For US Healthcare Professionals only
PRESCRIBINGINFORMATION REQUEST
SAMPLES
NUZYRA is indicated for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in adults caused by select susceptible microorganisms.
PRIVACY POLICY
Paratek Pharmaceuticals, Inc., and its respective divisions, subsidiaries and affiliates (“Paratek”) recognizes the importance of protecting your privacy. This Privacy Policy (“Policy”) discloses our information-gathering and dissemination practices for this website at www.nuzyra.com (“Website”).
By using this Website, you agree to be bound by the terms and conditions of this Policy and the Terms of Use. If you do not agree with the terms of this Policy or the Terms of Use, or other terms and conditions on this Website, then do not use this Website. You may also be subject to another privacy policy or other terms and conditions that are posted on Paratek’s website specific to a particular Paratek program or service (“Other Agreement”). Based upon your specific relationship(s) with Paratek, we may collect, use or disclose Personal Information (defined below) in ways described in more detail in one or more Other Agreements. To the extent the Other Agreement includes additional terms that are not covered by or are inconsistent with this Policy, the terms and conditions of the Other Agreement will supersede this Policy.
Within this Policy you will find covered matters related to the following:
How We Use Your Personal Information
Disclosure of Your Personal Information
Choice to Opt-Out and Access to Your Information
Governing Law and Jurisdiction
Children
This Website is not directed at children and we do not knowingly collect Personal Information (as defined below) online from children under the age of 13. If a child provides us with this type of information online, please contact us to have the account deactivated by sending us an e-mail at info@nuzyra.com or by calling us at 617-275-0040.
Information We Collect
Personal Information
We collect and store Personal Information that you provide voluntarily when using this Website. Personal Information is information that can identify you as a specific individual (“Personal Information”). You are responsible for providing accurate and complete information. Personal data does not include anonymized aggregate or statistical information from which such identification cannot be reconstituted.
Non-Personal Information
When you visit any page on this Website, we use a program that monitors and evaluates this Website’s traffic. It automatically records every visitor's host, domain name, pages visited, length of user session, browser type and/or IP address. This information does not contain Personal Information. We use this information to find out how many people visit this Website to determine the areas of greatest interest on this Website, and to make improvements to this Website.
When you visit and interact with this Website, Paratek and third parties with whom Paratek has contracted to provide services to Paratek, may collect non-personal information (for example, a catalog of the site pages you visit, or your IP address).
Cookies
As with many other sites, this Website may use “cookies” or other technologies to help us deliver content specific to your interests, to process your inquiries or requests, and/or to analyze your visiting patterns. Cookies, by themselves, will not be used by Paratek to disclose your individual identity. This information identifies your browser, but not you, to our servers when you visit this Website. If you want to disable the use of cookies or remove them at any time from your computer, you can disable or delete them using your browser (consult your browser’s “help” menu to learn how to delete cookies), however you must enable cookies to access certain information on this Website. Note that in limited instances, such as when you create an online account, or request one of our other services, cookies may contain and be associated with the Personal Information we collect.
We may also collect data by using “pixel tags,” “web beacons,” “clear GIFs” or similar means (collectively, “pixel tags”) that allow us to know when you visit this Website. Through pixel tags, we obtain non-personal information or aggregate information (i.e., your IP address, the areas of this Website you visit, your operating system, your browser version and the URL you came from) which can be used to enhance your online experience and understand traffic patterns.
Third-Party Advertisers
In addition, we may use third-party advertisers to serve or track advertisements on other websites. Please note that these third parties also may use cookies, pixel tags and other technologies to, among other things, enable such third parties to record which ads your browser has loaded and which site pages you may have been viewing when the ads were delivered or accessed. Use of such third-party sites is subject to the terms of use and privacy policies of those third parties. Paratek does not control the use of this technology or the resulting information and is not responsible for any actions or policies of such third parties.
How We Use Your Personal Information
We use your Personal Information to:
- complete any registration or other transactions you request online;
- improve this Website;
- improve our products and services, and identify, develop, and offer new or expanded products and services;
- personalize your experience on this Website, and customize the content and/or format of the pages you visit;
- notify you about updates, products, services, and/or special offers from Paratek, its affiliates, and selected third parties;
- ask you to participate in brief surveys; and/or
- generate aggregate statistical studies and conduct research related to our products and services and the use of this Website.
Based upon your specific relationship(s) with Paratek, we may use your Personal Information in ways described in more detail in one or more Other Agreements.
Disclosure of Your Personal Information
We disclose your Personal Information to certain third parties with whom we have a direct or indirect business or contract relationship, to provide the products and services you have requested.
When you request other services, we will provide your personal data to third parties with whom we arrange for those services to be provided. We may also disclose information to third parties that provide administrative or processing services for us, for example, printing, mailing, and/or payment processing.
Paratek’s use of third parties to provide services to you (e.g., payment services) is subject to the terms of use and privacy policies of those third-party websites and such third parties are responsible or liable for their use of your personal data.
We may also disclose Personal Information collected on this Website, in accordance with applicable law, to assert or defend our rights and property, to prevent harm to others, to collect a debt, or in response to legal processes such as subpoenas. We may also provide (or reserve the right to provide) Personal Information to credit reporting agencies and to cooperate with law enforcement authorities and other governmental authorities consistent with applicable laws.
If you have consented to our doing so, we may also share your personal data with third parties in order that they may offer you information about their goods and services.
Because non-personal information does not personally identify you, we may use or disclose such information for any purpose. In some instances, we may combine non-personal information with Personal Information (such as embedding e-mail addresses in cookies). If we do combine any non-personal information with Personal Information, the combined information will be treated by us as Personal Information in accordance with this Policy.
Based upon your specific relationship(s) with Paratek, we may disclose your Personal Information in ways described in more detail in one or more Other Agreements.
Choice to Opt-Out and Access to Your Information
When you create an account, or request one of our other services, you will have the ability to opt-out of receiving certain communications from Paratek, including voicemail or e-mail. If you do not opt-out at registration, but later decide that you would prefer not to receive e-mail communications from Paratek, please contact info@nuzyra.com. Remember, however, that Paratek may still send e-mail or call you in order to provide a product or service that you request.
Except as otherwise specified in an Other Agreement, you can also access your Personal Information to update or correct factual errors in your Personal Information by sending us an e-mail at info@nuzyra.com. To protect your privacy and security, we will also take reasonable steps to verify your identity before granting access or making corrections.
Links to Third Party Sites
This Website may contain links to other third party websites. Paratek does not control the privacy policies or practices of these third-party sites. You should review those policies before providing any information. Paratek is not responsible for the content or practices of any linked third-party sites, and we provide these links solely for the convenience and information of our visitors. Specifically, if you use a credit card to pay for any products or services, Paratek is not responsible for any information you provide regarding the credit card on this Website or by linking through to a credit card processor’s website.
Security
Paratek has established safeguards to help prevent unauthorized access to or misuse of your Personal Information, but cannot guarantee that your Personal Information will never be disclosed in a manner inconsistent with this Policy (for example, as a result of unauthorized acts by third parties that violate applicable law or relevant Web policies).
If you register for a Web account, you will be asked to select a password to help protect your information. These passwords help us verify your identity before granting access or making corrections to any of your Personal Information. You should never disclose your password to anyone. Paratek will never ask you for your password in an unsolicited phone call or e-mail. You are responsible for maintaining the secrecy of your passwords and any account information.
When you provide credit card information, it is transmitted using SSL technology to help prevent unauthorized access to or misuse of that information. You will know that SSL is being used when you see a full yellow key in a blue box in the lower left-hand corner of your browser or a full “lock” in the status bar of your Internet Explorer browser.
Changes
Paratek reserves the right to change this Policy to respond to new laws, regulations, technology, or for other business reasons. Please check this Website from time to time to review any such changes. Using this Website following the posting of changes to this Policy shall constitute your acceptance of the revised Policy.
Governing Law and Jurisdiction
You agree that any claim, action or proceeding arising out of this Policy, or your use of this Website, shall be governed by and construed in accordance with the laws of the United States and the Commonwealth of Massachusetts, without regard to principles of conflict of laws. Any claim, action or proceeding related to this Policy will be resolved exclusively in the state or federal courts located in the Commonwealth of Massachusetts and you consent to the jurisdiction of those courts.
Contact Information
If you have any questions or concerns about this Website or security policies, you may contact us by e-mail at info@nuzyra.com or write to us at: Paratek Pharmaceuticals, Inc., Website Inquiries Office, 75 Park Plaza, 4th Floor, Boston, MA 02116.
Special Notice to California Residents
Under California Law SB 27, California residents have the right to receive, once a year, information about third parties with whom we have shared Personal Information about you or your family for their marketing purposes during the previous calendar year, and a description of the categories of Personal Information shared. If you are a California resident and wish to make such a request, please send an e-mail to info@nuzyra.com and include the phrase “California Privacy Request” in the subject line, and provide us with your name, address and e-mail address. We will respond to you within thirty (30) days of receiving such a request.
Do Not Track
Although our Website currently does not have a mechanism to recognize the various web browser Do Not Track signals, we do offer you choices to manage your preferences as described in the sections above. To learn more about browser tracking signals and Do Not Track please visit https://allaboutdnt.com.
See also:
This Privacy Policy is effective as of: February 23, 2017
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.
Please see Full Prescribing Information for NUZYRA.