VABOMERE

VABOMERE- vaborbactam and meropenem injection, powder, for solution
The Medicines Company

1. INDICATIONS AND USAGE

1.1 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis

VABOMERE™ 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.

1.2 Usage

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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage of VABOMERE 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/1.73m 2. The duration of treatment is for up to 14 days.

2.2 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/1.73m 2. 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 [see Use in Specific Populations (8.6) and Clinical Pharmacology ( 12.3)] .

Meropenem and vaborbactam are removed by hemodialysis [see Clinical Pharmacology ( 12.3)] . For patients maintained on hemodialysis, administer VABOMERE after a hemodialysis session

Table 1: Dosage of VABOMERE in Patients with Renal Impairment

eGFR a

(mL/min/ 1.73m2)

Recommended Dosage Regimen for VABOMERE

(meropenem and vaborbactam) b, c, d

Dosing Interval
30 to 49 VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram) Every 8 hours
15 to 29 VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram) Every 12 hours
Less than 15

VABOMERE 1 gram (meropenem 0.5 grams and vaborbactam 0.5 grams)

Every 12 hours

a As calculated using the Modification of Diet in Renal Disease (MDRD) formula as follows: eGFR (mL/min/1.73m 2) = 175 x (serum creatinine) -1.154 x (age) -0.203 x (0.742 if female) x (1.212 if African American)

b All doses of VABOMERE are administered intravenously over 3 hours.

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

d The total duration of treatment is for up to 14 days.

2.3 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 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. After dilution, the final infusion concentration of meropenem and vaborbactam will be approximately between 2 mg/mL and 8 mg/mL.

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
4 grams (2 grams-2 grams) 2 vials Entire contents (approximately 21 mL) 250-1000 mL
2 grams (1 gram-1 gram) 1 vial Entire contents (approximately 21 mL) 125-500 mL
1 gram (0.5 gram-0.5 gram)

1 vial

10.5 mL (discard unused portion) 70-250 mL

5. 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.

2.4 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.

3 DOSAGE FORMS AND STRENGTHS

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 containing meropenem 1 gram (equivalent to 1.14 grams meropenem trihydrate) and vaborbactam 1 gram.

4 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 [see Warnings and Precautions ( 5.1)] .

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials [see Adverse Reactions ( 6.1)] . Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. 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. Before initiating therapy with VABOMERE, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibacterial drugs, and other allergens. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.

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