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Submitted URL: https://www.nuzyra.com/
Effective URL: https://www.nuzyra.com/hcp/
Submission: On July 06 via manual from US — Scanned from DE
Effective URL: https://www.nuzyra.com/hcp/
Submission: On July 06 via manual from US — Scanned from DE
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* For US Healthcare Professionals only
* PRESCRIBING INFORMATION
* REQUEST A REP / SAMPLE
NUZYRA is indicated for treatment of Community-Acquired Bacterial Pneumonia
(CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in adults
caused by select susceptible microorganisms. See complete Indications and Usage
below.
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* ABOUT
NUZYRA
* ANTIMICROBIAL
ACTIVITY
* DOSING
CABP Dosing
ABSSSI Dosing
* EFFICACY
CABP Efficacy
ABSSSI Efficacy
* CLINICAL
SAFETY
CABP Safety
ABSSSI Safety
* ACCESS
SUPPORT
Prescribe NUZYRA
Pharmacy Finder
Resources
* STAY UP
TO DATE
NUZYRA is indicated for treatment of Community-Acquired Bacterial Pneumonia
(CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in adults
caused by select susceptible microorganisms.
See complete Indications and Usage below.
--------------------------------------------------------------------------------
1. PRESCRIBING
INFORMATION
2. REQUEST
A REP/SAMPLE
--------------------------------------------------------------------------------
For US Healthcare Professionals only
* ABOUT NUZYRA
--------------------------------------------------------------------------------
* ANTIMICROBIAL ACTIVITY
--------------------------------------------------------------------------------
* DOSING
CABP Dosing ABSSSI Dosing
--------------------------------------------------------------------------------
* EFFICACY
CABP Efficacy ABSSSI Efficacy
--------------------------------------------------------------------------------
* CLINICAL SAFETY
CABP Safety ABSSSI Safety
--------------------------------------------------------------------------------
* ACCESS SUPPORT
Prescribe NUZYRA Pharmacy Finder Resources
--------------------------------------------------------------------------------
* STAY UP TO DATE
--------------------------------------------------------------------------------
* REQUEST A REP/SAMPLE
WHAT IS
NUZYRA?
WHAT IS NUZYRA?
CABP
DOSING
CABP DOSING
ABSSSI
DOSING
ABSSSI DOSING
PRESCRIBE
NUZYRA
PRESCRIBE NUZYRA
INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS
NUZYRA® (omadacycline) is a tetracycline-class antibacterial indicated for the
treatment of adult patients with the following infections caused by susceptible
microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following:
Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible
isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the
following:
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.
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to
omadacycline or tetracycline-class antibacterial drugs, or to any of the
excipients.
WARNINGS AND PRECAUTIONS
Mortality imbalance was observed in the CABP clinical trial with eight deaths
(2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in
patients treated with moxifloxacin. The cause of the mortality imbalance has not
been established. All deaths, in both treatment arms, occurred in patients > 65
years of age; most patients had multiple comorbidities. The causes of death
varied and included worsening and/or complications of infection and underlying
conditions. Closely monitor clinical response to therapy in CABP patients,
particularly in those at higher risk for mortality.
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.
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.
Hypersensitivity reactions have been reported with NUZYRA. 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. Discontinue
NUZYRA if an allergic reaction occurs.
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. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may
have similar adverse reactions. Adverse reactions, including photosensitivity,
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.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion
site reactions, alanine aminotransferase increased, aspartate aminotransferase
increased, gamma-glutamyl transferase increased, hypertension, headache,
diarrhea, insomnia, and constipation.
DRUG INTERACTIONS
Patients who are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing
aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing
preparations.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
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.
Please see Full Prescribing Information for NUZYRA.
EXPAND
COLLAPSE
INDICATIONS and IMPORTANT SAFETY INFORMATION
INDICATIONS
NUZYRA® (omadacycline) is a tetracycline-class antibacterial indicated for the
treatment of adult patients with the following infections caused by susceptible
microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following:
Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible
isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella
pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the
following:
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.
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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to
omadacycline or tetracycline-class antibacterial drugs, or to any of the
excipients.
WARNINGS AND PRECAUTIONS
Mortality imbalance was observed in the CABP clinical trial with eight deaths
(2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in
patients treated with moxifloxacin. The cause of the mortality imbalance has not
been established. All deaths, in both treatment arms, occurred in patients > 65
years of age; most patients had multiple comorbidities. The causes of death
varied and included worsening and/or complications of infection and underlying
conditions. Closely monitor clinical response to therapy in CABP patients,
particularly in those at higher risk for mortality.
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.
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.
Hypersensitivity reactions have been reported with NUZYRA. 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. Discontinue
NUZYRA if an allergic reaction occurs.
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. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may
have similar adverse reactions. Adverse reactions, including photosensitivity,
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.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial
infection is unlikely to provide benefit to the patient and increases the risk
of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%) are nausea, vomiting, infusion
site reactions, alanine aminotransferase increased, aspartate aminotransferase
increased, gamma-glutamyl transferase increased, hypertension, headache,
diarrhea, insomnia, and constipation.
DRUG INTERACTIONS
Patients who are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by antacids containing
aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing
preparations.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
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.
Please see Full Prescribing Information for NUZYRA.
This site is intended for healthcare professionals inside of the US.
© 2022 Paratek Pharmaceuticals, Inc. All rights reserved.
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 medical inquiries or to report an adverse event, or product quality
complaint, please contact Paratek Pharmaceuticals, Inc. at 1-833-PARATEK
(1-833-727-2835) or
www.paratekpharma.com/medical-affairs/medical-information-request.
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