Privacy Policy
Vanda Pharmaceuticals Inc. values your privacy and the security of your information. This Privacy Policy explains how Vanda ("Vanda," "we," or "us") collects and uses information obtained from users in connection with Fanapt.com and any of our other sites or services that link to this Privacy Policy (collectively, the "Services"). Please read the entire Privacy Policy before using our Services. By using the Services, you agree to abide by the terms of this Privacy Policy.
California Residents: for more information please click here
Information Collected.
You generally are not required to provide information about yourself when you visit the Services. However, we may ask you for some or all of the following types of information when you request additional information about FANAPT®(iloperidone). When you do so, our registration process requires you to provide your name, telephone number, email address and certain additional information about your interest in FANAPT® (collectively, "Subscription Data").
We also may collect certain information automatically when you visit the Services, including:
- Your browser type and operating system;
- Your Internet Protocol (IP) address, which is the number automatically assigned to your computer whenever you access the Internet and that can sometimes be used to derive your general geographic area;
- Other unique identifiers, including mobile device identification numbers;
- Sites you visited before and after visiting the Services;
- Pages you view and links you click on within the Services;
- Information collected through cookies, web beacons and other technologies;
- Information about your interactions with e-mail messages, such as the links clicked on and whether the messages were opened or forwarded; and
- Standard Server Log Information
Use of Information.
Vanda may use information that we collect through the Services to provide you with products, promotions, services, newsletters and information in accordance with your preferences and to respond to correspondence that we receive from you. Sometimes, we may use the information that we collect to contact you via email, telephoneor otherwise about FANAPT® (iloperidone), Vanda and our products and services; to learn more about your experience with FANAPT®; or to otherwise provide you with information that might be of interest to you. At your election at any time, you may choose to stop receiving future communications from Vanda ("opt-out;" see below for more information on how to opt-out). We also may use information that we collect to maintain or administer the Services, perform business analyses or for other internal purposes to improve the quality of our business, the Services and other products and services we offer. For example, Vanda uses information collected automatically to help diagnose problems with its server, analyze trends and administer the Services. We also may use information that you provide to customize and personalize your use of the Services and as otherwise described to you at the point of collection or pursuant to your consent.
Sharing of Information.
We are committed to maintaining your trust and we want you to understand when and with whom we may share the information we collect.
- Service Providers. We may share your information with service providers that perform certain functions or services on our behalf (such as to host the Services, manage databases, perform analyses or send communications for us).
- Other Parties When Required By Law or as Necessary to Protect the Services. We may disclose information to third parties if (1) required by law or (2) we have a good faith belief that such action is necessary to conform to applicable laws or comply with any legal, regulatory or similar requirement or investigation, to protect or defend the rights or property of Vanda, our corporate parents, affiliates and subsidiaries, or the users of our Services or to enforce the Terms of Use.
- In Connection With a Transfer of Assets. If we sell all or part of our business or make a sale or transfer of assets or are otherwise involved in a merger or business transfer or in the event of bankruptcy, we may transfer your information to one or more third parties as part of that transaction.
- Other Parties With Your Consent. We may share information about you with third parties when you consent to such sharing.
Security.
We take a number of steps to help protect against loss, misuse, unauthorized access, disclosure, alteration or destruction of the information you provide to us. Unfortunately, no data transmission over the Internet can be guaranteed to be 100% secure. As a result, Vanda cannot ensure the security of any information you provide and you do so at your own risk.
Children's Privacy.
The Services do 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").
Third Party Sites.
The Services may permit you to link to other websites on the Internetand other websites may contain links to the Services. These other websites are not under Vanda's control. The privacy and security practices of websites linked to or from the Services are not covered by this Privacy Policyand Vanda is not responsible for the privacy or security practices or the content of such websites.
Cookies, Pixel Tags and Similar Technologies.
Vanda also uses cookies, pixel tags, Local Shared Objects and similar technologies to automatically collect certain information, such as your browser type and operating system, IP address and other unique identifiers. "Cookies" are pieces of information that a website transfers to your computer's hard disk for record-keeping purposes. Pixel tags are very small images or small pieces of data embedded in images, also known as "web beacons" or "clear GIFs," that can recognize cookies, the time and date a page is viewed, a description of the page where the pixel tag is placed and similar information from your computer or device. Local Shared Objects (sometimes referred to as "Flash Cookies") are similar to standard cookies except that they can be larger and are downloaded to a computer or mobile device by the Adobe Flash media player. Vanda generally uses cookies and similar technologies to determine which areas of the Services users have visited and to compare users' experiences in using the Services so that it may better tailor the Services for them. You may be able to set your web browser to refuse cookies. However, if you choose to reject cookies, you may not be able to use certain online products, services or features on the Services. Please note that you may need to take additional steps beyond changing your browser settings to refuse or disable Local Shared Objects and similar technologies. For example, Local Shared Objects can be controlled through the instructions on Adobe's Setting Manager page. By using the Services, you consent to our use of cookies and similar technologies.
We may allow third parties to place and read their own cookies, pixel tags, web beacons, Local Shared Objects and similar technologies to collect information through the Services. For example, our third-party service providers may use these technologies to collect information that helps us with traffic measurement, research, analytics, and providing you with relevant advertisements. Opt-Out.
You may elect to avoid future communications from Vanda by sending an email to opt-out@vandapharma.com with your electronic mail address. Your California Privacy Rights
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 transmittedor 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, we currently do 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 Services.
Vanda does not share information that it collects with third parties for the third party's direct marketing purposes. Changes.
Vanda reserves the right to change or update this Privacy Policy at any time by posting a notice on the Services. Information collected by the Services is subject to the Privacy Policy in effect at the time of use. Contact.
If you have any questions regarding this Privacy Policy or the Services, please contact Vanda at:
Vanda Pharmaceuticals Inc.
Attn: Privacy Statement
2200 Pennsylvania Ave NW
Suite #300E
Washington DC 20037
Tel: 202-734-3400
Email: privacy@vandapharma.com
INDICATION AND IMPORTANT SAFETY INFORMATION
Fanapt® (iloperidone) is a prescription medication used for the treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
WARNING: Elderly patients with psychosis related to dementia (having lost touch with reality due to memory loss and experiencing a decline in day-to-day functioning) who are treated with antipsychotic medications are at an increased risk of death compared to patients treated with a placebo. Fanapt® is not approved for use in people with dementia-related psychosis.
WARNINGS AND PRECAUTIONS
- Patients should not use Fanapt® if they have a known allergy to Fanapt® or its ingredients. Allergic reactions, including anaphylaxis, rapid swelling of the skin (angioedema) and other symptoms of allergy (eg, throat tightness; swelling of the throat, face, lips, mouth and tongue; hives; rash and itching) have been reported.
- An increased risk of stroke has been reported in clinical studies of elderly people with dementia-related psychosis. Fanapt® is not approved for use in people with dementia-related psychosis.
- Fanapt® may change your heart rhythm (meaning there is more time between heartbeats). Heart rhythm changes have occurred in patients taking Fanapt® and are a risk factor for serious, even life-threatening medical issues. You should tell your healthcare provider if you have or have had heart problems. Contact your healthcare provider right away if you feel faint or have unpleasant feelings of irregular or forceful heartbeats as any of these feelings could be a sign of a rare, but serious side effect that could be fatal. You should not use Fanapt® with other drugs that are known to cause these same heart rhythm issues.
- Tell your healthcare provider if you have some or all of the following symptoms: very high fever, rigid muscles, shaking, confusion, sweating or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect that could be fatal. This may happen with Fanapt® or drugs like it.
- Abnormal or uncontrollable movements of the face, tongue or other parts of the body may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent. The chance of this condition going away decreases, depending on how long and how much medication has been taken. Tell your healthcare provider if you have body movements you can't control.
- Fanapt® and medicines like it have been associated with metabolic changes (high blood sugar, high cholesterol and triglycerides, and weight gain) that can increase cardiovascular/cerebrovascular risks. Increases in blood sugar levels (hyperglycemia), which in some cases can be serious and associated with coma or death, have been reported in patients taking Fanapt® and medicines like it. Changes in cholesterol and triglycerides have been seen in patients taking Fanapt® and medicines like it. Some patients may gain weight while taking Fanapt®. Your healthcare provider should check your blood sugar, fat levels and weight before you start and regularly while you take Fanapt®.
- Tell your healthcare provider about any medical conditions that you have, including problems with your liver. Fanapt® is not recommended for patients with severe liver problems.
- Tell your healthcare provider if you have a history of or have a condition that may increase your risk for seizures before you begin taking Fanapt®.
- Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with Fanapt®. This condition is most common when you start therapy, when restarting treatment or when the dose of Fanapt® is increased. You should consult your healthcare provider if you have or have had heart problems or conditions that lead to these sudden changes since Fanapt® should be used with caution in these patients.
- Fanapt® may increase the risk of falls, which could cause fractures or other injuries.
- Decreases in infection-fighting white blood cells (WBCs) have been reported in some patients taking antipsychotic agents. Patients with a preexisting history of low WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy. Some (including fatal) cases of agranulocytosis, a serious decrease in specific types of WBCs called neutrophils or granulocytes, have been reported in drugs like Fanapt®.
- Fanapt® can increase the level of the hormone prolactin. Tell your healthcare provider if you experience breast enlargement, breast pain or breast discharge, abnormal menstrual cycles in females or impotence in males. If elevated levels of prolactin persist, this may lead to bone loss.
- Medicines like Fanapt® can impact your body's ability to reduce your body temperature. You should avoid overheating and dehydration.
- Fanapt® and medicines like it have been associated with swallowing problems (dysphagia). If you have or have had swallowing problems, you should tell your healthcare provider.
- For males, in the rare event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using Fanapt® and seek immediate medical attention.
- Fanapt® and medicines like it can affect your judgment, thinkingor motor skills. You should not drive or operate hazardous machinery, including automobiles, until you know how Fanapt® affects you.
- A condition called intraoperative floppy iris syndrome has been observed in some patients taking drugs like FANAPT®. Please tell your healthcare provider if you take or have taken Fanapt® before cataract or other eye surgeries.
- The most common side effects for Fanapt® versus placebo in patients with schizophrenia were dizziness, dry mouth, feeling unusually tired or sleepy, stuffy nose, feeling faint/light-headed when standing quickly, racing heartbeat and weight gain. The most common side effects for Fanapt® versus placebo in a clinical study of patients with bipolar I disorder were racing heartbeat, dizziness, dry mouth, increase in liver enzymes, stuffy nose, weight gain, low blood pressure and feeling unusually tired or sleepy. Compared to placebo, the average weight gain in clinical studies in schizophrenia lasting 4 to 6 weeks was 6 poundsand in a clinical study of patients with bipolar I disorder over 4 weeks was 7 pounds. If you experience any of these symptoms, talk with your healthcare provider.
- When taking Fanapt®, you should avoid drinking alcohol and you should not breastfeed.
- You should notify your healthcare provider if you become pregnant or intend to become pregnant while taking Fanapt®.
- Tell your healthcare provider about all prescription and non-prescription medicines and supplements you are taking. Some medications may interact with Fanapt®.
- To access the full Prescribing Information, including BOXED WARNING, visit www.Fanapt.com.
- You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.