Exblifep Dosage

Generic name: cefepime hydrochloride 2g, enmetazobactam 0.5g
Dosage form: injection, powder, for solution

Medically reviewed by Drugs.com. Last updated on Feb 28, 2024.

Recommended Dosage and Administration

The recommended dosage 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. The duration of treatment is 7 days and up to 14 days for patients with concurrent bacteremia.

Recommended Dosage in Patients (18 Years of Age and Older) Based on Renal Function

The recommended dosage of EXBLIFEP in patients 18 years of age and older with varying degrees of renal function is described in Table 1 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage of EXBLIFEP accordingly [see Use in Specific Populations (8.6)].

Table 1: Recommended Dosage of EXBLIFEP in Patients (18 Years of Age and Older) Based on Renal Function
a As calculated using the Modification of Diet in Renal Disease (MDRD) formula
b The total duration of treatment is for 7 to 14 days.
c In patients requiring intermittent hemodialysis, complete the hemodialysis session before the start of EXBLIFEP dosing. Whenever possible, administer cefepime and enmetazobactam at the same time each day.
eGFRa (mL/min)	Recommended Dosage Regimen for EXBLIFEP (cefepime and enmetazobactam)b	Dosing Interval	Infusion Time
Greater than or equal to 130	EXBLIFEP 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam)	Every 8 hours	4 hours
90 to 129	EXBLIFEP 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam)	Every 8 hours	2 hours
60 to 89	EXBLIFEP 2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam)	Every 8 hours	2 hours
30 to 59	EXBLIFEP 1.25 grams (1 gram cefepime and 0.25 grams enmetazobactam)	Every 8 hours	2 hours
15 to 29	EXBLIFEP 1.25 grams (1gram cefepime and 0.25 grams enmetazobactam)	Every 12 hours	2 hours
less than 15 or receiving intermittent hemodialysisc	Loading dose of EXBLIFEP 1.25 grams (1 gram cefepime and 0.25 grams enmetazobactam) on the first day of treatment, followed by EXBLIFEP 0.625 grams (0.5 grams cefepime and 0.125 grams enmetazobactam)	Every 24 hours	2 hours

Preparation of EXBLIFEP for Intravenous Infusion Administration

Preparation

EXBLIFEP is supplied as a dry powder in a single-dose vial that must be reconstituted and further diluted prior to intravenous infusion as outlined below. EXBLIFEP does not contain preservatives. Aseptic technique must be used for reconstitution and dilution. Prepare the required dose for intravenous infusion using the steps described below:

Reconstitute the powder in the EXBLIFEP vial, with 10 mL of 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, or 2.5% Dextrose and 0.45% Sodium Chloride Injection, from a 250 mL infusion bag.
Mix gently to dissolve. The reconstituted EXBLIFEP solution will have a resultant concentration of 0.2 grams/mL (cefepime 0.16 grams/mL and enmetazobactam 0.04 grams/mL). The final volume is approximately 13 mL. The reconstituted solution is not for direct injection.

The reconstituted solution must immediately be diluted further in the 250 mL infusion bag used in Step 1. The same injection solution should be used for both reconstitution and dilution (e.g., if reconstitution in Step 1 is performed with 5% dextrose, the dilution in Step 3 should be performed with a 250 mL infusion bag of 5% dextrose). To dilute the reconstituted solution, withdraw the full or partial reconstituted vial contents and add it back into the infusion bag in accordance with Table 2 below.

Table 2: Preparation of EXBLIFEP Doses
EXBLIFEP (cefepime and enmetazobactam) Dose	Number of Vials to Reconstitute for Further Dilution	Volume to Withdraw from Each Reconstituted Vial for Further Dilution	Volume of Infusion Bag
2.5 grams (2 grams cefepime and 0.5 grams enmetazobactam)	1 vial	Entire contents (approximately 13 mL)	250 mL
1.25 grams (1 gram cefepime and 0.25 grams enmetazobactam)	1 vial	Partial contents (6.5 mL)	250 mL
0.625 grams (0.5 grams cefepime and 0.125 grams enmetazobactam)	1 vial	Partial contents (3.3 mL)	250 mL

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.
Visually inspect the diluted EXBLIFEP solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The color of the EXBLIFEP infusion solution for administration is clear to yellowish. Discard unused portion after use.