Internet Privacy Statement

About Your Privacy
The following outlines the Arbor Pharmaceuticals, LLC, Internet Privacy Statement regarding your use of our Web site.

Arbor Pharmaceuticals is aware of our visitors' concern for privacy when using this Web site. We want to give our Web site visitors the opportunity to know what information we collect about them and how they can limit the use of individually identifiable information beyond the purposes for which they first provided it. At all times, however, we reserve the right to disclose information where required by law or to comply with valid legal processes (such as a search warrant, subpoena, or court order) to protect the company's rights or property, including, without limitation, the right to transfer the data in the event of a transfer of control of Arbor Pharmaceuticals or the sale of substantially all our assets, or during emergencies when safety is at risk.

Please be sure to read this entire Internet Privacy Statement before using or submitting information to this Web site. By using this Web site, you agree with the terms of this Internet Privacy Statement. Whenever you submit information via this Web site, you consent to the collection, use, and disclosure of that information in accordance with this Internet Privacy Statement. Your use of this Web site is also subject to the Terms of Use for this Web site, which is incorporated herein by reference.

Data We Collect and How We Use It

Personal Information
If you request company information through Horizant.com, we will collect personally identifiable information such as your name, address, phone number, e-mail address, survey information, Web site registrations or any other information that might reasonably be used to identify you individually. We collect personally identifiable information from Web site visitors only when it is voluntarily provided. The personal data you provide is considered private and confidential. It will be collected by a third-party vendor that acts as a hosting service for our Web site. This information may also be retained by an outside vendor for storage purposes. We will not sell, rent or exchange your personally identifiable information with unaffiliated entities without your express consent to such transfer.

We may also collect 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, Web site 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, to improve our Web site and our services, or to send updates or notices about our company and the products we offer that we think may be of interest to you.

We may also combine the personally identifiable information you provide with other generally or publicly available information to help us identify visitors' preferences or interests. We may use the information to improve the content of our Web site or our products and services. Again, we do not sell, rent, or otherwise share with unaffiliated entities any personally identifiable information we collect unless you are first notified and expressly consent to such transfer.

Non-Personally Identifiable Information
Our Web server captures the internet protocol (IP) addresses of each connection to our Web site and the specific Web pages visited during that connection. An IP address is a number assigned to your computer by your internet service provider so you can access the Internet. It is generally considered to be non-personally identifiable information because in most cases it changes each time you connect to the Internet. IP addresses may be used to diagnose problems with our server, report aggregate information, determine the fastest route for your computer to use in connecting to the Web site, and administer and improve the Web site. Although the IP address and related information collected is stored in the server log files, no individual is authorized to access those files for any purpose other than system maintenance. We may also use this information to help improve our Web site and our services by better understanding our audience. We may also collect non-personally identifiable information in aggregate form to track data such as the total number of visitors to each page of our Web site, and the domain names of our visitors' Internet service providers. We may use this information, which remains in aggregate form, to understand how our visitors use our Web sites so that we may make them better.

Children
Arbor Pharmaceuticals does not knowingly collect any personally identifiable information from children under 13 years old through this Web site. However, if the parent or the guardian of a child under 13 believes that the child has provided us with personally identifiable information, the parent or guardian of that child should contact us to request that this information is deleted from our files. Anyone under 18 years old should seek a parent's or guardian's permission prior to using or disclosing any personal information on this Web site.

How You Can Control and Update Data About You

Updating Contact Information
We want to be sure that we keep only the most accurate and up-to-date information about you in our records. Therefore, whenever you believe that your contact information needs to be updated, you can contact us to correct or update your contact information. You may choose at any time to remove your name, telephone number and postal and e-mail addresses from the list we use to send notices or updates and elect not to receive correspondence from us by contacting us.

Data Integrity and Security

We take reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our Web site and to protect your information from loss, misuse and unauthorized access, disclosure, alteration or destruction. All information transmitted to this Web site is secure to the extent possible using existing technology. You should keep in mind, however, that no Internet transmission is ever 100% secure or error free. In particular, e-mail sent to or from this Web site may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. Moreover, where you use passwords, ID numbers, or other special access features on this Web site, it is your responsibility to safeguard them.

Cookies
We use "cookies," a standard technology that is used by many Web sites. A cookie is a small piece of data that is sent from a Web server to a Web browser and stored locally on the user's machine. The cookie is stored on the user's machine but is not an executable program. Cookies are managed by your browser. They enable us to track each time you revisit our site. If you do not want us to be able to track your visits to our site, you can disable cookies by turning them off in your browser.

Our cookies do not acquire any personally identifiable information. We use cookies to gather general traffic pattern and site usage information. We believe this allows us to continually improve our site for our users. Arbor Pharmaceuticals will not sell, trade, lease or reveal information that is obtained through cookies on your computer to any third party.

Hyperlinks
This Web site may provide links to other Web sites as a service to our visitors. These are Web sites we believe may have helpful information. However, we do not endorse, and are not responsible for, the content of third-party Web sites. Nor does Arbor Pharmaceuticals have any control over information you may choose to provide to those Web sites.

The privacy policy described here does not apply to third-party Web sites, even if they are linked to Arbor Pharmaceuticals's Web sites. Other Web sites you visit may have their own privacy policies or no policy at all. Other Web sites might use personal information differently than our policy permits. We strongly encourage you to review the privacy policies of any Web site before providing any personal information.

Future Updates

If we make changes to this privacy policy, we will post new information on this page for your convenience. Please check this Internet Privacy Statement regularly for any changes.

Questions
Questions about the Arbor Pharmaceuticals Internet Privacy Statement may be directed to Arbor Pharmaceuticals, LLC, Six Concourse Parkway, Suite 1800, Atlanta, GA 30328, or call 678-334-2420.

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INDICATIONS

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults. HORIZANT is not recommended for patients who are required to sleep during the daytime and remain awake at night.

HORIZANT® (gabapentin enacarbil) Extended-Release Tablets are indicated for the management of postherpetic neuralgia (PHN) in adults.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Effects on Driving
HORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.

Somnolence/Sedation and Dizziness
HORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

Lack of Interchangeability With Gabapentin
HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of HORIZANT results in different plasma concentrations of gabapentin relative to other gabapentin products. The safety and effectiveness of HORIZANT in patients with epilepsy have not been studied.

Suicidal Behavior and Ideation
HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. As a prodrug of gabapentin, HORIZANT also increases this risk. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Anyone considering prescribing HORIZANT must balance the risk of suicidal thoughts or behavior with the risk of untreated illness.

Patients, caregivers, and families should be informed that HORIZANT increases the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. HORIZANT is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.

It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. HORIZANT should be discontinued if an alternative etiology for the signs or symptoms cannot be established.

Discontinuation of HORIZANT
When discontinuing HORIZANT, patients with RLS receiving 600 mg or less once daily can discontinue the drug without tapering. If the recommended dose is exceeded, the dose should be reduced to 600 mg daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

In patients with PHN receiving HORIZANT twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.

Tumorigenic Potential
In an oral carcinogenicity study, gabapentin enacarbil increased the incidence of pancreatic acinar cell adenoma and carcinoma in male and female rats. The clinical significance of this finding is unknown.

ADVERSE REACTIONS
The most common adverse reactions for patients with RLS (incidence >10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness.

The most common adverse reactions for patients with PHN (incidence >10% and greater than placebo) were dizziness, somnolence, and headache.

DRUG INTERACTIONS
Gabapentin enacarbil is released faster from HORIZANT Extended-Release tablets in the presence of alcohol. Consumption of alcohol is not recommended when taking HORIZANT.

HORIZANT taken in conjunction with morphine causes increased somnolence/sedation, dizziness, and nausea.

USE IN SPECIAL POPULATIONS

Pregnancy and Lactation
Pregnancy Category C. There are no adequate and well-controlled studies with HORIZANT in pregnant women. In nonclinical studies in rat and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically. HORIZANT should be used during pregnancy only if potential benefit justifies potential risk to fetus.

It is not known whether gabapentin derived from HORIZANT is secreted in human milk; however, gabapentin is secreted into human milk following oral administration of gabapentin products. Because of the potential for adverse reactions in nursing infants from HORIZANT, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use
Safety and effectiveness of HORIZANT in pediatric patients have not been studied.

Renal Impairment
Gabapentin is known to be almost exclusively excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. The dose of HORIZANT should be adjusted in patients with renal impairment based upon creatinine clearance. HORIZANT is not recommended for treatment of RLS in patients receiving hemodialysis.

For additional safety information, consult the HORIZANT full Prescribing Information here.

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.

VIEW FULL IMPORTANT SAFETY INFORMATION

Effects on Driving
HORIZANT may cause significant driving impairment. The duration of driving impairment after starting therapy is unknown. Patients should not drive until they have enough experience on HORIZANT to know if it impairs their driving. Patients’ ability to assess their driving competence and degree of somnolence caused by HORIZANT can be imperfect.

Somnolence/Sedation and Dizziness
HORIZANT causes somnolence/sedation and dizziness. Patients should not drive or operate other complex machinery until they have enough experience on HORIZANT to know if it impairs their ability to perform these tasks.

 

References

  1. Horizant [prescribing information]. Atlanta, GA: Arbor Pharmaceuticals, LLC.

  2. The International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study. Group Rating Scale for restless legs syndrome. Sleep Med. 2003;4(2):121-132.

  3. Allen RP, Walters AS, Montplaisir J, et al. Restless Legs Syndrome prevalence and impact: REST General Population Study. Arch Intern Med. 2005;165:1286-1292.

  4. Lee DO, Ziman RB, Perkins AT, Poceta JS, Walters AS, Barrett RW, for the XP053 Study Group. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with Restless Legs Syndrome. J Clin Sleep Med. 2011;7(3):282-292.

  5. Cundy KC, Sastry S, Luo W, Zou J, Moors TL, Canafax DM. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol. 2008;48(12):1378-1388.

  6. García-Borreguero D, Kohnen R, Silber MH, et al. The long-term treatment of Restless Legs Syndrome/Willis–Ekbom disease: evidence-based guidelines and clinical consensus best practice guidance. A report from the International Restless Legs Syndrome Study Group. Sleep Med. 2013:14:675-684.

  7. Kushida CA, Becker P, Ellenbogen AL, Canafax DM, Barrett RW, for the XP052 Study Group. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology. 2009;72(5):439-446.

  8. Comella CL. Treatment of restless legs syndrome. Neurotherapeutics 2014;11(1):177-187.

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