Insmed privacy policy

POLICY

Welcome to www.ARIKAYCE.com (also referred to as "Site") owned and operated by Insmed Incorporated (also referred to as “Insmed,” “us,” or “we”). This Privacy Policy is designed to tell You (“You”) about our practices regarding collection, use, and disclosure of information that You provide or that is collected through this Site. This Privacy Policy does not apply to information collected from You through offline means or from Insmed websites that do not link to this Privacy Policy, with the following exception – if we merge information collected about You through offline means or from other Insmed websites with information collected through this Site, then the collection, use and disclosure of such merged information will be governed by the terms of this Privacy Policy for so long as it is so merged.

Please be sure to read this Privacy Policy before using or submitting information to this Site. This Privacy Policy is the sole authorized statement of Insmed's practices concerning the collection, use and protection of personal information through this Site.

YOUR CONSENT

By using this Site, You consent to the collection, use and disclosure of information in accordance with this Privacy Policy.

DEFINITION OF "PERSONAL INFORMATION"

As used in this Privacy Policy, “personal information” means information that identifies You and which is submitted to and/or collected by this Site.

INFORMATION YOU PROVIDE

Some areas of this Site ask You to submit personal information in order for You to benefit from the specified features or to participate in a particular activity. On the registration screen for such feature or activity, we clearly label which information is required for registration or participation, and which information is optional and may be given at Your discretion. You may always refuse to provide information to us, but this may lead to our inability to provide You with certain information, products or services or for You to participate in certain activities.

We also may collect information about you from publicly and commercially available sources or in other ways that we describe to you at the time of collection or otherwise with your consent.

PASSIVE INFORMATION COLLECTION

As You navigate through this Site, we may automatically collect (that is, gather without You actively providing the information) certain non-personal information, including by using cookies, web beacons, and other Internet technologies. For example, Your Internet browser automatically transmits to this Site certain information, such as the URL of the website You just came from, the Internet Protocol (IP) address, and the browser version Your computer is currently using. We also may collect information about your browsing behavior on our Site, such as the amount of time spent viewing content on the Site.

USE AND DISCLOSURE OF INFORMATION

We may use information collected through this Site to improve the content of the Site, to customize the Site to Your preferences, to communicate information to You (if You have requested it), to provide You with relevant ads, promotions, and offers on and off the Site, for our marketing, analysis, and research purposes, to review and respond to any comments or information You submit via the Site, and for any other purpose specified at the time the information is collected from You.

In addition, we may use and disclose to others non-personal information collected through this Site without any restrictions. In some instances, we may remove personal identifiers from data and maintain it as non-personal information. We also may combine non-personal information with personal information. If we do combine any non-personal information with personal information, the combined information will be treated as personal information under this Privacy Policy as long as it is so combined. We may disclose personal information You provide through this Site to other Insmed affiliates that agree to treat it in accordance with this Privacy Policy. We also may disclose personal information You provide through this Site to third parties that are not Insmed affiliates, but only:

  1. to agents, contractors and partners we use to support our business, in which case we will seek to restrict such third parties’ use of such data to the purposes for which it has been provided; provided, however, that Insmed shall not be responsible for third parties’ unauthorized uses, disclosures or other violations of this Privacy Policy or any other rights of users of this Site; or
  2. to a purchaser or successor entity in connection with the sale, merger, assignment, or other transfer of Insmed or any of its affiliates, or line of business or product of Insmed or any of its affiliates, or sale of substantially all of the assets of Insmed or any of its affiliates; or
  3. to respond to law enforcement requests or where we determine that disclosure is required by applicable laws, court orders, or government regulations; or
  4. to enforce our Terms of Use; to protect our operations; to protect the rights, privacy, safety or property of Insmed, You or others; or to permit us to pursue available remedies or limit the damages that we may sustain; or
  5. if You have consented to the disclosure. Please be advised that the collection, use, and disclosure of information contemplated in this Privacy Policy may involve a transfer of the information to jurisdictions located outside Your country of residence that may not have equivalent laws and rules regarding personal information.

NO THIRD-PARTY DIRECT MARKETING USE

Insmed will not sell or otherwise transfer the personal information You provide us at this Site to any third parties for their own direct marketing use unless we have obtained Your explicit consent for Your data to be shared in this manner.

COOKIES AND OTHER TECHNOLOGIES

We, as well as certain third parties that provide content, other functionality, or services to the Site, may use Internet technologies to collect information. These technologies include, cookies, local stored objects, web beacons and other means. By using the Site, you consent to our use of such cookies and similar technologies.

Cookies and Other Local Storage Technologies

Cookies are small files that may be stored by your device’s web browser and that can be used to recognize your device across different websites, services, devices, and browsing sessions. Your browser or device may offer settings related to cookies. For example, you may be able to configure your browser not to accept cookies or to notify you when a cookie is being sent. For more information about whether these settings are available and how they work, visit your browser or device settings or help material. If you decide not to accept cookies from us, you may not be able to take advantage of all the features of the Services.

Cookies are stored on your device or in “local storage.” We also use other types of local storage technologies, such as local stored objects (sometimes called “Flash cookies”), in connection with the Site. These technologies are similar to cookies in that they are stored on your device and can be used to maintain information about your activities and preferences. However, these other technologies may use parts of your device other than your browser, which means you may not be able to control their use using browser tools and settings. For more information about managing Flash cookies, please visit the Adobe Flash Player website.

Other Tracking Technologies

There are other Internet technologies, such as web beacons, that can be used to store information about your activities and preferences. Web beacons are small pieces of code placed on websites, videos, and in emails that can communicate information about your browser and device to a server. Beacons can be used among other things, to count the users who visit a particular page, to deliver or communicate with cookies, and to understand usage patterns.

THIRD PARTIES THAT PROVIDE CONTENT

Some of the content, functionality and services on our Site may be provided by third parties that are not affiliated with us. Such third parties include, for example, audience measurement companies that help us measure and analyze the overall usage of our Site and advertising providers that help us and our advertising partners provide ads on our Site or elsewhere that are tailored to Your interests and to understand Your response to those ads.

These and other third parties may collect or receive information about Your use of the Site, including through the use of cookies, web beacons, and other Internet technologies, and this information may be collected over time and combined with information collected on different websites and online services, including, for example, to deliver ads that are more relevant to you, both on and off our Site.

Some of these companies participate in industry-developed programs to provide consumers with choices about whether to receive targeted ads. To learn more and to opt out of such targeted advertising from participating companies, please visit the websites of the National Advertising Initiative and the Digital Advertising Alliance.

TELL-A-FRIEND

If You choose to use our referral function to tell a friend about our Site, our Site will ask You for Your friend's name and e-mail address as well as Your information. The form automatically sends Your friend a one-time e-mail inviting him or her to visit the Site. We do not access or store this information, except to send this invitation.

PERSONAL INFORMATION PROTECTION

We take measures designed to prevent unauthorized intrusion to this Site and the alteration, acquisition or misuse of personal information; however, we will not be responsible for loss, corruption or unauthorized acquisition or misuse of personal information that You provide through this Site or that is stored by us, or for any damages resulting from such loss, corruption or unauthorized acquisition or misuse.

OTHER WEBSITES

This Site may contain links or references to other websites. Please be aware that we do not control these linked websites and that this Privacy Policy does not apply to those websites. We encourage You to read the privacy policy of every website You visit.

ABOUT CHILDREN

This Site does not knowingly collect, use, or disclose personal information from children under the age of 13 without prior parental consent, except as permitted by the Children’s Online Privacy Protection Act (“COPPA”).

INTERNATIONAL USERS

Please note that this site is directed towards users who reside in the United States. By using this Site, you consent to the collection, storage, processing, and transfer of your information in and to the United States, or other countries and territories, pursuant to the laws of the United States. While some of these countries may not offer the same level of privacy protection as your own, Insmed commits to uphold the privacy protections as explained in this Policy.

YOUR CALIFORNIA PRIVACY RIGHTS

It is our policy not to share your personal information with third parties for their direct marketing purposes.

Some web browsers may transmit “do-not-track” signals to the websites with which the user communicates. Because of differences in how web browsers incorporate and activate this feature, it is not always clear whether users intend for these signals to be transmitted, or whether they even are aware of them. Because there currently is no industry standard concerning what, if anything, websites should do when they receive such signals, Insmed currently does not take action in response to these signals. If and when a final standard is established and accepted, we will reassess how to respond to these signals. In some cases, third parties may be able to collect information about a user’s online activities over time and across different websites when he or she uses our Site.

HOW TO CONTACT US

If you have questions, comments, or concerns about this Privacy Policy or the information practices of this Site, or if You would like to opt-out of future communications, please contact us by sending a letter to:

Insmed Incorporated
10 Finderne Avenue, Building 10
Bridgewater, NJ 08807
Attention: General Counsel
Tel: (908) 977-9900
E-mail: General Counsel

PRIVACY POLICY UPDATES

Please note that Insmed reserves the right to revise this Privacy Policy at any time at our sole discretion. Therefore, You are urged to review the Privacy Policy each time You access this Site to ensure that You are familiar with the most current version. Use of this Site following such modification constitutes Your acceptance of the revised Privacy Policy then in effect.

This Privacy Policy was last updated on May 18, 2017.
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IMPORTANT SAFETY INFORMATION AND INDICATION WARNING: Risk of Increased Respiratory Adverse Reactions including
allergic inflammation of lungs, coughing up blood, severe breathing problems and worsening of COPD.

ARIKAYCE can cause serious side effects, including:

  • allergic inflammation of the lungs. These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with fever, wheezing, coughing, shortness of breath, and fast breathing
  • coughing up of blood (hemoptysis). Coughing up blood is a serious and common side effect of ARIKAYCE
  • severe breathing problems. Severe breathing problems can be symptoms of bronchospasm. Bronchospasm is a serious and common side effect of ARIKAYCE. Bronchospasm symptoms include shortness of breath, difficult or labored breathing, wheezing, and coughing or chest tightness
  • worsening of chronic obstructive pulmonary disease (COPD). This is a serious and common side effect of ARIKAYCE

While using ARIKAYCE, these side effects may become serious enough that treatment in a hospital is needed. Call your healthcare provider or get medical help right away if you have any of these serious side effects while taking ARIKAYCE. Your healthcare provider may ask you to stop using ARIKAYCE for a short period of time or completely stop using ARIKAYCE.

Do not use ARIKAYCE if you are allergic to any aminoglycoside, or any of the ingredients in ARIKAYCE.

Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you:

  • have asthma, COPD, shortness of breath, or wheezing (bronchospasm)
  • have been told you have poor lung function
  • have hearing problems, such as ringing in your ears or hearing loss
  • have dizziness or a sense of the room spinning
  • have kidney problems
  • have neuromuscular disease, such as myasthenia gravis
  • are pregnant or plan to become pregnant. It is not known if ARIKAYCE can harm your unborn baby. ARIKAYCE is in a class of medicines that may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed
  • are breastfeeding or plan to breastfeed. It is not known if the medicine in ARIKAYCE passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ARIKAYCE

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.

ARIKAYCE may cause serious side effects, including:

  • hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo)
  • worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE
  • worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a class of medicines which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis)

The most common side effects of ARIKAYCE include: changes in voice and hoarseness (dysphonia), sore throat, diarrhea, muscle pain, nausea, tiredness (fatigue), fever, vomiting, headache, decreased weight, increased sputum, rash, chest discomfort, or cough during or after a dose of ARIKAYCE, especially in the first month after starting treatment.

These are not all of the possible side effects of ARIKAYCE. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is ARIKAYCE?

ARIKAYCE is a prescription medicine used to treat adults with refractory (difficult to treat) Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug treatment plan (regimen).

It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age.

This product was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specific patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.