LOS ANGELES, Oct. 4, 2023 /PRNewswire/ — Yuze Lee, the 12 year-old piano prodigy, will take the stage at the Renée and Henry Segerstrom Concert Hall on October 30th at 8 p.m. In celebration of the 150th anniversary of Rachmaninoff’s birth, the performance will feature the award-winning Pacific Symphony Orchestra and Yuze’s rendition of Rachmaninoff’s Piano Concerto No. 3 in D minor, Op. 30, that is sure to solidify Lee as one of the youngest and most talented young people in the classic music world today.
Lee’s musical journey began at a remarkably early age when he displayed an innate ability to replicate melodies he heard from his older brother’s drumming. From that moment, a profound love for music was born, and Lee’s dedication to the piano has only deepened with time.
“Yuze Lee is a remarkably talented young pianist whose playing is a vibrant tapestry of colors. His fingers effortlessly combine technical prowess with a rich expression of musicality and dynamic range, making him a shining star in the world of piano music,” said Jerome Lowenthal, award-winning classical pianist who has served as chair of the piano department at the Juilliard School in New York and faculty at Music Academy of the West in Santa Barbara, California.
Drawing inspiration from legendary composers such as Rachmaninoff, Beethoven, and Chopin, Lee’s performance promises to take audiences on a captivating journey through the romantic era of classical music.
“I’m honored to perform at The Renée and Henry Segerstrom Concert Hall and share the stage with the Pacific Symphony Orchestra for this special occasion,” said Lee. “This is really a dream come true. I look forward to creating an unforgettable evening of music that showcases the magic of Rachmaninoff and the joy I get from playing piano,” he concluded.
Founded in 1978, the Pacific Symphony Orchestra is the largest orchestra formed in the U.S. in the last 50 years and is not only a fixture of musical life in Southern California, but also is recognized as an outstanding ensemble making strides on both the national and international scenes. In Orange County, the orchestra presents more than 100 concerts and events each year and has been recognized with multiple ASCAP Awards for Adventurous Programming and included among the country’s five most innovative orchestras by the League of American Orchestras.
Event Details:
Date: October 30th, 2023
Time:8 p.m.
Location: Renée and Henry Segerstrom Concert Hall – 615 Town Center Drive, Costa Mesa, CA 92626
For tickets and more information, please click here.
About Yuze Lee Yuze Lee, a prodigious 12-year-old pianist and rising star, is a true connoisseur of the classical romantic era. Drawing inspiration from legendary pianists and composers such as Sergei Rachmaninoff, Ludwig Van Beethoven, and Frederic Chopin, Yuze’s musical artistry is a reflection of the profound depth and raw emotion of this iconic epoch. With a natural talent that emerged at an early age, Yuze discovered the beginning stages of his musical prowess when he heard his older brother play the drums and was able to immediately replicate the tune. From then on, his love affair with the piano began, and he has continued to nurture his musical ability ever since. With the help of Dr. Mingyi Gao of Steinway Hall of Fame, Non Profit M Music Group, Yuze’s musical aptitude has propelled him to perform on some of the most prestigious stages across the globe, from Singapore to Italy and the U.S., mesmerizing audiences with his virtuosic piano skills and technical mastery.
Inland Empire Health Plan to host Inland Empire Out of the Darkness Walk for 2023
RANCHO CUCAMONGA, Calif., Oct. 4, 2023 /PRNewswire/ — A chance to walk alongside those impacted by suicide is set for Saturday, Oct. 21, at Inland Empire Health Plan (IEHP) for the second year in a row.
Teams and individuals can now register for the Inland Empire Out of the Darkness Walk, an annual event planned in cities nationwide to raise awareness of suicide prevention through available resources from the likes of IEHP and the American Foundation for Suicide Prevention (AFSP). Walk proceeds support the AFSP’s mission to save lives and bring hope to those affected by suicide.
Losing someone to suicide, explained Garret Lopez, an IT Specialist I with IEHP, is a “different kind of mourning. It’s a different type of death, a death that always has a stigma behind it and is still difficult for my mom to even talk about.”
Lopez began participating in the walk in 2017 following the death of his sister, Melanie. Bringing the walk to IEHP has significant meaning behind it because for Lopez, it shows the not-for-profit health organization is living up to its mission of healing and inspiring the human spirit, he shared.
“Last year, I shared my story with everybody (in attendance) on the stairs of IEHP. That was a significant moment for me because I didn’t think I could ever bring the walk to where I work, let alone share my story of hope and resilience,” he continued. “That moment made it a lot more special for me because I spoke in memory of my sister and in a way was able to speak to her directly and say, ‘Look what we’re doing in your memory.’
“To have this event come to IEHP, where we have a large behavioral health team, makes it even more special because we have so many resources available to communities IEHP supports in both San Bernardino and Riverside counties. In a way, it seems like it has come full circle,” Lopez said.
The 2023 Inland Empire Out of the Darkness Walk will take participants around IEHP’s Rancho Cucamonga headquarters at 10801 Sixth St. the day of the event. Check-in begins at 9 a.m. and is followed by the walk at 10:30 a.m. Walkers are welcome to bring trinkets, signs and don T-shirts featuring quotable sayings and tributes to their loved ones.
Participants can register as a team or individually online at supporting.afsp.org. Contact Walk Chair Jay Jester at [email protected] or 760-899-5406 for support or to learn more.
Established in 1987, the American Foundation for Suicide Prevention is a voluntary health organization that provides support for those affected by suicide through community engagement, research, education and advocacy. AFSP is headquartered in New York but has local chapters in all 50 states.
Inland Empire Health Plan is a top 10 largest Medicaid health plan and the largest not-for-profit Medicare-Medicaid public health plan in the country. Now in its 27th year, IEHP’s community of team members and providers supports more than 1.6 million members in San Bernardino and Riverside counties. Behavioral Health resources through IEHP are offered 24/7 through its website at iehp.org or by calling Member Services at 800-440-4347 from 7 a.m. to 7 p.m. Monday through Friday, or from 8 a.m. to 5 p.m. Saturdays and Sundays.
If you or someone you know is having thoughts of suicide or self-harm, please contact the National Suicide Prevention Lifeline at by dialing 988 or by visiting 988lifeline.org and selecting the “988 Chat” option.
With a mission to heal and inspire the human spirit, Inland Empire Health Plan (IEHP) is one of the top 10 largest Medicaid health plans, the largest not-for-profit Medicare-Medicaid public health plan in the country, and for the third year in a row, certified as A Great Place To Work®. In its 27th year, IEHP supports more than 1.6 million Riverside and San Bernardino County residents enrolled in Medicaid or IEHP DualChoice (those with both Medi-Cal and Medicare). Today, IEHP has a growing network of nearly 6,800 providers and more than 3,000 team members who are fully committed to the vision: We will not rest until our communities enjoy optimal care and vibrant health. To learn more, go to iehp.org.
New Pooled Employer Plan Solution offers unique benefits
DRESHER, Pa., Oct. 4, 2023 /PRNewswire/ — Ascensus, whose technology and expertise help millions save for a better future, said it will begin offering the Ascensus | American Funds Pooled Employer Plan (PEP) solution on its independent, open-architecture recordkeeping platform beginning in spring 2024.
“We’re delighted to partner with Capital Group, home of American Funds, to offer the significant benefits and flexibility our PEP program provides,” said Jason Crane, head of Distribution for Ascensus Retirement. “Capital Group shares our goal to help more savers save more, and our commitment to offering a full product continuum to meet customer needs. American Funds’ investment experience and Ascensus’ award-winning service are a powerful combination—and all focused on driving better outcomes for partners, clients, and savers.”
Crane said Ascensus will be the first provider to offer American Funds Target Date Plus. This new investment solution is focused on creating a unique portfolio that matches a participant’s financial needs more closely than a traditional target date fund allocation determined only by age.
“After watching the PEP market evolve over the last several years and listening closely to advisors who desired a pooled plan offering, we are pleased to announce this partnership with Ascensus,” said Mike Bockstie, Senior Vice President, Institutional Retirement Sales, Capital Group. “The Ascensus-American Funds PEP Solution is the first in the industry to include Target Date Plus1 as a QDIA option for participants, which provides personalized allocation advice tailored to a retirement saver’s specific needs and objectives.”
The Ascensus | American Funds PEP offers the traditional administrative and investment fiduciary benefits of a pooled employer plan—with Wilshire taking on the role as 3(38) investment fiduciary—plus several key differentiators, including:
American Funds Target Date Plus, powered by Morningstar Investment Management LLC, with personalized allocation advice tailored to a retirement saver’s specific needs and objectives
A tiered investment menu grouping investment funds into logical categories (from target-date funds to customized portfolios) to build understanding and simplify participants’ decision making – inclusive of a number of leading fund managers
A fully bundled solution supported by Ascensus’ world class-rated client service team
Greater capabilities targeting better outcomes for participants through tools like My Forecast, where savers will be able to see a complete retirement readiness view
Plan design flexibility that works for each adopting employer, and
Ascensus has reached $1 billion in PEP assets under administration, representing more than 33,000 savers. The company has more than $742 billion in assets under administration overall.
1Capital Group and the Workplace Solutions group within Morningstar Investment Management LLC, a subsidiary of Morningstar, Inc., announced a new target date service, Target Date Plus, with personalized allocation advice tailored to a retirement saver’s specific needs and objectives, in 2022. The service, which employers can use as a qualified default investment alternative, blends the American Funds Target Date Retirement Series® with Morningstar Investment Management’s experience delivering online investment advice through its user interfaces and vast network of integrated recordkeepers.
2Earlier this year, Financial Finesse, the leading independent provider of financial wellness coaching benefits, announced the expansion of a successful initial program with Capital Group. The program brings Financial Finesse financial coaching to select Capital Group DCIO clients in the mid-sized plan sponsor market and PlanPremier® full-service recordkeeping clients in the large plan sponsor market.
About Wilshire
Wilshire is a global provider of market-leading indexes, advanced analytics, and multi-asset investment solutions. A trusted partner to a diverse range of more than 500 leading institutional investors and financial intermediaries, our clients rely on us to improve investment outcomes for a better future. Wilshire advises on over $1.3 trillion in assets and manages $86 billion in assets and is headquartered in the United States with offices worldwide.
As of June 30, 2023, Wilshire oversees defined contribution solutions representing $205 billion in assets, including a comprehensive suite of institutional-caliber ERISA 3(21) and ERISA 3(38) plan fiduciary services, along with participant advice and managed account solutions. Today more than 73,000 plans utilize Wilshire’s plan fiduciary services, and more than 280,000 plan participants utilize our managed account solutions. Wilshire is dedicated to expanding retirement plan coverage by empowering employers, their advisors and service providers with independent investment solutions focused on driving better outcomes.
Ascensus is a market-leading enabler of tax-advantaged savings—providing technology, services, and expertise that helps millions of people save for a better future.
The company is a premier savings program service provider, third-party administrator, and government savings facilitator. Its platforms, industry knowledge, and data-based insights enhance the growth and success of its partners, their clients, and savers through co-branded, private-labeled, and governmental partnerships.
Ascensus offers comprehensive qualified and nonqualified retirement plan solutions, third-party retirement plan administration, 529 education and ABLE savings program administration, corporate- and bank-owned life insurance solutions, and fiduciary and total rewards services.
The company’s brands include Ascensus; Newport, an Ascensus company; and FuturePlan by Ascensus. Ascensus has more than $742 billion in assets under administration and employs more than 5,600 associates as of June 30, 2023.
Capital Group, home of American Funds, has been singularly focused on delivering superior results for long-term investors using high-conviction portfolios, rigorous research, and individual accountability since 1931.
As of June 30, 2023, Capital Group manages more than $2.3 trillion in equity and fixed-income assets for millions of individuals and institutional investors around the world. Capital Group manages equity assets through three investment groups. These groups make investment and proxy voting decisions independently. Fixed-income investment professionals provide fixed-income research and investment management across the Capital organization; however, for securities with equity characteristics, they act solely on behalf of one of the three equity investment groups.
The Conductive Carbon Additives Market is likely to rise at a CAGR of 13.5% during 2023-2028, to reach US$ 7.3 billion in 2028, states Stratview Research.
DETROIT, Oct. 4, 2023 /PRNewswire/ — Stratview Research, a global market research firm has launched a report on the Conductive Carbon Additives Market which provides a comprehensive analysis of the global and regional industry forecast, current & emerging trends, segment analysis, and competitive landscape.
Segment Insights on the Conductive Carbon Additives Market
The Conductive Carbon Additives Market is segmented based on Conductivity Type, Material Type, Application Type, End-Use Industry Type, and Region.
Based on the material type – The conductive carbon additives market is segmented into carbon black, graphite, CNT, CNF, and graphene. Carbon black is likely to remain at the forefront during the forecast period. Carbon black additives are ideally suited for applications in li-ion batteries, advanced lead-acid batteries, alkaline batteries, and electrical components. The low surface area of conductive carbon blacks shows a particular advantage for dispersion and easy processing.
Based on the application type – The market is segmented into plastics/compounds, adhesives/sealants, coatings, inks, elastomers, and energy storage. In terms of value, the energy storage segment is expected to remain the dominant as well as the fastest-growing application type in the market during the forecast period. Energy storage is likely to offer winning opportunities during the forecast period. The segment is anticipated to mark a double-digit growth, in terms of both, value and volume, during 2023-2028.
Which Region Offers the Best Opportunity and Growth?
The report suggests that Asia-Pacific is expected to remain the largest market for conductive carbon additives during the forecast period, propelled by China. This growth is majorly attributed to the following –
– China is likely to remain the largest Asian market, in terms of both, production as well as consumption. The country has been an attractive market for several industry stakeholders concerning manufacturing.
Likewise, North America and Europe are also likely to create sizeable opportunities in the coming five years, driven by an expected rebound in vehicle production coupled with a paradigm shift from ICE to electric vehicles.
Conductive Carbon Additives Market Drivers
Some of the key drivers listed in the report are given below.
Growth in new trends, such as printed electronics, foldable electronics, and flexible electronics.
Increasing penetration of conductive additives with increasing demand for lightweight and composite materials.
Increasing demand for lightweight materials including carbon fiber composites, and exceptional increase in the penetration of electric vehicles, as well as miniaturization of electronic devices.
For Customization or Any Other Queries, Get in Touch with Our Industry Experts at [email protected]
Top Companies in the Conductive Carbon Additives Market?
The market is fairly consolidated with the presence of some regional and global players. Most of the major players compete in some of the governing factors including price, product offerings, regional presence, etc. The following are the key players in the conductive carbon additives market.
Aditya Birla Carbons
Asbury Carbons
Cabot Corporation
Orion Engineered Carbons S.A.
Tokai Carbon
Imerys Group
What Deliverables Will You Get in this Report?
Key questions this report answers
Relevant contents in the report
How big is the sales opportunity?
In-depth analysis of the Conductive Carbon Additives Market
How lucrative is the future?
Market forecast and trend data and emerging trends
Which regions offer the best sales opportunities?
Global, regional, and country-level historical data and forecasts
Which are the most attractive market segments?
Market segment analysis and forecast
Who are the top players and their market positioning?
Stratview Research is a global market research firm that specializes in aerospace & defense, chemicals, and a few other industries.
It launches a limited number of reports annually on the above-mentioned specializations. The reliability and insightfulness of the reports enable the readers to make convincing business decisions.
Stratview Research has been helping companies meet their global and regional growth objectives by offering customized research services. These include market assessment, due diligence, opportunity screening, voice of customer analysis, market entry strategies, and more.
Are you looking for any specific data customized to your objectives? We are just a mail away.
FT. LAUDERDALE, Fla., Oct. 4, 2023 /PRNewswire/ — Anju is pleased to announce its participation at the upcoming Society for Clinical Data Management (SCDM) conference, taking place from October 8-11, in San Diego, California. For 25 years SCDM has held global conferences that bring together clinical data managers, industry leaders and specialists to share innovative technologies, approaches, and the latest in clinical data management knowledge. With a focus on driving innovation and delivering impactful results, Anju’s presence at SCDM underscores their commitment to providing industry-leading solutions that empower organizations to excel in the management of clinical data.
Anju is delighted to announce the submission of TA Scan, one of its cutting-edge flagship products, for the inaugural Innovation Award, designed to celebrate and honor exceptional achievements in advancing the realm of healthcare throughdata-driven solutions. This is a testament to Anju’s unwavering dedication to pushing boundaries and addressing complex challenges within the life science industry. By leveraging their deep industry knowledge and adaptable technology, Anju delivers transformative solutions that empower organizations to thrive in the ever-evolving landscape.
“We are excited to be participating at SCDM this year and to submit TA Scan for the Innovation Award,” said Barbara Argibay, Vice President Data Division of Anju. “We are committed to providing versatile solutions that address the unique needs of our clients, and highly motivated to making clinical trials more inclusive with this new diversity analytics module. Innovation is the key to unlocking new possibilities and driving meaningful outcomes.”
Engaging with Anju at SCDM will provide attendees the opportunity to discover firsthand how their best-value solutions can transform clinical data management practices. Visit Anju’s booth 319 to explore their suite of products and discuss your specific needs with their industry experts.
About Anju:
Anju is a customer-first organization delivering adaptable life science solutions for clinical research, medical affairs, and data science. TrialMaster, IRMS MAX, and TA Scan, the company’s flagship products, lead the way in reducing complexities in the drug and device discovery and commercialization process. With a team of industry experts and a diverse suite of versatile products, Anju empowers clients to drive innovation, efficiency, and compliance. Anju is a portfolio company of Abry Partners serving the worldwide pharmaceutical, biotech and contract research Life Sciences markets.
For media inquiries, please contact:
Media Contact:
John F. Kouten JFK Communications, Inc. +1 609.241.7352 [email protected]
ATLANTA, Oct. 4, 2023 /PRNewswire/ — The Child Neurology Society Meeting, a prominent event in the field of pediatric neurology, is set to showcase cutting-edge research and developments in child neurology. As part of this conference, UCB will present two late-breaking posters that shed light on the care and management of Dravet syndrome.
Poster 1:Outcomes Among Individuals With Dravet Syndrome Using Fenfluramine: A Retrospective Analysis Using U.S. Claims Data
Dravet syndrome, a rare and severe developmental epileptic encephalopathy, has long presented challenges in terms of treatment and care. However, a new retrospective analysis utilizing U.S. claims data has unveiled promising outcomes for individuals with Dravet syndrome who were treated with fenfluramine, following its approval in June 2020 for the management of seizures associated with Dravet syndrome in the United States.1
The objective of this analysis was to quantify the relationship between fenfluramine and seizure-related healthcare events through claims data. The study utilized the Komodo U.S. healthcare claims database to measure healthcare utilization, including rescue anti-seizure medication use and healthcare visits. Individuals with Dravet syndrome were identified by ICD-10 codes. Patients receiving prior/concomitant cannabidiol or stiripentol were excluded.1
Among the 108 individuals with Dravet syndrome included in the analysis, 91 individuals (84%) had continuous fenfluramine use for a minimum of 6 months. This subset exhibited a 77% reduction in rescue antiseizure medication use (P<0.001). Moreover, the reductions extended to healthcare visits, with a 50% decrease in ER visits, a 27% reduction in outpatient visits, a 24% reduction in neurology visits, and a 24% reduction in inpatient hospitalizations.1
The findings suggest that meaningful reductions in healthcare utilization were observed among individuals with Dravet syndrome treated with fenfluramine for at least 6 months. The 6-month persistency rate of fenfluramine usage indicates not only its efficacy but also its tolerability in this patient population.1
Poster 2: Diagnosis and Information Management of Dravet Syndrome in Recently Diagnosed Pediatric Patients: Results From a Dravet Syndrome Foundation Caregiver Insight Survey
The second late-breaking poster explored the challenges surrounding the early diagnosis of Dravet syndrome. Caregivers of pediatric patients aged ≤4 years, diagnosed with Dravet syndrome, were surveyed to gather insights into their experiences.2
The survey, distributed via the Dravet Syndrome Foundation Family Network, received responses from 73 caregivers. The results highlighted that the average age at symptom onset was 5 months, while the average age at Dravet syndrome diagnosis was 12 months. Changes in healthcare providers were common, with the most frequent reasons being clinical expertise and trust. The poster further highlights the vital role that patient advocacy groups and online resources play in providing caregivers with valuable information and support during the diagnosis and management process.2
Authors: Andrea Wilkinson, BA, Danya Kaye, BA, Veronica Hood, PhD, Mary Anne Meskis, Laurie Bailey, BCPA, Rebecca Burns, PharmD, PhD, Amélie Lothe, PhD
These posters underscore the advancements in understanding and managing Dravet syndrome, as well as the pivotal role of both medical interventions and patient advocacy resources in enhancing the lives of those affected by this condition.1,2
About FINTEPLA® (fenfluramine)1
In the U.S., FINTEPLA is approved for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.
FINTEPLA is available in the U.S. through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.
Please see full Prescribing Information, including Boxed Warning, for additional important information on FINTEPLA.
INDICATION
FINTEPLA is a prescription medicine used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.
It is not known if FINTEPLA is safe and effective in children less than 2 years of age.
IMPORTANT SAFETY INFORMATION
FINTEPLA can cause serious side effects, including:
1. Problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension) have been associated with fenfluramine, the active ingredient in FINTEPLA. Your healthcare provider will do a test called an echocardiogram to check your heart and to evaluate for high blood pressure in the arteries of the lungs before you start taking FINTEPLA, again every 6 months during treatment, and one time 3 to 6 months after you take your last dose of FINTEPLA.
Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with FINTEPLA:
shortness of breath
chest pain
tiredness or weakness, especially with increased activity
sensations of a rapid, fluttering heartbeat (palpitations)
lightheadedness or fainting
irregular pulse
swollen ankles or feet
bluish color of your lips and skin (cyanosis)
Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in arteries of lungs (pulmonary arterial hypertension), FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS). Before you or your child receives FINTEPLA, your healthcare provider or pharmacist will make sure you understand how to take FINTEPLA safely. If you have any questions about FINTEPLA, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649.
2. Decreased appetite and decreased weight. Decreased appetite and decreased weight are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS).
Your weight should be checked regularly during your treatment with FINTEPLA.
Your healthcare provider may need to make changes to your FINTEPLA dose if your weight decreases. In some cases, FINTEPLA may need to be stopped.
3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects of FINTEPLA in people with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). Taking FINTEPLA with central nervous system (CNS) depressants, including alcohol, may increase sleepiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you.
4. Like all other antiepileptic drugs, FINTEPLA may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
thoughts about suicide or dying
new or worse anxiety
trouble sleeping (insomnia)
acting on dangerous impulses
attempts to commit suicide
feeling agitated or restless
other unusual changes in behavior or mood
new or worse irritability
an extreme increase in activity and talking (mania)
new or worse depression
panic attacks
acting aggressive, being angry or violent
How can I watch for early symptoms of suicidal thoughts and actions?
Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
5. Do not stop taking FINTEPLA without first talking to your healthcare provider. Stopping a seizure medicine such as FINTEPLA can suddenly cause you to have seizures more often or seizures that do not stop (status epilepticus).
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Do not take FINTEPLA if you:
are allergic to fenfluramine or any of the ingredients in FINTEPLA. See below for a complete list of ingredients in FINTEPLA.
are taking or have stopped taking medicines called monoamine oxidase inhibitors (MAOIs) in the last 14 days. This may cause a serious or life-threatening problem called serotoninsyndrome. If you are not sure whether or not you are taking one of these medicines, contact your healthcare provider.
Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:
have heart problems
have or have had weight loss
have or have had depression, mood problems, or suicidal thoughts or behavior
have kidney problems
have liver problems
are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while taking FINTEPLA. You and your healthcare provider will decide if you should take FINTEPLA while you are pregnant.
If you become pregnant while taking FINTEPLA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
are breastfeeding or plan to breastfeed. It is not known if FINTEPLA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking FINTEPLA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take FINTEPLA?
Read the Instructions for Use for information on the right way to use FINTEPLA.
Take FINTEPLA exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much FINTEPLA to take and when to take it.
FINTEPLA may be taken with or without food.
Measure your dose of FINTEPLA using the dosing syringe that is provided by the pharmacy. Do not use a household teaspoon or tablespoon.
FINTEPLA can be given through gastric and nasogastric feeding tubes.
What should I avoid while taking FINTEPLA?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you. FINTEPLA may cause you to feel sleepy.
What are the possible side effects of FINTEPLA?
FINTEPLA may cause serious side effects, including:
See “FINTEPLA can cause serious side effects” above
Serotonin syndrome. Serotonin syndrome is a life-threatening problem that can happen in people taking FINTEPLA, especially if FINTEPLA is taken with certain other medicines including: anti-depressant medicines called SSRIs, SNRIs, TCAs, and MAOIs; tryptophan; lithium; antipsychotics; St. John’s Wort; dextromethorphan; tramadol.
Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
mental status changes such as seeing things that are not there (hallucinations), agitation, or coma
changes in blood pressure
tight muscles
fast heartbeat
nausea, vomiting, diarrhea
high body temperature
trouble walking
High blood pressure (hypertension). Hypertension is both a serious and common side effect. FINTEPLA can cause your blood pressure to increase even if you have never had high blood pressure before. Your healthcare provider will check your blood pressure while you are taking FINTEPLA.
Increased pressure in your eyes (glaucoma). Symptoms of glaucoma may include:
red eyes
seeing halos or bright colors around lights
nausea or vomiting
decreased vision
eye pain or discomfort
blurred vision
If you have any of these symptoms, call your healthcare provider right away.
The most common side effects of FINTEPLA when used to treat Dravet syndrome (DS) include:
decreased appetite
diarrhea
low energy
respiratory infection
decreased weight
fever
constipation
abnormal echocardiogram
sleepiness
problems with movement, balance, and walking
increased drooling
increased blood pressure
vomiting
falls
seizures that do not stop
weakness
The most common side effects of FINTEPLA when used to treat Lennox-Gastaut syndrome (LGS) include:
diarrhea
tiredness
vomiting
sleepiness
decreased appetite
These are not all the possible side effects of FINTEPLA. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1–800–FDA–1088.
Keep FINTEPLA and all medicines out of the reach of children.
General information about the safe and effective use of FINTEPLA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FINTEPLA for a condition for which it was not prescribed. Do not give FINTEPLA to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in FINTEPLA? Active ingredient: fenfluramine hydrochloride Inactive ingredients: cherry flavor, citric acid, ethylparaben, hydroxyethylcellulose, methylparaben, potassium citrate, sucralose, and water. FINTEPLA contains no ingredient made from gluten-containing grain (wheat, barley, or rye) and contains not more than 0.1% of carbohydrates, which is from the cherry flavoring.
Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information on FINTEPLA.
For further information, contact UCB:
Corporate Communications Becky Malone, U.S. Media Relations T +919.605.9600 [email protected]
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of € 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
References
_______________________________________
1. Srihari Jaganathan, Derek Ems, Rob Sederman, Chen Chen, Shuang Wu; Outcomes Among Individuals with Dravet Syndrome Using Fenfluramine: A Retrospective Analysis Using U.S. Claims Data 2. Andrea Wilkinson, BA, Danya Kaye, BA, Veronica Hood, Ph.D., Mary Anne Meskis, Laurie Bailey, BCPA, Rebecca Burns, PharmD, Ph.D., Amélie Lothe, Ph.D.; Diagnosis and Information Management of Dravet Syndrome in Recently Diagnosed Pediatric Patients: Results from a Dravet Syndrome Foundation Caregiver Insight Survey