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Xerava is a brand name for Eravacycline. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xerava is indicated in adolescents from the age of 12 years weighing at least 50 kg, and in adults, for the treatment of complicated intra-abdominal infections (cIAI) (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days. 5). 2). Renal impairment No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis. 2). 2). Paediatric population The safety and efficacy of Xerava in children less than 12 years of age or adolescents with body weight below 50 kg have not been established.
8 but 3 no recommendation on a posology can be made. 6). Method of administration Intravenous use. 4). 6.
3%), which were generally mild or moderate in severity. Tabulated list of adverse reactions The adverse reactions identified with eravacycline are presented in Table 1. Adverse reactions are classified according to MedDRA system organ classification and frequency.
Frequency categories are derived according to the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials System Organ Class Common Uncommon Blood and lymphatic system disorders Hypofibrinogenaemia Increased international normalised ratio (INR) Prolonged activated partial thromboplastin time (aPTT) Prolonged prothrombin time (PT) Immune system disorders Hypersensitivity Nervous system disorders Dizziness Headache Vascular disorders Thrombophlebitisa Phlebitisb Gastrointestinal disorders Nausea Vomiting Pancreatitis Diarrhoea Hepatobiliary disorders Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia Skin and subcutaneous tissue disorders Rash Hyperhidrosis General disorders and administration site conditions Infusion site reactionc a.
Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reaction includes the preferred terms injection site erythema, infusion site hypoaesthesia, vessel puncture site erythema and vessel puncture site pain Description of selected adverse reactions Infusion site reactions Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
3). In case of hypersensitivity reactions, treatment with eravacycline must be discontinued immediately and appropriate emergency measures must be initiated. Clostridioides difficile-associated diarrhoea Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life-threatening.
8). In such circumstances, the discontinuation of eravacycline and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered. Medicinal products that inhibit peristalsis should not be given.
Infusion-site reactions Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions. 8). In case of serious reactions, eravacycline should be discontinued until a new intravenous access site is established.
Additional measures to reduce the occurrence and severity of infusion site reactions include decreasing the eravacycline infusion rate and/or concentration. Non-susceptible micro-organisms Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
If superinfection occurs during therapy, it may require interruption of treatment. Other appropriate measures should be taken and alternative antimicrobial treatment should be considered in accordance with existing therapeutic guidelines.
8). If pancreatitis is suspected, eravacycline should be discontinued. 6). Concomitant use of strong CYP3A4 inducers Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline. CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline. Co-administration of a strong CYP3A4 inducer (such as phenobarbital, rifampicin, carbamazepine, phenytoin, St. 5). Patients with severe hepatic impairment Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
1. Hypersensitivity to tetracycline class antibiotics.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Infusion site reactions can be mitigated by reducing the eravacycline infusion concentration or the infusion rate. Tetracycline class effects Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased blood urea nitrogen , azotaemia, acidosis, and hyperphosphataemia.
4). 7% of patients; all cases were mild in severity. 5%). In general, adverse reactions were mild or moderate in severity and similar to the adverse reactions observed in adults. Two events were assessed as severe including one event of anaphylactic reaction and one event of pleural effusion, which was also assessed as serious.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
2). In these cases, no recommendation on a posology can be made. 4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis. Coagulopathy Eravacycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT).
Additionally, hypofibrinogenaemia has been reported with the use of eravacycline. Therefore, blood coagulation parameters such as PT or other suitable anticoagulation test, including blood fibrinogen, should be monitored prior to treatment initiation with eravacycline and regularly while on treatment.