VABOMERE- meropenem-vaborbactam injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VABORBACTAM (UNII: 1C75676F8V) (VABORBACTAM - UNII:1C75676F8V), MEROPENEM (UNII: FV9J3JU8B1) (MEROPENEM ANHYDROUS - UNII:YOP6PX0BAO)

Available from:

The Medicines Company

INN (International Name):

VABORBACTAM

Composition:

VABORBACTAM 1 g in 2 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VABOMERE™ is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , and Enterobacter cloacae species complex. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphyla

Product summary:

VABOMERE 2 grams (meropenem and vaborbactam) for injection is supplied as a white to light yellow sterile powder for constitution in single‑dose, clear glass vials (NDC 65293‑009‑01) sealed with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial is supplied in cartons of 6 vials (NDC 65293‑009‑06). Each vial contains 1 gram of meropenem (equivalent to 1.14 grams of meropenem trihydrate), 1 gram of vaborbactam, and 0.575 gram of sodium carbonate. Store VABOMERE vials at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F) [see USP, Controlled Room Temperature (CRT)].

Authorization status:

New Drug Application

Summary of Product characteristics

VABOMERE- MEROPENEM-VABORBACTAM INJECTION, POWDER, FOR SOLUTION
THE MEDICINES COMPANY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VABOMERE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FORVABOMERE.
VABOMERE™ (MEROPENEM AND VABORBACTAM) FOR INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 2017
INDICATIONS AND USAGE
VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a
penem antibacterial, and vaborbactam, 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
bacteria. ( 1.1)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of VABOMERE and other
antibacterial drugs, VABOMERE should be used only to treat or prevent
infections that are proven or strongly suspected
to be caused by susceptible bacteria. ( 1.2)
DOSAGE AND ADMINISTRATION
Administer VABOMERE 4 grams (meropenem 2 grams and vaborbactam 2
grams) every 8 hours by intravenous
infusion over 3 hours for up to 14 days, in patients 18 years of age
and older with an estimated glomerular filtration rate
(eGFR) ≥50 mL/min/1.73m
. ( 2.1)
Dosage adjustment is recommended in patients with renal impairment who
have an eGFR less than 50 mL/min/ 1.73m
. ( 2.2)
EGFR (ML/MIN /1.73M
)
RECOMMENDED DOSAGE REGIMEN FOR VABOMERE
(MEROPENEM AND VABORBACTAM)
DOSING INTERVAL
30 to 49
VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram)
Every 8 hours
15 to 29
VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram)
Every 12 hours
Less than 15
VABOMERE 1 gram (meropenem 0.5 grams and vaborbactam 0.5 grams)
Every 12 hours
As calculated using the Modification of Diet in Renal Disease (MDRD)
formula;
All doses of VABOMERE are
administered intravenously over 3 hours;
Doses adjusted for renal impairment should be administered after a
hemodialysis session;
The total duration of treatment is for up to 14 day