COULD IMPROVED SEIZURE CONTROL HELP YOUR LOVED ONE DO MORE OF WHAT THEY LOVE?
If you’re caring for a loved one with Dravet syndrome, you know the toll it can take—on routines, relationships, and peace of mind. Even with multiple treatments, seizures often persist. Every plan requires a backup plan, and even fun is tempered by what-ifs.
It’s no wonder many families grow wary of new medications. But what if one addressed seizures in a different way?
A treatment with profound potential
FINTEPLA® (fenfluramine) is a prescription medicine used to treat seizures associated with Dravet syndrome 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 taking FINTEPLA (0.7 mg/kg/day) experienced a 79% reduction in monthly seizures compared with only 16% for patients taking a placebo. Adjusted for placebo, FINTEPLA reduced monthly seizures by 70% for patients taking 0.7 mg/kg/day—even after accounting for the placebo effect (improvement not caused by the actual treatment).
Half of the patients taking FINTEPLA 0.7 mg/kg/day experienced 21 or more consecutive seizure-free days compared with just 8 for those taking placebo. However, it’s important to note that these results may vary.
Patients added FINTEPLA (0.7 mg/kg/day) or placebo to their current antiseizure treatment plans during the study.
And, in a long-term study, over 1 in 3 patients achieved what experts define as “profound” seizure reduction—75% or more.
For many caregivers, these results aren’t just numbers—they’re new realities.
“Our life is definitely a lot more relaxed than it was back then…[Miller] is able to do everything a normal 6-year-old is able to do, and that’s such a blessing because it was not the situation when he was 2 years old.” — Chelsea, mother of Miller, living with Dravet syndrome
Fits into existing treatment plans
FINTEPLA is designed to work with your loved one’s current treatment regimen. 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. It’s taken by mouth and allows for flexible dosing based on how your loved one responds to and tolerates treatment.
This makes FINTEPLA a low-disruption option that supports your care plan.
Backed by safety monitoring and real-world experience
In clinical trials, some of the most common side effects for FINTEPLA included decreased appetite, symptoms related to gastrointestinal and digestive issues (like diarrhea, constipation, drooling, and vomiting), increased blood pressure, upper respiratory tract infection, sleepiness, low energy, fever, decreased weight, abnormal echocardiogram, and changes in movement or balance. Please see the full Important Safety Information below for a complete list of side effects reported in the clinical trials.
Some patients taking FINTEPLA experienced weight loss early on. However, in a long-term study, most patients’ weight loss stabilized with continued treatment.
To help protect your loved one’s heart, FINTEPLA is only available through 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 Lennox-Gastaut syndrome (LGS) worldwide. It’s been 5 years of progress—toward improved seizure control, fewer emergency medications, and more moments of laughter, connection, and peace for families.
“Having seizure-free moments allows her to live an 11-year-old’s life.” — Darlene, mother of Callie, living with Dravet syndrome
You’re not alone—support is built in
The ONWARD® support program and Clinical Nurse Educators (CNEs) are available to answer your questions, explain the process, and walk alongside you as you explore what FINTEPLA could mean for your family.
If you’ve ever wondered what more freedom, flexibility, or relief might look like, this could be the moment to explore your options.
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 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 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.
2. 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.
3. 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.
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; 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?
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).
Do not take FINTEPLA if you:
- 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?
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, 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.
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.
FINTEPLA® and ONWARD® are registered trademarks of the UCB Group of Companies.
©2025 UCB, Inc., Smyrna, GA 30080. All rights reserved.
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