Prescribing Information

For US Healthcare Professionals only

Dosing and administration

Once-daily* dosing in ABSSSI and CABP1

NUZYRA offers the flexibility of oral and IV dosing options1

*For treatment of CABP, the oral loading dose is 300 mg twice on Day 1.1

Oral Dosing

Treatment duration (ABSSSI and CABP): 7 to 14 days1

When prescribing oral NUZYRA, instruct patients to1:

Fast for at least 4 hours icon

Fast for at least 4 hours

and then take with water at bedtime or upon waking

Don't eat or drink for at least 4 hours icon

Not eat or drink

(except water) for 2 hours after taking NUZYRA

Do not consume for at least 4 hours icon

Not consume

dairy products, antacids, or multivitamins for 4 hours after taking NUZYRA

Warning icon

Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking either oral or IV NUZYRA.

IV Dosing for ABSSSI and CABP

Treatment duration: 7 to 14 days1

DAY 1: Loading Dose
200 mg by IV infusion over 60 minutes OR 100 mg by IV infusion over 30 minutes TWICE

Once-Daily Maintenance Dose
100 mg by IV infusion over 30 minutes

Image of Nuzyra vial enlarged

Vial is not shown at actual size.

When prescribing IV NUZYRA:

  • Do NOT administer with any solution containing multivalent cations (eg, calcium and magnesium) through the same intravenous line1
  • NUZYRA must be reconstituted with Sterile Water and then further diluted for Injection under aseptic conditions as follows: 2 vials (200 mg) to 2 mg/mL, and 1 vial (100 mg) to 1 mg/mL1
  • The compatibility of NUZYRA with other drugs and infusion solutions other than 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, has not been established1
  • Alternative IV loading dose: 100 mg over 30 minutes, twice on Day 11
  • Alternative oral maintenance dose: 300 mg (2 tablets) once daily1
  • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking either oral or IV NUZYRA1
  • For additional dosing information, please see full Prescribing Information, including Tables 1 and 2
How to order NUZYRA for your hospital

NUZYRA IV Preparation1

Reconstitution and dilution: Preparation of NUZYRA IV Infusion1

NUZYRA FOR INJECTION DOSE 200 mg 100 mg
Number of vials to reconstitute for further dilution 2 vials 1 vial
Volume of reconstituted solution (5 ml/vial) to withdraw for further dilution 10 mL 5 mL
Final infusion concentration of NUZYRA IV 2 mg/mL 1 mg/mL

NUZYRA Storage and Handling

Storage and handling1

  • NUZYRA for injection and NUZYRA tablets should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F)
  • Do not freeze

Storage of the diluted infusion solution1

  • If at room temperature (≤25°C [77°F]), use within 24 hours
  • If refrigerated (2°C to 8°C [35.6°F to 46.4°F]), use within 7 days
  • Do not freeze

Administration instructions (after reconstitution and dilution)1

  • After reconstitution and dilution, administer NUZYRA by intravenous infusion, using a total infusion time of 60 minutes for a 200-mg dose, or a total infusion time of 30 minutes for a 100-mg dose
  • Administer through a dedicated line or through a Y-site
    • If the same intravenous line is used for sequential infusion of several drugs, flush the line before and after NUZYRA IV infusion with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP
    • The compatibility of NUZYRA IV with other drugs and infusion solutions other than 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, has not been established

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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.

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