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Terms of Use

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

2. User Eligibility; Consent
These websites are provided by Upsher-Smith solely for use within the United States. Upsher-Smith makes no representations or warranty that the websites are usable and accurate outside of the United States. The websites are 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 websites 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 websites. 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 websites 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 either of these websites, 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 websites except as expressly specified in these Terms and Conditions of Use or elsewhere on each website.

5. Product and Service Information
The websites provide users with information regarding Upsher-Smith’s Qudexy® XR product. Periodically, Upsher-Smith may add new features or information on the websites, 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 either 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 websites (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 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 QudexyXR.com or HCP.QudexyXR.com WEBSITES, 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 websites 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 QudexyXR.com or HCP.QudexyXR.com websites. 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 QudexyXR.com or HCP.QudexyXR.com websites at any time without notice. By using the websites 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 committed to conducting our business in accordance with these principles in order to ensure that the confidentiality of personal information is protected and maintained.

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IMPORTANT SAFETY INFORMATION

WARNINGS & PRECAUTIONS
  • Acute Myopia and Secondary Angle Closure Glaucoma. A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in patients receiving topiramate, with symptoms typically occurring within 1 month of therapy initiation.  The primary treatment to reverse symptoms is discontinuation of Qudexy XR as rapidly as possible. If left untreated, elevated intraocular pressure can lead to serious sequelae, including permanent vision loss.
  • Visual Field Defects. Visual field defects have been reported in patients receiving topiramate independent of elevated intraocular pressure. If visual problems occur at any time during topiramate treatment, consideration should be given to discontinuing the drug.
  • Oligohydrosis and Hyperthermia. Oligohydrosis, resulting in hospitalization in some cases, has been reported in association with topiramate use. The majority of reports have been in pediatric patients, but all patients should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. Caution should be used when Qudexy XR is prescribed with other drugs that predispose patients to heat-related disorders.
  • Metabolic Acidosis. Qudexy XR can cause hyperchloremic, non-anion gap metabolic acidosis due to its inhibitory effect on carbonic anhydrase. Conditions that predispose patients to acidosis may be additive to the bicarbonate lowering effects of topiramate. Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering).
  • Suicidal Behavior and Ideation. Antiepileptic drugs (AEDs), including Qudexy XR increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients, their caregivers, and families should be informed of these risks, and behaviors of concern should be immediately reported to healthcare providers.
  • Cognitive/Neuropsychiatric Adverse Reactions. Immediate-release topiramate can cause, and therefore, Qudexy XR is expected to cause, cognitive/neuropsychiatric adverse reactions. In adults, the most frequent of these can be classified into three general categories: cognitive-related dysfunction, psychiatric/behavioral disturbances, and somnolence/fatigue. In pediatric epilepsy trials, adverse reactions included psychomotor slowing, difficulty with concentration/attention, speech disorders/related speech problems, and language problems. In migraine prophylaxis controlled trials, the most common cognitive adverse reaction was difficulty with memory. Patients should use caution when operating machinery including automobiles. Depression and mood problems may occur.
  • Fetal Toxicity. Topiramate can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed to topiramate in utero have an increased risk of cleft lip and/or cleft palate and of being small for gestational age. Qudexy XR should be used during pregnancy only if the potential benefit outweighs the potential risk. All women of childbearing potential should be informed of the potential hazard to the fetus and counseled to use effective contraception, keeping in mind that there is a potential for decreased contraceptive efficacy when using estrogen-containing birth control with topiramate.
  • Withdrawal of Antiepileptic Drugs. Antiepileptic drugs, including Qudexy XR, should be gradually withdrawn to minimize the potential for seizures or increased seizure frequency.
  • Hyperammonemia and Encephalopathy. Topiramate treatment can cause hyperammonemia, with and without encephalopathy. The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when used concomitantly with valproic acid. Patients with inborn errors of metabolism or reduced mitochondrial activity may have an increased risk of hyperammonemia. Measure ammonia if encephalopathic symptoms occur.
  • Kidney Stones. Topiramate increases the risk of kidney stones. Topiramate is a carbonic anhydrase inhibitor. Carbonic anhydrase inhibitors can promote stone formation by reducing urinary citrate excretion and by increasing urinary pH.  The concomitant use of Qudexy XR with any other drug producing metabolic acidosis, or potentially in patients on a ketogenic diet, may create a physiological environment that increases the risk of kidney stone formation, and should therefore be avoided.  Increased fluid intake increases the urinary output, lowering the concentration of substances involved in stone formation.  Hydration is recommended to reduce new stone formation.
  • Hypothermia with Concomitant Valproic Acid Use. Hypothermia has been reported in association with topiramate use with concomitant valproic acid, both in the presence and in the absence of hyperammonemia. Consideration should be given to stopping topiramate or valproate in patients who develop hypothermia.

USE IN SPECIFIC POPULATIONS
  • Nursing Mothers: Topiramate is excreted in human milk. The effects of topiramate on milk production are unknown. Diarrhea and somnolence have been reported in breastfed infants whose mothers receive topiramate treatment. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Qudexy XR and any potential adverse effects on the breastfed infant from Qudexy XR or from the underlying maternal
  • Females of Reproductive Potential: Women of childbearing potential who are not planning a pregnancy should use effective contraception because of the risks to the fetus of oral clefts and of being small for gestational age.
  • Pregnancy: Increased risk of cleft lip and/or palate and for being small for gestational age.
  • Patients with Renal Impairment: One-half of the usual adult dose is recommended.
  • Patients Undergoing Hemodialysis: To avoid rapid drops in topiramate plasma concentration, a supplemental dose of topiramate may be required.
  • Geriatric use: Dosage adjustment may be necessary for elderly with impaired renal function.

DRUG INTERACTIONS
  • Antiepileptic Drugs: Concomitant administration of phenytoin or carbamazepine with topiramate resulted in a clinically significant decrease in plasma concentrations of topiramate. A dosage adjustment may be needed. Concomitant administration of valproic acid and topiramate has been associated with hypothermia and hyperammonemia with or without encephalopathy.
  • CNS Depressants: Qudexy XR should be used with extreme caution if used in combination with alcohol and other CNS depressants.
  • Oral Contraceptives: The possibility of decreased contraceptive efficacy and increased breakthrough bleeding may occur.
  • Lithium: Lithium levels should be monitored when co-administered with high-dose Qudexy XR.
  • Other Carbonic Anhydrase Inhibitors: Patients should be monitored for the appearance or worsening of metabolic acidosis when Qudexy XR is given concomitantly with another carbonic anhydrase inhibitor.
  • Hydrochlorothiazide (HCTZ): The addition of HCTZ to Qudexy XR may require a decrease in the Qudexy XR dose.
  • Pioglitazone: When Qudexy XR is added to pioglitazone therapy or pioglitazone is added to Qudexy XR therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
  • Amitriptyline: Some patients may experience a large increase in amitriptyline concentration in the presence of Qudexy XR and any adjustments in amitriptyline dose should be made according to the patient’s clinical response and not on the basis of plasma levels.

ADVERSE REACTIONS
  • Epilepsy: The most common adverse reactions in adult and pediatric controlled, clinical trials of immediate-release topiramate were: paresthesia, anorexia, weight loss, speech disorders and related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision, and fever.
  • Migraine: The most common adverse reactions at recommended doses in adult and adolescent controlled, clinical trials were: paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.
  • Qudexy XR has been studied in a randomized, placebo-controlled, phase 3 clinical study in 249 adult patients with a history of partial-onset seizures with or without secondary generalization. See the ADVERSE REACTIONS section of the Qudexy XR full prescribing information for adverse reaction rates from this clinical trial.
  • The most serious adverse reactions are listed above in the WARNINGS AND PRECAUTIONS section.


INDICATIONS
Qudexy® XR (topiramate) Extended-Release Capsules are indicated for:
  • Migraine: Prophylaxis of migraine in patients 12 years and older.
  • Epilepsy: Initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older. Adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 2 years and older.


This safety information is not comprehensive.  Please refer to the full Prescribing Information for Qudexy XR, WARNINGS AND PRECAUTIONS and Medication Guide.  You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC. at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC
All other marks are the property of their respective owners.



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