This copy is for your personal, non-commercial use only.

 

WEBSITE PRIVACY STATEMENT

At Cephalon, we understand that numerous laws and regulations around the world govern data protection and we respect the fact that protecting your privacy is important to you. We also recognize that health and medical information is particularly sensitive. For those reasons, we want to explain our Internet privacy policy to you in this Website Privacy Statement. Please review this Statement to learn about how Cephalon collects, uses, shares and protects information.

First and foremost, however, we only collect your personal information you if you choose to give it to us. Cephalon may share your personal information with various outside companies or agents working on our behalf to help fulfill business transactions, and we also may share personal information with our company’s affiliates. However, we do not share any of your personal information with third parties for their own marketing use unless you explicitly give us permission to do so.

This Website Privacy Statement applies only to personal information collected online from the various websites of Cephalon. Other Cephalon privacy policies govern personal information that is not collected on Cephalon websites.

INFORMATION COLLECTED - INFORMATION YOU GIVE US

At our web sites, we only collect your personal information (such as your name, address, telephone number or e-mail address) when you choose to submit it to us. For example, you may choose to register to receive additional product information or information about a disease state that interests you.

In some cases, we remove personal identifiers from data and maintain it in aggregate form. We may combine this data with other information to produce anonymous, aggregated statistical information helpful to us in improving our products and services.

AUTOMATICALLY COLLECTED INFORMATION

We automatically collect certain types of information whenever you interact with us on our sites and in some e-mails we may send each other. Automatic technologies we use may include, for example, web server logs and IP addresses, cookies and web beacons.

Web Server Logs and IP Addresses: An IP address is a number assigned to your computer whenever you access the Internet that allows computers and servers to recognize and communicate with each other. Cephalon collects IP addresses to conduct system administration and report aggregate information to affiliates, business partners, service providers and/or vendors to conduct web site analysis and performance reviews.

Cookies: A cookie is a piece of information that is placed on your computer when you access certain web sites. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make your web experience better and to conduct web site analysis and performance reviews. Most web browsers are set up to accept cookies, although you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

Web Beacons: On certain web pages or e-mails, Cephalon may utilize a common Internet technology called a “web beacon” (also known as an “action tag” or “clear GIF technology”). Web beacons help analyze the effectiveness of web sites by measuring, for example, the number of visitors to a site or how many visitors clicked on key elements of a site.

Web beacons, cookies and other tracking technologies do not automatically obtain personal information about you. Only if you voluntarily submit personal information, such as by registering or sending e-mails, can these automatic tracking technologies be used to provide further information about your use of the web sites to improve their usefulness to you.

YOUR CHOICES

You have certain options regarding your use of our sites. Cephalon may require you to provide certain personal information in order for you to receive additional product information or information about a disease state. You could decide not to submit any personal information at all by not entering it into any forms or data fields on our sites and not using any available personalized services. Certain web sites may ask for your permission for certain uses of your personal information and you can agree to or decline those uses. If you opt-in for particular services or communications, such as an e-newsletter, you will be able to unsubscribe at any time by following the instructions included in each communication. If you decide to unsubscribe from a service or communication, we will work to remove your information promptly, although we may require additional information before we can process your request.

As described above, if you wish to prevent cookies from tracking you anonymously as you navigate our sites, you can reset your browser to refuse all cookies or to indicate when a cookie is being sent. Note, however, that some portions of our sites may not work properly if you refuse cookies.

USE OF PERSONAL INFORMATION

Cephalon and/or the service providers, vendors and other third parties we hire to perform services on our behalf may use any personal information you choose to give us to comply with your requests or as otherwise disclosed to you in this Website Privacy Statement or on the web page where you submit your information to us. We may refer to this information to better understand your needs and how we can improve our products and services.

We use aggregated information collected from our websites to help us understand trends and customer needs. For example, we may analyze the gender or age of visitors to sites about a particular medication or disease state, and we may use that analysis of aggregate data internally or share it with others.

DATA SHARING AND TRANSFER

Cephalon may share personal information about you with various outside companies or service providers or vendors working on our behalf to help fulfill business transactions, such as providing customer service, sending marketing communications about our products, services and offers, and doing technological maintenance. We may also share personal information with our company’s affiliates.

We may also disclose personal information for these purposes:

  1. in connection with the sale, assignment or other transfer of the business of the site to which the data relates;
  2. to respond to requests of government or law enforcement agencies or where required or permitted by applicable laws, court orders, or government regulations; or
  3. where needed for corporate audits or to investigate or respond to a complaint or security threat.

No Third-Party Direct Marketing Use: Cephalon will not sell or otherwise transfer the personal information you provide to us at our sites to any third parties for their own direct marketing use unless we provide clear notice to you and obtain your explicit consent for your data to be shared in this manner.

E-mail a Friend or Colleague: On some Cephalon sites, you can choose to send a link or a message to a friend or colleague referring them to a Cephalon web site. The e-mail addresses you may provide for a friend will be used to send your friend information on your behalf and will not be collected or used by Cephalon or other third parties for additional purposes.

Note to Users of Business or Professional Web Sites: If you have a business or professional relationship with Cephalon, we may use information you submit on our sites, including sites intended specifically for business and professional users, to fulfill your requests and develop our business relationship with you and the entities you represent. We may also share such information with third parties acting on our behalf.

LINKS TO OTHER SITES

Our sites contain links to a number of web sites that may offer useful information to our visitors. This Website Privacy Statement does not apply to those sites, and we recommend communicating with them directly for information on their privacy policies.

PRIVACY STATEMENT FOR CHILDREN UNDER 13

Cephalon does not knowingly collect or solicit personal information from anyone under the age of 13 or knowingly allow such persons to register on our websites. Our sites are not intended or designed to attract children under the age of 13. No one under age 13 is allowed to provide any personal information to Cephalon. If you are under 13, please do not send any information about yourself to Cephalon, including your name, address, telephone number, or email address. In the event that we learn that we have collected personal information from a child under age 13, we will delete that information as quickly as possible. If you believe that we might have any information from or about a child under 13, please contact us at globalprivacy@cephalon.com and we will delete such information.

ADDITIONAL INFORMATION ON WEB SITES

If a Cephalon web site has particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which your personal information is collected.

UPDATES TO WEBSITE PRIVACY STATEMENT

From time to time, Cephalon may revise this Website Privacy Statement. Any such changes will be promptly communicated on Cephalon’s websites. Continued use of our sites after receiving notice of a change in our Website Privacy Statement indicates your consent to the use of newly submitted personal information in accordance with the amended Website Privacy Statement.

HOW TO CONTACT CEPHALON

If you have any questions about Cephalon’s Website Privacy Statement or the information practices of our sites, you may contact us as follows:

Cephalon, Inc.
41 Moores Road
PO Box 4011
Frazer, PA 19355
610-344-0200
globalprivacy@cephalon.com


Effective Date: May 9, 2008

Important Information for Physicians

Indications

NUVIGIL® (armodafinil) is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSA), shift work sleep disorder (SWD) and narcolepsy.

In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice, the encouragement of and periodic assessment of CPAP compliance is necessary and a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is important. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

Important Safety Information

Warnings

Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults in association with the use of armodafinil and in adults and children in association with use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).

No serious skin rashes have been reported in adult clinical trials (0 per 1,595) of armodafinil. However, cases of serious rash have been reported in adults in postmarketing experience. Because armodafinil is the R isomer of modafinil, a similar risk of serious rash in pediatric patients with armodafinil cannot be ruled out.

In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients; these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). No serious skin rashes have been reported in adult clinical trials of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in postmarketing experience with modafinil.

Although benign rashes occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated with NUVIGIL. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis.

Multi-organ hypersensitivity reactions, including at least 1 fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. If a multi-organ hypersensitivity reaction is suspected, NUVIGIL should be discontinued.

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Precautions

  • Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that NUVIGIL therapy will not adversely affect their ability to engage in such activities.
  • Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. NUVIGIL should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on NUVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on NUVIGIL.
  • NUVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome P450 isoenzymes.
  • The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.
  • The concomitant use of NUVIGIL and alcohol has not been studied and should be avoided.

Common Adverse Reactions

In clinical trials, the most commonly reported adverse events (≥5%) were headache, nausea, dizziness, and insomnia. Most adverse experiences were rated as mild to moderate.

Drug Abuse and Dependence

NUVIGIL is a Schedule IV drug. Although the abuse potential of NUVIGIL has not been studied, its abuse potential is likely to be similar to that of modafinil. Modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Please see full prescribing information for NUVIGIL.