NUZYRA

NUZYRA- omadacycline injection, powder, lyophilized, for solution
NUZYRA- omadacycline tablet, film coated
Paratek Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

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.

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.

1.3 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. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

2 DOSAGE AND ADMINISTRATION

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)].

2.2 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.ORNUZYRA 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.ORNUZYRA Tablets:300 mg orally once daily. 7 to 14 Days
NUZYRA Tablets:450 mg orally once a day on day 1 and day 2.

2.4 Dosage Adjustments in Patients with Renal or Hepatic Impairment

No dosage adjustment is warranted in patients with renal or hepatic impairment [see Clinical Pharmacology (12.3)].

2.5 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 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.

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