VABOMERE (Page 6 of 6)

15 REFERENCES

  1. Kawamura S, Russell AW, Freeman SJ, and Siddall, RA: Reproductive and Developmental Toxicity of Meropenem in Rats. Chemotherapy, 40:S238-250 (1992).

16 HOW SUPPLIED/STORAGE AND HANDLING

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)].

17 PATIENT COUNSELING INFORMATION

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)].

Seizures

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)].

Antibacterial Resistance

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)].

Marketed by:
Melinta Therapeutics, Inc.
Lincolnshire, IL 60069 USA

MEL040-R002

PRINCIPAL DISPLAY PANEL — 2 g Vial Carton

Rx only

NDC 70842-120-06

VABOMERE
(meropenem and vaborbactam)
for injection

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.

Each vial contains meropenem 1 g,
vaborbactam 1 g, and sodium carbonate
0.575 g. The total sodium content of the
mixture is approximately 0.25 g (10.9 mEq).

Storage:
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 ControlledRoom Temperature]

MEL042

Contains 6 single dose 2 g vials

PRINCIPAL DISPLAY PANEL -- 2 g Vial Carton
(click image for full-size original)
VABOMERE meropenem-vaborbactam injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70842-120
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VABORBACTAM (VABORBACTAM) VABORBACTAM 1 g in 2 g
MEROPENEM (MEROPENEM ANHYDROUS) MEROPENEM 1 g in 2 g
Inactive Ingredients
Ingredient Name Strength
SODIUM CARBONATE 575 mg in 2 g
Product Characteristics
Color white (White to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70842-120-06 6 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (70842-120-01)
1 NDC:70842-120-01 2 g in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (70842-120-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209776 10/02/2017
Labeler — Melinta Therapeutics, Inc. (079949853)
Registrant — The Medicines Company (040861601)
Establishment
Name Address ID/FEI Operations
ACS DOBFAR S.p.A. 439962157 manufacture (70842-120)

Revised: 02/2019 Melinta Therapeutics, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.