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Nuzyra

  • Generic Name: omadacycline for injection
  • Brand Name: Nuzyra

Nuzyra (Omadacycline for Injection) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Nuzyra Side Effects Center

What Is Nuzyra?

Nuzyra (omadacycline) is a tetracycline class antibiotic indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms: Community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

What Are Side Effects of Nuzyra?

Common side effects of Nuzyra include:

Dosage for Nuzyra?

The loading dose of Nuzyra is 200 mg by intravenous infusion over 60 minutes OR 100 mg by intravenous infusion over 30 minutes twice and the maintenance dose of Nuzyra is 100 mg by intravenous infusion over 30 minutes once daily OR 300 mg orally once daily.

What Drugs, Substances, or Supplements Interact with Nuzyra?

Nuzyra may interact with anticoagulants, antacids (containing aluminum, calcium, or magnesium), bismuth subsalicylate, and iron containing preparations. Tell your doctor all medications and supplements you use.

Nuzyra During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Nuzyra. Tetracycline drugs such as Nuzyra may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy. 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, breastfeeding is not recommended during treatment with Nuzyra and for 4 days (based on half-life) after the last dose.

Additional Information

Our Nuzyra (omadacycline) for Injection, for Intravenous Use and Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Nuzyra Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • little or no urination; or
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • pain, irritation, redness, swelling, or a hard lump where the medicine was injected;
  • nausea, vomiting, diarrhea, constipation;
  • headache;
  • trouble sleeping;
  • increased blood pressure; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nuzyra (Omadacycline for Injection)

 

Nuzyra Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling:

  • Mortality Imbalance in Patients with Community-Acquired Bacterial Pneumonia [see WARNINGS AND PRECAUTIONS]
  • Tooth Development and Enamel Hypoplasia [see WARNINGS AND PRECAUTIONS]
  • Inhibition of Bone Growth [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Tetracycline Class Effects [see WARNINGS AND PRECAUTIONS]

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 clinical trials (Trial 1, Trial 2 and Trial 3). These trials included a single Phase 3 trial in CABP patients (Trial 1) and two Phase 3 trials in ABSSSI patients (Trial 2 and Trial 3). Across all Phase 3 trials, a total of 1073 patients were treated with NUZYRA (382 patients in Trial 1 and 691 in Trials 2 and 3 of which 368 patients were treated with only oral 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/m². 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.

Imbalance In Mortality

In Trial 1, eight deaths (2%) occurred in 382 patients treated with NUZYRA as compared to four deaths (1%) in 388 patients treated with moxifloxacin. All deaths, in both treatment arms, occurred in patients >65 years of age. The causes of death varied and included worsening and/or complications of infection and underlying conditions. The cause of the mortality imbalance has not been established [see WARNINGS AND PRECAUTIONS].

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.

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.

Most Common Adverse Reactions

Table 4 lists the most common adverse reactions occurring in ≥2% of patients receiving NUZYRA in Trial 1.

Table 4: Adverse Reactions Occurring in ≥2% of Patients Receiving NUZYRA in Trial 1

Adverse Reaction NUZYRA
(N = 382)		 Moxifloxacin
(N = 388)
Alanine aminotransferase increased 3.7 4.6
Hypertension 3.4 2.8
Gamma-glutamyl transferase increased 2.6 2.1
Insomnia 2.6 2.1
Vomiting 2.6 1.5
Constipation 2.4 1.5
Nausea 2.4 5.4
Aspartate aminotransferase increased 2.1 3.6
Headache 2.1 1.3

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. kg/m².

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/m².

In Trials 2 and 3, approximately 12% of NUZYRA treated patients had CrCl <90 ml/min. Overall, the mean and median calculated lesion area was similar across both trials. Trial 2 required at least 3 days of IV treatment followed by switch to oral regimen based on physician's discretion. Mean duration of IV treatment in Trial 2 was 4 days and mean total duration of treatment was 9 days in both treatment arms. In Trial 3, only oral therapy was administered, and mean total duration of treatment was 8 days in both treatment arms. The median days on treatment in the pooled ABSSSI trials was 9 days for both NUZYRA and linezolid.

Serious Adverse Reactions And Adverse Reactions Leading To Discontinuation

In the pooled ABSSSI trials, serious adverse reactions occurred in 16/691 (2.3%) of patients treated with NUZYRA and 13/689 (1.9%) of patients treated with comparator. Discontinuation of treatment due to adverse events occurred in 12 (1.7%) NUZYRA treated patients, and 10 (1.5%) comparator treated patients. There was 1 death (0.1%) reported in NUZYRA treated patients and 3 deaths (0.4%) reported in linezolid patients in ABSSSI trials.

Most Common Adverse Reactions

Table 5 includes the most common adverse reactions occurring in ≥2% of patients receiving NUZYRA in Trials 2 and 3.

Table 5: Adverse Reactions Occurring in ≥2% of Patients Receiving NUZYRA in Pooled Trials 2 and 3

Adverse Reaction NUZYRA
(N =691)		 Linezolid
(N = 689)
Nausea* 21.9 8.7
Vomiting 11.4 3.9
Infusion site reactions** 5.2 3.6
Alanine aminotransferase increased 4.1 3.6
Aspartate aminotransferase increased 3.6 3.5
Headache 3.3 3.0
Diarrhea 3.2 2.9
*In Trial 2, which included IV to oral dosing of NUZYRA, 40 (12%) patients experienced nausea and 17 (5%) patients experienced vomiting in NUZYRA treatment group as compared to 32 (10%) patients experienced nausea and 16 (5%) patients experienced vomiting in the comparator group. One patient (0.3%) in the NUZYRA group discontinued treatment due to nausea and vomiting.
*In Trial 3, which included the oral loading dose of NUZYRA, 111 (30%) patients experienced nausea and 62 (17%) patients experienced vomiting in NUZYRA treatment group as compared to 28 (8%) patients experienced nausea and 11 (3%) patients experienced vomiting in the linezolid group. One patient (0.3%) in the NUZYRA group discontinued treatment due to nausea and vomiting
**Infusion site extravasation, pain, erythema, swelling, inflammation, irritation, peripheral swelling and skin induration.

Selected Adverse Reactions Occurring In Less Than 2% Of Patients Receiving NUZYRA In Trials 1, 2 And 3

The following selected adverse reactions were reported in NUZYRA-treated patients at a rate of less than 2% in Trials 1, 2 and 3.

Cardiovascular System Disorders: tachycardia, atrial fibrillation

Blood and Lymphatic System Disorders: anemia, thrombocytosis

Ear and Labyrinth Disorders: vertigo

Gastrointestinal Disorders: abdominal pain, dyspepsia

General Disorders and Administration Site Conditions: fatigue

Immune System Disorders: hypersensitivity

Infections and Infestations: oral candidiasis, vulvovaginal mycotic infection

Investigations: creatinine phosphokinase increased, bilirubin increased, lipase increased, alkaline phosphatase increased

Nervous System Disorders: dysgeusia, lethargy

Respiratory, Thoracic, and Mediastinal disorders: oropharyngeal pain

Skin and Subcutaneous Tissue Disorders: pruritus, erythema, hyperhidrosis, urticaria

DRUG INTERACTIONS

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.

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].

Read the entire FDA prescribing information for Nuzyra (Omadacycline for Injection)

&Copy; Nuzyra Patient Information is supplied by Cerner Multum, Inc. and Nuzyra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.