This website, www.nuzyra.com (“Website”), is an Internet site maintained by Paratek Pharmaceuticals, Inc., and its respective divisions, subsidiaries and affiliates (“Paratek”).
Paratek may terminate, change, suspend or discontinue any aspect of this Website, including the availability of any features of the Website, at any time. Paratek may also impose limits on certain features and services or restrict your access to parts of or the entire Website without notice or liability.
The trademarks, logos, and service marks (“Trademarks”) appearing on this Website are the property of Paratek and/or its licensors/providers. Nothing contained on this Website should be construed as granting any license or right to use any Trademark without the prior written permission of the party that owns the Trademark.
No Medical Advice
This website does not provide medical or similar advice. If you need medical advice or services, promptly consult a professional healthcare provider.
No Warranties or Liability
PARATEK, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, REPRESENTATIONS AND WARRANTIES REGARDING ACCURACY, TIMELINESS, COMPLETENESS, NONINFRINGEMENT, MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.
Links to Other Websites
Your User Content and Communications
Our Website may allow users to post, submit, or display information, messages, suggestions, questions, comments, postings, advertisements, ratings, ideas, techniques, notes, know-how, drawings, concepts, designs, audiovisual material, photographs and pictures (including pictures of the user and other representations of the user’s name and likeness), digital images, or other content in any form (collectively “User Content”). It is the responsibility of the individual providing such User Content to ensure that no portion of the content is illegal, obscene, threatening, defamatory, invasive of privacy, infringing of intellectual property rights or otherwise injurious to third parties.
By posting User Content on this Website, you hereby grant Paratek an unrestricted, transferable, sub-licensable, irrevocable, royalty-free, worldwide, and perpetual license to reproduce, distribute, publicly display, make derivative works of, and otherwise use the User Content in any media whatsoever now known or later invented throughout the world for any purpose whatsoever, commercial or not. You hereby disclaim any right to any compensation from Paratek in connection with Paratek’s exercise of its license rights in and to the User Content you have posted on this Website. You acknowledge and agree that Paratek is under no obligation of confidence to you, and shall not be liable for any use or disclosure of any User Content. By posting the User Content on this Website, you represent and warrant that you own the copyright in such User Content or that you have a legitimate license to post the User Content, including photographs or other audiovisual material, without any restrictions whatsoever. You agree to indemnify and hold Paratek harmless from all actual and incidental costs and fees associated with Paratek’s defense of any claims arising from User Content, including, but not limited to, all attorneys’ fees.
Paratek reserves the right to review any User Content and remove, delete, redact, or otherwise modify such User Content, in its sole discretion, at any time and from time to time, without notice or further obligation to you. Paratek has no obligation to display or post any User Content. Paratek reserves the right to disclose, at any time and from time to time, any information or User Content that Paratek deems necessary or appropriate to satisfy any applicable law, regulation, contractual obligation, legal dispute process, or governmental request. Paratek shall have no liability in connection with any User Content submitted to, transmitted via, or displayed or posted on this Website.
Paratek is committed to respecting others’ intellectual property rights, and we ask our users to do the same. Paratek may, in its sole discretion, terminate the accounts or access rights of users who violate others’ intellectual property rights. If you believe that your work has been copied in a way that constitutes copyright infringement on this Website, please deliver the following information to Paratek’s Copyright Agent:
An electronic or physical signature of the person authorized to act on behalf of the copyright owner
A description of the copyrighted work that you claim has been infringed
A description of where the material that you claim is infringing is located on our Website
Your address, telephone number, and e-mail address so that we may contact you
A statement by you that you have a good faith belief that the disputed use is not authorized by the copyright owner, its agent, or the law
A statement by you, made under penalty of perjury, that the information in your notice to us is accurate and that you are the copyright owner or authorized to act on the copyright owner's behalf
Paratek’s Copyright Agent for notice of claims of copyright infringement on this Website can be reached as follows:
A copy of the notice and supporting materials should also be submitted electronically to firstname.lastname@example.org.
Governing Law and Jurisdiction
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.
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
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 of 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.
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.
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.