Prescribing Information

For US Healthcare Professionals only

How NUZYRA Works

A next-generation tetracycline1,2

Designed to overcome certain mechanisms of tetracycline resistance1,2

Distinct chemical modifications at the C-7 and C-9 positions3-5

Aminomethylcycline

C-7 Active Efflux Pumps

Position modification blocks resistance at efflux pumps and helps NUZYRA from being pushed out of bacterial cells.

The aminomethylcycline molecule features modifications at the active efflux pump C-7 position and the ribosomal protection protein C-9 position

C-9 Ribosomal Protection Proteins

Position modification overcomes ribosomal protection, allowing NUZYRA to bind effectively.

Activity against tough-to-treat pathogens1

NUZYRA has demonstrated clinical and in vitro activity against select pathogens.1,6

See NUZYRA activity against a wide range of pathogens

This includes certain gram-positive and gram-negative pathogens, as well as atypicals like:

Legionella pneumophila7

In CABP clinical infections and in vitro

And drug-resistant strains such as:

MRSA

(Methicillin-resistant Staphylococcus aureus)

In ABSSSI clinical infections and in vitro

VRE*

(Vancomycin-resistant Enterococcus faecium)

In vitro only

*The safety and effectiveness of NUZYRA in treating clinical infections due to this microorganism have not been established.1

DRSP

(Drug-resistant Streptococcus pneumoniae)

In CABP clinical infections and in vitro

  • Macrolide-resistant
  • Penicillin-resistant (in vitro only)
  • Tetracycline-resistant
Learn more about antimicrobial resistance

MRSA: A threat in need of innovative antibiotic therapies for ABSSSI8

The current SIS guidelines for the management of SSTIs recommend NUZYRA as an alternative treatment for suspected or confirmed MRSA in certain ABSSSIs.9

ABSSSI=acute bacterial skin and skin structure infections; CABP=community-acquired bacterial pneumonia; SIS=Surgical Infection Society; SSTIs=skin and soft tissue infections.

Criteria for selecting an antibiotic therapy1,9

Choice of an alternative antibiotic should be driven by multiple factors, including clinician experience, history of drug allergies or adverse events, drug interactions, and drug-disease interactions.

  • When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy
  • In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy
IMPORTANT SAFETY INFORMATION

INDICATIONS and USAGE

NUZYRA® (omadacycline) is a tetracycline-class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.

USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.

WARNINGS AND PRECAUTIONS

Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients >65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.

The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.

Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.

Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.

DRUG INTERACTIONS

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA.

Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.

USE IN SPECIFIC POPULATIONS

Lactation: Breastfeeding is not recommended during treatment with NUZYRA.

Please see full Prescribing Information for NUZYRA.

References: 1. NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc. 2. LaPlante KL, Dhand A, Wright K, Lauterio M. Re-establishing the utility of tetracycline-class antibiotics for current challenges with antibiotic resistance. Ann Med. 2022;54(1):1686-1700. 3. Honeyman L, Ismail M, Nelson ML, et al. Structure-activity relationship of the aminomethylcyclines and the discovery of omadacycline. Antimicrob Agents Chemother. 2015;59(11):7044-7053. 4. Zhanel GG, Esquivel J, Zelenitsky, et al. Omadacycline: a novel oral and intravenous aminomethylcycline antibiotic agent. Drugs. 2020;80(3):285-313. 5. Villano S, Steenbergen J, Loh E. Omadacycline: development of a novel aminomethylcycline antibiotic for treating drug-resistant bacterial infections. Future Microbiol. 2016;11:1421-1434. 6. 2020, 2021, and 2022 US Surveillance Data. Data on file. Paratek Pharmaceuticals, Inc. 7. Dubois J, Dubois M, Martel JF. In vitro and intracellular activities of omadacycline against Legionella pneumophila. Antimicrob Agents Chemother. 2020;64(5):e01972-19. 8. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2019. 9. Duane TM, Huston JM, Collom M, et al. Surgical Infection Society 2020 Updated Guidelines on the management of complicated skin and soft tissue infections. Surg Infect (Larchmt). 2021;22(4):383-399.