Xerava Generic Name: eravacycline for injection Brand Name: Xerava Xerava (Eravacycline for Injection) side effects drug center Related Drugs Avelox Claforan Doribax Flagyl Flagyl ER Flagyl Injection Fortaz Invanz Merrem IV Primaxin IM Primaxin IV Rocephin Timentin Tygacil Zosyn Zosyn Injection Health Resources E. coli (0157:H7) Infection PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Xerava Side Effects Center What Is Xerava? Xerava (eravacycline) is a tetracycline antibiotic used to treat complicated intra-abdominal infections in patients 18 years of age and older. What Are Side Effects of Xerava? Common side effects of Xerava include: infusion site reactions (pain, fluid leaking, numbness, swelling, blood clot, and redness), nausea, and vomiting Dosage for Xerava Administer the dose of Xerava for injection 1 mg/kg by intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days. What Drugs, Substances, or Supplements Interact with Xerava? Xerava may interact with strong CYP3A inducers and anticoagulants (blood thinners). Tell your doctor all medications and supplements you use. Xerava During Pregnancy and Breastfeeding Tell your doctor if you are pregnant or plan to become pregnant before using Xerava. Xerava, like other tetracycline antibiotics, may cause discoloration of teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy. It is unknown if Xerava passes into breast milk. Breastfeeding is not recommended during treatment with Xerava. Additional Information Our Xerava (eravacycline) for Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Xerava Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have: severe stomach pain, diarrhea that is watery or bloody (may occur up to 2 months after your last dose of eravacycline); severe headaches, dizziness, ringing in your ears, vision problems; severe pain in your upper stomach spreading to your back, nausea and vomiting; or signs of a fungal infection--skin itching or crusting, white patches in your mouth, vaginal itching or discharge, problems with your fingernails or toenails. Common side effects may include: nausea, vomiting; or pain, bruising, redness, swelling, burning, or irritation around the IV needle. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Read the entire detailed patient monograph for Xerava (Eravacycline for Injection) Xerava Professional Information SIDE EFFECTS The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [WARNINGS AND PRECAUTIONS] Tooth Discoloration [WARNINGS AND PRECAUTIONS] Inhibition of Bone Growth [WARNINGS AND PRECAUTIONS] Clostridium difficile-Associated Diarrhea [WARNINGS AND PRECAUTIONS] Tetracycline Class Adverse Reactions [WARNINGS AND PRECAUTIONS] 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. 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 Read the entire FDA prescribing information for Xerava (Eravacycline for Injection) &Copy; Xerava Patient Information is supplied by Cerner Multum, Inc. and Xerava Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
