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Nuzyra (omadacycline)

A modernized tetracycline designed to overcome mechanisms of tetracycline resistance.

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Paratek Pharmaceuticals

Paratek Pharmaceuticals

Positive outcomes. Positive patient stories. These are our priorities at Paratek Pharmaceuticals. We develop transformative solutions for patients with infectious diseases and other difficult to treat conditions, and we believe that with the right people, the right knowledge and the right drug, we can make a difference in patients’ lives.

617-807-6600

100 mg injection, 150 mg tablets, once daily dosing in hospital or at home. No dosage adjustment required for renal or hepatic impairment1

Reference
1.     NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc.

NUZYRA was designed to overcome the most common mechanisms of tetracycline resistance1:

  • Active efflux pumps
  • Ribosomal protection proteins

Clinical and in vitro activity against select1:

  • Gram-positives
  • Gram-negatives
  • Atypicals
  • Drug-resistant strains

Methicillin-resistant Staphylococcus aureus1

In ABSSSI clinical infections and in vitro

Streptococcus pneumoniae1-3

In CABP clinical infections and in vitro

  • Macrolide resistant
  • Penicillin resistant
  • Tetracycline resistant

Vancomycin-resistant Enterococcus faecium1

In vitro only

*The safety and effectiveness of NUZYRA in treating clinical infections due to this microorganism have not been established.1
References
1.     NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc.
2.     Data on file. Paratek Pharmaceuticals, Inc.
3.     Pfaller MA, Huband MD, Shortridge D, Flamm RK. Surveillance of omadacycline activity tested against clinical isolates from the United States and Europe as part of the 2016 SENTRY Antimicrobial Surveillance program. Antimicrob Agents Chemother. 2018;62(4):e02327-17.
4.     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.

NUZYRA is indicated for treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) in adults caused by select susceptible microorganisms. 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.

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

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, 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.

omadacycline

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.

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