Version May 2024
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).
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.
No dosage adjustment necessary.
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
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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
Hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any component of the formulation.
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 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.
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)
No
Solution (reconstituted) (Xerava Intravenous)
50 mg (per each): $73.80
100 mg (per each): $132.00
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.
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.
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.
Plague (Yersinia pestis)
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect 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 diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: 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. Risk X: 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. Risk D: Consider therapy modification
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lithium: Tetracyclines may increase the serum concentration of Lithium. Risk C: Monitor therapy
Mecamylamine: Tetracyclines may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Methoxyflurane: Tetracyclines may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination
Mipomersen: Tetracyclines may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Tetracyclines may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Penicillins: Tetracyclines may diminish the therapeutic effect of Penicillins. Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: 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. Risk X: 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. Risk D: Consider therapy modification
Sulfonylureas: Tetracyclines may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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 enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Tetracyclines may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
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]).
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.
Monitor hepatic function periodically. Observe for signs and symptoms of anaphylaxis during administration.
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)
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)
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.
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