Xerava 100mg Sdv Inj, 1 Vial
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Fluorocycline antibiotic
Pregnancy Category
Not available
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 appendicitis or diverticulitis that have spread. 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 adhere to all guidelines provided. This drug is administered via infusion into a vein over a specified period of time.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
For storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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 side effects, especially severe diarrhea, nausea, vomiting, or pain/redness at the injection site, to your healthcare provider immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1.5 mg/kg IV every 12 hours
Condition-Specific Dosing:
complicated intra-abdominal infections (cIAI):
1.5 mg/kg IV every 12 hours for 4 to 14 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed (not significantly removed by hemodialysis)
Hepatic Impairment:
Mild:
No adjustment needed (Child-Pugh A)
Moderate:
1.5 mg/kg IV every 24 hours (Child-Pugh B)
Severe:
1.5 mg/kg IV every 24 hours (Child-Pugh C)
Pharmacology
Mechanism of Action
Eravacycline is a fluorocycline antibacterial that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. This binding prevents the binding of aminoacyl-tRNA to the A site of the ribosome, thereby inhibiting protein synthesis. Eravacycline is bacteriostatic.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
End of infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 340 L (extensive tissue distribution)
ProteinBinding:
Approximately 79-90%
CnssPenetration:
Limited (not indicated for CNS infections)
Elimination:
HalfLife:
Approximately 20 hours
Clearance:
Approximately 13.6 L/hr
ExcretionRoute:
Primarily fecal (biliary excretion), with minor renal excretion
Unchanged:
Approximately 9% (renal), 80% (fecal)
Pharmacodynamics
OnsetOfAction:
Rapid (achieves therapeutic concentrations quickly after IV infusion)
PeakEffect:
End of infusion
DurationOfAction:
Maintained for 12 hours (dosing interval)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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 (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)
Raised pressure in the brain, which can cause:
+ Headache
+ Blurred vision
+ Double vision
+ Loss of vision
Other Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Upset stomach or vomiting
Irritation at the injection site
Reporting 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 right away:
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 (may be a sign of C. diff-associated diarrhea, a potentially life-threatening condition)
Raised pressure in the brain, which can cause:
+ Headache
+ Blurred vision
+ Double vision
+ Loss of vision
Other Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Diarrhea
Upset stomach or vomiting
Irritation at the injection site
Reporting 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 (may be a sign of C. difficile infection)
- New or worsening abdominal pain
- Fever or chills that return after starting treatment
- Significant pain, swelling, or redness at the injection site
- Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 and its symptoms.
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. To ensure safe use, disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems.
* Your doctor and pharmacist will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 and its symptoms.
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. To ensure safe use, disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems.
* Your doctor and pharmacist will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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.
Do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
Be cautious when exposed to sunlight, as this medication may increase your susceptibility to sunburn. Take necessary precautions to protect yourself from the sun, and notify your doctor if you experience excessive sunburning while taking this medication.
Pregnancy Warning
If you are pregnant or become pregnant while taking this medication, you must contact your doctor immediately, as it may harm the unborn baby.
Special Considerations for Children
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the tooth discoloration will be irreversible. It is crucial to discuss this risk with your doctor.
Age Restriction
This medication should not be administered to children under 8 years of age.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
Be cautious when exposed to sunlight, as this medication may increase your susceptibility to sunburn. Take necessary precautions to protect yourself from the sun, and notify your doctor if you experience excessive sunburning while taking this medication.
Pregnancy Warning
If you are pregnant or become pregnant while taking this medication, you must contact your doctor immediately, as it may harm the unborn baby.
Special Considerations for Children
In children under 8 years old, this medication may cause permanent tooth discoloration, resulting in a yellow-gray-brown color. If this occurs, the tooth discoloration will be irreversible. It is crucial to discuss this risk with your doctor.
Age Restriction
This medication should not be administered to children under 8 years of age.
Overdose Information
Overdose Symptoms:
- Limited experience with overdose. Expected symptoms would be an exaggeration of known adverse effects (e.g., severe nausea, vomiting, diarrhea, 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. Call 1-800-222-1222 (Poison Control) for further guidance.
Drug Interactions
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May significantly decrease eravacycline exposure, potentially leading to reduced efficacy. Co-administration should be avoided.
Moderate Interactions
- Warfarin: Although not specifically studied, other antibiotics can alter gut flora and affect vitamin K production, potentially enhancing the anticoagulant effect of warfarin. Monitor INR.
Monitoring
Baseline Monitoring
Culture and Susceptibility
Rationale: To confirm susceptibility of the causative pathogen(s) to eravacycline.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, especially if hepatic impairment is suspected, as dose adjustments are required for moderate to severe impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical Response
Frequency: Daily
Target: Improvement in signs and symptoms of infection
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or need for alternative therapy.
Infusion Site Reactions
Frequency: Daily during infusion
Target: Absence of pain, phlebitis, or erythema
Action Threshold: Discontinue infusion if severe reaction occurs; consider slower infusion rate or central line for mild reactions.
Gastrointestinal Symptoms (Nausea, Vomiting, Diarrhea)
Frequency: Daily
Target: Absence or mild, manageable symptoms
Action Threshold: Severe or persistent symptoms may require symptomatic treatment or re-evaluation of therapy. Consider C. difficile infection if severe diarrhea occurs.
Liver Function Tests (LFTs)
Frequency: Periodically, especially in patients with hepatic impairment or prolonged therapy
Target: Within normal limits or stable
Action Threshold: Significant elevations may require dose adjustment or discontinuation.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea (especially severe or persistent, indicative of C. difficile-associated diarrhea)
- Abdominal pain
- Infusion site reactions (pain, phlebitis, erythema, swelling)
- Headache
- Dizziness
- Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
Special Patient Groups
Pregnancy
Xerava should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Based on animal data, eravacycline may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth in the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects, though specific human data are lacking. Animal studies show skeletal and dental effects.
Second Trimester:
Risk of permanent tooth discoloration (deciduous teeth) and reversible inhibition of bone growth.
Third Trimester:
Risk of permanent tooth discoloration (deciduous teeth) and reversible inhibition of bone growth.
Lactation
Breastfeeding is not recommended during treatment with Xerava and for 4 days after the last dose. It is unknown if eravacycline is excreted in human milk, but tetracyclines are generally present in milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., tooth discoloration, inhibition of bone growth), a decision should be made whether to discontinue breastfeeding or discontinue the drug.
Infant Risk:
High (potential for permanent tooth discoloration and reversible inhibition of bone growth in the infant)
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is not recommended due to the potential for permanent tooth discoloration and reversible inhibition of bone growth, similar to other tetracycline-class antibacterial drugs.
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.
Clinical Information
Clinical Pearls
- Eravacycline is a novel fluorocycline antibiotic effective against a broad spectrum of Gram-negative and Gram-positive bacteria, including multidrug-resistant (MDR) pathogens such as carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant Enterococci (VRE).
- It is an IV-only antibiotic, specifically approved for complicated intra-abdominal infections (cIAI).
- Unlike some other tetracyclines, eravacycline does not require dose adjustment for renal impairment or hemodialysis, making it a useful option in patients with kidney disease.
- Dose adjustment is necessary for patients with moderate or severe hepatic impairment.
- Patients should be monitored for infusion site reactions, which are common.
Alternative Therapies
- Carbapenems (e.g., meropenem, imipenem/cilastatin, ertapenem)
- Piperacillin/tazobactam
- Ceftolozane/tazobactam
- Ceftazidime/avibactam
- Meropenem/vaborbactam
- Imipenem/cilastatin/relebactam
- Tigecycline
- Other broad-spectrum antibiotics or combinations depending on the specific pathogens and resistance patterns.
Cost & Coverage
Average Cost:
Not available per 100mg vial
Insurance Coverage:
Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Additionally, you may want to inquire about potential drug take-back programs in your area. Some medications may come with a separate patient information leaflet, so be sure to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to discuss them 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.