News Releases

MAPLE GROVE, Minn., Oct. 22, 2019 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it will be attending the 48^th Annual Meeting of the Child Neurology Society (CNS) October 23-26, 2019 in Charlotte, NC. Meeting attendees are encouraged to visit booth #414 to learn more about Vigadrone^® (vigabatrin) for Oral Solution, 500 mg a fully substitutable, AA-rated generic version of Sabril^® (vigabatrin) powder for oral solution*. 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, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.

"At this year's Child Neurology Society meeting, we look forward to discussing with healthcare professionals how Upsher-Smith's Access Pathways^® Program can help overcome the obstacles of prescribing vigabatrin," said Rusty Field, President and CEO of Upsher-Smith. "Since treating infantile spams requires early intervention, our priority is to ensure that physicians are able to start their patients on Vigadrone^® as quickly as possible."

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

• Benefit verification
• A starter prescription will be shipped immediately to the patient or caregiver while coverage is determined and continued while any payer issues are resolved
• Prior authorization support^†
• If the patient requires a prior authorization, the Access Pathways^® Program support team will contact their insurance provider and get the process going, as well as follow up with the physician, patient or caregiver to confirm the prior authorization is complete
• If needed, the patient will be provided with a starter prescription or bridge prescription while the prior authorization is completed
• A cash option is available if the patient is not covered or uninsured
• Co-Pay assistance for eligible patients**
• After-hours care 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 at 1-866-923-1954 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.

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

SOURCE Upsher-Smith Laboratories, LLC