Xerava 50mg Inj, 1vl
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Fluorocycline; Tetracycline derivative
Pregnancy Category
D
FDA Approved
Aug 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xerava is an antibiotic medication given by injection into a vein. It is used to treat serious infections inside the abdomen (belly), such as those that can occur after surgery or injury. It works by stopping the growth of bacteria that cause these infections.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and follow all instructions provided. This drug is administered as an intravenous infusion, which means it is given through a vein over a specified period of time.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on what to do next.
Lifestyle & Tips
- Complete the full course of treatment as prescribed by your doctor, even if you start to feel better. Stopping early can lead to the infection coming back or becoming harder to treat.
- Report any new or worsening symptoms to your healthcare provider, especially severe diarrhea, which could be a sign of a new infection (C. difficile).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 mg/kg IV every 12 hours
Condition-Specific Dosing:
complicatedIntraAbdominalInfections:
1 mg/kg IV every 12 hours
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No dose adjustment needed; eravacycline is not significantly removed by hemodialysis
Hepatic Impairment:
Mild:
No dose adjustment needed (Child-Pugh A)
Moderate:
No dose adjustment needed (Child-Pugh B)
Severe:
Reduce dose to 0.5 mg/kg IV every 12 hours (Child-Pugh C)
Confidence:
High
Pharmacology
Mechanism of Action
Eravacycline is a fluorocycline antibacterial, a novel tetracycline derivative. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, which prevents the incorporation of aminoacyl-tRNA molecules into the ribosome's A site. This action is bacteriostatic.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
Approximately 280 L (extensive tissue distribution)
ProteinBinding:
Approximately 79-90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 20 hours
Clearance:
Approximately 12.8 L/hr
ExcretionRoute:
Fecal (biliary) and renal
Unchanged:
Approximately 25% (urine), 60% (feces)
Pharmacodynamics
OnsetOfAction:
Rapid (IV administration)
PeakEffect:
End of infusion
DurationOfAction:
Maintained for 12 hours (dosing interval)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of a pancreas problem (pancreatitis), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Difficulty urinating or changes in urine output
Diarrhea, especially if it is severe, bloody, or watery (a condition called C. diff-associated diarrhea, or CDAD, may occur, which can lead to a life-threatening bowel problem)
Raised pressure in the brain, which can cause:
+ Headache
+ Blurred vision
+ Double vision
+ Loss of vision
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:
Diarrhea
Upset stomach or vomiting
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of too much acid in the blood (acidosis), such as:
+ Confusion
+ Fast breathing
+ Fast heartbeat
+ Irregular heartbeat
+ Severe stomach pain, upset stomach, or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Feeling extremely tired or weak
Signs of a pancreas problem (pancreatitis), including:
+ Severe stomach pain
+ Severe back pain
+ Severe upset stomach or vomiting
Difficulty urinating or changes in urine output
Diarrhea, especially if it is severe, bloody, or watery (a condition called C. diff-associated diarrhea, or CDAD, may occur, which can lead to a life-threatening bowel problem)
Raised pressure in the brain, which can cause:
+ Headache
+ Blurred vision
+ Double vision
+ Loss of vision
Other Possible Side Effects
Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention:
Diarrhea
Upset stomach or vomiting
Irritation at the injection site
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent diarrhea (especially if watery or bloody)
- New or worsening abdominal pain
- Fever or chills
- Nausea or vomiting that is severe or doesn't go away
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Unusual tiredness or weakness
- Signs of an allergic reaction (rash, hives, itching, swelling of the face/lips/tongue/throat, difficulty breathing)
- Pain, redness, or swelling at the injection site
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are breastfeeding, as you should not breastfeed for at least 4 days after using this medication.
If the patient is a child, as this medication is not approved for use in pediatric populations.
Potential interactions with other medications or health conditions, as this medication may affect or be affected by other drugs or health problems.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in combination with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are breastfeeding, as you should not breastfeed for at least 4 days after using this medication.
If the patient is a child, as this medication is not approved for use in pediatric populations.
Potential interactions with other medications or health conditions, as this medication may affect or be affected by other drugs or health problems.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems
Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so in combination with this medication.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To minimize the risk of a second infection, do not take this medication for a longer period than prescribed by your doctor.
As this medication may increase your sensitivity to the sun, be cautious when spending time outdoors, especially during peak sun hours. If you experience easy sunburning while taking this medication, notify your doctor promptly.
Pregnancy Warning
If you are pregnant or become pregnant while taking this medication, you must contact your doctor immediately, as it may cause harm to the unborn baby.
Special Considerations for Children
In children under 8 years old, this medication may cause a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. If this occurs, the tooth discoloration will be irreversible. It is crucial to discuss this potential risk with your doctor.
Contraindication in Young Children
This medication should not be administered to children under 8 years of age due to the potential risk of tooth discoloration and other adverse effects.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
To minimize the risk of a second infection, do not take this medication for a longer period than prescribed by your doctor.
As this medication may increase your sensitivity to the sun, be cautious when spending time outdoors, especially during peak sun hours. If you experience easy sunburning while taking this medication, notify your doctor promptly.
Pregnancy Warning
If you are pregnant or become pregnant while taking this medication, you must contact your doctor immediately, as it may cause harm to the unborn baby.
Special Considerations for Children
In children under 8 years old, this medication may cause a permanent change in tooth color, resulting in a yellow-gray-brown discoloration. If this occurs, the tooth discoloration will be irreversible. It is crucial to discuss this potential risk with your doctor.
Contraindication in Young Children
This medication should not be administered to children under 8 years of age due to the potential risk of tooth discoloration and other adverse effects.
Overdose Information
Overdose Symptoms:
- Limited clinical experience with overdose. Symptoms may include exaggerated adverse effects such as gastrointestinal disturbances (nausea, vomiting, diarrhea), or infusion site reactions.
What to Do:
There is no specific antidote for eravacycline overdose. Treatment should be symptomatic and supportive. Eravacycline is not significantly removed by hemodialysis. Contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): May significantly decrease eravacycline exposure, potentially reducing efficacy. Co-administration should be avoided if possible. If unavoidable, monitor for reduced efficacy.
Moderate Interactions
- Warfarin: Tetracyclines can depress plasma prothrombin activity. Monitor INR/PT closely if co-administered.
- Live bacterial vaccines (e.g., oral typhoid vaccine): Antibacterials may reduce the therapeutic effect of live bacterial vaccines. Administer live vaccines at least 3 days after discontinuing eravacycline.
Monitoring
Baseline Monitoring
Liver function tests (ALT, AST, bilirubin)
Rationale: To establish baseline and monitor for potential hepatotoxicity.
Timing: Prior to initiation of therapy
Renal function (SCr, BUN)
Rationale: To establish baseline, although no dose adjustment is needed for renal impairment.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC)
Rationale: To establish baseline and monitor for potential hematologic abnormalities.
Timing: Prior to initiation of therapy
Routine Monitoring
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically during prolonged therapy or if clinically indicated
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN) may warrant dose adjustment or discontinuation, especially in severe hepatic impairment.
Signs and symptoms of C. difficile-associated diarrhea (CDAD)
Frequency: Daily
Target: Absence of symptoms
Action Threshold: Development of severe diarrhea, abdominal pain, fever; consider CDAD diagnosis and appropriate management.
Infusion site reactions
Frequency: Daily during infusion
Target: Absence of redness, swelling, pain, phlebitis
Action Threshold: Development of severe local reactions may require slowing infusion rate, changing infusion site, or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Infusion site pain/phlebitis
- Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
- Signs of allergic reaction (rash, itching, swelling, difficulty breathing)
Special Patient Groups
Pregnancy
Eravacycline is classified as Pregnancy Category D. Use during pregnancy is generally not recommended due to potential for harm to the fetus, including permanent tooth discoloration and inhibition of bone growth, based on animal studies and the known effects of tetracycline-class drugs. Weigh potential benefits against risks.
Trimester-Specific Risks:
First Trimester:
Potential for skeletal abnormalities observed in animal studies. Avoid if possible.
Second Trimester:
Risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
Third Trimester:
Risk of permanent tooth discoloration and inhibition of bone growth in the fetus.
Lactation
It is not known if eravacycline is excreted in human milk, but it is excreted in the milk of lactating rats. Due to the potential for serious adverse reactions in a breastfed infant (e.g., tooth discoloration, enamel hypoplasia, inhibition of bone growth), breastfeeding is not recommended during treatment with eravacycline and for 2 days after the last dose.
Infant Risk:
L5 (Contraindicated/High Risk)
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use in pediatric patients under 8 years of age is generally contraindicated for tetracycline-class drugs due to the risk of permanent tooth discoloration and inhibition of bone growth.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger adult patients. No dose adjustment is required based on age alone. However, elderly patients may have reduced renal or hepatic function, which should be considered.
Clinical Information
Clinical Pearls
- Eravacycline is a novel fluorocycline antibiotic effective against a broad spectrum of Gram-positive and Gram-negative bacteria, including many multidrug-resistant (MDR) strains, making it a valuable option for complicated intra-abdominal infections.
- It maintains activity against strains resistant to other tetracyclines due to efflux pumps or ribosomal protection proteins.
- No dose adjustment is needed for renal impairment or mild-to-moderate hepatic impairment, simplifying dosing in these populations.
- Infusion site reactions are common; ensure proper IV access and monitor the site closely. Slowing the infusion rate may help mitigate these reactions.
- As with all antibiotics, consider the risk of Clostridioides difficile-associated diarrhea (CDAD) and advise patients to report persistent or severe diarrhea.
Alternative Therapies
- Meropenem
- Imipenem/cilastatin
- Doripenem
- Piperacillin/tazobactam
- Ceftolozane/tazobactam
- Cefiderocol
- Tigecycline
- Plazomicin
- Cefepime/metronidazole (for cIAI)
- Levofloxacin/metronidazole (for cIAI)
Cost & Coverage
Average Cost:
Check current per 50mg vial
Insurance Coverage:
Specialty Tier or Non-Preferred Brand (varies by plan)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed to someone else.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may have additional patient information leaflets available. If you have questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details.
Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. Many communities have drug take-back programs, which your pharmacist can help you locate.
Some medications may have additional patient information leaflets available. If you have questions or concerns about your medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details.