Vabomere

— THERAPEUTIC CATEGORIES —
  • Bacterial infections
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Vabomere Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Meropenem, vaborbactam 2g/vial (containing meropenem 1g + vaborbactam 1g); pwd for IV infusion after reconstitution and dilution; sodium content 10.9mEq/vial; preservative-free.

    Pharmacological Class

    Carbapenem + beta-lactamase inhibitor.

    How Supplied

    Single-dose vials—6

    Manufacturer

    Melinta Therapeutics

    Generic Availability

    NO

    Mechanism of Action

    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. 

    The vaborbactam component 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.

    Vabomere Indications

    Indications

    Susceptible complicated urinary tract infections (cUTI) including pyelonephritis.

    Vabomere Dosage and Administration

    Adult

    Give by IV infusion over 3hrs. ≥18yrs (eGFR ≥50mL/min/1.73m2): 4g every 8hrs. Renal impairment (eGFR 30–49mL/min/1.73m2): 2g every 8hrs; (eGFR 15–29mL/min/1.73m2): 2g every 12hrs; (eGFR <15mL/min/1.73m2): 1g every 12hrs. Give after hemodialysis session. All: treat for up to 14 days.

    Children

    <18yrs: not established.

    Vabomere Contraindications

    Not Applicable

    Vabomere Boxed Warnings

    Not Applicable

    Vabomere Warnings/Precautions

    Warnings/Precautions

    Previous hypersensitivity to penicillins, cephalosporins, other beta-lactams, or other allergens. Discontinue immediately if allergic reaction occurs. CNS disorders (eg, brain lesions, history of seizures). Bacterial meningitis. Renal impairment (thrombocytopenia possible); if eGFR <50mL/min/1.73m2: adjust dose (see Adult dose). Reevaluate dose if focal tremors, myoclonus, or seizures occur. Consider discontinuing if C. difficile-associated diarrhea suspected or confirmed. Elderly: monitor renal function. Advise females and males of reproductive potential to use an effective non-hormonal or barrier method of contraception during therapy. Pregnancy. Nursing mothers.

    Vabomere Pharmacokinetics

    Distribution

    Plasma protein bound: ~2% (meropenem); ~33% (vaborbactam). Steady-state volumes of distribution: 20.2 L (meropenem); 18.6 L (vaborbactam).

    Metabolism

    Hydrolysis.

    Elimination

    Renal. Half-life: 1.5 hours (meropenem), 1.99 hours (vaborbactam). Clearance: 15.1 L/h (meropenem), 10.9 L/h (vaborbactam).

    Vabomere Interactions

    Interactions

    Concomitant valproic acid or divalproex sodium: not recommended; if use necessary, consider supplemental anticonvulsant. Potentiated by probenecid: not recommended. May antagonize substrates of CYP1A2, CYP3A4, CYP2C, and/or P-gp; dose adjustments/monitoring may be needed. May potentiate substrates of OAT3 transporters; dose adjustments/monitoring may be needed. Antagonizes combined oral contraceptives (progestin and estrogen); use alternative non-hormonal forms or additional contraceptive methods. 

    Vabomere Adverse Reactions

    Adverse Reactions

    Headache, phlebitis/infusion site reactions, diarrhea; serious hypersensitivity reactions, C. difficile-associated diarrhea, possible neuromotor impairment (eg, seizures, delirium, paresthesias), superinfection.

    Vabomere Clinical Trials

    See Literature

    Vabomere Note

    Not Applicable

    Vabomere Patient Counseling

    See Literature

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