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.

Indication

HABP/VABP

VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.

cSSSI

VIBATIV is indicated for the treatment of adult patients with 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)

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

Mortality

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 occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.

Contraindication

Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.

VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.

Hypersensitivity Reactions

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.

Geriatric Use

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

Infusion Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome” like reactions including: flushing of the upper body, urticaria, pruritus, or rash.

QTc Prolongation

Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.

Most Common Adverse Reactions

The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.

Please see full Prescribing Information including Boxed Warning and Medication Guide.