Nuzyra

Warnings and Precautions, Tetracycline Class Effects (

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) (
  
  1.1 Community-Acquired Bacterial Pneumonia (CABP)

  NUZYRA is indicated for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms:

  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) (
  
  1.2 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

  NUZYRA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms:

  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.
  )
  

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. (

• Dosage of NUZYRA in CABP and ABSSSI Adult Patients (
  

  2.2 Dosage in Adults with Community-Acquired Bacterial Pneumonia (CABP)

  For treatment of adults with CABP the recommended dosage regimen (loading and maintenance) of NUZYRA is described in

  Table 1

  below.

  Table 1: Dosage of NUZYRA in Adult CABP Patients

  Loading Doses	Maintenance Dose	Treatment Duration
  NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1. OR	NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily.	7 to 14 Days
  NUZYRA Tablets: 300 mg orally twice on day 1.

  ,
  

  2.3 Dosage in Adults with Acute Bacterial Skin Structure and Skin Infections (ABSSSI)

  For treatment of adults with ABSSSI, the recommended dosage regimen (loading and maintenance) of NUZYRA is described in Table 2 below.

  Table 2: Dosage of NUZYRA in Adult ABSSSI Patients

  Loading Doses	Maintenance Dose	Treatment Duration
  NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1. OR	NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily.	7 to 14 Days
  NUZYRA Tablets: 450 mg orally once a day on day 1 and day 2.

  ):
  

• CABP and ABSSSI
  : Treatment duration is 7 to 14 days. (
  
  2.2 Dosage in Adults with Community-Acquired Bacterial Pneumonia (CABP)

  For treatment of adults with CABP the recommended dosage regimen (loading and maintenance) of NUZYRA is described in

  Table 1

  below.

  Table 1: Dosage of NUZYRA in Adult CABP Patients

  Loading Doses	Maintenance Dose	Treatment Duration
  NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1. OR	NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily.	7 to 14 Days
  NUZYRA Tablets: 300 mg orally twice on day 1.
  ,
  
  2.3 Dosage in Adults with Acute Bacterial Skin Structure and Skin Infections (ABSSSI)

  For treatment of adults with ABSSSI, the recommended dosage regimen (loading and maintenance) of NUZYRA is described in Table 2 below.

  Table 2: Dosage of NUZYRA in Adult ABSSSI Patients

  Loading Doses	Maintenance Dose	Treatment Duration
  NUZYRA Injection: 200 mg by intravenous infusion over 60 minutes on day 1. OR 100 mg by intravenous infusion over 30 minutes, twice on day 1. OR	NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily. OR NUZYRA Tablets: 300 mg orally once daily.	7 to 14 Days
  NUZYRA Tablets: 450 mg orally once a day on day 1 and day 2.
  )
  
• 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. (
  
  2.1 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

  [see Drug Interactions (7.2)]

  . Co-infusion with other medications has not been studied

  [see Dosage and Administration (2.5)]

  .

  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

  [see Drug Interactions (7.2)and Clinical Pharmacology (12.3)].
  )
  
• See full prescribing information for the preparation of NUZYRA IV and other administration instructions. (
  
  2.1 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

  [see Drug Interactions (7.2)]

  . Co-infusion with other medications has not been studied

  [see Dosage and Administration (2.5)]

  .

  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

  [see Drug Interactions (7.2)and Clinical Pharmacology (12.3)].
  ,
  
  2.5 Preparation and Administration of NUZYRA for Injection Intravenous Solution

  Reconstitution and Dilution

  :

  • 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.
  • 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.
  • Gently swirl the contents and let the vial stand until the cake has completely dissolved and any foam disperses. Do not shake the vial.
  • 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.
  • 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.
  • 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 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 Solution

  The NUZYRA diluted infusion solution may be used within 24 hours at room temperature (less than or equal to 25°C) or within 7 days when refrigerated (2°C to 8°C). Do not freeze. Allow the infusion bag to reach room temperature prior to use.

  Administration

  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

  [see Dosage and Administration (2.2, 2.3)]

  .

  Administer NUZYRA intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, before and after infusion of NUZYRA. 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.
  )
  

• For Injection
  : 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate) as a lyophilized powder in a single dose vial for reconstitution and further dilution before intravenous infusion (
  
  
  3.1 NUZYRA for Injection

  Each single-dose vial contains 100 mg omadacycline (equivalent to 131 mg omadacycline tosylate) which must be reconstituted and further diluted prior to intravenous infusion. The lyophilized powder is a yellow to dark orange cake.
  )
  
• Tablets
  : 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate) (
  
  
  3.2 NUZYRA Tablets

  Each tablet contains 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate) in yellow, diamond-shaped, film-coated tablets debossed with OMC on one side and 150 on the other side.
  )