PROVIGIL | HCP | Privacy Policy

At Cephalon, we understand that protecting your privacy is important and that your health information is particularly sensitive. We only collect personally identifiable information about you if you choose to give it to us. Please review this Privacy Statement to learn more about how Cephalon collects, uses, shares and protects information online.

Cephalon shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, and we also may share personally identifiable data with our company's affiliates. However, we do not share any of your personally identifiable information with third parties for their own marketing use unless you explicitly give us permission to do so.

INFORMATION COLLECTED

Information You Give Us

At our websites, we only collect your personally identifiable information (such as your name, address, telephone number or email 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 also 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 receive certain types of information whenever you interact with us on our sites and in some emails 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. All computer identification on the Internet is conducted with IP addresses, which allow 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 and/or vendors to conduct site analysis and website performance review.

Cookies

A cookie is a piece of information that is placed on your computer when you access certain websites. The cookie uniquely identifies your browser to the server. Cookies allow us to store information on the server to help make the Web experience better for you and to conduct site analysis and website performance review. 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 emails, 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 websites 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 personally identifiable information about you. Only if you voluntarily submit personally identifiable information, such as by registering or sending emails, can these automatic tracking technologies be used to provide further information about your use of the websites and/or interactive emails to improve their usefulness to you.

YOUR CHOICES

You have several choices regarding your use of our websites. Cephalon may require you to provide certain personally identifiable information in order for you to receive additional product information or information about a disease state. You could decide not to submit any personally identifiable information at all by not entering it into any forms or data fields on our sites and not using any available personalized services. Certain sites may ask for your permission for certain uses of your 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 DATA

Cephalon and/or the companies we hire to perform services on our behalf will use any personally identifiable information you choose to give us to comply with your requests or as otherwise disclosed to you in this 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 (non-personally identifiable) information 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 shares personally identifiable data about you with various outside companies or agents working on our behalf to help fulfill business transactions, such as providing customer services, sending marketing communications about our products, services and offers, and doing technological maintenance. We may also share personally identifiable data with our company's affiliates.

We may also disclose personally identifiable information for these purposes:

(a) in connection with the sale, assignment or other transfer of the business of the site to which the data relates;
(b) to respond to appropriate requests of legitimate government agencies or where required by applicable laws, court orders, or government regulations; or
(c) 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 personally identifiable information you provide to us at our websites 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.

Email 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 website. Email 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.

LINKS TO OTHER SITES

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

Privacy Statement for Children

Our websites are not intended or designed to attract children under the age of 13. We do not collect any personally identifiable information from anyone we know to be under the age of 18.

Additional Information on Websites

If a website has particular provisions relating to privacy that differ from those stated here, those provisions will be disclosed to you on the page on which personally identifiable information is collected.

Note to Users of Business or Professional Websites

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.

Updates to Privacy Statement

From time to time, Cephalon may revise this Privacy Statement. Any such changes to this Privacy Statement will be promptly communicated on this page. Continued use of our sites after receiving notice of a change in our Privacy Statement indicates your consent to the use of newly submitted information in accordance with the amended Cephalon Privacy Statement. The effective date of this Privacy Statement is May 9, 2005.

How to Contact Cephalon

If you have any questions about the Cephalon 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

INDICATIONS

PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder.

In OSAHS, PROVIGIL 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 PROVIGIL. 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 INFORMATION FOR PHYSICIANS

Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with use of modafinil. 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. 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, postmarketing, in adults and children taking modafinil. PROVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

Modafinil 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 armodafinil, the R-enantiomer of modafinil. Angioedema has been reported in postmarketing experience with modafinil. 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, PROVIGIL 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 have included mania, delusions, hallucinations, and suicidal ideation, some resulting in hospitalization. In controlled trials in adults, psychiatric symptoms resulting in treatment discontinuation were anxiety, nervousness, insomnia, confusion, agitation, and depression. Caution should be exercised when PROVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing PROVIGIL if psychiatric symptoms develop.

Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. PROVIGIL tablets should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on PROVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on PROVIGIL.

PROVIGIL 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 PROVIGIL tablets and for one month after discontinuation of therapy.

The concomitant use of PROVIGIL and alcohol has not been studied and should be avoided.

In clinical trials, most adverse experiences were mild to moderate. The most frequently reported adverse events (≥5%) were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

PROVIGIL is a Schedule IV drug. PROVIGIL 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 PROVIGIL.

PRO1307