Prescribing Information

For US Healthcare Professionals only

Antimicrobial resistance (AMR)

The fight against AMR

An ongoing threat to global health

Worldwide, AMR-related infections contributed directly to approximately

1.25 million deaths,

and indirectly to roughly 5 million deaths in 2019 alone.1

If the AMR trend doesn’t slow down, the number of deaths could grow to

10 million deaths

per year globally by 2050.2

In the United States, it‘s estimated that

up to 160,000 people die from AMR per year.3

Identifying antimicrobial resistance and susceptibility

Antimicrobial susceptibility testing is used for guidance in the treatment of bacterial infections. Tested pathogens are classified as “susceptible,” “resistant,” or “intermediate” when the results are uncertain.4,5

Resistance - A pathogen is said to be “resistant” when a given antibiotic (at the correct dosage) cannot stop the growth or kill the pathogen causing the infection. The likelihood of successful treatment is not high.4,5

Susceptibility - A pathogen is said to be susceptible when a given antibiotic can stop the growth or kill the pathogen causing the infection. The likelihood of successful treatment is high.4,5

The role of antimicrobial stewardship against AMR

Antimicrobial stewardship programs have been established by healthcare organizations to promote the appropriate use of antimicrobials, reduce AMR, and improve patient outcomes.6

According to the CDC, more than

80% of hospitals

in the United States have stewardship programs.7

Prevalence of methicillin-resistant Staphylococcus aureus (MRSA)8

The clinical relevance of these in vitro data is unknown. Treatment decisions should not be based on this information.

2009-2023 US Surveillance Data

MRSA across the US

Based on 10,274 clinical isolates collected from US medical centers during 2009-2023.

MRSA, and especially community-acquired MRSA, is a major consideration for healthcare providers (HCPs) choosing treatment for ABSSSI. MRSA has become the most common causative agent for purulent skin infections in the US and is associated with higher rates of complications, recurrence, and treatment failures—often leading to hospitalizations. HCPs tend to select an ABSSSI treatment to include coverage of MRSA.8

Resistance to some common oral therapies8

Current susceptibility rates (%S) of gram-positive SSTI pathogens for oral antibiotics9

Pathogen Beta-lactam TMP-SMX Linezolid Clindamycin† Doxycycline
S. aureus (4,017) 58.3% (oxacillin data) 96.0% 100% 88.0% 97.6%
MRSA (1,675) 0% (oxacillin data) 91.5% 100% 77.1% 95.6%
Beta-hemolytic streptococci* (511) 100% (amoxicillin-clavulanic acid data) ND 100% 72.5% 41.8% (tetracycline data)

The clinical relevance of these in vitro data is unknown. Treatment decisions should not be based on this information.

Clinical isolates (SSTI) origin collected from US medical centers from 2020 to 2022 as part of the SENTRY Antimicrobial Surveillance Database. Criteria as published by CLSI (2023).

CLSI=Clinical and Laboratory Standards Institute; MRSA=methicillin-resistant Staphylococcus aureus; ND=not determined; S. aureus=Staphylococcus aureus; SSTI=skin and soft tissue infection; TMP-SMX=trimethoprim-sulfamethoxazole.

*Includes Streptococcus agalactiae (176), Streptococcus canis (5), Streptococcus dysgalactiae (64), and Streptococcus pyogenes (266).

†Testing for inducible clindamycin resistance was not performed in surveillance studies; the actual clindamycin susceptibility rates may be lower than the values presented.

Overall US susceptibility rates for S. pneumoniae8

Pathogen Azithromycin Amoxicillin/clavulanate Doxycycline Cefpodoxime
S. pneumoniae 56.4%a 90.4%b 76.6%c 77.7%d

The clinical relevance of these in vitro data is unknown. Treatment decisions should not be based on this information.

Based on 17,641 clinical isolates collected from US medical centers during 2009-2023.

S. pneumoniae=Streptococcus pneumoniae.

aBased on 4712 clinical isolates collected during 2009-2010, 2016-2023. bBased on 7213 clinical isolates collected during 2009-2023. cBased on 4678 clinical isolates collected during 2009-2011, 2016-2023. dBased on 1038 clinical isolates collected during 2019-2023.

Tetracycline icon

Next-generation tetracyclines
offer broad-spectrum activity against certain pathogens for appropriate patients with ABSSSI or CABP.10

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.11

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. Ho CS, Wong CTH, Aung TT, et al. Antimicrobial resistance: a concise update. Lancet Microbe. 2025;6(1):100947. 2. Review on Antimicrobial Resistance. Tackling drug-resistant infections globally: final report and recommendations. Published May 2016. Accessed September 26, 2025. 3. Burnham JP, Olsen MA, Kollef MH. Re-estimating annual deaths due to multidrug-resistant organism infections. Infect Control Hosp Epidemiol. 2019;40(1):112-113. 4. National Library of Medicine. Antibiotic Sensitivity Test. MedlinePLus. Updated August 21, 2024. Accessed September 26, 2025. https://medlineplus.gov/lab-tests/antibiotic-sensitivity-test/ 5. Rodloff A, Bauer T, Ewig S, Kujath P, Müller E. Susceptible, intermediate, and resistant - the intensity of antibiotic action. Dtsch Arztebl Int. 2008;105(39):657-662. 6. Association for Professionals in Infection Control and Epidemiology. Antimicrobial Stewardship. Accessed September 26, 2025. https://apic.org/professional-practice/practice-resources/antimicrobial-stewardship/ 7. 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. 8. 2009-2023 US Surveillance Data. Data on file. Paratek Pharmaceuticals, Inc. 9. 2020, 2021, and 2022 US Surveillance Data. Data on file. Paratek Pharmaceuticals, Inc. 10. 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. 11. NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc.