Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: PAION Deutschland GmbH, Heussstraße 25, 52078 Aachen, Germany
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.
The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5).
No dose adjustment is required in elderly patients (see section 5.2).
No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis. Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
The safety and efficacy of Xerava in children and adolescents less than 18 years of age have not been established. No data are available. Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6).
Intravenous use.
Xerava is administered only by intravenous infusion over approximately 1 hour (see section 4.4).
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
In trials administering up to 3 mg/kg eravacycline to healthy volunteers it has been observed that doses higher than the recommended dose lead to a higher rate of nausea and vomiting.
In the case of suspected overdose Xerava should be discontinued and the patient monitored for adverse reactions.
3 years.
Chemical and physical in-use stability after reconstitution in the vial has been demonstrated for 1 hour at 25°C.
Chemical and physical in-use stability after dilution has been demonstrated for 72 hours at 2°C-8°C and 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 72 hours at 2°C–8°C, unless the method of reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Store in a refrigerator (2°C–8°C). Keep the vial in the carton in order to protect from light.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
10 mL Type I glass vial with butyl rubber stopper and aluminium cap.
Pack sizes: 1 vial, 10 vials and multipacks containing 12 (12 packs of 1) vials.
Not all pack sizes may be marketed.
Each vial is for single use only.
Aseptic technique must be followed when preparing the infusion solution.
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.
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 3.
Gently invert the bag to mix the solution.
Table 4. Example calculations for weights ranging from 40 kg to 200 kg1:
| 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.
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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
