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
- Both formulations require loading doses
- 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
RESOURCES
- Omadacycline (Nuzyra) Package Insert
- Omadacycline for the Treatment of Mycobacterium abscessus Disease: A Case Series. OFID 2020.
- Omadacycline: A Modernized Tetracycline. CID 2019.
- Omadacycline Enters the Ring: A New Antimicrobial Contender. Pharmacotherapy 2018.
- The role of omadacycline in skin and soft tissue infections. COID 2018.
- New and improved? A review of novel antibiotics for Gram-positive bacteria. CMI 2017.
- Return of the tetracyclines: omadacycline, a novel aminomethylcycline antimicrobial. DoT 2018.
- Discovery, pharmacology, and clinical profile of omadacycline, a novel aminomethylcycline antibiotic. BMC 2016.
- Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function. AAC 2018.
- Mechanism of action of the novel aminomethylcycline antibiotic omadacycline. AAC 2014.