Meropenem and vaborbactam

What is Meropenem and vaborbactam?

• Meropenem: It is a synthetic penem antibacterial drug.

1. Chemical name: (4R,5S,6S)-3-[[(3S,5S)-5-(dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, trihydrate
2. Empirical formula: C17H25N3O5S∙3H2O
3. Molecular weight: 437.52

• Vaborbactam: It is a cyclic boronic acid beta-lactamase inhibitor.

1. Chemical name: (3R,6S)-2-hydroxy-3-[[2-(2-thienyl)acetyl]amino]-1,2-oxaborinane-6-acetic acid
2. Empirical formula: C12H16BNO5S
3. Molecular weight: 297.14

What are the uses of this medicine?

• It 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.
• It 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.

How does this medicine work?

• The meropenem component of the drug is a penem antibacterial drug. The bactericidal action of meropenem results from the inhibition of cell wall synthesis. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding protein (PBP) targets. Meropenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, with the exception of carbapenem hydrolyzing beta-lactamases.

• The vaborbactam component of the drug is a non-suicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as Klebsiella pneumoniae carbapenemase (KPC). Vaborbactam does not have any antibacterial activity. Vaborbactam does not decrease the activity of meropenem against meropenem-susceptible organisms.

Who Should Not Use this medicine?

It is contraindicated in patients with known hypersensitivity to any components of the drug (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.

What are the brand names and dosage forms of this medicine?

• Brand name: Vabomere; NDC codes: 70842-120-01, 70842-120-06.
• 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 containing meropenem 1 gram (equivalent to 1.14 grams meropenem trihydrate) and vaborbactam 1 gram.

Is this medicine FDA approved?

It is approved by US FDA on August 29, 2017.

What are the active and inactive ingredients in in this medicine?

• Active ingredients:

1. Vaborbactam: 1g in 2g
2. Meropenem: 1g in 2g

• Inactive ingredient:

1. sodium carbonate: 575mg  in 2g

How should this medicine be used?

The recommended dosage of VABOMERE is 4 grams (meropenem 2 grams and vaborbactam 2 grams) administered every 8 hours by intravenous (IV) infusion over 3 hours in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) greater than or equal to 50 mL/min/1.73m2. The duration of treatment is for up to 14 days.

What side effects can this medication cause?

• Hypersensitivity Reactions
• Seizure Potential
• Clostridioides difficile-associated Diarrhea
• Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid
• Thrombocytopenia
• Potential for Neuromotor Impairment
• Development of Drug-Resistant Bacteria
• Overgrowth of Nonsusceptible Organisms

What to do in case of emergency/overdose?

• Meropenem and vaborbactam can be removed by hemodialysis. In subjects with end-stage renal disease (ESRD) administered meropenem 1 gram and vaborbactam 1 gram, the mean total recovery in dialysate following a hemodialysis session was 38% and 53% of the administered dose of meropenem and vaborbactam, respectively.
• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

Fetal malformations were observed in vaborbactam-treated rabbits, therefore advise pregnant women of the potential risks to the fetus. There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with VABOMERE, meropenem, or vaborbactam in pregnant women.

Can this medicine be used in children?

The safety and effectiveness of VABOMERE in pediatric patients (younger than 18 years of age) has not been established. Studies of VABOMERE have not been conducted in patients younger than 18 years of age.

What should I know about storage and disposal of this medication?

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)

• Dailymed label info on Meropenem and vaborbactam
• FDA Meropenem and vaborbactam

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