What is Nuzyra, and how does it work?

Nuzyra (omadacycline) is a tetracycline class antibiotic indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:

  • Community-acquired bacterial pneumonia (CABP) and
  • acute bacterial skin and skin structure infections (ABSSSI).

What are the side effects of Nuzyra?

Common side effects of Nuzyra include:

What is the dosage for Nuzyra?

Important Administration Instructions

Nuzyra For Injection
  • Do NOT administer Nuzyra for injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous line. Co-infusion with other medications has not been studied.
Nuzyra Tablets
  • Fast for at least 4 hours and then take 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.

Dosage In Adults With Community-Acquired Bacterial Pneumonia (CABP)

  • For treatment of adults with CABP the recommended dosage regimen of Nuzyra is described in Table 1 below. Use Nuzyra for injection administered by intravenous infusion for the loading dose in CABP patients.

Table 1: Dosage of Nuzyra in Adult CABP Patients

Loading DosesMaintenance DoseTreatment Duration
200 mg by intravenous infusion over 60 minutes on day 1. Or 100 mg by intravenous infusion over 30 minutes, twice on day 1.100 mg by intravenous infusion over 30 minutes once daily. Or 300 mg orally once daily.7 to 14 Days

Dosage In Adults With Acute Bacterial Skin Structure And Skin Infections (ABSSSI)

  • For treatment of adults with ABSSSI, the recommended dosage regimen of Nuzyra is described in Table 2 below.
  • Use Nuzyra for injection administered by intravenous infusion or Nuzyra tablets orally administered for the loading dose in ABSSSI patients.

Table 2: Dosage of Nuzyra in Adult ABSSSI Patients

Loading DosesMaintenance DoseTreatment Duration
200 mg by intravenous infusion over 60 minutes on day 1. Or 100 mg by intravenous infusion over 30 minutes, twice on day 1.100 mg by intravenous infusion over 30 minutes once daily. Or 300 mg orally once daily.7 to 14 Days
450 mg orally once a day on day 1 and day 2.300 mg orally once daily.

Dosage Adjustments In Patients With Renal Or Hepatic Impairment

  • No dosage adjustment is warranted in patients with renal or hepatic impairment.

Preparation And Administration Of Nuzyra For Injection Intravenous Solution

Reconstitution And Dilution
  1. Nuzyra must be reconstituted and then further diluted under aseptic conditions. To prepare the required dose for intravenous infusion, reconstitute and dilute the appropriate number of vials, as determined from Table 3 below.
  2. Reconstitute each 100 mg vial of Nuzyra with 5 mL of Sterile Water, 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, for Injection.
  3. Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial.
  4. The reconstituted Nuzyra solution should be yellow to dark orange in color; if not, the solution should be discarded. Visually inspect the reconstituted Nuzyra solution for particulate matter and discoloration prior to further dilution and administration. If necessary, invert the vial to dissolve any remaining powder and swirl gently to prevent foaming.
  5. Immediately (within 1 hour), withdraw 5 mL or 10 ml of the 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 solution will either be 1 mg/mL or 2 mg/mL in accordance with Table 3 below. Discard any unused portion of the reconstituted solution.
  6. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Table 3: Preparation of Nuzyra Intravenous Infusion

Nuzyra for Injection DoseNumber of Vials to Reconstitute for Further DilutionVolume of Reconstituted Solution (5 mL/vial) to Withdraw for Further DilutionFinal Infusion Concentration of Nuzyra
200 mg2 Vials10 mL2 mg/mL
100 mg1 Vial5 mL1 mg/mL

 

What drugs interact with Nuzyra?

Anticoagulant Drugs

  • Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking Nuzyra.

Antacids And Iron Preparations

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

Is Nuzyra safe to use while pregnant or breastfeeding?

  • Nuzyra, like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy.
  • There is no information on the presence of omadacycline in human milk, the effects on the breastfed infant or the effects on milk production.
  • Tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including omadacycline, by the breastfed infant is not known.
  • Because there are other antibacterial drug options available to treat CABP and ABSSSI in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with Nuzyra and for 4 days (based on half-life) after the last dose.

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Summary

Nuzyra (omadacycline) is a tetracycline class antibiotic indicated for the treatment of adult patients with the infections caused by susceptible microorganisms, including community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

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Medically Reviewed on 10/14/2020
References
All sections courtesy of the U.S. Food and Drug Administration