Fintepla is a brand-name oral solution that’s prescribed for seizures related to certain types of epilepsy. Fintepla contains the active ingredient fenfluramine and belongs to the antiseizure drug class.

Fintepla is approved by the Food and Drug Administration (FDA) to treat seizures in adults and children ages 2 years and older with one of the following types of epilepsy: Dravet syndrome or Lennox-Gastaut syndrome.

Drug details

You’ll find key information about Fintepla below.

  • Drug form: oral solution
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? no
  • Year of FDA approval: 2020

Fintepla is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Fintepla can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Fintepla. These lists do not include all possible side effects.

Side effects might differ slightly between people with Dravet syndrome and Lennox-Gastaut syndrome. (Fintepla is approved to treat seizures associated with these conditions.)

For more information about the possible side effects of Fintepla, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The FDA tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Fintepla, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Fintepla. To learn about other mild side effects, talk with your doctor or pharmacist, or view Fintepla’s prescribing information.

Mild side effects of Fintepla can include:

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Fintepla aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • lack of muscle coordination, which may include symptoms such as:
    • difficulty speaking, such as slurred speech
    • difficulty walking, such as walking more slowly than usual
    • balance problems that increase the risk of falling
  • glaucoma, which may include symptoms such as:
  • suicidal thoughts or behaviors, which may include symptoms such as:
    • thoughts of death or self-harm
    • agitation, anxiety, or restlessness
    • new or worsened depression or irritability
  • status epilepticus, which is a medical emergency and may include symptoms such as:
    • seizures that last at least 5 minutes
    • multiple seizures in a row with loss of consciousness
    • muscle stiffness or twitching
  • high blood pressure, which doesn’t typically cause symptoms
  • risk of valvular heart disease and PAH
  • severe allergic reaction (see “Allergic reaction” below)

Note: Fintepla has a boxed warning for valvular heart disease and PAH. A boxed warning is the most serious warning from the FDA. To learn more, see the “Fintepla precautions” section below.

Side effects in children

Fintepla is approved to treat seizures caused by certain types of epilepsy in children ages 2 years and older. For more details, see the “Fintepla uses” section below.

Most side effects of Fintepla in children are expected to be the same as those in adults. (For lists of possible side effects, see “Mild side effects” and “Serious side effects” just above.)

It’s important to note that loss of appetite and weight loss may delay growth in children. For this reason, your child’s doctor may check their height and weight during treatment. If they find signs of delayed growth, your child’s doctor may switch them to a treatment other than Fintepla.

If you have questions about how Fintepla may affect your child, talk with their doctor.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects if it’s safe to do so.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

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Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Fintepla. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Fintepla, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Fintepla dosage your doctor prescribes will depend on several factors. These include:

  • the severity of the condition you’re taking Fintepla to treat
  • your body weight
  • other medications you may be taking
  • other medical conditions you may have

The following information describes dosages that are commonly prescribed or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Fintepla comes as a cherry-flavored oral solution. It’s available in one strength: 2.2 milligrams of drug per milliliter of solution (2.2 mg/mL).

You’ll take the solution using a 3-mL or 6-mL oral syringe provided by the pharmacy. Do not use a household teaspoon or tablespoon, as they may not measure the correct amount of solution.

In some cases, Fintepla may be given through a feeding tube. Your doctor can tell you more about this method for receiving doses.

Fintepla dosages are calculated in mg of medication per kilogram (kg) of body weight. One kg is about 2.2 pounds (lb). Your doctor or pharmacist will calculate your dosage.

Dosage for seizures

Fintepla is prescribed to treat seizures caused by certain types of epilepsy. For more details, see the “Fintepla uses” section below.

The starting dosage of Fintepla is 0.1 mg per kg of body weight, taken twice daily. For example, a person weighing 66 kg (about 145 lb) would be prescribed 6.6 mg (3 mL) of Fintepla twice daily.

Your doctor may increase your Fintepla dosage weekly depending on how well the drug is working. The maximum ongoing dosage of Fintepla for seizures is 0.35 mg per kg of body weight, taken twice daily. However, the maximum total daily dose of Fintepla will not exceed 26 mg.

Your doctor may prescribe a different dosage depending on several factors. These include other medications you’re taking and whether you have kidney or liver disease. If you have questions about the dosage that’s right for you, talk with your doctor.

Children’s dosage

Fintepla is prescribed to treat seizures caused by certain types of epilepsy in children ages 2 years and older.

The dosage of Fintepla for children is the same as for adults. For details, see “Dosage for seizures” above.

About taking Fintepla

Below you’ll find information about key dosage issues.

  • When to take: You should take Fintepla twice per day.
  • If you miss a dose: If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, skip your missed dose and take your next dose at the regular time. If you aren’t sure about whether you should take a missed dose or skip it, talk with your doctor or pharmacist.
  • Taking Fintepla with food: You can take Fintepla with or without food.
  • Length of use: Fintepla is meant to be a long-term treatment. If you and your doctor determine that Fintepla is safe and effective for you, you’ll likely take it long term.
  • Length of time to work: Fintepla starts working as soon as you take it. However, it may take several days or weeks for the symptoms of your condition to ease. In clinical trials, many people had fewer seizures within 4 weeks of starting treatment with Fintepla.

Overdose

Taking more than the recommended dosage of Fintepla can lead to serious side effects. Do not take more Fintepla than your doctor recommends.

Overdose symptoms

Symptoms of an overdose can include:

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

As with all medications, the cost of Fintepla can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Fintepla, or if you need help understanding your insurance coverage, help is available.

A program called Onward Copay Assistance Program is available for Fintepla. For more information and to find out if you’re eligible for support, visit the program website.

To learn more about saving money on prescriptions, check out this article.

Generic version: Fintepla is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

The FDA approves prescription drugs such as Fintepla to treat certain conditions.

Fintepla for seizures

Fintepla is FDA approved to treat seizures caused by one of the following types of epilepsy: Dravet syndrome or Lennox-Gastaut syndrome.

Dravet syndrome and Lennox-Gastaut syndrome develop early in life. They can cause many types of seizures and other symptoms. For treating seizures, Fintepla is prescribed for adults and children ages 2 years and older.

You can learn more about Dravet syndrome and Lennox-Gastaut syndrome by visiting our epilepsy and seizures hub.

Fintepla and children

Fintepla is approved to treat seizures caused by Dravet syndrome and Lennox-Gastaut syndrome in children ages 2 years and older.

If you’d like to learn more about Fintepla’s uses, talk with your doctor.

Fintepla can interact with several other medications and certain supplements. The drug isn’t known to interact with any foods.

Before taking Fintepla, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications and supplements

Below is a list of medications and supplements that can interact with Fintepla. This list does not contain all drugs that may interact with Fintepla. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Medications that can interact with Fintepla• certain antiseizure drugs, such as stiripentol (Diacomit) and clobazam (Onfi, Sympazan)
• selective serotonin reuptake inhibitors, such as fluvoxamine (Luvox) and paroxetine (Brisdelle, Paxil, others)
• serotonin-norepinephrine reuptake inhibitors, such as venlafaxine (Effexor XR) and duloxetine (Cymbalta)
• tricyclic antidepressants, such as amitriptyline and nortriptyline (Pamelor)
• monoamine oxidase inhibitors (MAOIs), such as phenelzine (Nardil) and selegiline (Emsam, Zelapar)
• triptans, such as rizatriptan (Maxalt, RizaFilm, others) and sumatriptan (Imitrex, Tosymra, others)
• bupropion (Aplenzin, Wellbutrin XL, others)
• dextromethorphan (Delsym)
• lithium (Lithobid)
• mirabegron (Myrbetriq)
• omeprazole (Prilosec)
• quinidine
• tramadol (ConZip, Qdolo)
Supplements that can interact with Fintepla• L-tryptophan
• St. John’s wort

Alcohol interaction

It’s not safe to consume alcohol while taking Fintepla. Doing so could worsen certain side effects of Fintepla, including sleepiness and lack of muscle coordination. If you have questions about the safety of drinking alcohol while taking Fintepla, talk with your doctor or pharmacist.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Fintepla, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of drugs that are alternatives to Fintepla for seizures caused by Dravet syndrome include:

Examples of drugs that are alternatives to Fintepla for seizures caused by Lennox-Gastaut syndrome include:

If you can become pregnant, consider the following information about pregnancy and breastfeeding.

Fintepla and pregnancy

It’s not known whether Fintepla should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

If you’re prescribed Fintepla during pregnancy, consider enrolling in the drug’s pregnancy registry. This registry helps collect information about pregnancy-related issues that may occur with Fintepla. To learn more, talk with your doctor or call 888-233-2334.

Fintepla and breastfeeding

It’s not known whether Fintepla should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

Here are answers to some frequently asked questions about Fintepla.

How does Fintepla work?

The way Fintepla works for seizures isn’t fully understood. The drug increases the level of a chemical called serotonin in the brain. Having higher serotonin levels is thought to help treat seizures.

Fintepla is prescribed to treat seizures caused by certain types of epilepsy. For details, see the “Fintepla uses” section above.

Your doctor or pharmacist may be able to provide more information about how Fintepla works for your condition.

Can Fintepla cause long-term side effects?

It’s rare but possible. Fintepla may cause side effects that start during treatment but can continue after treatment ends. These include the risk of valvular heart disease and PAH.

Fintepla has a boxed warning for these risks. This is the most serious warning from the FDA. To learn more, see the “Fintepla precautions” section below.

If you have other questions about possible long-term side effects of Fintepla, talk with your doctor or pharmacist.

Is Fintepla safe for older adults?

Yes, in general, Fintepla is safe for adults ages 65 years and older. Clinical trials did not include enough older adults to know whether Fintepla has different effects on them than on other adults.

However, doctors may prescribe a lower dosage of Fintepla to older adults to help reduce their risk of side effects. The decision to prescribe a lower dosage will depend on other medical conditions the person has and how their body responds to the drug.

For example, it’s more likely that older adults could have conditions that cause heart, kidney, or liver damage. In this case, dosage adjustments are recommended. To learn about this drug’s recommended dosage, see the “Fintepla dosage” section above.

If you have questions about the safety of Fintepla given your age, talk with your doctor. They can recommend whether this drug is a safe treatment option for you.

This drug comes with several precautions.

FDA warning: Risk of valvular heart disease and pulmonary arterial hypertension

This drug has a boxed warning. This is the most serious warning from the FDA. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Fintepla may increase the risk of valvular heart disease and pulmonary arterial hypertension (PAH). With valvular heart disease, you have damage to a valve in your heart. With PAH, you have high blood pressure in the arteries of your lungs.

Valvular heart disease and PAH may cause symptoms that include:

Due to this risk, doctors can prescribe Fintepla only through the Fintepla risk evaluation and mitigation strategy program. This program helps you and your doctor manage the risk of possible valvular heart disease and PAH with Fintepla.

Your doctor will monitor you for valvular heart disease and PAH with an echocardiogram. Your doctor will give you this test before starting Fintepla treatment and every 6 months during treatment. Also, they’ll repeat this test 3 months and 6 months after your last dose of the drug.

Abnormal echocardiogram results were common in Fintepla’s clinical trials, but there were no reports of valvular heart disease or PAH. However, these conditions have been reported with other forms of fenfluramine, Fintepla’s active ingredient.

If your echocardiogram test results are abnormal, your doctor will decide whether it’s safe to take Fintepla.

To learn more about this warning, talk with your doctor.

Other precautions

Before taking Fintepla, discuss your health history with your doctor. Fintepla may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Note: For more information about the potential negative effects of Fintepla, see the “Fintepla side effects” section above.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.