IDStewardship

Omadacycline (Nuzyra)

Photo source: Paratek Pharmaceuticals

KEY POINTS

  • Omadacycline (Nuzyra) is an aminomethylcycline antibiotic in the tetracycline class, that works via inhibition of the 30S ribosomal subunit, which blocks bacterial protein synthesis
    • Active against bacteria expressing tetracycline resistance via efflux pumps tetK and tetL, as well as ribosomal protection protein tetM
    • Not impacted by beta-lactamases, so can work versus ESBL+ isolates
    • Generally considered bacteriostatic
  • FDA-approved October 2, 2018 for:
    • Community acquired bacterial pneumonia (CABP)
    • Acute bacterial skin and skin structure infections (ABSSSI)
  • Has activity versus a variety of bacteria including:
    • Gram positive bacteria (e.g., Streptococcus pneumoniae, Streptococcus pyogenes, MRSA, VRE)
    • Anaerobic bacteria (e.g., Bacteroides fragilis)
    • Gram negative bacteria (e.g., Klebsiella pneumoniae, Acinetobacter spp., Stenotrophomonas maltophilia)
      • Lacks coverage for Pseudomonas aeruginosa
    • Atypical bacteria (e.g., Chlamydophylia pneumoniae, Legionella pneumophilia, Mycoplasma pneumoniae)
  • Available as injectable and oral
    • Both formulations require loading doses
      • CABP dosing is IV loading dose (200mg over 60 minutes x1 or 100mg over 30 minutes x2 given BID) followed by maintenance with 100mg IV daily or 300mg PO daily
      • ABSSSI dosing is IV or oral loading dose (IV as above, oral option is 450mg once on day 1 and day 2) followed by maintenance dosing 100mg IV over 30 minutes daily or 300mg oral daily
    • Oral formulation should be taken after 4 hours of fasting and no food or drink except water should be consumed for 2 hours following administration
      • No dairy products, antacids, or MVI for 4 hours after taking the oral dose
    • Tablet comes as 150mg of omadacycline and vial comes as 100mg of omadacycline
    • No dose adjustment for renal or hepatic function
  • The more common adverse effects include: nausea, vomiting, infusion reactions, AST/ALT/GGT increase, hypertension, headache, constipation, diarrhea, and insomnia
  • May cause tooth discoloration & enamel hypoplasia or inhibit bone growth during development (up to 8 years of age)
  • Carries a warning for mortality imbalance in patients with CABP, where it had a mortality rate of 2% versus moxifloxacin at 1%
  • May cause drug-drug interactions with anticoagulants, because tetracyclines depress plasma thrombin activity

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