Dosing and Administration1

Recommended Dosage

The recommended dosage of VABOMERE™ (meropenem and vaborbactam) is
4 grams (meropenem 2 grams and vaborbactam
2 grams) administered every 8 hours by intravenous (IV) infusion over 3 hours in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) greater than or equal to 50 mL/min/1.73m2. The duration of treatment is for up to 14 days.

Dosage Adjustments in Patients with Renal Impairment

4 g of VABOMERE=2 g meropenem and 2 g of vaborbactam.

Dosage adjustment is recommended in patients with renal impairment who have an eGFR <50mL/min/1.73m2.

Dosage Adjustments in Patients With Renal Impairment

Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than
50 mL/min/1.73m2. The recommended dosage of VABOMERE in patients with varying degrees of renal function is presented in Table 1. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage of VABOMERE accordingly.

Meropenem and vaborbactam are removed by hemodialysis. For patients maintained on hemodialysis, administer VABOMERE after a hemodialysis session.

Table 1. Dosage of VABOMERE in Patients With Renal Impairment

eGFRa
(mL/min/1.73m2)
Recommended Dosage
Regimen for VABOMERE
(meropenem and vaborbactam)b,c,d
Dosing Interval
30-49 VABOMERE 2 grams (meropenem
1 gram and vaborbactam 1 gram)
Every 8 hours
15-29 VABOMERE 2 grams (meropenem
1 gram and vaborbactam 1 gram)
Every 12 hours
<15 VABOMERE 1 gram (meropenem
0.5 grams and vaborbactam
0.5 grams)
Every 12 hours

aAs calculated using the Modification of Diet in Renal Disease (MDRD) formula as follows: eGFR (mL/min/1.73m2) = 175 x (serum creatinine)-1.154 x (age)-0.203 x (0.742 if female) x (1.212 if African American).

bAll doses of VABOMERE are administered intravenously over 3 hours.

cDoses adjusted for renal impairment should be administered after a hemodialysis session.

dThe total duration of treatment is for up to 14 days.

Preparation and Administration of VABOMERE for Intravenous Infusion

Preparation

VABOMERE is supplied as a dry powder in a single-dose vial that must be constituted and further diluted prior to intravenous infusion as outlined below. VABOMERE does not contain preservatives. Aseptic technique must be used for constitution and dilution.

  1. To prepare the required dose for intravenous infusion, constitute the appropriate number of vials, as determined from Table 2 below. Withdraw 20 mL of 0.9% Sodium Chloride Injection, USP, from an infusion bag and constitute each vial of VABOMERE.
  2. Mix gently to dissolve. The constituted VABOMERE solution will have an approximate meropenem concentration of 0.05 gram/mL and an approximate vaborbactam concentration of 0.05 gram/mL. The final volume is approximately 21.3 mL. The constituted solution is not for direct injection.
  3. The constituted solution must be diluted further, immediately, in a 0.9% Sodium Chloride Injection, USP infusion bag before intravenous infusion. The intravenous infusion of the diluted solution must be completed within 4 hours if stored at room temperature or 22 hours if stored refrigerated at 2°C to 8°C (36°F to 46°F).
  4. To dilute the constituted solution, withdraw the full or partial constituted vial contents from each vial and add it back into the infusion bag in accordance with Table 2 below.

Table 2: Preparation of VABOMERE Doses

VABOMERE (meropenem and vaborbactam) Dose Number of Vials to Constitute for Further Dilution Volume to Withdraw From Each Constituted Vial for Further Dilution Volume of Infusion Bag Final Infusion Concentration of VABOMERE
4 grams
(2 grams-
2 grams)
2 vials Entire contents (approximately
21 mL)
250 mL500 mL1,000 mL 16 mg/mL8 mg/mL4 mg/mL
2 grams
(1 gram-
1 gram)
1 vial Entire contents (approximately
21 mL)
125 mL250 mL500 mL 16 mg/mL8 mg/mL4 mg/mL
1 gram
(0.5 gram-
0.5 gram)
1 vial 10.5 mL (discard unused portion) 70 mL125 mL250 mL 14.3 mg/mL8 mg/mL4 mg/mL

Visually inspect the diluted VABOMERE solution for particulate matter and discoloration prior to administration (the color of the VABOMERE infusion solution for administration ranges from colorless to light yellow). Discard unused portion after use.

Drug Compatibility

VABOMERE solution for administration by 3-hour infusion is only compatible with 0.9% Sodium Chloride Injection, USP.

Compatibility of VABOMERE solution for administration with other drugs has not been established.

ordering information

ordering information

See VABOMERE ordering information

REGISTER NOW

REGISTER NOW

Register for updates and resources

Reference: 1. Vabomere [package insert]. Lincolnshire, IL: Melinta Therapeutics, Inc.; 2018.

INDICATIONS 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.
  • Clostridium 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.