Prescribing Information

For US Healthcare Professionals only

Image of ABSSSI Patient 3

ABSSSI patient with post-op cellulitis, treated at home

Actor portrayal.

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Clinically cured* with single course of oral NUZYRA—no hospitalization required1

*Clinical cure at the post-treatment evaluation was defined as survival after completion of study treatment without receiving any other antibacterial therapy or unplanned major surgical intervention, and having sufficient resolution of infection such that further antibacterial therapy is not needed.2

Before & After1

Initial cellulitis presentation

Before image of a patient's foot showing initial cellulitis presentation.

During course of treatment

Image of a patient's foot showing changes during the course of treatment.

Final healed wound

After image of a patient's foot showing the final healed wound.

Patient Overview

68-year-old female with cellulitis surrounding post-surgical wound dehiscence

  • Presented with edema, erythema, and increasing pain at 5 weeks post-op
  • Patient preferred treatment at home

Clinical Course

Day
1

Initiated on oral NUZYRA 450 mg loading dose x 2 days

Day
3

Swelling decreased; continued oral NUZYRA 300 mg once daily. Total treatment duration was 10 days

Day
10

Cellulitis resolved
See additional medical findings

Physical findings1

  • Painful right foot bunion complication (hallux varus deformity) from prior surgery
  • Developed signs of cellulitis with edema, erythema, and increased pain at 5 weeks
  • No drainage
  • No malodor
  • Patient was afebrile

Post-op=post-operation.

Terms of Use: This work is licensed under a Creative Commons Attribution 4.0 International (CC BY 4.0). The photos were taken by Dr. Philip Wrotslavsky.

This case study reflects a real patient experience using NUZYRA. The results presented are consistent with those observed in the OASIS-2 clinical trial in patients with ABSSSI. Individual results may vary.

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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. Wrotslavsky P. Empiric treatment approach for the management of post-operative incisional infections with omadacycline. FASTRAC. 2023;3(1):1-6. 2. NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc.