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Upsher-Smith Launches Newly Designed Website for Qudexy® XR (topiramate) Extended-Release Capsules

Qudexy® XR Now Indicated for the Prevention of Migraine Headache in Adults and Adolescents

Maple Grove, MN – August 21, 2017 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its enhanced website for Qudexy® XR (topiramate) Extended-Release Capsules. The site features Upsher-Smith’s Access Pathways Program designed to reduce the barriers associated with prescribing Qudexy® XR. QudexyXR.com offers healthcare professionals the tools necessary to help their patients Start, Stay and Save on Qudexy® XR therapy, including an informational video, a guide on how to get started and a patient enrollment form. In addition to being indicated to treat certain types of seizures, Qudexy® XR is now indicated for use in the prevention of migraine headache in adults and adolescents 12 years of age and older.

“Upsher-Smith understands that access and affordability for extended-release brand products can be a challenge for patients and an administrative hurdle for physician offices,” said Rusty Field, President and CEO, Upsher-Smith. “The updated website offers resources that will provide eligible patients co-pay assistance and administrative support to practitioners that will allow them to prescribe Qudexy® XR with greater ease.”

Eligible patients enrolled in the Access Pathways Program will receive a $0 co-pay offer*. Cash paying patients, or those who may not have insurance, will benefit from a low cost option. The program also offers:

  • Benefitverification
  • Prior authorizationsupport†
  • E-voucher pharmacyfinder
  • Pharmacy stockingassistance

To learn more about Upsher-Smith’s Access Pathways Program, please visit QudexyXR.com or call 1-855-282-4887 Monday-Friday from 8:00 a.m. – 7:00 p.m. (EST).

WHAT IS QUDEXY XR?

Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medicine used for:

  • Migraine: To prevent migraine headaches in adults and adolescents 12 years and
  • Monotherapy Epilepsy: Initial monotherapy to treat certain types of seizures (partial- onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older.
  • Adjunctive Epilepsy: Adjunctive therapy to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW?

Qudexy® should not be taken by patients with metabolic acidosis who are also taking a medicine called metformin.

What should I tell my healthcare provider BEFORE starting Qudexy XR?

Qudexy XR can cause serious side effects, including:

  • Serious eye problems, which may include blurred or sudden decrease in vision, eye pain and redness or a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). If left untreated, this can lead to permanent vision loss.
  • Decreased sweating and fever. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
  • Increased acid level in the blood (metabolic acidosis). This may or may not cause symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or trouble thinking clearly. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients.
  • High blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness and cause tiredness or vomiting. This can also happen when Qudexy XR is taken with a medicine called valproic acid (e.g., Depakene® and Depakote®).
  • Kidney stones. Drink plenty of fluids when taking Qudexy XR to decrease your chances of getting kidney stones.
  • Low body temperature. Taking Qudexy XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.
  • Effects on thinking and alertness. Qudexy XR may affect how you think, and can cause confusion, problems with concentration, attention, memory, or speech. Qudexy XR may cause depression or mood problems, tiredness, and sleepiness.
  • Dizziness or loss of muscle coordination.
  • Fetal harm. Taking Qudexy XR while pregnant increases the fetus risk of cleft lipand/or cleft palate and of being small for gestational age. Alternative treatment or effective birth control should be used. Discuss with your healthcare
  • Suicidal thoughts and actions. Like other antiepileptic drugs, Qudexy XR maycause suicidal thoughts and actions in a very small number of people, about 1 in 500. Tell your healthcare provider right away if you experience these effects, or any symptoms of depression or mood changes.

Tell your healthcare provider right away if you have any of the above symptoms, are planning to become pregnant, or if you become pregnant while taking Qudexy XR.

Call your healthcare provider right away if you have any of the above symptoms.

Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before taking Qudexy XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have: thoughts about suicide or dying; attempt to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, have trouble sleeping (insomnia); have new or worsening irritability; feel or act aggressive, angry, or violent; act on dangerous impulses; experience an extreme increase in activity and talking (mania); or other unusual changes in your behavior or mood.

The most common side effects of Qudexy XR include: tingling of the arms and legs (paresthesia), not feeling hungry, weight loss, nervousness, nausea, speech problems, tiredness, dizziness, sleepiness/drowsiness, a change in the way foods taste, upper respiratory tract infection, decreased feeling or sensitivity especially in the skin, slow reactions, difficulty with memory, fever, abnormal vision, diarrhea, and pain in the abdomen. These are not all the possible side effects of Qudexy XR. For more information, ask your healthcare provider or
pharmacist.

Before taking Qudexy XR, tell your healthcare provider about all of your medical conditions, including if you: have had depression, mood problems, or suicidal thoughts or behavior; have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or planning to become pregnant; or if you are breastfeeding. The medicine in Qudexy XR (topiramate) passes into your breast milk. It is not known if the medicine, topiramate, that passes into breast milk can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Qudexy XR.

Qudexy XR should not be taken while drinking alcohol, as this can cause serious side effects such as severe sleepiness, dizziness, and an increase in seizures.

Patients taking Qudexy XR should not drive, swim, climb, or operate heavy machinery until it is known how Qudexy XR affects them. Qudexy XR can slow thinking and motor skills and may affect vision. Some patients with epilepsy taking Qudexy XR will continue to have unpredictable seizures.

Do not stop Qudexy XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Qudexy XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop..

This is the most important information to know about Qudexy XR, but is not comprehensive. For more information, talk to your healthcare provider and read the Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com for the full Prescribing Information 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-FDA-1088.

Qudexy and Access Pathways are trademarks of Upsher-Smith Laboratories, LLC.

About Upsher-Smith

Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that has strived to deliver quality, affordable generic medications for nearly a century. In June 2017, Upsher-Smith was acquired by Sawai Pharmaceutical Co., Ltd., a large publicly traded generics company in Japan that had been seeking entry into the U.S. market. Upsher-Smith and Sawai share a strikingly similar family history and hold many of the same cherished goals and values— most importantly, the philosophy of always putting patients first.

Upsher-Smith will continue to do those things we feel we do best, which is provide a consistent supply of quality, affordable medications and invest in our historically strong industry relationships. Ultimately, we believe our acquisition by Sawai represents a tremendous opportunity to leverage each other for growth worldwide as we embark together on an exciting new chapter in generics. For more information, visit www.upsher-smith.com.

CONTACT:
Daina Basile
Kovak-Likly Communications
203-762-8833, dbasile@klcpr.com

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