EXBLIFEP
Generic Name/API: cefepime and enmetazobactam
Manufacturer: Novartis
Dosage Forms & Strength & Pack Size:
EXBLIFEP 2.5 grams (cefepime and enmetazobactam) for injection, is supplied as a sterile powder for reconstitution in single-dose vials containing 2 grams cefepime and 0.5 grams enmetazobactam
Storage:
Store EXBLIFEP 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) [see USP, Controlled Room Temperature (CRT)]. Keep the vials in the outer carton to protect from light.
Storage conditions for reconstituted and diluted solutions of EXBLIFEP for injection are described in another section of labeling [see Dosage and Administration.
EXBLIFEP is a combination of cefepime, a cephalosporin antibacterial, and enmetazobactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of EXBLIFEP and other antibacterial drugs, EXBLIFEP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
____________WARNINGS AND PRECAUTIONS _______________
• Hypersensitivity Reactions: Hypersensitivity reactions have been reported in patients treated with EXBLIFEP. Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, have been reported with beta-lactam antibacterial drugs. If an allergic reaction to EXBLIFEP occurs, discontinue the drug and institute appropriate therapy. (5.1)
• Neurotoxicity: Neurotoxicity has been reported during treatment with cefepime, a component of EXBLIFEP. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment of cefepime. If neurotoxicity occurs, discontinue EXBLIFEP and institute appropriate supportive measures. (5.2)
• Clostridioides difficile-Associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including EXBLIFEP. Evaluate if diarrhea occurs. (5.3)
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