- Kawamura S, Russell AW, Freeman SJ, and Siddall, RA: Reproductive and Developmental Toxicity of Meropenem in Rats. Chemotherapy, 40:S238-250 (1992).
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 70842-120-01) 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 70842-120-06).
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)].
Serious Allergic Reactions
Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask patient about any previous hypersensitivity reactions to VABOMERE (meropenem and vaborbactam), penicillins, cephalosporins, other beta-lactams, or other allergens [see Warnings and Precautions (5.1)].
Patients receiving VABOMERE on an outpatient basis must be alerted of adverse events such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment. Until it is reasonably well established that VABOMERE is well tolerated, patients should not operate machinery or motorized vehicles [see Warnings and Precautions (5.2)].
Potentially Serious Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterial drugs including VABOMERE, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible [see Warnings and Precautions (5.3)].
Interaction with Valproic Acid
Counsel patients to inform their physician if they are taking valproic acid or divalproex sodium. Valproic acid concentrations in the blood may drop below the therapeutic range upon co-administration with VABOMERE. If treatment with VABOMERE is necessary and continued, alternative or supplemental anti-convulsant medication to prevent and/or treat seizures may be needed [see Warnings and Precautions (5.4)].
Counsel patients that antibacterial drugs, including VABOMERE, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When VABOMERE is prescribed to treat a bacterial infection, tell patients that although it is common to feel better early in the course of therapy, take the medication exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by VABOMERE or other antibacterial drugs in the future [see Warnings and Precautions (5.7)].
Melinta Therapeutics, Inc.
Lincolnshire, IL 60069 USA
(meropenem and vaborbactam)
2 g per vial*
*Meropenem 1 gram (equivalent
to 1.14 g meropenem trihydrate)
and vaborbactam 1 g
For Intravenous Infusion Only
Single Dose Only
Discard Unused Portion After Use
MUST BE CONSTITUTED THEN DILUTED
See prescribing information for constitution
and dilution instructions and complete
directions for use.
Store 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
Melinta Therapeutics, Inc.Lincolnshire, IL 60069 USA
Product of Italy
Contains 6 single dose 2 g vials
|VABOMERE meropenem-vaborbactam injection, powder, for solution|
|Labeler — Melinta Therapeutics, Inc. (079949853)|
|Registrant — The Medicines Company (040861601)|
|ACS DOBFAR S.p.A.||439962157||manufacture (70842-120)|
Revised: 06/2019 Melinta Therapeutics, Inc.
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