Prescribing Information

For US Healthcare Professionals only

Microbiologic Data

NUZYRA offers broad-spectrum activity

See in vitro activity in a wide range of pathogens1,2

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

CLSI=Clinical and Laboratory Standards Institute; ESBL=extended spectrum beta-lactamase; FDA=Food and Drug Administration; MIC=minimal inhibitory concentration; R=resistant; S=susceptible.

aCriteria as published by CLSI (2023) and US FDA (2023). bUsing FDA ABSSSI breakpoints. cUsing FDA CABP breakpoints. dCriteria as published by CLSI (2023). eUS isolates, collection dates not available. fClinical isolates, 1995-2014. gCriteria as published by CLSI (2011). hUS and Chinese reference strains and clinical isolates, 2016.

NUZYRA reaches high concentrations in the lungs1

Mean (± SD) concentrations of NUZYRA in AC, ELF, and plasma

Mean concentrations of NUZYRA in AC, ELF, and plasma shown relative to time.
Image showcasing NUZYRA’s concentration rates in plasma, epithelial lining fluid, and alveolar cells

SD=standard deviation.

High concentrations of NUZYRA were observed in the alveolar cells (AC) and epithelial lining fluid (ELF), as compared to plasma, following multiple 100-mg IV doses of NUZYRA to healthy adults during bronchoscopy sampling times.1

Early and sustained clinical response with NUZYRA1

See efficacy data
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. 2020, 2021, and 2022 US Surveillance Data. Data on file. Paratek Pharmaceuticals, Inc. 3. Kohlhoff SA, Huerta N, Hammerschlag MR. In vitro activity of omadacycline against Chlamydia pneumoniae. Antimicrob Agents Chemother. 2019;63(2):e01907-e01918. 4. Dubois J, Dubois M, Martel JF. In vitro and intracellular activities of omadacycline against Legionella pneumophila. Antimicrob Agents Chemother. 2020;64(5):e01972-19. 5. Waites KB, Crabb DM, Liu Y, Duffy LB. In vitro activities of omadacycline (PTK 0796) and other antimicrobial agents against human mycoplasmas and ureaplasmas. Antimicrob Agents Chemother. 2016;60(12):7502-7504.