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Eravacycline: Drug information

Eravacycline: Drug information
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For additional information see "Eravacycline: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Xerava
Pharmacologic Category
  • Antibiotic, Tetracycline Derivative
Dosing: Adult
Intra-abdominal infection

Intra-abdominal infection (alternative agent): IV: 1 mg/kg every 12 hours; total duration of therapy (which may include transition to oral antibiotics) is 4 to 5 days following adequate source control (Ref). Note: Alternatively, 1.5 mg/kg every 24 hours may be considered (Ref).

Plague, bubonic or pharyngeal

Plague (Yersinia pestis), bubonic or pharyngeal (alternative agent) (off- label use):

Note: Consult public health officials for event-specific recommendations.

IV: 1 mg/kg every 12 hours for 10 to 14 days or longer based on clinical resolution (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Liver Impairment: Adult

Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary

Severe impairment (Child-Pugh class C): 1 mg/kg every 12 hours on day 1, then 1 mg/kg every 24 hours

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

1% to 10%:

Cardiovascular: Hypotension (1%)

Gastrointestinal: Diarrhea (2%), nausea (7%), vomiting (4%)

Local: Infusion-site reaction (8%)

Miscellaneous: Wound dehiscence (1%)

<1%:

Cardiovascular: Chest pain, palpitations

Dermatologic: Hyperhidrosis, skin rash

Endocrine & metabolic: Hypocalcemia

Gastrointestinal: Acute pancreatitis, dysgeusia, increased serum amylase, increased serum lipase, pancreatic necrosis

Hematologic & oncologic: Decreased white blood cell count, neutropenia, prolonged partial thromboplastin time

Hepatic: Increased gamma-glutamyl transferase, increased serum alanine aminotransferase

Hypersensitivity: Hypersensitivity reaction

Nervous system: Anxiety, depression, dizziness, insomnia

Renal: Decreased creatinine clearance

Respiratory: Dyspnea, pleural effusion

Postmarketing:

Hypersensitivity: Anaphylaxis

Nervous system: Hypoesthesia (infusion related) (Miller 2022)

Neuromuscular & skeletal: Rhabdomyolysis (Belk 2024)

Contraindications

Hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic/Hypersensitivity reactions: Life-threatening (anaphylactic) reactions have been reported; discontinue if an allergic reaction occurs. Avoid use in patients with known hypersensitivity to tetracyclines.

• Antianabolic effects: May be associated with antianabolic effects observed with the tetracycline class (including increased BUN, azotemia, acidosis, and hyperphosphatemia). Discontinue use if antianabolic effects occur.

• Fixed drug eruption: May be associated with fixed drug eruption due to structural similarities with tetracyclines. Discontinue use if fixed drug eruption is suspected.

• Hepatotoxicity: May be associated with abnormal liver function tests due to structural similarities with tetracyclines; discontinue use when suspected.

• Pancreatitis: May be associated with pancreatitis due to structural similarities with tetracyclines. Discontinue use if pancreatitis occurs.

• Photosensitivity: May be associated with photosensitivity due to structural similarities with tetracyclines. Discontinue use if photosensitivity occurs.

• Pseudotumor cerebri: May be associated with pseudotumor cerebri due to structural similarities with tetracyclines. Discontinue use if pseudotumor cerebri occurs.

• Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides difficile infection (CDI) and colitis; CDI has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment recommended in severe hepatic impairment.

Special populations:

• Pediatric: May cause permanent tooth discoloration, enamel hypoplasia, or reversible inhibition of bone growth; use should be avoided during tooth and bone development (children <8 years of age).

Other warnings/precautions:

• Limitations of use: Not indicated for the treatment of complicated urinary tract infection in adults; eravacycline failed to demonstrate efficacy in 2 randomized, double-blind, active-controlled clinical trials.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous [preservative free]:

Xerava: 50 mg (1 ea); 100 mg (1 ea)

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Xerava Intravenous)

50 mg (per each): $80.50

100 mg (per each): $140.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

IV: Infuse diluted solution IV over ~60 minutes through dedicated line or via Y-site. If the same IV line is used for sequential infusion of several drugs, flush line with NS before and after eravacycline administration. Do not mix with other drugs or add to solutions containing other drugs.

Use: Labeled Indications

Intra-abdominal infection: Treatment of complicated intra-abdominal infections caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients ≥18 years.

Limitations of use: Not indicated for the treatment of complicated urinary tract infections.

Use: Off-Label: Adult

Plague (Yersinia pestis)

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inducers), CYP3A4 (Minor with inhibitors), OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminolevulinic Acid (Systemic): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Systemic). Risk X: Avoid

Aminolevulinic Acid (Topical): Photosensitizing Agents may increase photosensitizing effects of Aminolevulinic Acid (Topical). Risk C: Monitor

Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification

BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid

BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor

Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease serum concentration of Eravacycline. Management: Increase the eravacycline dose to 1.5 mg/kg every 12 hours when combined with strong CYP3A4 inducers. Risk D: Consider Therapy Modification

Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid

Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor

Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor

Lithium: Tetracyclines may increase serum concentration of Lithium. Risk C: Monitor

Mecamylamine: Tetracyclines may increase neuromuscular-blocking effects of Mecamylamine. Risk X: Avoid

Methotrexate: Tetracyclines may increase serum concentration of Methotrexate. Risk C: Monitor

Methoxsalen (Systemic): Photosensitizing Agents may increase photosensitizing effects of Methoxsalen (Systemic). Risk C: Monitor

Methoxyflurane: Tetracyclines may increase nephrotoxic effects of Methoxyflurane. Risk X: Avoid

Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor

Neuromuscular-Blocking Agents: Tetracyclines may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor

Penicillins: Tetracyclines may decrease therapeutic effects of Penicillins. Risk C: Monitor

Porfimer: Photosensitizing Agents may increase photosensitizing effects of Porfimer. Risk X: Avoid

Retinoic Acid Derivatives: Tetracyclines may increase adverse/toxic effects of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Risk X: Avoid

Sodium Bicarbonate (Systemic): May decrease serum concentration of Tetracyclines. Risk C: Monitor

Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification

Sulfonylureas: Tetracyclines may increase hypoglycemic effects of Sulfonylureas. Risk C: Monitor

Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification

Verteporfin: Photosensitizing Agents may increase photosensitizing effects of Verteporfin. Risk C: Monitor

Vitamin K Antagonists: Tetracyclines may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor

Pregnancy Considerations

Tetracyclines cross the placenta.

As a class, tetracyclines accumulate in developing teeth and long tubular bones (Mylonas 2011). Exposure during the second and third trimesters of pregnancy may cause reversible inhibition of bone growth. Permanent discoloration of teeth (yellow, gray, brown) can occur following in utero exposure and is more likely to occur following long-term or repeated exposure.

Eravacycline is not one of the recommended antibiotics for the treatment of plague (Y. pestis) in pregnant patients (CDC [Nelson 2021]).

Breastfeeding Considerations

It is not known if eravacycline is present in breast milk.

Other tetracyclines are present in breast milk; the extent of eravacycline absorption by a breastfeeding infant is not known. Due to the potential for serious adverse reactions in the breastfed infant (including tooth discoloration and inhibition of bone growth), breastfeeding is not recommended by the manufacturer during therapy or for 4 days after the last dose.

Monitoring Parameters

Monitor hepatic function periodically. Observe for signs and symptoms of anaphylaxis during administration.

Mechanism of Action

Eravacycline is a fluorocycline antibiotic within the tetracycline class that binds to the 30S ribosomal subunit and prevents the incorporation of amino acid residues into elongating peptide chains, thereby, inhibiting bacterial protein synthesis.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vdss: ~321 L (~4 L/kg) (Newman 2018)

Protein binding: 79% to 90% (increases with increasing plasma concentrations)

Metabolism: Primarily by CYP3A4- and FMO-mediated oxidation

Half-life elimination: 20 hours

Excretion: Urine: ~34% (20% as unchanged drug); Feces: 47% (17% as unchanged drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Cmax was 13.9%, 16.3%, and 19.7% higher and AUC was 22.9%, 37.9%, and 110.3% higher in patients with mild (Child-Pugh class A), moderate (Child-Pugh class B), and severe (Child-Pugh class C) hepatic impairment compared to healthy subjects, respectively.

Anti-infective considerations:

Parameters associated with efficacy: Concentration dependent; associated with free area under the curve (fAUC24)/minimum inhibitory concentration (MIC): Goal: ~6 to 30 (Thabit 2018; Zhao 2017). Note: Based on limited data; goal not well established.

Expected drug concentrations in patients with normal renal function:

Adults: IV: 1 mg/kg every 12 hours:

Cmax (peak):

Single dose: 2.125 mg/L (Newman 2018).

Multiple dose: 1.825 mg/L (Newman 2018).

AUC0-12:

Single dose: 4.305 mg•hour/L (Newman 2018).

Multiple dose: 6.309 mg•hour/L (Newman 2018).

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  2. Belk MG, Ku PM, George DL, Hobbs ALV. Rhabdomyolysis suspected to be caused by eravacycline therapy: a case report. J Pharm Pract. 2024;37(1):239-242. doi:10.1177/08971900221117872 [PubMed 36656727]
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  5. Miller RB, McClure KM, Stewart RG, Shealy SC, Brown K, Bookstaver PB. Eravacycline infusion-related hypoesthesia: a case report. Am J Health Syst Pharm. 2022;79(14):1146-1150. doi:10.1093/ajhp/zxac098 [PubMed 35380159]
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  9. Refer to manufacturer's labeling.
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