Treatment and Transitions of Care with VABOMERE |
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Efficacy and SafetySummary of clinical trial data and safety profile. Efficacy & Safety |
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Patient Types – ProfilesTypical patients who may benefit from Vabomere. Kathy Xavier |
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Patient Types – ProfilesTypical patients who may benefit from Vabomere. Kathy Xavier |
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IDSA GuidanceIDSA recommendations and placement in therapy. IDSA |
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Dosing & AdministrationRecommended dosing and routes of administration. Dosing |
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Dosing & AdministrationRecommended dosing and routes of administration. Dosing |
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Flexible Care Across SettingsInpatient, outpatient, and home care options. Home Infusion Resource |
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Preparation & StoragePreparation, storage, and shelf-life guidelines. Preparation |
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Preparation & StoragePreparation, storage, and shelf-life guidelines. Preparation |
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Billing & CodingReimbursement, billing scenarios, and J-code. Guide |
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Billing & CodingReimbursement, billing scenarios, and J-code. Guide | ||||
INDICATION AND USAGE
VABOMERE® (meropenem and vaborbactam) 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.
IMPORTANT SAFETY INFORMATION
Contraindications
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 anaphylactic reactions to beta-lactam antibacterial drugs.
Warnings and Precautions
- Hypersensitivity reactions were reported in patients treated with VABOMERE® in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE® occurs, discontinue the drug immediately.
- Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE®. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
- Rhabdomyolysis has been reported with the use of meropenem, a component of VABOMERE® If signs or symptoms of rhabdomyolysis such as muscle pain, tenderness or weakness, dark urine, or elevated creatine phosphokinase are observed, discontinue VABOMERE and initiate appropriate therapy.
- Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE®, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.
- The concomitant use of VABOMERE® and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE® is necessary, consider supplemental anticonvulsant therapy.
- In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
- Alert patients receiving VABOMERE® on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
- Prescribing VABOMERE® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
- As with other antibacterial drugs, prolonged use of VABOMERE® may result in overgrowth of nonsusceptible organisms.
Adverse Reactions
The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE® were headache, phlebitis/infusion site reactions, and diarrhea.
Please see full Prescribing Information.|
Distribution Change for AmerisourceBergen, Cardinal, and McKesson – Now Order Exclusively through Specialty Distribution |
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