A MODERNIZED TETRACYCLINE

DESIGNED TO OVERCOME MECHANISMS OF TETRACYCLINE RESISTANCE

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

MRSA

Methicillin-resistant Staphylococcus aureus1

In ABSSSI clinical infections and in vitro

SP

Streptococcus pneumoniae1-3

In CABP clinical infections and in vitro

  • Macrolide resistant
  • Penicillin resistant
  • Tetracycline resistant

VRE*

Vancomycin-resistant Enterococcus faecium1

In vitro only

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

Once-daily dosing in the hospital or at home

Available in once-daily IV and oral formulations1

Similar drug exposure in the IV (100 mg) and oral (300 mg) single doses1

No dosage adjustment required for renal or hepatic impairment1

May help in patients with treatment complexities

NO CLINICALLY RELEVANT QTc PROLONGATION OBSERVED1


LIMITED DRUG-DRUG INTERACTIONS1

NUZYRA is not expected to interact with drugs metabolized by cytochrome P450 enzymes

  • Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage

  • Absorption of oral tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations


Tetracyclines are associated with a lower risk of C difficile4

  • No cases of Clostridium difficile reported throughout the completed clinical program (N=1947)2

  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents1

  • Evaluate if diarrhea occurs1



No clinically relevant QTc prolongation observed1


LIMITED DRUG-DRUG INTERACTIONS1

NUZYRA is not expected to interact with drugs metabolized by cytochrome P450 enzymes

  • Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage

  • Absorption of oral tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations


Tetracyclines are associated with a lower risk of C difficile4

  • No cases of Clostridium difficile reported throughout the completed clinical program (N=1947)2

  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents1

  • Evaluate if diarrhea occurs1

INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS
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.

Clostridium 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 of 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.

To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for NUZYRA.

References:

  1. 1. NUZYRA [Prescribing Information]. Boston, MA: Paratek Pharmaceuticals, Inc.

  2. 2. Data on file. Paratek Pharmaceuticals, Inc, Boston, MA.

  3. 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. 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.