XERAVA SIDE EFFECTS
- Generic Name: eravacycline for injection
- Brand Name: Xerava
- Drug Class: Tetracyclines
SIDE EFFECTS
The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section:
- Hypersensitivity Reactions
- Tooth Discoloration
- Inhibition of Bone Growth
- Clostridium difficile-Associated Diarrhea
- Tetracycline Class Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
XERAVA was evaluated in 3 active-controlled clinical trials (Trial 1, Trial 2 and Trial 3) in adults with cIAI. These trials included two Phase 3 trials (Trial 1and Trial 2) and one Phase 2 trial (Trial 3, NCT01265784). The Phase 3 trials included 520 patients treated with XERAVA and 517 patients treated with comparator antibacterial drugs (ertapenem or meropenem). The median age of patients treated with XERAVA was 56 years, ranging between 18 and 93 years old; 30% were age 65 years and older. Patients treated with XERAVA were predominantly male (57%) and Caucasian (98%). The XERAVA- treated population included 31% obese patients (BMI ≥ 30 kg/m2) and 8% with baseline moderate to severe renal impairment (calculated creatinine clearance 15 to less than 60 mL/min). Among the trials, 66 (13%) of patients had baseline moderate hepatic impairment (Child Pugh B); patients with severe hepatic impairment (Child Pugh C) were excluded from the trials.
Adverse Reactions Leading To Discontinuation
Treatment discontinuation due to an adverse reaction occurred in 2% (11/520) of patients receiving XERAVA and 2% (11/517) of patients receiving the comparator. The most commonly reported adverse reactions leading to discontinuation of XERAVA were related to gastrointestinal disorders.
Most Common Adverse Reactions
Adverse reactions occurring at 3% or greater in patients receiving XERAVA were infusion site reactions, nausea and vomiting.
Table 1 lists adverse reactions occurring in ≥ 1% of patients receiving XERAVA and with incidences greater than the comparator in the Phase 3 cIAI clinical trials. A similar adverse reaction profile was observed in the Phase 2 cIAI clinical trial (Trial 3).
Table 1. Selected Adverse Reactions Reported in ≥ 1% of Patients Receiving XERAVA in the Phase 3 cIAI Trials (Trial 1 and Trial 2)
| Adverse Reactions | XERAVAa N=520 n (%) |
Comparatorsb N=517 n (%) |
| Infusion site reactionsc | 40 (7.7) | 10 (1.9) |
| Nausea | 34 (6.5) | 3 (0.6) |
| Vomiting | 19 (3.7) | 13 (2.5) |
| Diarrhea | 12 (2.3) | 8 (1.5) |
| Hypotension | 7 (1.3) | 2 (0.4) |
| Wound dehiscence | 7 (1.3) | 1 (0.2) |
| Abbreviations: IV=intravenous a XERAVA dose equals 1 mg/kg every 12 hours IV. b Comparators include ertapenem 1 g every 24 hours IV and meropenem 1 g every 8 hours IV. c Infusion site reactions include: catheter/vessel puncture site pain, infusion site extravasation, infusion site hypoaesthesia, infusion/injection site phlebitis, infusion site thrombosis, injection site/vessel puncture site erythema, phlebitis, phlebitis superficial, thrombophlebitis, and vessel puncture site swelling. |
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Other Adverse Reactions Of XERAVA
The following selected adverse reactions were reported in XERAVA-treated patients at a rate of less than 1% in the Phase 3 trials:
Cardiac disorders: palpitations
Gastrointestinal System: acute pancreatitis, pancreatic necrosis
General Disorders and Administrative Site Conditions: chest pain
Immune system disorders: hypersensitivity
Laboratory Investigations: increased amylase, increased lipase, increased alanine aminotransferase, prolonged activated partial thromboplastin time, decreased renal clearance of creatinine, increased gamma-glutamyltransferase, decreased white blood cell count, neutropenia
Metabolism and nutrition disorders: hypocalcemia
Nervous System: dizziness, dysgeusia
Psychiatric disorders: anxiety, insomnia, depression
Respiratory, Thoracic, and Mediastinal System: pleural effusion, dyspnea
Skin and subcutaneous tissue disorders: rash, hyperhidrosis
SRC: NLM .