Dravet syndrome is a rare, treatment-resistant, lifelong form of epilepsy that begins in the first year of life and is characterized by frequent and/or prolonged seizures.1,2 Watch the video above to learn how Miller’s mother, Chelsea, navigates her son’s Dravet syndrome diagnosis.
Visit Fintepla.com to learn more and download a discussion guide to help you make the most of your conversation with your healthcare provider.
Chelsea has been compensated for her time by Zogenix. This video was developed by The Mighty in partnership with Zogenix.
For more information about FINTEPLA® (fenfluramine) oral solution, CIV, please see Medication Guide and full Prescribing Information, including Boxed Warning, at Fintepla.com and Important Safety Information below.
INDICATION
- FINTEPLA is a prescription medicine used to treat seizures associated with Dravet syndrome in patients 2 years of age and older.
- FINTEPLA is a federally controlled substance (C-IV) because it contains fenfluramine. Keep FINTEPLA in a safe place to prevent misuse, abuse, and protect it from theft. Never give your FINTEPLA to anyone else, because it may harm them. Selling or giving away this medicine is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines, or street drugs.
- 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 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:
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Because of the risk of heart valve problems and pulmonary arterial hypertension, FINTEPLA is only available through a restricted program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. 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.
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- 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. 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:
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How can I watch for early symptoms of suicidal thoughts and actions?
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- 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 (MAOI), serotonin agonists, or serotonin reuptake inhibitors 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 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 liver problems
- have kidney 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.
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- 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,
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- 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 include:
- diarrhea
- low energy
- respiratory infection
- tiredness
- fever
- constipation
- abnormal echocardiogram
- problems with movement, balance, and walking
- increased drooling
- infection
- vomiting
- falls
- seizures that do not stop
- weakness
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).
Please see Medication Guide and full Prescribing Information, including Boxed Warning, for additional information about FINTEPLA.
References:
- Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52(suppl 2):3-9. https://www.ncbi.nlm.nih.gov/pubmed/21463272
- Dravet C. Dravet syndrome history. Dev Med Child Neurol. 2011;53(suppl 2):1-6. https://www.ncbi.nlm.nih.gov/pubmed/21504424
Transcription:
Chelsea: Hey, my name is Chelsea. My husband Matt and I have two children. Our son Miller is age 7 and he has Dravet syndrome. We also have a daughter who is five who does not have Dravet syndrome. Miller is just the most fun-loving kid that you’ve ever met. He doesn’t know a stranger. He loves people. He loves interacting with people. He loves to talk to people. He loves to be a part of this community. He really is just the kindest, sweetest boy that you would ever meet.
When Miller had his first seizure, I think [for] my husband and I, both of our hearts just dropped. We knew something was wrong and we were scared for our child. The [seizures] were pretty infrequent. But they would come anytime that he had an increase in temperature, [like a] fever, or if he got too hot or too cold, he would start seizing. At about two and a half, that’s when his seizures started to change. They started to increase in frequency, length and duration.
Excitement was a big trigger for him. One of the seizures [happened] when Miller was excited [while] dropping him off for Mother’s Day out [event]. They had a really cool robot inside and just walking [into the classroom] and all the excitement of the first day, as soon as Miller got into the room, he started seizing. We knew it was just from the excitement of the classroom. Seizures impacted our family greatly. As a mom with two small kids, there was limits to where we could go or what we could do. We often had to stay home a lot just because that’s where I knew I could keep him the safest.
Miller received a diagnosis of Dravet syndrome after he had a particularly long seizure that didn’t stop with rescue medication. Dravet syndrome is the type of epilepsy in which the children never outgrow the seizures and is lifelong. So you always have to be ready for a seizure to happen at any time. On top of the seizures, there’s also behavioral and developmental delays. It is a spectrum disorder [so] he may [also] have challenges with learning and socialization.
It was just heartbreaking to hear that as a parent and to also not have many options available. When we started trying different medications for Miller to help with his seizure control, [he was] still seizing every seven to 10 days without a trigger. And when he was sick, we would be having up to five to 10 seizures a day that would require rescue medication. It was really hard to keep trying different things and then not seeing any change in the seizure frequency. And to watch your child suffer from frequent seizures, we would always get our hopes up [and] it was really hard to make the decision to put such a young child on medication.
We just wanted to find an effective way to reduce the number of seizures that Miller was having, and to give him longer stretches of seizure-free days. When we were at that point, we knew we had to add something. And that’s when we looked into what FINTEPLA could possibly do. Looking at the data of people who had been treated [with] it and the success rate of people who were responding to it, we knew that this was something worth trying for our child and that is why we decided to try FINTEPLA.
As a part of FINTEPLA REMS program, Miller had to get an echocardiogram before he started treatment. Now Miller gets echocardiograms every 6 months to make sure there’s no changes from the medication to his heart. An echo is just a sonogram of your heart. They put some jelly on your chest, and they have a cool camera, and they take pictures of your child’s heart. The echo takes about 20 to 30 minutes, I’m able to be with Miller the entire time. And I sit right next to his bed.”
Text on screen: Your healthcare provider will do a test called an echocardiogram to check your heart and 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.
When we started Miller on FINTELPA we knew that something was different. We started noticing that he was able to play longer without having a seizure. Our biggest test was when he got sick since fever and ear infections were our largest triggers. And when we saw that he could have seizure control even during an illness that was just a huge game changer for him and our family. We’ve noticed fewer seizures, even when he gets excited about things or gets sick.
Chelsea: “So, when starting Fintepla we noticed one of the side effects we saw was that Miller was a little bit more tired than usual. That side effect resolved itself over time.”
Text on screen: Taking FINTEPLA may increase sleepiness. This often resolves over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how FINTEPLA affects you.
Chelsea: “When Miller was having a lot of seizures, we were really hesitant to allow him to play as freely with his peers and his sister. Just because we knew that a lot of the things that came with play, like overheating and excitement would cause a seizure. We really had to limit his interactions with other kids and when he was having seizures so frequently, he would miss school. We have a seizure rescue plan with the school in case he does have a seizure, but he hasn’t had a seizure at school in a long time. It’s just so great to see him growing up and making friends. We used to avoid going to the beach because his seizures were so frequent. Now our family goes to the beach and Miller has fewer seizures while we’re there. It is just so great to see Miller playing with his sister at the beach. Days without seizures are really important to us.”
Text on screen: In a clinical study, FINTEPLA was shown to reduce seizures by 79% on averagea, compared to a 16% reduction for patients taking other antiepileptic medicines alone.
aFor patients taking the higher dose of FINTEPLA (0.7 mg/kg/day). Results may vary.
Chelsea: “The process for obtaining Fintepla, we’ve gone through Zogenix Central, and they’ve been awesome. They’ve answered all our questions about insurance, they ran to check our benefits. They made sure to communicate with us the entire time about any approvals that we would need, or anything like that. They are always a phone call away. The specialty pharmacy that we use to get FINTEPLA, they are very knowledgeable, they’ve worked with me to make sure that I was home to be able to receive the medication. I have full confidence in both the pharmacy and Zogenix Central in order to be able to process Miller’s claims and prescriptions and to be able to make sure that he gets the medicine when he needs it. Both were very helpful and really ease the process of getting Fintepla to us. So through the Zogenix Central, we have a specific person who has handled all of Miller’s information and have her contact information so we feel really confident with the support she is able to provide for our family to be able to obtain FINTEPLA.”
Text on screen: Zogenix Central is a program dedicated to giving personalized support, education, and resources to help patients and families navigate the process of starting and staying on FINTEPLA. This includes help obtaining access to FINTEPLA at an affordable cost.
US-FIN1-2100025 February 2021
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