Exblifep
Generic name: cefepime and enmetazobactam
Dosage form: intravenous (IV) infusion
What is Exblifep?
Exblifep is a combination antibiotic used for complicated urinary tract infections (cUTIs) that contains two antibiotics, cefepime and enmetazobactam. Exblifep is used when the bacteria causing the UTI is resistant to other antibiotics, especially if the resistance is due to Extended Spectrum Beta Lactamases (ESBLs).
Exblifep contains cefepime (Maxipime), which is fourth-generation cephalosporin combined with enmetazobactam, which is a beta-lactamase inhibitor. Exblifep is given as an IV infusion that takes about 2 hours and is given every 8 hours for 7 to 14 days.
Exblifep received FDA approval to treat adults (18 years and older) with complicated UTI, including kidney infection (pyelonephritis) caused by specific bacteria Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex, that susceptible to Exblifep.
Exblifep side effects
Common Exblifep side effects are headache, infusion side effects including inflammation of the vein (phlebitis), increased liver enzyme transaminases, and high bilirubin levels; these side effects occurred in 5% or more of patients using Exblifep.
Less common Exblifep side effects include diarrhea, anemia, hypersensitivity, vomiting, and nausea; these side effects occurred in less than 5% of patients using Exblifep.
Serious Exblifep side effects
Get emergency medical help if you have signs of an allergic reaction to this medicine: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Other serious side effects include neurotoxicity, diarrhea due to Clostridioides difficile, increased prothrombin time, and development of drug-resistant bacteria.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Related/similar drugs
amoxicillin, doxycycline, ciprofloxacin, ceftriaxone, Augmentin, levofloxacin
Warning
Hypersensitivity Reactions
Hypersensitivity reactions can occur, which can be serious and occasionally fatal, including anaphylaxis and serious skin reactions.
Neurotoxicity
Neurotoxicity has been reported during treatment with cefepime, a component of Exblifep, 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.
Clostridioides difficile-associated Diarrhea
Clostridioides difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including this medicine, 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.
Prolonged Prothrombin Time
Many cephalosporins, including cefepime, one of the antibiotics in Exblifep, have been associated with decreased 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 at-risk patients, and exogenous vitamin K should be administered as indicated.
Development of Drug-Resistant Bacteria
Using Exblifep without a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and it increases the risk of the development of drug-resistant bacteria.
Positive Direct Coombs’ Tests
Positive direct Coombs’ tests with or without hemolysis can occur during treatment with cefepime, one of the antibiotics in Exblifep. Patients who develop hemolytic anemia should discontinue the drug, and appropriate therapy should be started. Positive Coombs’ test may be observed in newborns whose mothers have received cephalosporin antibacterial drugs before birth.
Interactions with Urine Glucose Testing
Using cefepime, one of the antibioics in Exblifep may result in a false-positive reaction for glucose in the urine when using some methods (e.g., ClinitestTM tablets).
Before taking this medicine
Also, see the ‘Warnings section’.
Exblifep should not be used in patients with a history of serious hypersensitivity reactions to the active ingredients cefepime or enmetazobactam, or other beta-lactam antibacterial drugs.
Pregnancy
Tell your healthcare provider if you are pregnant or planning a pregnancy. There is no available data on the use of Exblifep or enmetazobactam during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for this medicine and any potential adverse effects on the breastfed child from or from the underlying maternal condition.
Talk to your healthcare provider about the best way to feed your baby while taking this medicine.
How will I receive Exblifep?
Exblifep is a solution given into your vein by a 2 hour intravenous (IV) infusion every 8 hours for 7 days and up to 14 days for patients with concurrent bacteremia.
Dosing information
The recommended dose of Exblifep 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.
Dose changes are required for varying degrees of renal function. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage accordingly.
Exblifep 2.5 grams (cefepime and enmetazobactam) for injection contains 2 grams cefepime and 0.5 grams enmetazobactam as a sterile powder for reconstitution in single-dose vials.
Overdose
Patients who receive an overdose should be carefully observed and given supportive treatment. Cefepime and enmetazobactam can be removed by hemodialysis, although no clinical information is available on using hemodialysis to treat Exblifep overdosage. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, neuromuscular excitability, and nonconvulsive status epilepticus
Interactions
Tell your healthcare provider all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Sometimes, it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Examples of Interactions with Exblifep include:
Aminoglycosides Monitor renal function if aminoglycosides are to be administered with Exblifep because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibacterial drugs.
Diuretics Monitor renal function when Exblifep is concomitantly administered with potent diuretics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.
Drug/Laboratory Test Interactions It is recommended that glucose tests based on enzymatic glucose oxidase reactions be used in patients using Exblifep. The administration of Exblifep may result in a false-positive reaction for glucose in the urine with certain
This list is not complete. Not all possible interactions are listed here.
Storage
Vials Store vials refrigerated at 2°C to 8°C (36°F to 46°F); excursions are permitted to 15°C to 25°C (59°F to 77°F) Keep the vials in the outer carton to protect from light.
Diluted solution. Store the prepared diluted solution refrigerated at 2°C to 8°C (36°F to 46°F) for up to 4 hours prior to administration. The intravenous infusion administration of the diluted solution must be completed within 6 hours of dilution.
Company
Manufactured for: Allecra Therapeutics SAS, 68300 Saint Louis, France
References
More about Exblifep (cefepime / enmetazobactam)
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
