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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              • 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.

              • 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 (1)

              • 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)

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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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Xerava intravenous
                -
                50 mg vial
                Xerava intravenous
                -
                50 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                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.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each 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.