Internet Privacy Policy

This is the Theravance Biopharma, Inc. Internet Privacy Statement for this website. We can be reached at Theravance Biopharma US, Inc., 901 Gateway Boulevard, South San Francisco, CA 94080, or by telephone at 1-855-633-8479.

Theravance Biopharma is aware of our visitors’ concern for privacy when using this website (www.VIBATIV.com). We want to give our website visitors the opportunity to know what information we collect about them and how they can limit the use of individually identifiable information beyond the purposes of which they first provided it. At all times, however, Theravance Biopharma reserves the right to disclose information where required by law or to comply with valid legal processes (such as a search warrant, subpoena, or court order), to protect the company’s rights or property, including without limitation the right to transfer the data in the event of a transfer of control of Theravance Biopharma or the sale of substantially all of its assets, or during emergencies when safety is at risk.

Please be sure to read this entire Internet Privacy Statement before using or submitting information to this site. By using this site, you agree with the terms of this Internet Privacy Statement. Whenever you submit information via this site, you consent to the collection, use, and the disclosure of that information in accordance with this Internet Privacy Statement. Your use of this site is also subject to the Terms of Use for this website (www.VIBATIV.com).

Data we collect and how we use it

Personally Identifiable Information

Personally identifiable information includes your name, address, email, telephone number, survey information, site registrations, or any other information which might reasonably be used to identify you individually. Theravance Biopharma collects personally identifiable information from website visitors only when it is voluntarily provided. We may use this information to respond to an email or other inquiry or request, to help improve our website and our services, or to send updates or notices about our company and the products we offer that we think may be of interest to you. Personally identifiable information will not be sold, rented, or exchanged with unaffiliated entities unless the user is first notified and expressly consents to such transfer.

Theravance Biopharma may also combine the personally identifiable information you provide with other generally or publicly available information to help us identify visitors’ preferences or interest. We may use the information to improve the content of our website or our products and services. Again, we do not sell, rent, or otherwise share with unaffiliated entities any personally identifiable data we collect unless the user is first notified and expressly consents to such transfer.

Theravance Biopharma does not set cookies for this site or collect any information via the use of bits of information deposited in the website visitors’ computers.

Nonpersonally Identifiable Information

The Theravance Biopharma Web server captures the Internet Protocol (IP) addresses of each connection to our site and the specific webpages visited during that connection. An IP address is a number assigned to your computer by your Internet Service Provider so you can access the Internet and is generally considered to be nonpersonally identifiable information because in most cases it changes each time you connect to the internet. IP addresses may be used to diagnose problems with our server, report aggregate information, determine the fastest route for your computer to use in connecting to the site, and administer and improve the site. Although the IP address and related information collected is stored in the server log files, no individual is authorized to access those files for any purpose other than system maintenance. We may also use this information to help improve our website and our services by better understanding our audience. Theravance Biopharma may also collect nonpersonally identifiable information in aggregate form to track data such as the total number of visitors to each page of our website, and the domain names of our visitors’ Internet service providers. We may use this information, which remains in aggregate form, to understand how our visitors use our website so that we may make it better.

Children

Theravance Biopharma does not knowingly collect any personally identifiable information from children under 13 years old through this website. However, if the parent or the guardian of a child under 13 believes that the child has provided us with personally identifiable information, the parent or guardian of that child should contact us at 1-855-633-8479, if they want this information deleted from our files. Anyone under 18 years old should seek his or her parent or guardian’s permission prior to using or disclosing any personal information on this site.

How you can control and update data about you

We want to be sure that we keep only the most accurate and up-to-date information about you in our records. Therefore, whenever you believe that your contact information needs to be updated, you can contact us at 1-855-633-8479 to correct or update your contact information. You may choose at any time to remove your name, telephone number, and postal and email addresses from the list we use to send notices or updates and elect not to receive correspondence from us by contacting 1-855-633-8479.

Data integrity and security

Theravance Biopharma takes reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our site and to protect your information from loss, misuse and unauthorized access, disclosure, alteration, or destruction. All information transmitted to this website is secure to the extent possible using existing technology. You should keep in mind, however, that no Internet transmission is 100% secure or error free. In particular, email sent to or from this site may not be secure, and you should therefore take special care in deciding what information you send to us via email. Moreover, where you use passwords, ID numbers, or other special access features on this site, it is your responsibility to safeguard them.

Links to other websites

This website may provide links to other websites as a service to our visitors. These are websites we believe may have helpful information. However, Theravance Biopharma does not endorse and is not responsible for the content of third-party sites. Nor does Theravance Biopharma have any control over information you may choose to provide to those sites.

The privacy policy described here does not apply to third-party sites, even if they are linked to Theravance Biopharma websites. Other Internet sites you visit may have their own privacy policies or no policy at all. Other websites might use personal information differently than our policy permits. We strongly encourage you to review the privacy policies of any site before providing any personal information.

Changes

Because this policy is subject to change, you should check this Internet Privacy Statement regularly to see if there have been any changes.

Questions about Theravance Biopharma’s Internet Privacy Statement may be directed to 1-855-633-8479.



PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING

VIBATIV (telavancin) Injection

Indication

VIBATIV is indicated in adults for the treatment of:

• complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).

• hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.


To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS

Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤50 mL/min. There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients undergoing hemodialysis.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS

VIBATIV should not be used with intravenous unfractionated heparin sodium because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration. VIBATIV should not be used in patients with known hypersensitivity to VIBATIV (telavancin).

WARNINGS AND PRECAUTIONS

There is decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment. Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min. Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time. Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin. Administer VIBATIV over at least 60 minutes to minimize infusion-related reactions. Clostridium difficile-associated diarrhea has been reported and may range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. Avoid use in patients at risk for QTc prolongation. Use with caution in patients taking drugs known to prolong the QT interval.

ADVERSE REACTIONS

The most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea; in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine.

WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING
MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL
ADVERSE DEVELOPMENTAL OUTCOMES

See full prescribing information for the complete boxed warning



• Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
• Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients.
• Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV.
• Avoid use of VIBATIV during pregnancy unless potential benefit to the patient outweighs potential risk to the fetus.
• Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans.