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1. Terms

By accessing the VIGAFYDE.com website provided by Upsher-Smith Laboratories, LLC (“Upsher-Smith”), you are agreeing to be bound by these website Terms and Conditions of Use, which constitute the agreement that governs your use of the VIGAFYDE.com website. You should carefully read these Terms and Conditions of Use before using the site. If you do not agree to be bound by these terms of use, you should immediately exit the site.

2. User Eligibility; Consent

The VIGAFYDE.com website is provided by Upsher-Smith solely for use within the United States. Upsher-Smith makes no representations or warranty that the VIGAFYDE.com website is usable and accurate outside of the United States. The VIGAFYDE.com website is not intended for use by children under the age of 13. Upsher-Smith will not knowingly collect information about children under the age of 13 and will otherwise comply with the Children’s Online Privacy Act. Any user of the website should monitor the use of the website by children under their care and ensure that those children are aware of the dangers of providing information about themselves over the Internet.

3. License and Site Access

Upsher-Smith hereby grants you permission to access and make personal, non-commercial use of the VIGAFYDE.com website. You may view, copy, print and distribute limited quantities of material from the website, so long as the material is used by you solely for informational, non-commercial purposes. Your permission to access and use the website will be deemed automatically to have been terminated, effective immediately, should you breach these Terms and Conditions of Use. Any rights not expressly granted to you by these Terms and Conditions of Use are expressly reserved by Upsher-Smith.

4. Intellectual Property

All intellectual property associated with the VIGAFYDE.com website, including, without limitation, its content, trademarks, service marks, trade dress and other proprietary intellectual property appearing on the website or referenced therein, are the sole property of Upsher-Smith. Any rights associated with any such item of intellectual property are retained by its owner and protected by applicable law. These Terms and Conditions of Use expressly prohibit any use of any intellectual property associated with the website except as expressly specified in these Terms and Conditions of Use or elsewhere on the website.

5. Product and Service Information

The VIGAFYDE.com website provides users with information regarding Upsher-Smith’s VIGAFYDE product. Periodically, Upsher-Smith may add new features or information on the website, all of which will be subject to these Terms of Use. You are encouraged to periodically review the current version of these Terms of Use. Upsher-Smith shall have no responsibility for errors of any kind in connection with the VIGAFYDE.com website. Errors and the consequences of those errors may include, without any limitation, any of the following: technical, typographical, or photographic errors. Upsher-Smith does not warrant that any of the materials on its website are accurate, complete, or current. Upsher-Smith may make changes to the materials contained on its website at any time without notice. Upsher-Smith does not, however, make any commitment to update the materials.

6. No Warranty

The VIGAFYDE.com website (including any content or information contained within it), any other Upsher-Smith website, and any linked website, is provided “as is” and on an “as available” basis. AS TO THE SITE, AND TO ANY OTHER SUCH UPSHER-SMITH WEBSITE AND LINKED WEBSITE, TO THE FULLEST EXTENT PERMITTED BY LAW, UPSHER-SMITH EXPRESSLY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FIRMNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

You assume total responsibility for your use of the VIGAFYDE.com website and any linked website. Any material downloaded or otherwise obtained through your use of the website is so obtained at your own discretion and risk. Upsher-Smith will not be responsible for any damage to your computer system or loss of data that results from so obtaining any such material.

7. Limitation of Liability

IN NO EVENT SHALL UPSHER-SMITH, ITS RELATED ENTITIES, SUBSIDIARIES, JOINT VENTURES, PARTNERS, OFFICERS, DIRECTORS OR EMPLOYEES BE LIABLE FOR ANY DIRECT, INDIRECT, COMPENSATORY, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES WHICH MAY ARISE, DIRECTLY OR INDIRECTLY, FROM THE ACCESS TO THE VIGAFYDE.com WEBSITE, FROM THE USE OF IT, FROM THE INABILITY TO USE IT, THROUGH THE AUTHORIZED DOWNLOADING OF ANY CONTENT (INCLUDING, WITHOUT LIMITATION, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE WEBSITE) OR IN CONNECTION WITH ANY VIRUSES, BUGS, ACTION OR INACTION OF ANY COMPUTER SYSTEM, TELEPHONE LINE, HARDWARE, SOFTWARE OR PROGRAM MALFUNCTION, OR ANY OTHER ERROR, FAILURE OR DELAY IN DATA TRANSMISSION OR NETWORK CONNECTION EVEN IF ADVISED OF THE POSSIBILITY OF THAT DAMAGE.

Upsher-Smith has no liability for the deletion of any communications or information collected, maintained, or transmitted by the VIGAFYDE.com website or the failure to store any information, including personalized settings. Upsher-Smith has no liability with respect to any information posted by users on chat rooms, bulletin boards or any other user forum.

8. Links

Upsher-Smith is not responsible for the contents of any sites linked to the VIGAFYDE.com website. The inclusion of any link does not imply endorsement by Upsher-Smith of the site. Use of any such linked website is at your own risk.

9. Site Terms of Use Modifications

Upsher-Smith may revise these Terms and Conditions of Use for the VIGAFYDE.com website at any time without notice. By using this website you are agreeing to be bound by the then current version of these Terms and Conditions of Use.

10. Governing Law

Any claim relating to Upsher-Smith’s website shall be governed by the laws of the State of Minnesota without regard to its conflict of law provisions.

Privacy Policy

Your privacy is very important to us. The current privacy policy for Upsher-Smith may be viewed at http://www.upsher-smith.com/privacy-policy/

Upsher-Smith is very committed to conducting our business in accordance with these principles in order to ensure that the confidentiality of personal information is protected or maintained.

APPROVED USE

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW
ABOUT VIGAFYDE™ (vigabatrin) ORAL SOLUTION?

APPROVED USE

WHAT IS VIGAFYDE?
VIGAFYDE™ (vigabatrin) Oral Solution is a prescription medicine used to treat: Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your baby’s healthcare provider decide the possible benefits of taking VIGAFYDE are more important than the possible risk of vision loss.

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All caregivers of babies who take VIGAFYDE:

  • Your baby is at risk for permanent vision loss with any amount of VIGAFYDE.
  • Your baby’s risk of vision loss may be higher the more VIGAFYDE is taken daily and the longer it is taken.
  • It is not possible for your baby’s healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped.
  • Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your baby’s healthcare provider will explain the details of this Program to you.
  • VIGAFYDE can damage the vision of anyone who takes it. Some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called “tunnel vision”). Your baby may also have blurry vision. If this happens, it will not get better.
  • Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal. These changes can mean that vision damage has occurred.
  • Regular vision testing is recommended. It is recommended that your healthcare provider test your baby’s vision before or within 4 weeks after starting VIGAFYDE, and at least every 3 months during treatment until VIGAFYDE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGAFYDE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your baby’s healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
  • Vision tests cannot prevent the vision damage that can happen with VIGAFYDE, but they do allow VIGAFYDE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
  • If you do not have these vision tests regularly, your baby’s healthcare provider may stop prescribing VIGAFYDE. Your baby may not be able to complete vision testing. If vision testing cannot be done, the healthcare provider may continue prescribing VIGAFYDE but will not be able to watch for any vision loss.
  • Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGAFYDE. It is not known if these changes are harmful.
  • A type of swelling in the brain called intramyelinic edema (IME) has been seen in postmortem examination of infants treated with vigabatrin.
  • Risk of suicidal thoughts or actions. VIGAFYDE is approved for use in patients 1 month to 2 years of age [see WHAT IS VIGAFYDE?]. VIGAFYDE is not approved for use in adolescents or adults. Like other antiepileptic drugs, vigabatrin may cause suicidal thoughts and actions in some adolescents and adults (about 1 in 500 people). A healthcare provider should be called right away if a patient taking vigabatrin experiences any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worrying.
  • Do not stop VIGAFYDE without first talking to a healthcare provider. Stopping VIGAFYDE suddenly can cause seizures that will not stop.

VIGAFYDE is more concentrated than vigabatrin solutions prepared from powder. The volume of VIGAFYDE solution prescribed by your baby’s healthcare provider may be less than the volume prescribed for other vigabatrin solutions prepared from powder. Always double check the volume (mL) that you are to give your baby when you get a new prescription filled.

VIGAFYDE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, and weight gain.

VIGAFYDE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.

Before starting VIGAFYDE, tell your baby’s doctor about all of their medical conditions including any allergic reaction to vigabatrin, vision problems, kidney problems, or low red blood cell counts (anemia). Tell your doctor about all the medicines your baby is receiving.

The most common side effects of VIGAFYDE in babies include: sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable), swelling in the bronchial tubes (bronchitis), ear infection and irritability.

Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away.

This is the most important information to know about VIGAFYDE, but not all of the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGAFYDE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGAFYDE.com, upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

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