XERAVA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG PER VIAL [SIN15930P]

Product Info

XERAVA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG PER VIAL

[SIN15930P]

2. INDICATIONS AND USAGE

2.1. Complicated Intra-abdominal Infections
XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older [see Microbiology (10.4) and Clinical Studies (12.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Limitations of Use
XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI) [see Clinical Studies (12.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

2.2. Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA 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.

3. DOSAGE AND ADMINISTRATION

3.1. Recommended Adult Dosage
The recommended dose regimen of XERAVA is 1 mg/kg every 12 hours. Administer intravenous infusions of XERAVA over approximately 60 minutes every 12 hours.

The recommended duration of treatment with XERAVA for cIAI is 4 to 14 days. The duration of therapy should be guided by the severity and location of infection and the patient’s clinical response.

3.2. Dosage Modifications in Patients with Hepatic Impairment
In patients with severe hepatic impairment (Child Pugh C), administer XERAVA 1 mg/kg every 12 hours on Day 1 followed by XERAVA 1 mg/kg every 24 hours starting on Day 2 for a total duration of 4 to 14 days. No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B) [see Use in Specific Populations (8.6) and Clinical Pharmacology (10.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

3.3. Dosage Modifications in Patients with Concomitant Use of a Strong Cytochrome P450 Isoenzymes (CYP) 3A Inducer
With concomitant use of a strong CYP3A inducer, administer XERAVA 1.5 mg/kg every 12 hours for a total duration of 4 to 14 days. No dosage adjustment is warranted in patients with concomitant use of a weak or moderate CYP3A inducer [see Drug Interactions (7.1) and Clinical Pharmacology (10.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

3.4. Preparation and Administration
XERAVA is for intravenous infusion only. Each vial is for a single dose only.

Preparation
XERAVA is supplied as a sterile yellow to orange dry powder in a single-dose vial that must be reconstituted and further diluted prior to intravenous infusion as outlined below. XERAVA does not contain preservatives. Aseptic technique must be used for reconstitution and dilution as follows:

1. Calculate the dose of XERAVA based on the patient weight; 1 mg/kg actual body weight. Prepare the required dose for intravenous infusion, by reconstituting the appropriate number of vials needed. Reconstitute each vial of XERAVA with 5 mL of Sterile Water for Injection, USP or with 5mL of 0.9% Sodium Chloride Injection, USP. When the XERAVA vial content is reconstituted with 5 mL sterile Water for Injection, USP or with 5 mL of 0.9% Sodium Chloride Injection, USP, it will deliver 50 mg (10 mg/mL) of eravacycline (free base equivalents).

2. Swirl the vial gently until the powder has dissolved entirely. Avoid shaking or rapid movement as it may cause foaming. The reconstituted XERAVA solution should be a clear, pale yellow to orange solution. Do not use the solution if you notice any particles or the solution is cloudy. Reconstituted solution is not for direct injection. The stability of the solution after reconstitution in the vial has been demonstrated for 1 hour at room temperature (not to exceed 25°C). If the reconstituted solution in the vial is not diluted in the infusion bag within 1 hour, the reconstituted vial content must be discarded.

3. The reconstituted XERAVA solution is further diluted for intravenous infusion to a target concentration of 0.3 mg/mL, in a 0.9% Sodium Chloride Injection, USP infusion bag before intravenous infusion. To dilute the reconstituted solution, withdraw the full or partial reconstituted vial content from each vial and add it into the infusion bag to generate an infusion solution with a target concentration of 0.3 mg/mL (within a range of 0.2 to 0.6 mg/mL). Do not shake the bag.

4. The diluted solutions must be infused within 12 hours if stored at room temperature (not to exceed 25°C) or within 72 hours if stored refrigerated at 2°C to 8°C. Reconstituted XERAVA solutions and diluted XERAVA infusion solutions should not be frozen.

5. Visually inspect the diluted XERAVA solution for particulate matter and discoloration prior to administration (the XERAVA infusion solution for administration is clear and ranges from light yellow to orange). Discard unused portions of the reconstituted and diluted solution.

Administration of the Intravenous Infusion
The diluted XERAVA solution is administered as an intravenous infusion over approximately 60 minutes.

XERAVA may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of XERAVA with 0.9% Sodium Chloride Injection, USP.

3.5. Drug Compatibilities
XERAVA is compatible with 0.9% Sodium Chloride Injection, USP.

The compatibility of XERAVA with other drugs and infusion solutions has not been established.

XERAVA should not be mixed with other drugs or added to solutions containing other drugs.

4. CONTRAINDICATIONS

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients [see Warnings and Precautions (5.1) and Adverse Reactions (6) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].