Discover the possibilities of progress with this seizure treatment for your loved one

This is a sponsored post written in collaboration with UCB

Written by UCB |

Caring for a loved one with Lennox-Gastaut syndrome (LGS) can reshape every part of daily life—from routines to relationships to peace of mind. Even after trying multiple treatments, seizures may persist, leaving families constantly preparing for the unexpected. Over time, this can leave caregivers feeling cautious about what comes next. Exploring a treatment option that addresses seizures differently may help open new possibilities.

Significant and maintained reduction across seizure types

FINTEPLAĀ® (fenfluramine) is a prescription medicine used to treat seizures associated with LGS in patients 2 years of age and older. FINTEPLA is available only through FINTEPLA Risk Evaluation and Mitigation Strategy (REMS), which requires monitoring because of the risk of problems with heart valves or high blood pressure in the arteries of the lungs.

In a 14-week clinical study, patients who added FINTEPLA (0.7 mg/kg/day) to their existing treatment plans experienced a 24% reduction in monthly drop seizures compared with only 9% for patients taking a placebo. In this study, 0.7 mg/kg/day was the only dose of FINTEPLA shown to significantly reduce monthly drop seizures, though individual results may vary. Drop seizures included generalized tonic-clonic (GTC), tonic, atonic, and tonic-atonic seizures.

Reductions were maintained throughout the study across all four drop seizure types: GTC (46%), tonic (31%), atonic (34%), and tonic-atonic (47%). It’s important to note, however, that reductions in tonic and atonic seizures were not statistically significant, which means the specific impact of FINTEPLA on them is unknown.

At the end of the study, healthcare providers and caregivers evaluated each patient’s overall functioning using the Clinical Global Impression–Improvement (CGI-I) scale, where scores of 1 to 3 indicate improvement. More patients treated with FINTEPLA were rated as improved compared with those taking placebo.

And, in a long-term study, 25% of patients achieved 17 or more consecutive drop seizure–free days, while 50% of patients experienced at least 7 days in a row without drop seizures. Throughout this study, patients added FINTEPLA (up to 0.7 mg/kg/day) to their current antiseizure treatment plans.

It is important to keep in mind that this was an open-label study, which means patients and doctors knew FINTEPLA was being used and no placebo was involved. Because of this open-label, flexible-dose design, no conclusions of efficacy should be made and individual results may vary.

For many caregivers, improvements like these aren’t just numbers, they’re new realities.

ā€œWe now travel more often since Asaiah’s seizures are reduced; we go more places.ā€ — April, mother of Asaiah, living with LGS

Designed to work with current treatment regimens

In most cases, FINTEPLA can be added without disrupting current treatments or compromising the progress your loved one has already made. There’s no need to adjust baseline antiseizure medications, and it’s compatible with common therapies like ketogenic diets, vagal nerve stimulation, and feeding tubes. FINTEPLA is taken by mouth and allows for flexible dosing based on how your loved one responds to and tolerates treatment.

However, it’s important to talk with your loved one’s healthcare provider about all of their medical conditions and every medicine they take—including prescription and over-the-counter drugs, vitamins, and herbal supplements—to be sure FINTEPLA is appropriate.

FINTEPLA should not be taken if your loved one is allergic to fenfluramine or any of the ingredients in FINTEPLA, or if they have taken medicines called monoamine oxidase inhibitors (MAOIs) within the last 14 days, as this may cause a serious or life-threatening problem called serotonin syndrome.

Backed by safety monitoring and real-world experience

In clinical trials, some of the most common side effects for FINTEPLA included diarrhea, tiredness, vomiting, sleepiness, and decreased appetite. Some patients taking FINTEPLA experienced weight loss early in treatment; however, in a long-term study, approximately half of the patients’ weight loss stabilized with continued treatment. A small proportion of patients taking FINTEPLA 0.7 mg/kg/day discontinued treatment due to side effects.

While these side effects were the most common, they are not all the possible side effects of FINTEPLA. It’s important to talk with your healthcare provider or pharmacist for more information, and you should always report any side effect that bothers you or does not go away. For medical advice regarding side effects, call your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088. Please see the full Important Safety Information below for a complete list of side effects reported in the clinical trials.

To help protect your loved one’s heart, FINTEPLA is only available through the FINTEPLA REMS—an FDA-required safety program designed to monitor for rare but serious risks, including potential problems with heart valves (valvular heart disease) and high blood pressure in the lungs (pulmonary arterial hypertension). As part of this program, regular echocardiograms are required before, during, and one time after treatment to help monitor heart health over time.

Since its approval in 2020, FINTEPLA has been prescribed to more than 10,000 patients with Dravet syndrome and LGS worldwide. It’s been over 5 years of progress—toward improved seizure control, fewer emergency medications, and more moments of laughter, connection, and peace for families.

ā€œHaving fewer seizures allows Ezekiel to be up and alert and an active part of his own day.ā€ — Jessie, mother of Ezekiel, living with LGS

Could FINTEPLA be the add-on treatment your family has been waiting for?
Visit the FINTEPLA website to learn more and download the caregiver brochure.

IMPORTANT SAFETY INFORMATIONĀ 

FINTEPLA can cause serious side effects, including:Ā 

  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 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
  • tiredness or weakness, especially with increased activity
  • lightheadedness or fainting
  • swollen ankles or feet
  • chest pain
  • sensations of a rapid, fluttering heartbeat (palpitations)
  • irregular pulse
  • bluish color of your lips and skin (cyanosis)

Because of the risk of heart valve problems (valvular heart disease) and high blood pressure in the arteries of the 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.

  1. Decreased appetite and decreased weight. Decreased appetite and decreased weight are serious and common side effects of FINTEPLA.
  • 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.
  1. Sleepiness, sedation, and lack of energy (lethargy). These are serious and common side effects of FINTEPLA. 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.
  2. 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; trouble sleeping (insomnia); attempts to commit suicide; new or worse irritability; new or worse depression; acting aggressive, being angry or violent; new or worse anxiety; acting on dangerous impulses; feeling agitated or restless; an extreme increase in activity and talking (mania); panic attacks; other unusual changes in behavior or mood.

How can I watch for early symptoms of suicidal thoughts and actions?Ā 

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.

  1. 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).

Do not take FINTEPLA if you:Ā Ā 

  • are allergic to fenfluramine or any of the ingredients in FINTEPLA. See the Medication Guide 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 serotonin syndrome. 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 your medical conditions, including heart problems; weight loss; depression, mood problems, or suicidal thoughts or behavior; kidney problems; liver problems; are pregnant or plan to become pregnant; are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of FINTEPLA?Ā 

FINTEPLA may cause serious side effects, including:Ā 

  • See ā€œFINTEPLA can cause serious side effectsā€ 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, or diarrhea; high body temperature; trouble walking.

  • High blood pressure (hypertension). Hypertension is a serious and common side effect. FINTEPLA can cause your blood pressure to increase even if you have never had high blood pressure before.
  • 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 patients with 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 patients with 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.Ā 

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.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information on FINTEPLA.

FINTEPLAĀ® is a registered trademark of the UCB Group of Companies.
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