Privacy Policy
Genentech, Inc. and Astellas Pharma US, Inc. respect the privacy of visitors to their websites, 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, email address, and telephone number). That is why we have established the Privacy Policy for this website, 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 Privacy Policy will inform you of:
- How you will be informed of updates to this Privacy Policy
- What personally identifiable information of yours we may collect from you through our website
- How we may use your personally identifiable information
- Limits on how we would share and disclose your personally identifiable information
- Our policy regarding links to third party websites
- Security of our website
- How you can correct and update your personally identifiable information
Please note that the Genentech, Inc. and Astellas Pharma US, Inc. websites are 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.
Privacy Policy Updates
Due to the Internet's rapidly evolving nature, Genentech, Inc. and Astellas Pharma US, Inc. may need to update this Privacy Policy from time to time. If so, Genentech, Inc. and Astellas Pharma US, Inc. will post the updated Privacy Policy on our website located at www.tarceva.com so users are always aware of what personally identifiable information we may collect and how we may use this information. Genentech, Inc. and Astellas Pharma US, Inc. encourage you to review this Privacy Policy regularly for any changes. Your continued use of this website will be subject to the then-current Privacy Policy.
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 only if you voluntarily provide it to us and you have the option not to provide any personally identifiable information to us. 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 email 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, email 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 email 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.
- Email Content to a Friend. Information obtained from you regarding friend or family name and email 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 email inviting them to visit the website. We may store this information for the sole purpose of sending this one-time email.
Genentech and Astellas Pharma US, Inc. are the owners of all information collected on this website.
Minors
You must be 18 years of age or older to submit registration or survey information. If you are under the age of 18 and wish to register to obtain further information or be included in a survey, then your parent or legal guardian must register to obtain the information or to participate in the survey.
Cookies and GIF files
Some of our websites may use cookie technology 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. Usage of a cookie is in no way linked to any personally identifiable information while on our website. Once the user closes their browser, the cookie simply terminates. 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.
This website may use pixels, or transparent GIF files, to help manage online advertising. These GIF files are provided by our ad management partners. These files enable these partners to recognize a unique file on your web browser, which in turn enables us to learn which advertisements bring users to our website. The information contained in GIF files that we collect and share with our ad management partners is anonymous and is not personally identifiable.
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 business.
Sharing and Disclosure
We may provide your personally identifiable information that we collect and the data generated by cookies to a parent, subsidiary or affiliate entity within the Genentech, Inc. and Astellas Pharma US, Inc. corporate family, 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 emails 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 in accordance with this Privacy Policy. We will also disclose your personally identifiable information if we reasonably believe we are required to do so by law, regulation or other government authority (such as reporting safety information to the Food and Drug Administration). 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 upon a merger, consolidation or other corporate reorganization in which Genentech, Inc. and Astellas Pharma US, Inc. participate or to a purchaser of all or substantially all of Genentech, Inc. and Astellas Pharma US, Inc.'s assets. Such successor entity shall be bound by the terms and conditions of this Privacy Policy.
Links to Third Party Sites
Some of our websites may contain links to other websites on the Internet that are not under the control of or maintained by Genentech, Inc. and Astellas Pharma US, Inc. Such links do not constitute an endorsement by Genentech, Inc. and Astellas Pharma US, Inc. of those other websites, the content displayed therein, or the persons or entities associated therewith. You acknowledge that Genentech, Inc. and Astellas Pharma US, Inc. are providing these links to you only as a convenience, and you agree that Genentech, Inc. and Astellas Pharma US, Inc. 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, Inc. and Astellas Pharma US, Inc. 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, Inc. and Astellas Pharma US, Inc. may use encryption, password protection, secure socket layers, internal restrictions and other security measures to help prevent unauthorized access to your personally identifiable information.
Correction/Updating Personally Identifiable Information
Genentech, Inc. and Astellas Pharma US, Inc. provide you with the ability to update the personally identifiable information that you have provided to us via Tarceva.com. You may "opt-out" of receiving emails from us to your current email address by using the unsubscribe feature on this site and included in the emails we send. To receive emails at a new email address, please re-subscribe to email updates with your new information.
Privacy Policy Last updated: July 2006
Advanced Non-Small Cell Lung Cancer (NSCLC) Indications
Tarceva monotherapy is indicated for:
- the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
Important Safety Information
There have been reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva. In the NSCLC studies, the incidence of serious ILD-like events in the Tarceva treated patients versus placebo treated patients was 0.7% versus 0% in the maintenance study and 0.8% for both groups in the 2nd/3rd line study. The overall incidence of ILD-like events in approximately 32,000 Tarceva-treated patients from all studies (including uncontrolled studies and studies with concurrent chemotherapy) was approximately 1.1%.
Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, ILD, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome and lung infiltration. Symptoms started from 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy.
Tarceva should be interrupted for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.
Cases of hepatorenal syndrome, acute renal failure (including fatalities), and renal insufficiency have been reported. Some were secondary to baseline hepatic impairment while others were associated with severe dehydration due to diarrhea, vomiting, and/or anorexia or concurrent chemotherapy use. In the event of dehydration, particularly in patients with contributing risk factors for renal failure (eg, pre-existing renal disease, medical conditions or medications that may lead to renal disease, or other predisposing conditions including advanced age), Tarceva therapy should be interrupted and appropriate measures should be taken to intensively rehydrate the patient. Periodic monitoring of renal function and serum electrolytes is recommended in patients at risk of dehydration.
Cases of hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) is recommended. In the setting of worsening liver function tests, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Tarceva dosing should be interrupted or discontinued if total bilirubin is >3 x ULN and/or transaminases are >5 x ULN in the setting of normal pretreatment values.
Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Tarceva. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range.
Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
Corneal perforation and ulceration have been reported during use of Tarceva. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have been observed with Tarceva treatment and are known risk factors for corneal ulceration/perforation. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.
International Normalized Ratio (INR) elevation and infrequent reports of bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in clinical studies, some associated with concomitant warfarin administration. Patients taking warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR. Some infrequent cases of gastrointestinal bleeding were also associated with concomitant NSAID administration.
Tarceva is pregnancy category D. When receiving Tarceva, women of childbearing potential should be advised to avoid pregnancy and pregnant women apprised of the potential hazard to a fetus. Adequate contraception methods should be used during therapy, and for at least 2 weeks after completing therapy. Because of the potential for serious adverse reactions in nursing infants from Tarceva, a decision should be made whether to discontinue nursing or discontinue the drug.
Erlotinib is metabolized predominantly by CYP3A4, and inhibitors of CYP3A4 would be expected to increase exposure. Caution should be used during co-treatment with Tarceva and ketoconazole or other strong CYP3A4 inhibitors such as, but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO) and voriconazole, and grapefruit or grapefruit juice.
The CYP3A4 inducer rifampicin has been shown to decrease erlotinib AUC, thus, alternate treatments lacking CYP3A4 inducing activity are strongly recommended. In the absence of an alternative treatment, Tarceva dose modification should be considered. If the Tarceva dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other CYP3A4 inducers such as, but not limited to: rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort.
Drugs that alter the pH of the upper GI tract may alter the solubility of erlotinib and reduce its bioavailability. The concomitant use of proton pump inhibitors, such as omeprazole with Tarceva should be avoided if possible. If patients need to be treated with an H2-receptor antagonist such as ranitidine, it should be used in a staggered manner. Although the effect of antacids on erlotinib pharmacokinetics has not been evaluated, the antacid dose and the Tarceva dose should be separated by several hours, if an antacid is necessary.
Patients should be advised to stop smoking while taking Tarceva as cigarette smoking has been shown to reduce erlotinib AUC. However, if patients continue to smoke, a cautious increase in the dose of Tarceva, not to exceed 300 mg, may be considered while monitoring the patient's safety. If the Tarceva dose is adjusted upward, the dose should be reduced immediately to the indicated starting dose upon cessation of smoking.
The most common adverse reactions in patients with NSCLC receiving single-agent Tarceva 150 mg were rash and diarrhea. In the 2nd/3rd line study, severe rash and diarrhea (9% & 6% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients. In the maintenance study, severe rash and diarrhea (6.0% & 1.8% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea resulted in dose reductions or interruption (5.1% and 2.8%, respectively) and discontinuation (1.2% and 0.5%, respectively) of Tarceva-treated patients.
