Nuzyra

Q: Who makes Nuzyra?

Nuzyra is listed by 1 labeler in the FDA NDC directory, including Paratek Pharmaceuticals, Inc..

omadacycline · Injection, Powder, Lyophilized, For Solution · Intravenous, Oral

Prescription (Rx) Tetracycline-class Antibacterial

Uses

1 INDICATIONS AND USAGE NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms ( 1 ): Community-acquired bacterial pneumonia (CABP) ( 1.1 ) Acute bacterial skin and skin structure infections (ABSSSI) ( 1.2 ) 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 bacteria. ( 1.3 ) 1.1 Community-Acquired Bacterial Pneumonia 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 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.

Dosage and administration

Recommended Dosage of NUZYRA in CABP and ABSSSI Adult Patients ( 2.2 , 2.3 ): Infection Loading Doses Maintenance Dose CABP NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.2 ) OR NUZYRA Tablets: Day 1: 300 mg orally twice ( 2.2 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.2 ) ABSSSI NUZYRA Injection: Day 1: 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice ( 2.3 ) OR NUZYRA Tablets: Day 1 and Day 2: 450 mg orally once daily ( 2.3 ) NUZYRA Injection: 100 mg by intravenous infusion over 30 minutes once daily OR NUZYRA Tablets: 300 mg orally once daily ( 2.3 ) CABP and ABSSSI : Treatment duration is 7 to 14 days. ( 2.2 , 2.3 ) 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 ) See full prescribing information for the preparation of NUZYRA IV and other administration instructions. ( 2.1 , 2.5 ) 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 Recommended 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: Recommended 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 Recommended 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: Recommended 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. 2.4 Recommended 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 : 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.

Dosage forms and strengths

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 ) Tablets : 150 mg omadacycline (equivalent to 196 mg omadacycline tosylate) ( 3.2 ) 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. 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.

Contraindications

4 CONTRAINDICATIONS NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients [see Warnings andPrecautions (5.3) and Adverse Reactions (6.1) ]. Known hypersensitivity to omadacycline, tetracycline class antibacterial drugs or any of the excipients in NUZYRA ( 4 )

Warnings and precautions

Tooth Discoloration and Enamel Hypoplasia : The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. ( 5.1 , 8.1 , 8.4 ) Inhibition of Bone Growth: The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. ( 5.2 , 8.1 , 8.4 ) Clostridioides difficile -Associated Diarrhea : Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Tooth Discoloration and Enamel Hypoplasia The use of NUZYRA during tooth development (last half of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the tetracycline class drugs, but it has been observed following repeated short-term courses. Enamel hypoplasia has also been reported with tetracycline class drugs. Advise the patient of the potential risk to the fetus if NUZYRA is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ]. 5.2 Inhibition of Bone Growth The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Advise the patient of the potential risk to the fetus if NUZYRA is used during the second or third trimester of pregnancy [see Use in Specific Populations (8.1 , 8.4) ] . 5.3 Hypersensitivity Reactions Hypersensitivity reactions have been reported with NUZYRA [see Adverse Reactions (6.1) ]. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline class antibacterial drugs. NUZYRA is structurally similar to other tetracycline class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline class antibacterial drugs [see Contraindications (4) ] . Discontinue NUZYRA if an allergic reaction occurs. 5.4 Clostridioides difficile- Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.5 Tetracycline Class Effects NUZYRA is structurally similar to tetracycline class of antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, fixed drug eruption, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected. 5.6 Development of Drug-Resistant Bacteria Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage (1.3) ].

Side effects

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Tooth Development and Enamel Hypoplasia [see Warnings and Precautions (5.1) ] Inhibition of Bone Growth [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Tetracycline Class Effects [see Warnings and Precautions ( 5.5 )] ABSSSI: The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, headache and diarrhea. CABP : The most common adverse reactions (incidence ≥2%) are alanine aminotransferase increased, headache, hypertension, and aspartate aminotransferase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overview of the Safety Evaluation of NUZYRA NUZYRA was evaluated in three Phase 3 pivotal clinical trials (Trial 1, Trial 2 and Trial 3) and one Phase 3 postmarketing clinical trial (Trial 4). These trials included one pivotal Phase 3 trial in CABP patients (Trial 1), one Phase 3 postmarketing trial in CABP patients (Trial 4), and two pivotal Phase 3 trials in ABSSSI patients (Trial 2 and Trial 3). Across all Phase 3 trials, a total of 1409 patients were treated with NUZYRA. In Trials 2 and 3, 691 patients with ABSSSI received NUZYRA, of which 368 patients were treated with only oral NUZYRA. In Trials 1 and 4, 718 patients with CABP were treated with NUZYRA. Clinical Trial Experience in Patients with Community-Acquired Bacterial Pneumonia Trial 1 was a Phase 3 CABP trial that enrolled 774 adult patients, 386 randomized to NUZYRA (382 received at least one dose of NUZYRA and 4 patients did not receive the study drug) and 388 randomized to moxifloxacin (all 388 received at least one dose of moxifloxacin). The mean age of patients treated with NUZYRA was 61 years (range 19 to 97 years) and 42% were greater than or equal to 65 years of age. Overall, patients treated with NUZYRA were predominantly male (53.7%), white (92.4%), and had a mean body mass index (BMI) of 27.3 kg/m 2 . Approximately 47% of NUZYRA treated patients had CrCl <90 ml/min. Patients were administered an IV to oral switch dosage regimen of NUZYRA. The total treatment duration was 7 to 14 days. Mean duration of IV treatment was 5.7 days and mean total duration of treatment was 9.6 days in both treatment arms. Trial 4 was a Phase 3 CABP trial that enrolled 670 adult patients, 336 randomized to NUZYRA (all 336 received at least one dose of NUZYRA) and 334 randomized to moxifloxacin (332 received at least one dose of moxifloxacin and 2 patients did not receive the study drug). The mean age of patients treated with NUZYRA was 63.3 years (range 23 to 96 years) and 47.6% were greater than or equal to 65 years of age. Overall, patients treated with NUZYRA were predominantly male (53.0%), white (99.7%), and had a mean body mass index (BMI) of 27.0 kg/m 2 . Approximately 54% of NUZYRA treated patients had CrCl <90 ml/min. Patients were administered an IV to oral switch dosage regimen of NUZYRA. The total treatment duration was 7 to 10 days with up to 14 days allowed for patients with positive blood cultures at the Screening visit. Mean duration of IV treatment was 6.6 days and mean total duration of treatment was 9.0 days in both treatment arms. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1, a total of 23/382 (6.0%) patients treated with NUZYRA and 26/388 (6.7%) patients treated with moxifloxacin experienced serious adverse reactions. There were eight deaths (2%) in 382 patients treated with NUZYRA as compared to four deaths (1%) in 388 patients treated with moxifloxacin. Discontinuation of treatment due to any adverse reactions occurred in 21/382 (5.5%) patients treated with NUZYRA and 27/388 (7.0%) patients treated with moxifloxacin. In Trial 4, a total of 17/336 (5.1%) patients treated with NUZYRA and 15/332 (4.5%) patients treated with moxifloxacin experienced serious adverse reactions. There were six deaths (1.8%) in each treatment group (6/336 in the NUZYRA group, and 6/332 in the moxifloxacin group). Discontinuation of treatment due to any adverse reactions occurred in 9/336 (2.7%) patients treated with NUZYRA and 9/332 (2.7%) patients treated with moxifloxacin. Most Common Adverse Reactions Table 4 lists the most common adverse reactions occurring in ≥2% of CABP patients receiving NUZYRA in Trial 1 and Trial 4. Table 4: Adverse Reactions Occurring in ≥2% of CABP Patients Receiving NUZYRA in Pooled Trials 1 and Trial 4 Adverse Reaction NUZYRA (N = 718) Moxifloxacin (N = 720) Alanine aminotransferase increased 2.8 2.6 Headache 2.8 2.8 Hypertension 2.2 1.7 Aspartate aminotransferase increased 2.1 1.9 Clinical Trials Experience in Patients with Acute Bacterial Skin and Skin Structure Infections Trial 2 was a Phase 3 ABSSSI trial that enrolled 655 adult patients, 329 randomized to NUZYRA and 326 randomized to linezolid. Trial 3 was a Phase 3 ABSSSI trial that enrolled 735 adult patients, 368 randomized to NUZYRA and 367 randomized to linezolid. In Trial 2 (IV to oral switch trial), the mean age of patients treated with NUZYRA was 47 years (range 19 to 88). Overall, patients treated with NUZYRA were predominantly male (62.8%), white (91.0%) and had a mean BMI of 28.1 kg/m 2 . In Trial 3 (oral only trial), the mean age of patients was 43 years (range 18 to 86). Patients treated with NUZYRA were predominantly male (65.8%), white (88.9%), and had a mean BMI of 27.9 kg/m 2 .

Drug interactions

Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. ( 7.1 ) Absorption of tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations. ( 2.1 , 7.2 ) 7.1 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. 7.2 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 [see Dosage and Administration (2.1) ].

Use in specific populations

Lactation : Breastfeeding is not recommended during treatment with NUZYRA. ( 8.2 ) 8.1 Pregnancy Risk Summary 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 [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages. Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg. Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] . Results of studies in rats with omadacycline have shown tooth discoloration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15-20%. Data Animal Data Intravenous infusion of omadacycline to pregnant rats during organogenesis (gestation days 6-17) at doses of 5 to 80 mg/kg/day resulted in maternal lethality at 80 mg/kg/day. Increased embryo-fetal lethality and fetal malformations (whole body edema) occurred at 60 mg/kg/day (7 times the clinical AUC), dose-dependent reductions in fetal body weight occurred at all doses, and delayed skeletal ossification occurred at doses as low as 10 mg/kg/day (Systemic exposure based on AUC at a similar dose in unmated female rats in a separate study was approximately half the clinical exposure). In pregnant rabbits, intravenous infusion of 5, 10 or 20 mg/kg/day during organogenesis (gestation days 7-18) resulted in maternal lethality and body weight loss at 20 mg/kg/day. Embryo-fetal lethality, congenital malformations of the skeleton, and reduced fetal weight also occurred at 20 mg/kg/day (7 times the clinical AUC). Cardiac and lung malformations were present in dose-related incidence at 10 and 20 mg/kg/day. The fetal no-adverse-effect-level in the rabbit embryo-fetal development study was 5 mg/kg/day, at approximately 1.2 times the clinical steady state AUC. Intravenous infusion of omadacycline to pregnant and lactating rats at doses of 7.5, 15 and 30 mg/kg/day did not adversely affect survival, growth (other than lower pup body weights and/or gains at the high dose that were only statistically significant at sporadic intervals), postnatal development, behavior, or reproductive capability of offspring at maternal doses up to 30 mg/kg/day (approximately equivalent to 3 times the IV clinical dose of 100 mg/day, based on doses normalized for total body surface area), the highest dose tested, although dosing was discontinued early in a number of animals in this group due to injection site intolerance. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy. 8.2 Lactation Risk Summary 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. 8.3 Females and Males of Reproductive Potential Contraception Females NUZYRA may produce embryonic or fetal harm [see Use in Specific Populations (8.1) ]. Advise patients to use an acceptable form of contraception while taking NUZYRA. Infertility Males In rat studies, injury to the testis and reduced sperm counts and motility occurred in male rats after treatment with omadacycline [see Nonclinical Toxicology (13.1) ]. Females In rat studies, omadacycline affected fertility parameters in female rats, resulting in reduced ovulation and increased embryonic loss at intended human exposures [see NonclinicalToxicology (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of NUZYRA in pediatric patients below the age of 18 years have not been established. Due to the adverse effects of the tetracycline class of drugs, including NUZYRA on tooth development and bone growth, use of NUZYRA in pediatric patients less than 8 years of age is not recommended [see Warnings and Precautions (5.1 , 5.2) ]. 8.5 Geriatric Use Of the total number of patients who received NUZYRA for ABSSSI in clinical trials 2 and 3 (n=691), 57 (8.2%) patients were ≥65 years of age, including 20 (2.9%) patients who were ≥75 years of age. Of the total number of patients who received NUZYRA for CABP in clinical trials 1 and 4 (n=718), 330 (46%) patients were ≥65 years of age, including 156 (21.7%) patients who were ≥75 years of age [see Clinical Studies (14)] .

Pregnancy

8.1 Pregnancy Risk Summary 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 [see Warnings and Precautions ( 5.1 , 5.2) , Data, Use in Specific Populations ( 8.4 )]. The limited available data of NUZYRA use in pregnant women is insufficient to inform drug associated risk of major birth defects and miscarriages. Animal studies indicate that administration of omadacycline during the period of organogenesis resulted in fetal loss and/or congenital malformations in pregnant rats and rabbits at 7 times and 3 times the mean AUC exposure, respectively, of the clinical intravenous dose of 100 mg and the oral dose of 300 mg. Reductions in fetal weight occurred in rats at all administered doses (see Data ). In a fertility study, administration to rats during mating and early pregnancy resulted in embryo loss at 20 mg/kg/day; systemic exposure based on AUC was approximately equal to the clinical exposure level [see Nonclinical Toxicology ( 13.1) ] . Results of studies in rats with omadacycline have shown tooth discoloration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15-20%. Data Animal Data Intravenous infusion of omadacycline to pregnant rats during organogenesis (gestation days 6-17) at doses of 5 to 80 mg/kg/day resulted in maternal lethality at 80 mg/kg/day. Increased embryo-fetal lethality and fetal malformations (whole body edema) occurred at 60 mg/kg/day (7 times the clinical AUC), dose-dependent reductions in fetal body weight occurred at all doses, and delayed skeletal ossification occurred at doses as low as 10 mg/kg/day (Systemic exposure based on AUC at a similar dose in unmated female rats in a separate study was approximately half the clinical exposure). In pregnant rabbits, intravenous infusion of 5, 10 or 20 mg/kg/day during organogenesis (gestation days 7-18) resulted in maternal lethality and body weight loss at 20 mg/kg/day. Embryo-fetal lethality, congenital malformations of the skeleton, and reduced fetal weight also occurred at 20 mg/kg/day (7 times the clinical AUC). Cardiac and lung malformations were present in dose-related incidence at 10 and 20 mg/kg/day. The fetal no-adverse-effect-level in the rabbit embryo-fetal development study was 5 mg/kg/day, at approximately 1.2 times the clinical steady state AUC. Intravenous infusion of omadacycline to pregnant and lactating rats at doses of 7.5, 15 and 30 mg/kg/day did not adversely affect survival, growth (other than lower pup body weights and/or gains at the high dose that were only statistically significant at sporadic intervals), postnatal development, behavior, or reproductive capability of offspring at maternal doses up to 30 mg/kg/day (approximately equivalent to 3 times the IV clinical dose of 100 mg/day, based on doses normalized for total body surface area), the highest dose tested, although dosing was discontinued early in a number of animals in this group due to injection site intolerance. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity also has been noted in animals treated early in pregnancy.

Pediatric use

8.4 Pediatric Use Safety and effectiveness of NUZYRA in pediatric patients below the age of 18 years have not been established. Due to the adverse effects of the tetracycline class of drugs, including NUZYRA on tooth development and bone growth, use of NUZYRA in pediatric patients less than 8 years of age is not recommended [see Warnings and Precautions (5.1 , 5.2) ].

Geriatric use

8.5 Geriatric Use Of the total number of patients who received NUZYRA for ABSSSI in clinical trials 2 and 3 (n=691), 57 (8.2%) patients were ≥65 years of age, including 20 (2.9%) patients who were ≥75 years of age. Of the total number of patients who received NUZYRA for CABP in clinical trials 1 and 4 (n=718), 330 (46%) patients were ≥65 years of age, including 156 (21.7%) patients who were ≥75 years of age [see Clinical Studies (14)] . No overall differences in safety or effectiveness were observed between these patients and younger adult patients. However, greater sensitivity of some older individuals cannot be ruled out. No significant difference in NUZYRA exposure was observed between healthy elderly subjects and younger subjects following a single 100 mg IV dose of NUZYRA [see Clinical Pharmacology (12.3) ] .

Overdosage

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.

Description

11 DESCRIPTION NUZYRA contains omadacycline tosylate, an aminomethylcycline which is a semisynthetic derivative of the tetracycline class of antibacterial drugs, for intravenous or oral administration. The chemical name of omadacycline tosylate is (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-9-(2,2-dimethylpropylaminomethyl)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide, 4-methylbenzenesulfonate. The molecular formula is C 36 H 48 N 4 O 10 S (monotosylate salt) and the molecular weight is 728.9 (monotosylate salt). The following represents the chemical structure of omadacycline tosylate: NUZYRA (omadacycline) for injection is a yellow to dark orange sterile lyophilized powder. Each vial of NUZYRA for injection contains 100 mg of omadacycline (equivalent to 131 mg omadacycline tosylate). Inactive ingredients: Sucrose (100 mg); may include hydrochloric acid and/or sodium hydroxide for pH adjustment. NUZYRA (omadacycline) tablets for oral administration are yellow film coated tablets containing 150 mg of omadacycline (equivalent to 196 mg omadacycline tosylate), and the following inactive ingredients: Colloidal silicon dioxide, crospovidone, glycerol monocaprylocaprate, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyvinyl alcohol, sodium bisulfite, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide. Chemical Structure

Mechanism of action

12.1 Mechanism of Action NUZYRA is an antibacterial drug [see Microbiology (12.4) ].

How supplied

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.

Storage

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.

Patient 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 (5.3) ] . 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 (5.5) ] . Antibacterial Resistance Patients should be counseled 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.

Label text from the FDA structured product label by Paratek Pharmaceuticals, Inc. (revised May 27, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Omadacycline in 2 products

Nuzyra NDC products (2)

NDC	Strength & form	Labeler	Type
71715-001	Omadacycline 100 mg/5mL Injection, Powder, Lyophilized, For Solution	Paratek Pharmaceuticals, Inc.	NDA
71715-002	Omadacycline 150 mg/1 Tablet, Film Coated	Paratek Pharmaceuticals, Inc.	NDA

Frequently asked questions

What is Nuzyra used for?

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Who makes Nuzyra?

Nuzyra is listed by 1 labeler in the FDA NDC directory, including Paratek Pharmaceuticals, Inc..