NUZYRA Film-coated tablet Ref.[10362] Active ingredients: Omadacycline

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 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:

2.3 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:

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:

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.

No specific information is available on the treatment of overdosage with NUZYRA. Following a 100 mg single dose intravenous administration of omadacycline, 8.9% of dose is recovered in the dialysate.

NUZYRA for Injection and NUZYRA Tablets should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] [see Dosage and Administration (2.5)]. Do not freeze.