For US Healthcare Professionals only
PRESCRIBINGINFORMATION REQUEST
SAMPLES
NUZYRA is indicated for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in adults caused by select susceptible microorganisms.
IV ADMINISTRATION
IV PREPARATION
PREPARATION1
- NUZYRA® (omadacycline) must be reconstituted and then further diluted under aseptic conditions. Reconstitute and dilute the appropriate number of vials as determined from the table below.
- Reconstitute each 100 mg vial with 5 mL of Sterile Water, 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for Injection.
- Gently swirl contents and let vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial.
- If the NUZYRA solution is not yellow to dark orange, the reconstituted solution should be discarded. Prior to further dilution and administration, inspect for particulate matter and discoloration. If necessary, invert vial to dissolve any remaining powder and swirl gently to prevent foaming.
- Immediately (within 1 hour), withdraw 5 or 10 mL of reconstituted solution and further dilute to a 100 mL (nominal volume) of 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, bag for injection. The concentration of the final diluted infusion will either be 1 mg/mL or 2 mg/mL, as per the table below. Discard any unused portion of reconstituted solution.
- As with all parenteral drug products, whenever solution and container permit, inspect visually for particulate matter and discoloration prior to administration.
RECONSTITUTION AND DILUTION1
| PREPARATION OF NUZYRA IV INFUSION | |||
| NUZYRA FOR INJECTION DOSE | NUMBER OF VIALS TO RECONSTITUTE FOR FURTHER DILUTION | VOLUME OF RECONSTITUTED SOLUTION (5 mL/VIAL) TO WITHDRAW FOR FURTHER DILUTION | FINAL INFUSION CONCENTRATION OF NUZYRA |
200 mg |
2 Vials |
10 mL |
2 mg/mL |
100 mg |
1 Vial |
5 mL |
1 mg/mL |
STORAGE OF THE DILUTED INFUSION SOLUTION1
- If at room temperature (≤25°C), use within 24 hours
- If refrigerated (2°C to 8°C), use within 7 days
- Do not freeze
INFUSION INSTRUCTIONS (AFTER RECONSTITUTION AND DILUTION)1
- Loading Dose: Use a total intravenous infusion time of 60 minutes for a 200 mg dose
- Note: There is an alternative IV loading dose for CABP and ABSSSI of 100 mg to be administered twice on Day 1 over a period of 30 minutes
- Once-Daily Maintenance Dose: Use a total intravenous 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 infusion, with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP
- 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 established
STORAGE AND HANDLING1
- NUZYRA for Injection and NUZYRA Tablets should be stored 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
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INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONSNUZYRA® (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, 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:
- NUZYRA [Prescribing Information]. Paratek Pharmaceuticals, Inc.