Arbor™ Pharmaceuticals, LLC
Arbor Pharmaceuticals, LLC appreciates the privacy considerations applicable to visits to one of our websites. Because your privacy is important to us, we provide this notice about the collection and use of information. By using one of our websites, you accept the practices described in this Privacy Notice.
Visitor Information. Website visitors can access the website's home page, and browse some areas of the site, without disclosing any personally identifiable information. We reserve the right to track information provided to us by your browser, which may include the website you came from, the type of browser you use to view the site, the time and date of access, and other information that does not personally identify you. On some of our sites, we may require you to register to access portions of the site. If we do require you to register, Arbor may use certain methods to validate your identity as a user so that appropriate site access rights can be enacted for you, which methods may include the use of usernames and passwords. You are responsible for maintaining the privacy of your password.
Registered User Information. For those websites where registration or membership is required to obtain access, visitors are requested to provide identifying information, such as name, gender, contact information, and other identifying information, in order to obtain access. We use such websites in order that we may, among other things, better communicate our healthcare information to you and personalize your experience at our websites. In such cases, your view of the website may change to reflect the information that you share with us or that we have otherwise obtained about you.
Information needed by us will be clearly identified to you and must be accurately and timely provided by you. In the event that the information that you are required to provide changes, please update your user account with us and notify us of the change. Failing to provide and maintain the accuracy and completeness of our records regarding such information is prohibited.
Online Communications/Transactions. We reserve the right to collect information that you voluntarily provide to us through responses to the "contact us" page and any surveys, search functions, questionnaires, feedback and the like that might be placed on the website by us. On some of our websites, we may offer health assessment tools that ask you to provide self-assessment information. We may also ask you to provide additional information such as your e-mail address if you want to obtain additional services or information or to resolve complaints or concerns. We typically use the information that you provide to help us better understand our customers and their interests, develop and improve our products, and communicate information about our products and services to you.
For those websites, if any, where we may allow physicians or other healthcare professionals (the "Customers") to order our products online, we require that certain Customer information be provided to us and may collect or otherwise obtain additional information about Customers. Additionally in such instances, we may interact with other sources in order to verify identity and validate licensure status. In some cases, we may also ask Customers for specific financial processing information, such as credit card information, so that we may process online a transaction. In such cases it may be necessary for us to contact third party financial or credit organizations to confirm such Customer's credit card information for the order.
Marketing/Promotion. From time to time, we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested. At times, we also may seek to contact you using the information that you have provided or we have legally obtained in order to make you aware of certain developments and share information. In doing so, we may send information to you that we believe will benefit you, including information about the products of Arbor and our affiliates. In such instances where we contact you, we will provide you with an opportunity to tell us that you do not want to receive such promotional and/or information, and should you elect not to receive promotional or informational material from us and properly notify us of such election, we will remove you as a recipient consistent with your request.
Other Uses of Collected Data. Aside from the uses already described, we also use the information gathered from or about visitors for market analysis and product development. Please be aware that we may provide such information, typically in an aggregate form with identifying information removed, to third parties. When aggregate health information is provided, we pool it from many individual records and strip it of any data that could be used to identify an individual before it is used. We require any third party that receives aggregated healthcare data from us to agree not to attempt to re-identify the people it belongs to. YOU SHOULD BE AWARE THAT WE ALSO RESERVE THE RIGHT TO DISCLOSE INFORMATION ABOUT YOU WHEN WE BELIEVE THAT WE ARE REQUIRED TO DO SO BY LAW.
Storage of health information. Personally identifiable health information you share with us is required to be stored by us, we will do so using our database servers at data centers that are hosted by us or third-parties who have entered into agreements with us that require them to observe our confidentiality requirements. Data centers are designed to be physically secure and protected from unauthorized access by unauthorized persons. When necessary to do so, we may release personal health information if, in our judgment and/or after review by an attorney, the release is compelled by law or regulation or is necessary to prevent the death or serious injury of an individual.
Third parties. Please be aware that at times third parties may be working on our behalf that require limited access to some of the personal information we maintain about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will mask the URL you are visiting in the browser address window. We typically require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We also try to limit such other companies from using personally identifiable healthcare information.
Updating Your Information and Contacting Us. You can always contact us in order to (i) remove the personal information that you have provided to us from our systems, (ii) update the personal information that you have provided to us, and (iii) change your preferences with respect to marketing contacts by e-mailing us at: BiDil@arborpharma.com or if available, also logging into your account to update your information.
Please contact us with your questions about this privacy statement or about Arbor's handling of your information at: firstname.lastname@example.org
Copyright © 2014 Arbor Pharmaceuticals, LLC
Important information about BiDil®
(isosorbide dinitrate/hydralazine hydrochloride):
INDICATIONS AND USAGE
BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
IMPORTANT SAFETY INFORMATION
BiDil is contraindicated in patients who are allergic to organic nitrates.
WARNINGS AND PRECAUTIONS
Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors such as sildenafil, vardenafil, or tadalafil could result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Reasonable supportive care should consist of those measures used to treat a nitrate overdose with elevation of the extremities and central volume expansion.
Treatment with hydralazine hydrochloride may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. If systemic lupus erythematosus-like symptoms occur in patients treated with BiDil, discontinuation of BiDil should be considered only after a thorough benefit-to-risk assessment. Symptoms and signs of systemic lupus erythematosus usually regress when hydralazine hydrochloride is discontinued but residua have been detected many years later. Long-term treatment with steroids may be necessary.
Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. BiDil should be used with caution in patients who may be volume depleted or who are already hypotensive.
Hydralazine hydrochloride can cause tachycardia potentially leading to myocardial ischemia and angina attacks. Careful clinical and hemodynamic monitoring is recommended when BiDil is administered to patients with acute myocardial infarction to avoid the hazards of hypotension and tachycardia.
Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop.
Isosorbide dinitrate therapy may aggravate angina associated with hypertrophic cardiomyopathy.
Headache and dizziness were the most frequent adverse events occurring at an incidence greater than 2% in clinical studies compared to placebo. Others included chest pain, asthenia, nausea, bronchitis, hypotension, sinusitis, ventricular tachycardia, palpitations, hyperglycemia, rhinitis, paresthesia, vomiting, amblyopia, hyperlipidemia, and tachycardia.
The full Prescribing Information for BiDil is available here.