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)?
WARNING: PERMANENT
VISION LOSS See Medication Guide and full Prescribing
Information for complete information.
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All people who
take VIGADRONE:
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- 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.
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- 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.
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SOURCE Upsher-Smith Laboratories, Inc.