UPSHER-SMITH REINFORCES ITS COMMITMENT TO RARE DISEASE COMMUNITIES THROUGH ENHANCED PROMISE OF SUPPORT™ PROGRAM

MAPLE GROVE, Minn., July 1, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today unveiled its enhanced Promise of Support™ Program – a patient-centered program designed to offer patients, caregivers, and healthcare providers in the rare disease community comprehensive support throughout the treatment journey. This program is the cornerstone of Upsher-Smith's dedication to the rare disease community.

Upsher-Smith's Promise of Support™ Program ensures timely and reliable access to medications through customized services such as quick start and bridge supply programs. Through its partnership with specialty pharmacy, PANTHERx^® Rare, Upsher-Smith commits to providing a best-in-class experience for patients requiring rare disease medications, responding with urgency, and maintaining clear, open communication. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families.

"Upsher-Smith's Promise of Support™ Program embodies our longstanding commitment, now in its seventh year, to those impacted by rare diseases," said Jim Maahs, Vice President, Specialty & Rare Disease. "By reducing the complexities of the treatment journey, we hope to offer peace of mind to patients, families, and caregivers to focus on what truly matters – their health and well-being. Upsher-Smith is dedicated to understanding the unique needs of rare disease communities and providing value-added services that ease access to critical medications."

Upsher-Smith's rare disease portfolio continues to grow with the addition of high-quality medications that match or exceed the level of service provided by innovator brands. To learn more about the Upsher-Smith Promise of Support™ Program for the VIGADRONE^® family of products, visit VIGADRONE.com, and to stay updated on TORPENZ™ (everolimus) Tablets, slated for availability mid-2024, visit www.torpenz.com/availability.

Please see Important Safety Information for VIGDADRONE^®, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.

VIGADRONE^® (vigabatrin) is a prescription medicine used to treat:

• Infantile Spasms (IS) in patients 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking VIGADRONE are more important than the possible risk of vision loss.
• Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) along with other treatments if:
  • The CPS do not respond well enough to several other treatments, and
  • You and your healthcare provider decide the possible benefit of taking VIGADRONE is more important than the risk of vision loss.
    VIGADRONE should not be the first medicine used to treat CPS.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE^® (vigabatrin)?

• 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. 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, you may only be able to see things straight in front of you (sometimes called "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 or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your 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 VIGADRONE, but they do allow VIGADRONE 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 patients, until it is severe.
• If you do not have these vision tests regularly, 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 patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGADRONE. It is not known if these changes are harmful.
• A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of patients treated with vigabatrin.
• 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 (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
• 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 depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about 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. Breastfeeding is not recommended.

If you are pregnant or plan to become pregnant, VIGADRONE can cause harm to 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: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness.

The most common side effect of VIGADRONE in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults.

The most common side effects of VIGADRONE 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 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 it is not all the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit vigadrone.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.

About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, 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. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

About Bora
Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Headquartered in Taiwan, Bora has dedicated itself to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability.

VIGADRONE, TORPENZ, and PROMISE OF SUPPORT are trademarks of Upsher-Smith Laboratories, LLC.

SOURCE Upsher-Smith Laboratories, Inc.