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Privacy Policy

Genentech, Inc. ("Genentech") and Novartis Pharmaceuticals Corporation ("Novartis") respects the privacy of visitors to this website, and we recognize your need for appropriate protection and management of personally identifiable information you share with us (any information by which you can be identified, including but not limited to name, address, e-mail address, and telephone number). We have established this Online Privacy Policy so that you are informed about how we treat any personally identifiable information that you provide to us in the course of using this website. This Online Privacy Policy will inform you of:

  1. How you will be informed of updates to this Privacy Policy
  2. What personally identifiable information of yours we may collect from you through our website and how we may use this information
  3. Limits on how we would share and disclose your personally identifiable information
  4. Our policy regarding collection of personally identifiable information from minors
  5. How this website uses cookies and similar technologies
  6. Our policy regarding browser "do not track" signals
  7. How this website uses social media plugins
  8. Our policy regarding links to third party websites
  9. Security of our website
  10. How you can correct and update your personally identifiable information

Please note that this website is directed towards users who reside in the United States of America. It is not our intent to gather personally identifiable information from individuals residing outside the U.S. Your access to and use of the website constitute acceptance of this Privacy Policy and consent to Genentech's and Novartis' collection and use of your information as outlined below.

Online Privacy Policy Updates

From time to time, Genentech and Novartis may revise this Online Privacy Policy. Any such changes to this Online Privacy Policy will be promptly reflected on this page. Genentech and Novartis encourage you to review this Online Privacy Policy regularly for any changes. Your continued use of this website will be subject to the then-current Online Privacy Policy. The effective date of this Online Privacy Policy is April 29, 2015.

Information Collection and Use

You can generally visit our website without revealing any personally identifiable information about yourself. However, to access certain options and services we may ask you to provide certain personally identifiable information, and without providing such personally identifiable information, you may be unable to access certain options and services. We (along with our third party partners engaged to provide marketing and advertising on our behalf) collect personally identifiable information about you when you visit our website only if you voluntarily provide it to us, and you have the option not to provide any personally identifiable information to us through this website. The following is personally identifiable information that you may voluntarily provide to us and how we use it:

  • Surveys. Information obtained from you on web surveys, such as contact information (name and shipping address), demographic information (zip code, age level) and medical condition. We may use this personally identifiable information to provide you with information and services for which you have expressed an interest or that you may find useful based on your answers in a survey. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website.
  • Newsletters. Information obtained from you from your request to subscribe to a newsletter, such as contact information (name and e-mail address). We may use this personally identifiable information to deliver the newsletters that you have elected to receive.
  • Registration. Information obtained from you on registration forms used to process your requests for services and information, such as contact information (name, address, e-mail address), password, username or code, age, date of birth, gender, ethnicity and medical condition. This registration information may also be gathered if you register for certain services via fax or mail. We may use this information to send you a welcoming e-mail to verify your username and password, website updates, special offers, notices regarding relevant medical conditions and treatment, or other information responsive to the data that you provide to us. Additionally, we may refer to your personally identifiable information to better understand your needs and how we can improve our website.
  • E-mail Content to a Friend. Information obtained from you regarding friend or family name and e-mail address, if you elect to use our referral service for sending some of our website content to friends and family. We may use this personally identifiable information to automatically send the friend or family member a one-time e-mail inviting them to visit the website. We may store this information for the sole purpose of sending this one-time e-mail.

We may combine the personally identifiable information you share with us through this website with other information you have shared with us, both online and offline. We may also combine this personally identifiable information with records provided by third parties. We use this consolidated information to help us better design our products, to communicate information to you, to enhance our marketing and research activities, and to facilitate other business functions.

In addition to the purposes described above, any information we collect may also be used for analytics purposes (e.g., evaluating site usage patterns, assessing throughput) so that we can gauge the effectiveness of our programs and improve the usefulness of information presented to users.

Genentech and Novartis are the owners of all information collected on this website.

Sharing and Disclosure

We may provide your personally identifiable information that we collect and the data generated by cookies (discussed below) to a parent, subsidiary or affiliate entity within the Genentech and/or Novartis corporate families, partner entities, and the vendors and service agencies that we may engage to assist us. For example, we may provide your personally identifiable information to an organization in order to complete a service (e.g., send out newsletter e-mails you have requested), to assist us in reviewing the data or to provide marketing or advertising on our behalf. Any organization to which we provide such personally identifiable information is also required to keep your personally identifiable information confidential.

We will also disclose your personally identifiable information if we reasonably believe we are required to do so by law, regulation, legal process, or other government authority (such as reporting safety information to the Food and Drug Administration); to investigate fraud; to protect your safety or the safety of others; or when we have reason to believe that disclosing this information is necessary to protect our rights or the rights of a third party who may be harmed by your activities.

We will not sell your personally identifiable information to any other company or organization except we may transfer your personally identifiable information to a successor entity of either Genentech or Novartis upon a merger, consolidation or other corporate reorganization in which either Genentech or Novartis participates or to a purchaser of all or a portion of either Genentech's or Novartis' assets. Such successor entity shall be bound by the terms and conditions of this Privacy Policy.

Minors

This website is not intended for or designed to attract children under the age of 13. Moreover, we do not knowingly collect any personally identifiable information from anyone under the age of 18 without the consent of a parent or guardian, and you must be 18 years of age or older to submit registration or survey information. Should you believe that a minor of whom you are a parent or guardian has registered, please contact us at privacy.office@gene.com and we will make reasonable efforts to remove all personally identifiable information related to the minor.

Cookies, LSOs, GIF Files, and Other Tracking Technologies

Some of our websites may use cookies, local shared objects (LSOs) and other tracking technologies to identify users who have previously visited so the user is recognized upon return, thereby saving them time while on our website. A cookie is a piece of data stored on the user's hard drive containing information about the user. If a user rejects the cookie, they may still use our website. A cookie may be placed by us, or by vendors or service agencies who work with us or with our partners. Similar to a cookie, a Local Shared Object is a collection of data that a web site running Adobe Flash can place on your hard drive to recognize a repeat visitor and store settings and other information.

This website and emails we send to you may contain transparent GIF files (also known as "web beacons," "action tags," or "pixel tags") to help manage online advertising. These GIF files are used by us and our ad management partners to recognize when a visitor views a web page or opens an email. This information enables us to learn which emails and advertisements bring users to our website.

If you have provided us with personally identifiable information, e.g., through a registration or a request for certain materials, we may associate this personally identifiable information with information gathered through these tracking technologies. This allows us to offer increased personalization and functionality.

This website may use Google Analytics, a web analytics service provided by Google, Inc. ("Google"). Google Analytics uses cookies to analyze use patterns and may collect information about your use of the website, including your IP address. More information on Google Analytics can be found here: www.google.com/policies/privacy/partners/.

Do-Not-Track Signals and Similar Mechanisms

Some web browsers may transmit "do-not-track" signals to websites with which the browser communicates. This website does not currently respond to these "do-not-track" signals.

Social Media Plugins

This website may use social media plugins (e.g., the Facebook "Like" button, "Share to Twitter" button) to enable you to easily share information with others. When you visit our website, the operator of the social plugin can place a cookie on your computer, enabling that operator to recognize individuals who have previously visited our site. If you are logged into the social media website (e.g., Facebook, Twitter, Google+) while browsing on our website, the social plugins allow that social media website to receive information that you have visited our website. The social plugins also allow the social media website to share information about your activities on our website with other users of their social media website. For example, Facebook Social Plugins allow Facebook to show your Likes and comments on our pages to your Facebook friends. Facebook Social Plugins also allow you to see your friends' Facebook activity on our website. Neither Genentech nor Novartis control any of the content from the social media plugins. For more information about social plugins from other social media websites, you should refer to those sites' privacy and data sharing statements.

Log Files and Aggregate Information

We may track the total number of visitors to our website, the number of visitors to each page of our website, IP addresses, and the domain names of our users' Internet Service Providers, and we may analyze these data for trends and statistics in the aggregate, but such information will be in aggregate form only and it will not contain personally identifiable data. Such aggregate information is not linked to any personally identifiable information that can identify any individual person.

We may use such aggregate information to analyze trends, administer the website, track user's movement, and gather broad demographic information for aggregate use. We may share this aggregate information with our corporate partners and contracted vendors to assist us in operating the website and to enable them to better understand Genentech's and/or Novartis' businesses.

Links to Third Party Sites

This website may contain links to other websites on the Internet that are not under the control of or maintained by either Genentech or Novartis. Such links do not constitute an endorsement by Genentech or Novartis of those other websites, the content displayed therein, or the persons or entities associated therewith. You acknowledge that Genentech and Novartis are providing these links to you only as a convenience, and you agree that Genentech and Novartis are not responsible for the content of such websites. Your use of these other linked websites is subject to the respective terms of use and privacy policies located on the linked websites.

Security

Genentech, Novartis, and their third party providers may employ procedural and technological security measures, consistent with industry practice. Such measures are reasonably designed to protect your personally identifiable information from loss, unauthorized access, disclosure, alteration or destruction. Genentech and Novartis may use encryption, password protection, secure socket layers, internal restrictions and other security measures to help prevent unauthorized access to your personally identifiable information gathered through this website. However, you provide your information to us at your own risk. We cannot guarantee that your data will not be lost, accessed without authorization, disclosed, altered, or destroyed.

Correction/Updating Personally Identifiable Information

Genentech and Novartis are committed to respecting your right to access and correct your personal information. You can call 877-GENENTECH and we will be happy to assist you with your request. You may also "opt out" of receiving e-mails and other communications from us pertaining to the information and content of this website by using the unsubscribe feature included in the e-mails we send. If you have any questions about this online privacy policy or the information practices of this site, you may contact us by email at privacy.office@gene.com or by mail at:

Contacting Genentech

Genentech USA, Inc.
Attn: Privacy Office
1 DNA Way
South San Francisco, CA 94080

History of Updates and Changes to this Privacy Policy

Privacy Policy last updated: April 29, 2015

  • Revised introduction and reordered sections for ease of readability.
  • Revised 'Sharing and Disclosure' section to clarify circumstances in which personally identifiable information may be shared with third parties. The revised language explicitly includes where required by legal process, to protect your safety or the safety of others, as well as circumstances in which such disclosures are necessary to protect Genentech's rights or the rights of a third party.
  • Added section 'Do Not Track Signals and Similar Mechanisms'.
  • Added section 'Social Media Plugins'.
  • Revised 'Cookies, LSOs, GIF Files, and Other Tracking Technologies' section to add language on Google analytics, address new types of online tracking technologies, and notify users of the possibility of personally identifiable information being associated with such technologies.
  • Revised 'Security' section to expressly make clear that use of this website is at the user's own risk.

Privacy Policy Effective July 16, 2013

INDICATION

XOLAIR® (omalizumab) IS INDICATED FOR:

  • Moderate to severe persistent asthma in patients 6 years of age and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.

  • Chronic idiopathic urticaria in patients 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

Limitations of Use:

  • XOLAIR is not indicated for treatment of other allergic conditions or other forms of urticaria.
    XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

CONTRAINDICATIONS

The use of XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis

Anaphylaxis has been reported to occur after administration of XOLAIR in asthma premarketing clinical trials and in postmarketing spontaneous reports. The frequency of anaphylaxis attributed to XOLAIR use was estimated to be 0.1% and at least 0.2% (based on an estimated exposure of about 57,300 patients from June 2003 through December 2006), respectively.

A case-control study showed that among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Anaphylaxis occurred with the first dose of XOLAIR in 2 patients and with the fourth dose in 1 patient; the time to onset of anaphylaxis was 90 minutes after administration in 2 patients and 2 hours after administration in 1 patient. Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

Malignancy

Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (eg, elderly, current smokers) is not known.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non-XOLAIR-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

Acute Asthma Symptoms

XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.

Corticosteroid Reduction

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions

In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

Fever, Arthralgia, and Rash

In postapproval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

Parasitic (Helminth) Infection

Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests

Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma patients, because these levels may not reflect steady state free IgE levels.

ADVERSE REACTIONS
Indication-Specific Adverse Reactions

Asthma:

In patients ≥12 years of age, the most commonly observed adverse reactions (≥1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were: arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).

In pediatric patients 6 to <12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

Injection Site Reactions

In adults and adolescents, injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred more frequently in XOLAIR-treated patients compared with patients in the placebo group (12% vs 9%, respectively).

Chronic Idiopathic Urticaria:

In patients ≥12 years of age, the most commonly observed adverse reactions: (≥2% XOLAIR-treated patients and more frequent than in placebo) from 3 placebo-controlled CIU studies (Day 1 to Week 12) for XOLAIR 150 mg and 300 mg, respectively, were: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Injection site reactions of any severity occurred during the trials in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma

A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non-XOLAIR-treated patients ≥12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR-treated patients were diagnosed with severe asthma (50%) compared to the non-XOLAIR-treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR-treated patients (13.4) compared to non-XOLAIR-treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

Pregnancy

The data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at 888-669-6682.

Please see [accompanying] full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

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