News Releases

MAPLE GROVE, Minn., Dec. 6, 2019 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it will be attending the 2019 Annual Meeting of the American Epilepsy Society (AES) December 6-10, 2019 in Baltimore, MD. Meeting attendees are encouraged to visit booth #526 to learn more about Upsher-Smith's epilepsy products including Vigadrone^® (vigabatrin) for Oral Solution 500 mg, a fully substitutable, AA-rated generic version of Sabril^® (vigabatrin) powder for oral solution* and Qudexy^® XR (topiramate) extended-release capsules. Representatives will also be on hand to discuss Upsher-Smith's Access Pathways^® Program, a program designed to reduce the barriers associated with prescribing vigabatrin by providing brand-quality support to physicians, patients, and caregivers.

Vigadrone^® is indicated for the treatment of:

• Infantile Spasms (IS)—monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
• Refractory Complex Partial Seizures (CPS)—adjunctive therapy in patients ≥10 years of age who have responded inadequately to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss; Vigadrone^® is not indicated as a first line agent.

Please see Important Safety Information for Vigadrone^®, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.
"Treating infantile spasms requires early intervention, and at Upsher-Smith, ensuring that physicians are able to quickly and seamlessly start their patients on vigabatrin is a priority," said Rusty Field, President and CEO of Upsher-Smith. "That is why we launched Vigadrone^®, a fully substitutable generic, with brand-quality support. We look forward to discussing how our Access Pathways^® Program provides physicians, patients and caregivers with a dedicated, experienced team to overcome the obstacles that sometimes come along with prescribing vigabatrin."

Access Pathways^® is fully committed to providing the support patients and caregivers need, regardless of when they need it. The program includes:

• Benefit verification
• Prior authorization support^†
• A cash option for patients not covered or uninsured
• Co-Pay assistance for eligible patients**
• After-hours and weekend support

To learn more about Access Pathways^®, visit vigadrone.com. Access Pathways^® Program Support can be reached at 1-866-923-1954 Monday-Friday from 8:00 a.m. – 8:00 p.m. EST or on weekends and after hours.

Vigabatrin REMS Program
The U.S. FDA has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.

Healthcare providers must be certified in the Vigabatrin REMS Program to prescribe Vigadrone^® and patients must be enrolled in the Vigabatrin REMS Program to receive Vigadrone^®. All certified prescribers and enrolled patients in the SABRIL^® REMS Program have been transitioned to the Vigabatrin REMS Program and do not need to recertify or re-enroll. 

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE?

• Because VIGADRONE 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 healthcare provider will explain the details of this Program to you.

• VIGADRONE can damage the vision of anyone who takes it. People who take VIGADRONE do not lose all of their vision, but some people can have severe loss, particularly their peripheral vision. With severe vision loss, you may have "tunnel vision". You may also have blurry vision. If this happens, it will not get better.

• Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby 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 (or your child's) vision before, during, and after treatment with VIGADRONE. 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 VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse. 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, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss.

• Magnetic resonance imaging (MRI) changes in babies with IS. Brain pictures taken by MRI show changes in some babies after they are given VIGADRONE. It is not known if these changes are harmful.

• Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you experience these effects, or any symptoms of depression or mood changes.

• Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop.

VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.

Before starting VIGADRONE, tell your doctor about all of your (or your child's) medical conditions, including mental illnesses, and all the medicines you (or your child) take.

If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby. 

If you are pregnant or plan to become pregnant, it is not known if VIGADRONE will harm your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant.

The most common side effects of VIGADRONE in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled.

The most common side effects of VIGADRONE in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.

The most common side effects of VIGADRONE in babies include: sleepiness—some 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 you or your child have any side effect that bothers you or that does not go away. 

This is the most important information to know about VIGADRONE, but not all of the possible side effects of VIGADRONE. For more information, ask your healthcare provider or pharmacist, or please visit vigadrone.com/PI for VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit 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.

Important Patient Safety Information for Qudexy^® XR (topiramate) Extended-Release Capsules

WHAT IS QUDEXY XR?

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

• To prevent migraine headaches in adults and adolescents 12 years and older.
• To treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 2 years and older.
• With other medicines 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 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.

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.

Qudexy XR can harm your unborn baby. All women of childbearing age should talk to their healthcare provider about possible alternative treatments. If you take Qudexy XR during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Also, if you take Qudexy XR during pregnancy, your baby may be smaller than expected at birth; the long-term effects of this are not known. If the decision is made to use Qudexy XR, you should use effective birth control (contraception).Tell your healthcare provider right away if you become, or plan to become pregnant while taking Qudexy XR.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  Especially tell your healthcare provider if you take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote); any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills (Qudexy XR may make birth control pills less effective); medicines used to prevent seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide or acetazolamide). 

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 taking Qudexy XR slowly.

Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause side effects such as sleepiness and dizziness.

Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision. Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictable seizures.

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 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.

About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. Since 1919, it has brought generics and brands to a wide array of customers backed by an attentive level of service, strong industry relationships, and dedication to uninterrupted supply.        

As Upsher-Smith celebrates its 100-year anniversary, the company enters a new ambitious era that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage each other for growth worldwide and embark on an exciting new chapter as they seek to deliver the best value for their stakeholders, and most importantly, Do More Good™ for the patients they serve. For more information, visit www.upsher-smith.com.

*Sabril is a registered trademark of Lundbeck.
^†Prior authorization support can be provided only for indicated disease states.
**Medicare, Medicaid and other state and federal health care program patients are not eligible.

Vigadrone, Qudexy, Access Pathways and Do More Good are trademarks of Upsher-Smith Laboratories, LLC.

PM-000681

SOURCE Upsher-Smith Laboratories, LLC