eravacycline (Rx)

Brand and Other Names:Xerava
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and eravacycline

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            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

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            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
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            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.

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            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)

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            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
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.