Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstition
- 50mg/single-dose vial
Intra-abdominal Infections
Indicated for treatment of complicated intra-abdominal infections (cIAIs)
1 mg/kg IV q12hr x 4-14 days; infuse IV over ~60 minutes
Dosage Modifications
Renal impairment: No dosage adjustment required
Hepatic impairment
- Mild-to-moderate (Child-Pugh A or B): No dosage adjustment required
- Severe (Child-Pugh C): 1 mg/kg q12 hr on Day 1, followed by 1 mg/kg q24 hr starting on Day 2 for a total duration of 4-14 days
Coadministration with CYP3A inducers
- Strong inducer: Increase dose to 1.5 mg/kg q12hr x 4-14 days
- Weak or moderate inducer: No dosage adjustment required
Dosing Considerations
Limitations of use: Not indicated for treatment of complicated urinary tract infections
Susceptible microorganisms for cIAI
- Escherichia coli
- Klebsiella pneumoniae
- Citrobacter freundii
- Enterobacter cloacae
- Klebsiella oxytoca
- Enterococcus faecalis, Enterococcus faecium
- Staphylococcus aureus, Streptococcus anginosus group
- Clostridium perfringens
- Bacteroides species
- Parabacteroides distasonis
Usage
- Reduce development of drug-resistant bacteria and maintain effectiveness by using only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
- Select or modify therapy based on culture and susceptibility
- In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric therapy selection
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- amoxicillin
eravacycline decreases effects of amoxicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- ampicillin
eravacycline decreases effects of ampicillin by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Tetracyclines may interfere with the bactericidal action of penicillins. Monitor for decreased therapeutic effects of penicillins if concomitantly used with a tetracycline.
- microbiota oral
eravacycline decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- palovarotene
eravacycline, palovarotene. Other (see comment). Avoid or Use Alternate Drug. Comment: Systemic retinoid use has been associated with cases of benign intracranial hypertension (pseudotumor cerebri), some of which involved concomitant use of tetracyclines.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of eravacycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer tetracyclines at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of eravacycline by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Administer tetracyclines at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
Monitor Closely (2)
- warfarin
eravacycline increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
- zinc
zinc will decrease the level or effect of eravacycline by cation binding in GI tract. Modify Therapy/Monitor Closely. Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hr.
Minor (0)
Adverse Effects
1-10%
Infusion site reactions (7.7%)
Nausea (6.5%)
Vomiting (3.7%)
Diarrhea (2.3%)
Hypotension (1.3%)
Wound dehiscence (1.3%)
<1%
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, lipase, ALT, GGT; prolonged aPTT; decreased creatinine clearance, WBC 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
Warnings
Contraindications
Hypersensitivity to eravacycline, tetracycline antibacterials, or any of the excipients
Cautions
Life-threatening hypersensitivity (anaphylaxis) reported; avoid with history of tetracycline allergy; discontinue if allergic reaction occurs
Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, consider discontinuing ongoing antibacterial drug use not directed against C difficile and initiating treatment-appropriate measures
Structurally similar to tetracyclines and may have similar adverse reactions, including photosensitivity; pseudotumor cerebri; and antianabolic action, which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests
May cause overgrowth of nonsusceptible organisms, including fungi
Prescribing without proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
Use during tooth and bone development
- Use during tooth development (last half of pregnancy, infancy, and childhood to age 8 years) may cause permanent discoloration of the teeth (yellow-grey-brown); enamel hypoplasia reported with tetracyclines; advise patient of potential risk
- May cause reversible inhibition of bone growth during pregnancy, infancy, and early childhood
- All tetracyclines form a stable calcium complex in any bone-forming tissue
- Decreased fibula growth rate observed in premature infants given PO tetracycline in doses of 25 mg/kg q6hr; reversible when drug discontinued
- Also see Pregnancy
Drug interaction overview
- Coadministration with strong CYP3A inducers decreases eravacycline exposure, which may reduce efficacy; increased eravacycline dose is recommended (see Dosage Modifications)
- Tetracyclines may depress plasma prothrombin activity; patients taking an anticoagulant therapy may require a lower anticoagulant dose
Pregnancy
Pregnancy
Like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy
Animal data
- Animal studies indicate that eravacycline crosses the placenta and is found in fetal plasma; doses above ~3 and 2.8 times the clinical exposure, based on AUC in rats and rabbits, respectively, administered during the period of organogenesis, were associated with decreased ossification, decreased fetal body weight, and/or increased postimplantation loss
Infertility
- Based on animal studies, can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility
Lactation
Unknown if excreted in human breast milk
Eravacycline (and its metabolites) is excreted in the milk of lactating rats
Tetracyclines are excreted in human milk; however, extent of absorption of tetracyclines, including eravacycline, by the breastfed infant is not known
Since other antibacterial drug options are available to treat cIAI in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment and for 4 days (based on half-life) after the last dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Fluorocycline antibacterial within the tetracycline class; disrupts bacterial protein synthesis by binding the 30S ribosomal subunit, thus preventing incorporation of amino acid residues into elongating peptide chains
Absorption
Peak plasma concentration: 2125 ng/mL (Day 1); 1825 ng/mL (Day 10)
AUC: 4305 ng·h/mL (Day 1); 6809 ng·h/mL (Day 10)
Distribution
Protein bound: 79-90%
Vd: 321 L
Metabolism
Metabolized primarily by CYP3A4- and FMO-mediated oxidation
Elimination
Half-life: 20 hr
Excretion: 34% urine (20% unchanged); 47% feces (17% unchanged)
Administration
IV Compatibilities
0.9% NaCl
IV Preparation
Reconstitution
- Reconstitute 50-mg vial with 5 mL sterile water for injection, to result in 10-mg/mL solution
- Gently swirl vial until powder completely dissolved; avoid shaking or rapid movement to avoid foaming
- Reconstituted solution should appear clear, pale yellow to orange
- Do not use if particles are noticed or solution is cloudy
- Reconstituted solution is not for direct injection
Further dilute reconstituted solution
- Dilute further in 0.9% NaCl infusion bag to a target concentration of 0.3 mg/mL (range of 0.2-0.6 mg/mL)
- Do not shake diluted bag
- Must be infused within 6 hr of preparation if stored at room temperature or within 24 hr if refrigerated (see Storage); do not freeze
IV Administration
Infuse over ~60 minutes
May be administered IV through dedicated line or Y-site
If same IV line is used for sequential infusion of several drugs, flush before and after eravacycline infusion with 0.9% NaCl
Storage
Unopened vial
- Refrigerate at 2-8°C (36-46°F)
- Keep vial in carton until use
Reconstituted vial or diluted solution
- Must be infused within 6 hr if stored at room temperature (not to exceed 25°C/77°F) or within 24 hr if refrigerated at 2-8°C (36-46°F)
- Do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Xerava intravenous - | 50 mg vial |  | |
| Xerava intravenous - | 50 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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