UPSHER-SMITH TO SHOWCASE RARE DISEASE PORTFOLIO AT 2025 AAN ANNUAL MEETING
Company to Feature First and Only Ready-to-Use Liquid Vigabatrin at Booth #846
MAPLE GROVE, Minn., April 4, 2025 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its participation at the 2025 American Academy of Neurology (AAN) Annual Meeting, from April 5-9, 2025 in San Diego, California. Representatives from Upsher-Smith will be available at Booth #846 to share information with clinicians about its expanding portfolio of products for rare diseases, including the first and only ready-to-use liquid vigabatrin, VIGAFYDE(TM) (vigabatrin) Oral Solution. VIGAFYDE(TM) is indicated for infantile spasms (IS) as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the risk of vision loss.
"Since the successful launch of VIGADRONE(®) (vigabatrin) for Oral Solution to the specialty pharmacy channel in 2018, we have broadened our offerings to include VIGADRONE(®) (vigabatrin) Tablets, TORPENZ(TM) (everolimus) Tablets, and VIGAFYDE(TM) ready-to-use solution," said Jim Maahs, Head of Commercial, Upsher-Smith. "As part of our commitment to supporting the rare disease community, Upsher-Smith is dedicated to not only maintaining, but enhancing the support and resources available to patients, caregivers, and healthcare practitioners. We encourage attendees to stop by our booth during this year's AAN meeting to learn more."
About Upsher-Smith's Rare Disease Portfolio
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. The Company offers three vigabatrin formulations including VIGAFYDE(TM) Oral Solution, VIGADRONE(®) Powder for Oral Solution and VIGADRONE(®) Tablets. VIGAFYDE(TM), the only ready-to-use vigabatrin oral solution, is the first new drug application (NDA) approved for infantile spasms in 15 years. As the only premixed, ready-to-use vigabatrin formulation, VIGAFYDE(TM) represents a welcome expansion of vigabatrin treatment options, offering patients and caregivers a simpler dose preparation process which may improve dosing accuracy.
Upsher-Smith representatives will be available throughout the conference at exhibit booth #846 to engage with clinicians about their products including VIGAFYDE(TM), and VIGADRONE(®) and the Promise of Support(TM) Program, which has been providing comprehensive support to patients prescribed VIGADRONE(®) since 2018. Representatives will also be available to discuss Upsher-Smith's TORPENZ(TM) Tablets, an oral mTOR inhibitor used to treat certain manifestations of Tuberous Sclerosis Complex (TSC). TORPENZ(TM), is the only everolimus backed by the Upsher-Smith Promise of Support(TM) Program to deliver reliable and consistent support to patients, caregivers, and healthcare providers in the TSC community. TORPENZ(TM) is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery and is also indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
About Upsher-Smith's Promise of Support(TM) Program
Central to Upsher-Smith's commitment to rare disease communities is its Promise of Support(TM) Program, ensuring comprehensive assistance for patients, caregivers, and healthcare providers throughout the treatment journey. For nearly a decade, the program has offered resources for uninterrupted medication supply, prior authorization support, patient education materials, collaboration with a leading specialty pharmacy partner, and streamlined prescribing and enrollment procedures. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families.
To learn more about Upsher-Smith, its products, and the Promise of Support(TM) Program visit: www.upsher-smith.com.
Vigabatrin REMS
All vigabatrin products are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use.
Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them.
WHAT IS VIGAFYDE?
VIGAFYDE(TM) (vigabatrin) Oral Solution is a prescription medicine used to treat:
-- Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and
your baby's healthcare provider decide the possible benefits of taking
VIGAFYDE are more important than the possible risk of vision loss.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGAFYDE(TM) (vigabatrin)?
WARNING: PERMANENT VISION LOSS
See Medication Guide and full Prescribing Information for complete information.
All caregivers of babies who take
VIGAFYDE:
Your baby is at risk for permanent vision loss with any amount of VIGAFYDE.
Your baby's risk of vision loss may be higher the more VIGAFYDE is taken daily and the longer it is taken.
It is not possible for your baby's healthcare provider to know when vision loss
will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped.
-- Because VIGAFYDE 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 baby's healthcare provider will explain the details of this Program
to you.
-- VIGAFYDE 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,
your baby may only be able to see things straight in front of them
(sometimes called "tunnel vision"). Your baby may also have blurry
vision. If this happens, it will not get better.
-- Tell your healthcare provider right away if your baby might not be
seeing as well as before starting VIGAFYDE or 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 baby's vision before or within 4 weeks
after starting VIGAFYDE, and at least every 3 months during treatment
until VIGAFYDE is stopped. It is also recommended that vision be tested
about 3 to 6 months after VIGAFYDE is stopped. It is difficult to test
vision in babies, but to the extent possible, all patients should have
their vision tested. Your baby's 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
VIGAFYDE, but they do allow VIGAFYDE 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 babies, until it is
severe.
-- If you do not have these vision tests regularly, your baby's healthcare
provider may stop prescribing VIGAFYDE. Your baby may not be able to
complete vision testing. If vision testing cannot be done, the
healthcare provider may continue prescribing VIGAFYDE 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 VIGAFYDE. It is not known if these changes are
harmful.
-- A type of swelling in the brain called intramyelinic edema (IME) has
been seen in postmortem examination of infants treated with vigabatrin.
-- Risk of suicidal thoughts or actions. VIGAFYDE is approved for use in
patients 1 month to 2 years of age [see WHAT IS VIGAFYDE?]. VIGAFYDE is
not approved for use in adolescents or adults. Like other antiepileptic
drugs, vigabatrin may cause suicidal thoughts and actions in some
adolescents and adults (about 1 in 500 people). A healthcare provider
should be called right away if a patient taking vigabatrin experiences
any symptoms, especially sudden changes in mood, behaviors, thoughts, or
feelings, and especially if they are new, worse, or worrying.
-- Do not stop VIGAFYDE without first talking to a healthcare provider.
Stopping VIGAFYDE suddenly can cause seizures that will not stop.
VIGAFYDE is more concentrated than vigabatrin solutions prepared from powder. The volume of VIGAFYDE solution prescribed by your baby's healthcare provider may be less than the volume prescribed for other vigabatrin solutions prepared from powder. Always double check the volume (mL) that you are to give your baby when you get a new prescription filled.
VIGAFYDE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, and weight gain.
VIGAFYDE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.
Before starting VIGAFYDE, tell your baby's doctor about all of their medical conditions including any allergic reaction to vigabatrin, vision problems, kidney problems, or low red blood cell counts (anemia). Tell your doctor about all the medicines you baby is receiving.
The most common side effects of VIGAFYDE 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 your baby has any side effect that bothers them or that does not go away.
This is the most important information to know about VIGAFYDE, but not all of the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGAFYDE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGAFYDE.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.
WHAT IS VIGADRONE?
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)?
WARNING: PERMANENT VISION LOSS
See Medication Guide and full Prescribing Information for complete information.
All people who take
VIGADRONE:
You are at risk for permanent vision loss with any amount of VIGADRONE.
Your risk of vision loss may be higher the more VIGADRONE you take daily and the longer you take it.
It is not possible for
your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGADRONE or any time during treatment. It may even happen after treatment has stopped.
-- 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.
WHAT ARE TORPENZ (everolimus) TABLETS?
TORPENZ is a prescription medicine used to treat the following types of benign (non-cancerous) tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):
-- Brain tumors called subependymal giant cell astrocytoma (SEGA), when the
tumor cannot be removed completely by surgery, in adults and children 1
year and older.
-- Kidney tumors called angiomyolipoma, when the tumor does not require
surgery right away, in adults.
For additional information, including safety information, for non-TSC indications, see the full Prescribing Information, including Patient Information.
WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT TORPENZ(TM) (everolimus) TABLETS in Tuberous Sclerosis Complex?
Do not take TORPENZ if you have had an allergic reaction to everolimus. Talk to your healthcare provider before taking TORPENZ if you are allergic to sirolimus or temsirolimus. Ask your provider if you do not know.
TORPENZ can cause serious side effects, including:
-- Lung or breathing problems. In some people, these may be severe and can
be life threatening. Tell your healthcare provider right away if you
have new or worsening cough, shortness of breath, chest pain, difficulty
breathing or wheezing.
-- Higher likelihood of infection such as pneumonia, or a bacterial,
fungal, or viral infection. Viral infections may include active
hepatitis B in people who have had hepatitis B in the past
(reactivation). In some adults and children, these infections may be
severe and can be life threatening. You may need to be treated as soon
as possible. Tell your healthcare provider right away if you have a
temperature of 100.5F or above, chills, or do not feel well. Symptoms of
infection may include:
o Fever
o Loss of appetite
o Chills
o Nausea
o Skin rash
o Pale stools or dark urine
o Joint pain and swelling
o Yellowing of the skin
o Tiredness o Pain in the upper right side of the
stomach
-- Severe allergic reactions. Get medical help right away if you have signs
of an allergic reaction, including rash, itching, hives, flushing,
trouble breathing or swallowing, chest pain or dizziness.
-- Possible increased risk for a type of allergic reaction called
angioedema in people who take an Angiotensin-Converting Enzyme (ACE)
inhibitor with TORPENZ. Talk with your healthcare provider before taking
TORPENZ if you are not sure if you take an ACE inhibitor. Get medical
help right away if you have trouble breathing or develop swelling of
your tongue, mouth, or throat during treatment with TORPENZ.
-- Mouth ulcers and sores. Mouth ulcers and sores are common during
treatment with TORPENZ but can also be severe. When you start TORPENZ,
your healthcare provider may tell you to also start a prescription
mouthwash to reduce the likelihood of getting mouth ulcers or sores and
to reduce their severity. Follow your provider's instructions on how to
use this mouthwash. If you develop pain, discomfort, or open sores in
your mouth, tell your provider.
-- Kidney failure. In some people, this may be severe and can be life
threatening. Your healthcare provider should check your kidney function
before and during treatment.
-- Wound healing problems. Wounds may not heal properly during TORPENZ
treatment. Tell your healthcare provider if you plan to have any surgery
before starting or during treatment. You should stop TORPENZ at least 1
week before planned surgery. Your provider should tell you when to start
taking TORPENZ again after surgery.
-- Increased blood sugar and fat (cholesterol and triglyceride) levels in
the blood. Your healthcare provider should check your fasting blood
sugar, cholesterol, and triglyceride levels in the blood before you
start and during treatment.
-- Decreased blood cell counts. TORPENZ can cause you to have decreased red
blood cells, white blood cells and platelets. Your healthcare provider
should check your blood cell counts before you start and during
treatment.
-- Worsening side effects from radiation treatment that can sometimes be
severe. Tell your healthcare provider if you have had or are planning to
receive radiation therapy.
Before taking TORPENZ, tell your healthcare provider about all of your medical conditions, including if you:
-- Have or have had kidney or liver problems, have diabetes or high blood
sugar, have high blood cholesterol, have any infections, or previously
had hepatitis B.
-- Are scheduled to receive any vaccinations. You should not receive a
"live vaccine" or be around people who have recently received a "live
vaccine" during your treatment with TORPENZ. If you are not sure about
the type of immunization or vaccine, ask your provider. For children,
work with your provider to complete the recommended childhood series of
vaccines before your child starts TORPENZ.
-- Are pregnant, can become pregnant, or have a partner who can become
pregnant. TORPENZ can cause harm to your unborn baby. For females who
are able to become pregnant, your provider will give you a pregnancy
test before you start TORPENZ. Use effective birth control during
treatment and for 8 weeks after your last dose of TORPENZ. Males with a
female partner should use effective birth control during treatment and
for 4 weeks after your last dose of TORPENZ.
-- Are breastfeeding or plan to breastfeed. Do not breastfeed during
treatment and for 2 weeks after your last dose of TORPENZ.
-- Are planning to have or have had a recent surgery. You should stop
taking TORPENZ at least 1 week before planned surgery.
-- Have received or are planning to receive radiation therapy.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TORPENZ with some medicines can cause serious side effects. Keep a list of medications you take, and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your provider if you take:
-- St. John's Wort (Hypericum perforatum)
-- Medicine for fungal or bacterial infections, tuberculosis, seizures,
HIV-AIDS, heart conditions or high blood pressure, including ACE
inhibitors
-- Medicines that weaken your immune system (your body's ability to fight
infections and other problems)
Ask your provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your provider might need to prescribe a different medicine or your dose of TORPENZ may need to be changed. Tell your provider before you start any new medicine.
You should not drink grapefruit juice or eat grapefruit during your treatment with TORPENZ. It may make the amount of TORPENZ in your blood increase to a harmful level.
The most common side effect of TORPENZ in people who have SEGA or renal angiomyolipoma include respiratory tract infection.
Other side effects that may occur with TORPENZ:
-- Absence of menstrual periods (menstruation). Tell your healthcare
provider if this happens.
-- TORPENZ may affect fertility and may affect your ability to become
pregnant if you are female or your ability to father a child if you are
male. Talk to your provider if this is a concern.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of TORPENZ. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You can also visit TORPENZ.com, upsher-smith.com or call 1-888-650-3789.
You are encouraged to report negative side effects of prescription drugs to 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. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit www.bora-corp.com.
VIGADRONE, TORPENZ and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC.
VIGAFYDE is a trademark of Pyros Pharmaceuticals, Inc.
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