NUZYRA (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

NUZYRA for Injection

NUZYRA for Injection is supplied as a sterile lyophilized powder in a single-dose colorless glass vial, with each vial containing 100 mg of NUZYRA (equivalent to 131 mg omadacycline tosylate).

They are supplied as follows: 100-mg single-dose vial (NDC 71715-001-02), packaged in cartons of 10.

NUZYRA Tablets

NUZYRA Tablets 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.

They are supplied as follows:

Blister package of 6 (NDC 71715-002-21)

Blister package of 30 (5 blister cards of 6 tablets each) NDC 71715-002-27

16.2 Storage and Handling

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.

17 PATIENT COUNSELING INFORMATION

Nausea and Vomiting

Advise patients that nausea and vomiting can be an adverse reaction to NUZYRA. Advise patients that a greater proportion of patients who received the oral loading dose of NUZYRA for treatment of ABSSSI experienced nausea and vomiting.

Allergic Reactions

Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious allergic reactions require immediate treatment. Ask the patient about any previous hypersensitivity reactions to NUZYRA, or other tetracycline class antibacterials [see Warnings and Precautions (5.4)].

Administration with Food

Instruct patients to fast 4 hours before and 2 hours after taking NUZYRA tablets and not to consume dairy products, antacids, or multivitamins for 4 hours after taking NUZYRA tablets [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].

Tooth Discoloration and Inhibition of Bone Growth

Advise patients that NUZYRA, like other tetracycline-class drugs, may cause permanent tooth discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tell your healthcare provider right away if you become pregnant during treatment [see Warnings and Precautions (5.1, 5.2) and Use in Specific Populations (8.1, 8.4)].

Lactation

Advise women not to breastfeed during treatment with NUZYRA and for 4 days after the last dose [see Use in Specific Populations (8.2)]

Diarrhea

Advise patients that diarrhea is a common problem caused by antibacterial drugs, including NUZYRA, which usually ends when the antibacterial drugs is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery or bloody stools (with or without stomach cramps and fever). If this occurs, patients should contact their physician as soon as possible.

Tetracycline Class Adverse Reactions

Inform patients that NUZYRA is similar to tetracycline-class antibacterial drugs and may have similar adverse reactions [see Warnings and Precautions (5.6)].

Antibacterial Resistance

Advise patients that antibacterial drugs including NUZYRA should only be used to treat bacterial infections. They do not treat viral infections (e.g. , the common cold). When NUZYRA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by NUZYRA or other antibacterial drugs in the future.

Distributed by:

Paratek Pharmaceuticals, Inc.
Boston, MA, USA

PARATEK® and the hexagon logo are registered trademarks of Paratek Pharmaceuticals, Inc.
NUZYRA® and its design logo are registered trademarks of Paratek Pharmaceuticals, Inc.
For patent information: www.paratekpharma.com/products/patent.
© 2021 Paratek Pharmaceuticals, Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL — 10 Vial Carton

NDC 71715-001-02
Contains 10 of NDC 71715-001-01

RX ONLY

NUZYRA®
(omadacycline)
for injection

100 mg per single-dose vial.
Must be reconstituted
and further diluted.For intravenous infusion only.

100 mg

Contains 10 vials

PRINCIPAL DISPLAY PANEL -- 10 Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6 Tablet Blister Pack Carton

NDC 71715-002-21
RX ONLY

once-daily
NUZYRA®
(omadacycline)150 mg tablets

Contains 6 tablets

PRINCIPAL DISPLAY PANEL -- 6 Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 30 Tablet Blister Pack Carton

NDC 71715-002-27
RX ONLY

once-daily
NUZYRA®
(omadacycline)
150 mg tablets

Contains 30 tablets(5 blister cards of 6 tablets each)

PRINCIPAL DISPLAY PANEL -- 30 Tablet Blister Pack Carton
(click image for full-size original)
NUZYRA omadacycline injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71715-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
omadacycline (omadacycline) omadacycline 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sucrose
Hydrochloric Acid
Sodium Hydroxide
Water
Product Characteristics
Color YELLOW (Yellow to Dark Orange) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71715-001-02 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (71715-001-01)
1 NDC:71715-001-01 10 mL in 1 VIAL, GLASS This package is contained within the CARTON (71715-001-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209817 02/01/2019
NUZYRA omadacycline tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71715-002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
omadacycline (omadacycline) omadacycline 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
GLYCERYL MONOCAPRYLOCAPRATE
FERRIC OXIDE YELLOW
Lactose monohydrate
Microcrystalline cellulose
POLYVINYL ALCOHOL, UNSPECIFIED
Sodium bisulfite
Sodium lauryl sulfate
Sodium stearyl fumarate
Talc
Titanium dioxide
Product Characteristics
Color YELLOW Score no score
Shape DIAMOND Size 19mm
Flavor Imprint Code OMC;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71715-002-24 16 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:71715-002-23 14 TABLET, FILM COATED in 1 BLISTER PACK None
3 NDC:71715-002-21 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK (71715-002-28)
3 NDC:71715-002-28 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (71715-002-21)
4 NDC:71715-002-27 5 BLISTER PACK in 1 CARTON contains a BLISTER PACK (71715-002-28)
4 NDC:71715-002-28 6 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (71715-002-27)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209816 02/01/2019
Labeler — Paratek Pharmaceuticals, Inc. (076333934)
Establishment
Name Address ID/FEI Operations
CIPAN 449040773 API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Carbogen Amcis AG (Carbogen) 481385565 API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Carbogen Amcis AG (Carbogen NE) 480029695 ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Conframa France (Confarma) 492738125 ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Solvias AG (Solvias) 480739627 ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Finorga (Novasep) 276669694 API MANUFACTURE (71715-001), API MANUFACTURE (71715-002), ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Alcami Carolinas Corporation (Alcami) 831351445 ANALYSIS (71715-001), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Almac Pharma Services Limited (Almac) 233170864 MANUFACTURE (71715-002), ANALYSIS (71715-002)
Establishment
Name Address ID/FEI Operations
Patheon Italia S.p.A. (Patheon) 434078638 MANUFACTURE (71715-001), ANALYSIS (71715-001)
Establishment
Name Address ID/FEI Operations
Almac Pharma Services LLC (Almac Audubon) 078607239 PACK (71715-001), PACK (71715-002)
Establishment
Name Address ID/FEI Operations
Sharp Corporation (Sharp) 143696495 PACK (71715-001), PACK (71715-002)
Establishment
Name Address ID/FEI Operations
Sharp Corporation (Sharp) 002346625 PACK (71715-002)

Revised: 06/2021 Paratek Pharmaceuticals, Inc.

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