including metallo-β-lactamases (like VIM and NDM), OXA-48, and serine-β-lactamases (like KPC or GES). By preventing these enzymes from functioning, taniborbactam makes cefepime more effective against gram-negative bacteria that are resistant to several medications

Drug Interaction

Adverse Reaction

Frequency not defined 

Changes in mood 

Inflammation 

Bloody or watery diarrhea 

Reactions at the site of injection 

Sore tongue 

White and thick vaginal discharge 

Loss of appetite 

Irregular heartbeat 

Convulsions 

Breathing difficulty 

Muscle cramps 

Tremor 

Yellowing of skin or eyes 

Dark urine 

Fever and chills 

Nose bleeds or bleeding gums 

Black Box Warning

Black Box Warning 

There is no safety evidence available. 

Contraindication / Caution

Contraindication/Caution: 

Cross-hypersensitivity 

Neurotoxicity 

Pregnancy / Lactation

Pregnancy Warnings: 

Pregnancy category: N/A 

Lactation: 

Excretion of the drug in human breast milk is unknown  

Pregnancy Categories: 

Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester. 

Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women. 

Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women. 

Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits. 

Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women. 

Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

Cefepime-taniborbactum is a BL/BI (beta-lactam/beta-lactamase inhibitor). it is an investigational drug. 

Pharmacodynamics: 

When it comes to the microbiological intent-to-treat (microITT) population’s primary effectiveness endpoint of composite microbiologic and clinical success at the Test of Cure (TOC) visit (Day 19–23), cefepime-taniborbactam outperformed meropenem. 

Pharmacokinetics: 

Still under investigation. 

Adminstartion

Administration: 

The combination drug cefepime and taniborbactam should be given intravenously or as advised by the physician.

Patient Information Leaflet

Patient information leaflet 

Generic Name: cefepime-taniborbactum 

Why do we use cefepime-taniborbactum? 

Cefepime-taniborbactum, an investigational drug, is being studied for its use in treating complicated urinary tract infections and pyelonephritis in adults. It is also effective against treating infections caused by CRE (carbapenem-resistant Enterobacterales), MDR-PA (multidrug-resistant- Pseudomonas aeruginosa), CRPA (carbapenem-resistant Pseudomonas aeruginous), and   ESBL (extended-spectrum beta-lactamase) expressing Enterobacterales.