Prescribing Information

For US Healthcare Professionals only

Appropriate Patients

Comorbidities impacting antibiotic choice for ABSSSI or CABP?

Consider NUZYRA for appropriate patients with ABSSSI or CABP, including those with certain comorbidities

Renal insufficiency

Accordion trigger

No dosing adjustment required. Renal insufficiency does not impact NUZYRA elimination.1,2

Allergies to certain antibiotics

Accordion trigger

NUZYRA may be an alternative antibiotic treatment for patients with beta-lactam, fluoroquinolone, or sulfonamide hypersensitivities.3,4

Diabetes

Accordion trigger

NUZYRA maintains safety and tolerability in diabetic patients regardless of their body weight.4,5

QTc prolongation risk

Accordion trigger

No clinically relevant QTc prolongation was observed in clinical studies with NUZYRA.1

COPD and asthma (mild to moderate)

Accordion trigger

NUZYRA is an option for patients with CABP and mild-to-moderate COPD and asthma.6

Clinical studies excluded patients with unstable cardiovascular disease, clinically significant liver or renal insufficiency, or severe COPD.7

COPD=chronic obstructive pulmonary disease.

Your patients with ABSSSI or CABP and certain comorbidities may benefit from these NUZYRA attributes

NO DOSING ADJUSTMENT REQUIRED1

  • In patients with impaired hepatic or renal function, including those on hemodialysis

Alternative for patients with certain allergies1

  • NUZYRA may be an antibiotic treatment option for appropriate patients with beta-lactam, fluoroquinolone, or sulfonamide hypersensitivities

Limited drug-drug interactions1

  • NUZYRA is not expected to interact with drugs metabolized by cytochrome P450 enzymes
  • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA
  • Absorption of oral tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron-containing preparations

No clinically relevant QT interval (QTc) prolongation observed1

High volume of tissue distribution in lung (CABP patients) including high penetration into ELF (1.5x plasma)1

Low (~20%) plasma protein binding, which is not concentration dependent

ELF=epithelial lining fluid.

No cases of C. Difficile reported in the NUZYRA clinical trials8

  • Tetracyclines are associated with a lower risk of C. difficile9
  • C. difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents1
  • Evaluate if diarrhea occurs1
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. UpToDate®. Community-acquired pneumonia: Empiric outpatient antibiotic selection in adults. Accessed November 13, 2024. https://www.uptodate.com/contents/overview-of-community-acquired-pneumonia-in-adults#H1488131322 3. UpToDate®. Methicillin-resistant Staphylococcus aureus (MRSA) in adults: Treatment of skin and soft tissue infections. Accessed November 13, 2024. https://www.uptodate.com/contents/methicillin-resistant-staphylococcus-aureus-mrsa-in-adults-treatment-of-skin-and-soft-tissue-infections 4. Pai MP, Wilcox M, Chitra S, McGovern P. Safety and efficacy of omadacycline by body mass index in patients with community-acquired bacterial pneumonia: subanalysis from a randomized controlled trial. Respir Med. 2021;184:106442. 5. Pai MP, Wilcox MH, Chitra S, McGovern PC. Safety and efficacy of omadacycline by BMI categories and diabetes history in two phase III randomized studies of patients with acute bacterial skin and skin structure infections. J Antimicrob Chemother. 2021;76(5):1315-1322. 6. Torres A, Garrity-Ryan L, Kirsch C, et al. Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia. Int J Infect Dis. 2021;104:501-509. 7. Stets R, Popescu M, Gonong JR, et al. Omadacycline for community-acquired bacterial pneumonia. N Engl J Med. 2019;380(6):517-527. 8. Data on file. Paratek Pharmaceuticals, Inc. 9. Brown KA, Khanafer N, Daneman N, Fisman DN. Meta-analysis of antibiotics and the risk of community-associated Clostridium difficile infection. Antimicrob Agents Chemother. 2013;57(5):2326-2332.