What is Xerava used for?

Xerava is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

What pharmaceutical form is Xerava available in?

Xerava: Proszek do sporządzania koncentratu roztworu do infuzji 50 mg (dożylna)

What are the side effects of Xerava?

Summary of the safety profile In clinical trials, the most common adverse reactions in patients with cIAI treated with eravacycline (n=576) were nausea (3.0%), vomiting, infusion site phlebitis (each 1.9%), phlebitis (1.4%), infusion site thrombosis (0.9%), diarrhoea (0.7%), vessel puncture site erythema (0.5%), hyperhidrosis, thrombophlebitis, infusion site hypoaesthesia, and headache (each 0.3%), which were generally mild or moderate in severity. Tabulated list of adverse reactions The adverse

Who should NOT take Xerava?

Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Hypersensitivity to tetracycline class antibiotics.

Does Xerava interact with other medications?

Potential for other medicinal products to affect the pharmacokinetics of eravacycline Concomitant administration of the strong CYP 3A4/3A5 inducer rifampicin altered the pharmacokinetics of eravacycline, decreasing exposure by approximately 32% and increasing clearance by approximately 54%. The eravacycline dose should be increased by approximately 50% (1.5 mg/kg intravenous q12h) when co-administered with rifampicin or other strong CYP3A inducers such as phenobarbital, carbama

Can Xerava be used during pregnancy?

Pregnancy There are limited data on the use of eravacycline in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. As for other tetracycline class antibiotics, eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses exposed in utero during the 2 nd and 3 rd trimester, due to accumulation in tissues with a high calcium turnov

What ATC class does Xerava belong to?

Xerava: ATC J01AA13. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Xerava

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA13. Mechanism of action The mechanism of action of eravacycline involves the disruption of bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains. The C-7 and C-9 substitutions in eravacycline are not present in any naturally occurring or semisynthetic tetracyclines and the substitution pattern imparts microbiological activities including retention of in vitro potency against Gram-positive and Gram-negative strains expressing tetracycline-specific resistance mechanism(s) (i.e., efflux mediated by tet(A), tet(B), and tet(K); ribosomal protection as encoded by tet(M) and tet(Q)).‍‍‍‍‍‍‍ Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline. Eravacycline is also not affected by aminoglycoside inactivating or modifying enzymes. Mechanism of resistance Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ. There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems. Other bacterial resistance mechanisms that could potentially affect eravacycline are associated with upregulated, non-specific intrinsic multidrug-resistant (MDR) efflux. Susceptibility testing breakpoints Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for eravacycline are: Table 2 Minimum inhibitory concentration breakpoints of eravacycline for different pathogens Pathogen MIC breakpoints (µg/mL) Susceptible (S ≤) Resistant (R >) Escherichia coli 0.5 0.5 Staphylococcus aureus 0.25 0.25 Enterococcus spp . 0.125 0.125 Viridans Streptococcus spp. 0.125 0.125 Pharmacokinetic/pharmacodynamic relationship The area under the plasma concentration-time curve (AUC) divided by the minimum inhibitory concentration (MIC) of eravacycline has been shown to be the best predictor of efficacy in vitro , utilising human steady state exposures in a chemostat and confirmed in vivo in animal models of infection. Clinical efficacy against specific pathogens Efficacy has been demonstrated in clinical trials against the pathogens listed for cIAI that were susceptible to eravacycline in vitro : • Escherichia coli • Klebsiella pneumoniae • Staphylococcus aureus • Enterococcus faecalis • Enterococcus faecium • Viridans Streptococcus spp. Antibacterial activity against other relevant pathogens In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa Paediatric population The European Medicines Agency has deferred the obligation to submit the results of trials with Xerava in one or more subsets of the paediatric population in cIAI (see section 4.2 for information on paediatric use).

⚠️ Warnings

General precautions Each vial is for single use only. Aseptic technique must be followed when preparing the infusion solution. Instructions for reconstitution The contents of the required number of vials should each be reconstituted with 5 mL water for injections or with 5 mL sodium chloride 9 mg/mL (0.9%) solution for injection, and swirled gently until the powder has dissolved entirely.‍‍‍‍‍‍‍ Shaking or rapid movement should be avoided as it may cause foaming. Reconstituted Xerava should be a clear, pale yellow to orange solution. The solution should not be used if any particles are noticed or the solution is cloudy. Preparation of the infusion solution For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/mL (0.9%) solution for injection. The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL. See example calculations in Table 4. Gently invert the bag to mix the solution. Table 4 Example calculations for weights ranging from 40 kg to 200 kg 1 Patient weight (kg) Total Dose (mg) Number of vials to needed to reconstitute Total volume to be diluted (mL) Recommended infusion bag size 40 40 1 2 100 mL 60 60 1 3 250 mL 80 80 1 4 250 mL 100 100 1 5 250 mL 150 150 2 7.5 500 mL 200 200 2 10 500 mL 1 The exact dose needs to be calculated based on the specific patient weight. For patients weighing ≥ 40 kg – 49 kg : Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 100 mL infusion bag. For patients weighing 50 kg – 100 kg : Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 250 mL infusion bag. For patients weighing > 100 kg : Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 500 mL infusion bag. Infusion The ready to use solution should be inspected visually for particulate matter prior to administration. Reconstituted and diluted solutions containing visible particles or that are cloudy in appearance should be discarded. Following dilution, Xerava is administered intravenously over approximately 1 hour. The reconstituted and diluted solution must be administered as an intravenous infusion only. It must not be administered as an intravenous bolus. If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/mL (0.9%) solution for injection. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Xerava

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