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Eravacycline

Medically reviewed by Drugs.com. Last updated on May 25, 2020.

Pronunciation

(ER a va SYE kleen)

Dosage Forms

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)

Brand Names: U.S.

  • Xerava

Pharmacologic Category

  • Antibiotic, Tetracycline Derivative

Pharmacology

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.

Distribution

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

Metabolism

Primarily by CYP3A4- and FMO-mediated oxidation

Excretion

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

Half-Life Elimination

20 hours

Protein Binding

79% to 90% (increases with increasing plasma concentrations)

Special Populations: 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.

Use: Labeled Indications

Intra-abdominal infections, complicated: 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.

Contraindications

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

Dosing: Adult

Intra-abdominal infections, complicated: IV: 1 mg/kg every 12 hours for 4 to 14 days

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

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Reconstitute each vial with 5 mL NS or SWFI to a concentration of 10 mg/mL. Swirl gently; avoid shaking, which may cause foaming. Do not use if solution is cloudy or has visible particles. Reconstituted solution must be further diluted to allow for IV administration. Transfer full or partial vial contents to an IV bag of NS to a final concentration of 0.3 mg/mL (within a range of 0.2 to 0.6 mg/mL). Do not shake the bag. Reconstituted solution should be clear, yellow to orange color.

Administration

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.

Storage

Store intact vials in original carton at 2°C to 8°C (36°F to 46°F). Reconstituted vial may be stored at room temperature (≤25°C [77°F]) but must be further diluted within 1 hour. Diluted solutions for infusion may be stored at room temperature (≤25°C [77°F]) for up to 24 hours or refrigerated (2°C to 8°C [36°F to 46°F]) for up to 7 days. Do not freeze. Note: Prior to October 2019, the manufacturer's labeling stated diluted solutions for infusion could be stored at room temperature (≤25°C [77°F]) for ≤6 hours or refrigerated (2°C to 8°C [36°F to 46°F]) for ≤24 hours.

Drug Interactions

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

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

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

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Lithium: Tetracyclines may increase the serum concentration of Lithium. Monitor therapy

Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination

Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Monitor therapy

Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Monitor therapy

Retinoic Acid Derivatives: Tetracyclines may enhance the adverse/toxic effect of Retinoic Acid Derivatives. The development of pseudotumor cerebri is of particular concern. Exceptions: Adapalene; Bexarotene (Topical); Tretinoin (Topical). Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Adverse Reactions

1% to 10%:

Cardiovascular: Hypotension (1%)

Gastrointestinal: Nausea (7%), vomiting (4%), diarrhea (2%)

Local: Infusion site reaction (8%)

Miscellaneous: Wound dehiscence (1%)

<1%, postmarketing, and/or case reports: Acute pancreatitis, anaphylaxis, anxiety, chest pain, decreased creatinine clearance, decreased white blood cell count, depression, dizziness, dysgeusia, dyspnea, hyperhidrosis, hypersensitivity reaction, hypocalcemia, increased amylase, increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum lipase, insomnia, neutropenia, palpitations, pancreatic necrosis, pleural effusion, prolonged partial thromboplastin time, skin rash

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).

• 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.

• Photosensitivity: May be associated with photosensitivity due to structural similarities with tetracyclines.

• Pseudotumor cerebri: May be associated with pseudotumor cerebri due to structural similarities with tetracyclines.

• Superinfection: Use may result in fungal or bacterial superinfection, including Clostridioides (formerly Clostridium) 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.

Monitoring Parameters

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

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.

Patient Education

What is this drug used for?

• It is used to treat bacterial infections.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Vomiting

• Injection site irritation

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin

• Acidosis like confusion, fast breathing, fast heartbeat, abnormal heartbeat, severe abdominal pain, nausea, vomiting, fatigue, shortness of breath, or loss of strength and energy

• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting

• Headache

• Vision changes

• Change in amount of urine passed

• Unable to pass urine

Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools

• Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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