Cefepime, enmetazobactam
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mohammad Waqas Danish, MBBS
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Overview
Cefepime, enmetazobactam is an fourth generation cephalosporin with an extended spectrum Beta-Lactamase Inhibitor that is FDA approved for the treatment of complicated urinary tract infections, including p.yelonephritis. Common adverse reactions include increase in transaminases, increased bilirubin, headache, and phlebitis/infusion site reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Complicated Urinary Tract Infections, including Pyelonephritis
Cefepime,Enmetazobactam is indicated for the treatment of with complicated urinary tract infections (cUTI) including pyelonephritis in patients aged 18 and above, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex . It should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
Dosage
The recommended dosage is 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) between 60 and 129 mL/min. The duration of treatment is 7 days and up to 14 days for patients with concurrent bacteremia.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefepime, enmetazobactam in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefepime, enmetazobactam in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefepime, enmetazobactam in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefepime, enmetazobactam in pediatric patients.
Contraindications
The drug is contraindicated in patients with a history of serious hypersensitivity reactions to the components (cefepime and enmetazobactam) or other beta-lactam antibacterial drugs.
Warnings
Hypersensitivity Reactions
Hypersensitivity reactions have been reported in patients treated with this drug. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with this drug is instituted, carefully inquire about previous hypersensitivity reactions to cefepime, cephalosporins, penicillins, or other beta-lactams because cross-hypersensitivity among beta-lactam antibacterial drugs have been reported. If an allergic reaction occurs, discontinue the drug and institute appropriate supportive measures.
Neurotoxicity
Neurotoxicity has been reported during treatment with cefepime, a component of this drug, including life-threatening or fatal occurrences of the following: encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment. However, some cases of neurotoxicity occurred in patients receiving a dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, symptoms of neurotoxicity were reversible and resolved after discontinuation of cefepime and/or after hemodialysis. If neurotoxicity associated with this drug therapy occurs, discontinue and institute appropriate supportive measures.
Clostridioides difficile-associated Diarrhea
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including this drug, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Positive Direct Coombs’ Tests
Positive direct Coombs’ tests with or without hemolysis have been reported during treatment with cefepime, a component of this drug. In patients who develop hemolytic anemia, discontinue the drug and institute appropriate therapy. Positive Coombs’ test may be observed in newborns whose mothers have received cephalosporin antibacterial drugs before parturition.
Prolonged Prothrombin Time
Many cephalosporins, including cefepime, a component of EXBLIFEP, have been associated with a decrease in prothrombin activity. Those at risk of developing a prolonged prothrombin time include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy. Prothrombin time should be monitored in patients at risk, and exogenous vitamin K administered as indicated.
Development of Drug-Resistant Bacteria
Prescribing this drug in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Interactions with Urine Glucose Testing
The administration of cefepime, a component of the drug, may result in a false-positive reaction for glucose in the urine when using some methods.(e.g., ClinitestTM tablets)
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Cefepime, enmetazobactam Clinical Trials Experience in the drug label.
Postmarketing Experience
The following adverse reactions and altered laboratory tests have been identified during post-approval use of cefepime or other cephalosporin-class antibacterial drugs. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia, hemolytic anemia, pancytopenia Nervous system disorders: Encephalopathy (including disturbance of consciousness, hallucinations, stupor, and coma), aphasia, myoclonus, seizures, and nonconvulsive status epilepticus Immune system disorders: Anaphylaxis including anaphylactic shock, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis Hepatobiliary disorders: Hepatic dysfunction including cholestasis Renal and urinary disorders: Renal dysfunction, toxic nephropathy Vascular disorders: Hemorrhage
Drug Interactions
There is limited information regarding Cefepime, enmetazobactam Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cefepime, enmetazobactam in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefepime, enmetazobactam in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cefepime, enmetazobactam during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cefepime, enmetazobactam in women who are nursing.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
Of the 516 patients treated with EXBLIFEP in the cUTI trial (Trial 1), 204 (40%) patients were 65 years of age and older, while 78 (15%) patients were 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. Serious neurologic adverse reactions have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, a component of this drug including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. No dosage adjustment based on age is required. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored as appropriate. Dosage adjustment for elderly patients should be based on renal function. This drug.is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored as appropriate. Dosage adjustment for elderly patients should be based on renal function.
Gender
There is no FDA guidance on the use of Cefepime and Enmetazobactam with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cefepime and Enmetazobactam with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cefepime, enmetazobactam in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cefepime, enmetazobactam in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cefepime and Enmetazobactam in women of reproductive potentials and males
Immunocompromised Patients
There is no FDA guidance on the use of Cefepime and Enmetazobactam in immunocompromised patients.
Administration and Monitoring
Administration
There is limited information regarding Cefepime, enmetazobactam Administration in the drug label.
Monitoring
There is limited information regarding Cefepime, enmetazobactam Monitoring in the drug label.
IV Compatibility
This drug is compatible with 0.9% Sodium Chloride Injection, 5% Dextrose injection, and 2.5% Dextrose and 0.45% Sodium Chloride. Compatibility for administration with other drugs has not been established.
Overdosage
There is limited information regarding Cefepime, enmetazobactam overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cefepime, enmetazobactam Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Cefepime, enmetazobactam Mechanism of Action in the drug label.
Structure
There is limited information regarding Cefepime, enmetazobactam Structure in the drug label.
Pharmacodynamics
There is limited information regarding Cefepime, enmetazobactam Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Cefepime, enmetazobactam Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Cefepime, enmetazobactam Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cefepime, enmetazobactam Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cefepime, enmetazobactam How Supplied in the drug label.
Storage
There is limited information regarding Cefepime, enmetazobactam Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cefepime, enmetazobactam Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cefepime, enmetazobactam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cefepime, enmetazobactam Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cefepime, enmetazobactam Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.