Omadacycline

NUZYRA 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). Acute bacterial skin and skin structure infections (ABSSSI). 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 bacteria.

NUZYRA is an antibacterial drug.

Recommended Dosage of NUZYRA in CABP and ABSSSI Adult Patients: Infection Loading Doses Maintenance Dose CABP NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice. OR NUZYRA Tablets: Day 1: 300 mg orally twice. NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily. ABSSSI NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice. OR NUZYRA Tablets: Day 1 and Day 2: 450 mg orally once daily. CABP and ABSSSI: Treatment duration is 7 to 14 days. Fast for at least 4 hours and then take NUZYRA tablets with water. After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours.

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

Tooth Discoloration and Enamel Hypoplasia: 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. Inhibition of Bone Growth: 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. Clostridioides difficile -Associated Diarrhea: Evaluate if diarrhea occurs.

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Tooth Development and Enamel Hypoplasia Inhibition of Bone Growth Hypersensitivity Reactions Tetracycline Class Effects ABSSSI: The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea. CABP: The most common adverse reactions (incidence ≥2%) are alanine aminotransferase increased, headache, hypertension, and aspartate aminotransferase increased.

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.

NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze.