Meropenem/Vaborbactam

Meropenem/vaborbactam is used for complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex in adults 18 years and older.

Meropenem/vaborbactam is available under the following different brand names: Vabomere.

Dosages of Meropenem/Vaborbactam:

Dosage Forms and Strengths

Injection, Sterile Powder for Reconstitution

• (1g/1g)/vial: 2 g

Dosage Considerations – Should be Given as Follows:

Urinary Tract Infections

• Indicated for complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex in adults 18 years and older
• 4 g (meropenem [2g]/vaborbactam [2g]) intravenously (IV) every 8 hours for up to 14 days; infuse over 3 hours

Dosage Modifications

Renal impairment

• Treatment duration for all doses: Up to 14 days
• eCrCl greater than 50 mL/min/1.73²: No dosage adjustment necessary
• eCrCl 30-49 mL/min/1.73²: 2 g (meropenem [1g]/vaborbactam [1g]) IV every 8 hours
• eCrCl 15-29 mL/min/1.73²: 2 g (meropenem [1g]/vaborbactam [1g]) IV every 12 hours
• eCrCl less than 15 mL/min/1.73²: 1 g (meropenem [0.5g]/vaborbactam [0.5g]) IV every 12 hours
• Dose adjustments for renal impairment should be administered after hemodialysis session

Dosing Considerations

• Meropenem is known to be substantially excreted by the kidneys, and the risk of adverse reactions may be greater in patients with renal impairment
• Geriatric patients are more likely to have decreased renal function; use caution in dose selection and monitor if necessary
• Children under 18 years: Safety and efficacy not established

Common side effects of meropenem/vaborbactam include:

• Headache
• Phlebitis/infusion site reactions
• Diarrhea
• Hypersensitivity
• Nausea
• Increased ALT
• Increased AST
• Fever
• Low blood potassium (hypokalemia)
• Less common side effects of meropenem/vaborbactam include:
• Low white blood cell count (leukopenia)
• Chest discomfort
• Sore throat
• Vaginal yeast infection
• Oral thrush
• Creatinine phosphokinase increase
• Decreased appetite
• High blood potassium (hyperkalemia)
• High blood sugar (hyperglycemia)
• Low blood sugar (hypoglycemia)
• Dizziness
• Tremor
• Numbness and tingling
• Lethargy
• Hallucination
• Insomnia
• Azotemia
• Renal impairment
• Deep vein thrombosis
• Low blood pressure (hypotension)
• Vascular pain

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Meropenem/vaborbactam has no listed severe interactions with other drugs.
• Serious interactions of meropenem/vaborbactam include:
  • BCG vaccine live
  • cholera vaccine
  • divalproex sodium
  • probenecid
  • typhoid vaccine live
  • valproic acid
• Moderate interactions of meropenem/vaborbactam include:
  • bazedoxifene/conjugated estrogens
  • conjugated estrogens
  • conjugated estrogens, vaginal
  • dienogest/estradiol valerate
  • digoxin
  • estradiol
  • estrogens conjugated synthetic
  • estrogens esterified
  • estropipate
  • mestranol
  • sodium picosulfate/magnesium oxide/anhydrous citric acid
• Mild interactions of meropenem/vaborbactam include:
  • balsalazide
  • biotin
  • niacin
  • pantothenic acid
  • pyridoxine
  • pyridoxine (antidote)
  • thiamine
  • vitamin K1 (phytonadione)

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains meropenem/vaborbactam. Do not take Vabomere if you are allergic to meropenem/vaborbactam or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to any components of meropenem/vaborbactam, other carbapenem drugs, or patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Meropenem/Vaborbactam?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Meropenem/Vaborbactam?”

Cautions

• Hypersensitivity reactions reported; inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibacterial drugs, and other allergens prior to initiating treatment; if an allergic reaction occurs, discontinue meropenem/vaborbactam immediately; see Contraindications
• Thrombocytopenia may occur in renally impaired patients; no clinical bleeding has been reported
• Potential for neuromotor impairment; alert outpatients regarding possible adverse reactions (e.g., seizures, delirium, headaches, paresthesias) that could interfere with mental alertness and/or cause motor impairment; advise patients not to operate machinery or motorized vehicles
• To reduce the development of drug-resistant bacteria and to maintain the effectiveness, only prescribe to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
• Prolonged use may result in overgrowth of nonsusceptible organisms; repeat evaluation; if superinfection does occur during therapy, appropriate measures should be taken

Seizure potential

• Seizures and other adverse CNS reactions were reported; these reactions occur most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function
• Continue anticonvulsants in patients with known seizure disorders; if focal tremors, myoclonus, or seizures occur, evaluate neurologically, place on anticonvulsants if not already instituted, and determine if meropenem/vaborbactam dose should be decreased or discontinued

Clostridium difficile-associated diarrhea

• Clostridium difficile-associated diarrhea (CDAD) may occur with use of nearly all antibacterial agents, including meropenem/vaborbactam; severity ranges from mild diarrhea to fatal colitis; treatment with antibacterial agents alters normal flora of the colon, leading to overgrowth of C. difficile
• If CDAD is suspected/confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued; appropriate management (e.g., fluid/electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, surgical evaluation) should be institute

Drug interactions overview

• Probenecid competes with meropenem for active tubular secretion, resulting in increased plasma concentrations of meropenem; coadministration with probenecid is not recommended
• Concomitant use of meropenem/vaborbactam with valproic acid and divalproex sodium is generally not recommended; case reports have shown that coadministration of carbapenems (eg, meropenem) to patients receiving valproic acid or divalproex sodium results in decreased valproic acid concentrations
• Consider administration of antibacterial drugs other than carbapenems to treat infections in patients whose seizures are well controlled on valproic acid or divalproex sodium; if administration of meropenem/vaborbactam is necessary, consider supplemental anticonvulsant therapy

Pregnancy and Lactation

• Human data are insufficient to establish a drug-associated risk of major birth defects or miscarriages with meropenem/vaborbactam use in pregnant women. Consult your doctor.
• Meropenem is reported to be excreted in human milk. It is unknown whether vaborbactam is excreted in human milk. No information is available on the effects of meropenem/vaborbactam on the breastfed child or milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for meropenem/vaborbactam and any potential adverse effects on the breastfed child from meropenem/vaborbactam or the underlying maternal condition.