Fintepla
Fintepla (fenfluramine) is an antiepileptic (antiseizure) medication that's used for people ages 2 years and older. This medication is only meant for those with seizures caused by Dravet syndrome or Lennox-Gastaut syndrome, not other seizure conditions. Fintepla (fenfluramine) comes as an oral solution, so it's a good option for people who can't swallow pills.
What is Fintepla (fenfluramine)?
What is Fintepla (fenfluramine) used for?
- Treatment of seizures caused by Dravet syndrome (DS)
- Treatment of seizures caused by Lennox-Gastaut syndrome (LGS)
How Fintepla (fenfluramine) works
Fintepla (fenfluramine) is an antiepileptic. It's not entirely clear how this medication works to treat seizures. But it's thought to act on the serotonin system in your body, which might help you have fewer seizures.
Drug facts
Side effects of Fintepla (fenfluramine)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Dravet syndrome
- Poor appetite (up to 49%)
- Diarrhea (up to 31%)
- Feeling tired or unwell (up to 30%)
- Drowsiness or lack of energy (up to 26%)
- Upper respiratory tract infection (up to 21%)
- Fever (up to 21%)
Lennox-Gastaut syndrome
- Poor appetite (up to 36%)
- Feeling tired or unwell (up to 24%)
- Drowsiness or lack of energy (up to 22%)
- Vomiting (up to 14%)
- Diarrhea (up to 13%)
- Upper respiratory tract infection (up to 8%)
Less Common Side Effects
- Constipation
- Weight loss
- Poor balance and coordination
- Weak muscle tone
- Tremor or feeling shaky
- Abnormal behavior
- Irritability
- Higher blood pressure
- Drooling
- Ear infection
Fintepla (fenfluramine) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Lung or heart valve problems: difficulty breathing, tiredness, dizziness, chest pain, heart racing, swollen ankles, bluish-colored lips or skin
- Serotonin syndrome: fast heart rate, sweating, muscle stiffness or spasms, fever, confusion
- Suicidal thoughts or behavior
The following Fintepla (fenfluramine) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart valve disease—shortness of breath, chest pain, unusual weakness or fatigue, dizziness, feeling faint or lightheaded, fever, sudden weight gain, fast or irregular heartbeat
- Increase in blood pressure
- Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
- Pulmonary arterial hypertension (PAH)—shortness of breath, unusual weakness or fatigue, swelling of the ankles, hands, or feet, dizziness, feeling faint or lightheaded, chest pain, fast or irregular heartbeat, blue skin or lips
- Sudden eye pain or change in vision such as blurry vision, seeing halos around lights, vision loss
- Thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Diarrhea
- Dizziness
- Drowsiness
- Loss of appetite with weight loss
- Loss of balance or coordination
- Unusual weakness or fatigue
- Vomiting
Pros and cons of Fintepla (fenfluramine)
Pros
- Available in liquid form, which is helpful for people who can't swallow pills
- Cherry flavored and doesn't contain any ingredients made from gluten-containing grain
- Can give through gastric and nasogastric feeding tubes
- Can use for children as young as 2 years old
Cons
- Only for treatment of seizures caused by Dravet syndrome or Lennox-Gastaut syndrome
- Only available as a brand medication, so there's no lower-cost generic available
- Need to enroll in a special medication safety program in order to get it
Pharmacist tips for Fintepla (fenfluramine)
- You can take Fintepla (fenfluramine) with or without food. Food won't affect how this medication works in your body.
- Fintepla (fenfluramine) can make you feel drowsy, tired, or weak. Avoid activities that require you to be alert, such as driving a car or operating machinery, until you know how the medication affects you. These effects usually get better over time.
- Read the Instructions For Use that come with Fintepla (fenfluramine) on how to measure out your dose. If you have any concerns or questions about the instructions, contact your provider or pharmacist for help.
- Measure your Fintepla (fenfluramine) dose using the oral dosing syringe that comes with the medication only. Don't use a regular household teaspoon or tablespoon to measure out your dose because they aren't accurate. You might accidentally take an incorrect amount of medication. This can raise your risk of seizures or side effects.
- Rinse the oral syringe after each use with clean tap water and let it air dry. It's also safe to put the syringe in the dishwater to clean.
- Don't stop taking Fintepla (fenfluramine) without speaking to your provider first. Stopping this medication suddenly can raise your risk of having seizures more often or seizures that don't stop. Contact your provider if you want to stop taking Fintepla (fenfluramine) so they can instruct you on how to do so safely.
- Fintepla (fenfluramine) can lower your child's appetite, which can lead to weight loss. Your child's provider will track their growth closely during treatment. If you notice a change in your child's weight or appetite, let the provider know because they might prescribe a lower dose of medication.
- Keep the Fintepla (fenfluramine) bottle and oral syringe at room temperature. Don't refrigerate or freeze it since this could damage the medication.
- Throw away any medication that you haven't used 3 months after first opening the bottle. If the "Discard After" date on the bottle comes sooner than 3 months, follow the "Discard After" date and throw away any unused medication then.
Common questions about Fintepla (fenfluramine)
No. Fintepla (fenfluramine) was originally only approved to treat seizures caused by Dravet syndrome. But in early 2022, it was also approved to treat seizures caused by a severe form of epilepsy known as Lennox-Gastaut syndrome. Fintepla (fenfluramine) has only been studied for use in these two seizure conditions, so it's not known if it's safe or works well for other causes of seizure. Talk with your provider about the best seizure treatment for you.
A Risk Evaluation and Mitigation Strategy (REMS) program is an extra safety requirement from the FDA for certain medications that have serious risks. The FDA requires a REMS program for Fintepla (fenfluramine) because in rare cases, the medication can cause problems with your heart or high blood pressure in the blood vessels of your lungs. The Fintepla REMS Program helps make sure this medication is safe for you. You, your provider, and the pharmacy must all enroll in this program to help spot these potential problems early before symptoms begin to appear.
In studies of people with Dravet syndrome, about half of the participants taking Fintepla (fenfluramine) had a seizure-free period of at least 3 weeks. In addition, Fintepla (fenfluramine) lowered monthly Dravet syndrome-related seizures by about 70%. For people with seizures caused by Lennox-Gastaut syndrome, Fintepla (fenfluramine) lowered monthly seizures by about 24%.
Your provider might recommend you to continue your other antiseizure medications while you're taking Fintepla (fenfluramine). Sometimes, your provider might recommend other treatments in addition to Fintepla (fenfluramine). Some of these treatments include Diacomit (stiripentol), clobazam (Onfi), valproic acid, and certain lifestyle changes. Talk with your provider about your seizure treatment plan. Fintepla (fenfluramine) can interact with many medications, which can affect how well or how safe your medications are for you. So always check with your provider before starting something new so they can make sure your treatment is right for you.
It's not known if Fintepla (fenfluramine) is safe to take during your pregnancy or if it will cause harm to you or your unborn baby. If you're pregnant or planning to get pregnant, it's best to speak with your provider about the risks and benefits of treatment before starting this medication. If you're pregnant and are taking Fintepla (fenfluramine), there's a program called the North American Antiepileptic Drug (NAAED) Pregnancy registry that you can enroll in. This registry will collect health information about you and your unborn baby. It's encouraged that you enroll in the registry by calling 1-888-233-2334 or visiting its website.
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Risks and warnings for Fintepla (fenfluramine)
Fintepla (fenfluramine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Heart and lung problems
- Risk factors: Taking certain medications that raise serotonin levels in the body, including Fintepla (fenfluramine) | History of valvular heart disease
Medications that work similarly to Fintepla (fenfluramine) might be linked to high blood pressure in the lungs (pulmonary hypertension) and damage to heart valves. Before you start this medication, your provider will check your heart and lungs with an imaging scan called an echocardiogram. You'll need to get imaging done every 6 months during treatment. Then, continue to get imaging every 3 to 6 months after finishing treatment with Fintepla (fenfluramine). Discuss options with your provider if you have a history of valvular heart disease or already have high blood pressure in your lungs.
Because of the risks of serious heart and lung problems, Fintepla (fenfluramine) is only available through a restricted distribution program called the Fintepla REMS program. You'll have to enroll in this program and follow its monitoring requirements. Your pharmacy must also register with this program, so you won't be able to fill your prescription at just any pharmacy.
Poor appetite and weight loss
- Risk factors: Taking higher doses of Fintepla (fenfluramine)
Fintepla (fenfluramine) can lower your appetite, which can lead to weight loss. This effect seems to be related to the amount of medication you're taking. Talk with your provider if you notice that your appetite is lower than usual or that you're losing weight while taking this medication. You might need a lower dose of Fintepla (fenfluramine).
Suicidal thoughts or behavior
Antiepileptic (antiseizure) medications like Fintepla (fenfluramine) can raise your risk of suicide or thoughts of suicide. Watch for any new or worsening depression and any unusual changes in mood, especially during the first few months of taking this medication or if your dose changes. Report anything concerning to your provider. If you have thoughts of hurting yourself, call 911 or get medical attention right away.
Serotonin syndrome
- Risk factors: Taking monoamine oxidase inhibitors (MAOI) 14 days before starting Fintepla (fenfluramine) | Taking other medications that raise serotonin levels in your brain
Serotonin syndrome is a rare but potentially life-threatening condition where there's too much serotonin in the brain. Serotonin is one of the chemicals in your brain responsible for your mood. Your risk for serotonin syndrome goes up if you use Fintepla (fenfluramine) with other medications that affect serotonin levels, such as certain antidepressants, MAOI medications like selegiline, lithium, and migraine medications called triptans. Make sure your provider knows about all the medications you take before starting Fintepla (fenfluramine). Don't start any new medications while taking Fintepla (fenfluramine) without letting your pharmacist or provider know. Symptoms of serotonin syndrome include fast heart rate, sweating, muscle stiffness or spasms, fever, and confusion. Get medical help right away if you have any of these symptoms.
Higher blood pressure
Fintepla (fenfluramine) can raise your blood pressure, even in people who don't have high blood pressure. Your provider will check your blood pressure during treatment to make sure it stays in a healthy range.
Eye problems
Fintepla (fenfluramine) can cause your pupils to dilate (widen) and can even cause glaucoma (high pressure in the eye). Let your provider know if you have a history of eye problems. Also contact them if you start having vision changes or eye discomfort while taking this medication. You might need to stop Fintepla (fenfluramine) if you develop vision changes.
Fintepla (fenfluramine) dosage
Typical dosage for Fintepla (fenfluramine)
Your dose is based on your body weight. The typical starting dose is 0.1 mg/kg of body weight by mouth twice a day.
After a week, your or your child's provider will adjust the dose depending on how many seizures are still happening and the side effects you or your child might have. The maximum dose is 26 mg per day.
Your dose might differ if you have kidney or liver problems, or if you're also taking certain medications, including Diacomit (stiripentol) and clobazam (Onfi).
Fintepla (fenfluramine) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Fintepla (fenfluramine) will not be safe for you to take.
- Currently take or have taken medications called monoamine oxidase inhibitors (MAOIs) within the last 14 days
