Fintepla

Pronunciation: fin-TEP-la
Generic name: fenfluramine
Dosage form: oral solution
Drug classes: CNS stimulants, Miscellaneous anticonvulsants

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 26, 2023.

What is Fintepla?

Fintepla is a prescription medicine used to treat the seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

Fintepla is a federally controlled substance (C-IV) because it contains fenfluramine. Keep this medicine in a safe place to prevent misuse and abuse, and to 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 this medicine is safe and effective in children less than 2 years of age.

Warnings

Do not take Fintepla if you:

are allergic to fenfluramine or any of the inactive ingredients in Fintepla
are taking or have within the last 14 days stopped taking medicines called monoamine oxidase inhibitors (MAOI), serotonin agonists, or serotonin reuptake inhibitors. Taking these medications with Fintepla may cause a serious or life-threatening problem called serotonin syndrome.

Valvular heart disease and pulmonary arterial hypertension

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.

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 treatment, every 6 months during treatment, and one time 3 to 6 months after you take your last dose.

Call your healthcare provider right away if you develop any of these signs and symptoms of heart or lung problems during treatment with Fintepla:

bluish color to your lips and skin (cyanosis)
chest pain
irregular pulse
light-headedness or fainting
sensations of a rapid, fluttering heartbeat (palpitations)
shortness of breath
swollen ankles or feet
tiredness or weakness especially with increased activity.

Blood pressure increases

Your blood pressure will need regular monitoring throughout treatment with Fintepla.

Decreased appetite and decreased weight

Fintepla may cause a decreased appetite and weight loss. Your weight should be checked regularly and your dosage may need to be decreased if your weight decreases. In some cases, treatment may need to be stopped.

Glaucoma

Tell your doctor if you have a sudden decrease in your eyesight or develop eye pain.

Sleepiness, sedation, and lack of energy (lethargy)

Fintepla may make you drowsy or sleepy. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Fintepla affects you.

Taking Fintepla with central nervous system (CNS) depressants including alcohol may increase sleepiness.

Suicidal behavior and thoughts

Like 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 or worse, or if you experience any unusual changes in behavior or mood or have thoughts about suicide or dying.

Withdrawal of treatment

Do not stop taking Fintepla without first talking to your healthcare provider. When it comes time to discontinue the medication, it needs to be done slowly because stopping medications for seizures suddenly can cause you to have seizures more often or have seizures that do not stop (status epilepticus).

Before taking this medicine

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, suicidal thoughts, or behavior
have liver problems
have kidney problems
are pregnant, plan to become pregnant, or are breastfeeding.

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.

Pregnancy

There is no data on the use of Fintepla in pregnant women. Tell your healthcare provider right away if you are intending to become pregnant.

If you inadvertently 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 at www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Fintepla passes into your breast milk.

How is Fintepla given?

Fintepla may be taken with or without food.

Measure your dose using the dosing syringe that is provided by the pharmacy. Do not use a household teaspoon or tablespoon. Fintepla may be given through gastric and nasogastric feeding tubes.
Because of the risk of heart valve problems and pulmonary arterial hypertension fenfluramine is only available through a restricted program called the Fintepla Risk Evaluation and Mitigation (REMS) Program. Before you or your child receives Fintepla, your healthcare provider or pharmacist will make sure you understand how to take the medicine safely. If you have any questions, ask your healthcare provider, visit www.FinteplaREMS.com, or call 1-877-964-3649.
Read the Instructions for Use leaflet that comes with your prescription. Take this medicine exactly as your healthcare provider tells you to take it.
The usual starting dose is 0.1 mg/kg twice daily which can be increased weekly based on tolerability, effectiveness, kidney disease, and other medications.

What are the side effects of Fintepla?

The most common side effects of Fintepla include:

abnormal echocardiogram
constipation
decreased appetite
diarrhea
falls
fever
high blood pressure
increased drooling
infection
low energy
problems with movement, balance, and walking
respiratory infection
tiredness
vomiting
weakness.

May cause drowsiness. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Fintepla affects you.

Other side effects

Fintepla may cause serotonin syndrome. Call your healthcare provider right away if you have any of the following symptoms:

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.

Fintepla may also cause increased pressure in your eye (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. You may report side effects to FDA at 1-800-FDA-1088.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect Fintepla?

Many drugs can affect Fintepla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Common medications that may interact with Fintepla include:

antidepressant medications called SSRIs, SNRIs, TCAs, and MAOIs
antipsychotics
clobazam
cyproheptadine
dextromethorphan
lithium
St. John’s Wort
stiripentol
tramadol
tryptophan.

Storage

Store Fintepla at room temperature between 68°F to 77°F (20°C and 25°C).

Do not refrigerate or freeze.
Store the bottle and syringe together in a clean area.
Throw away (discard) any unused Fintepla 3 months after first opening the bottle or if the Discard After date on the package or bottle has passed. Whichever one comes first.
Keep all medicines out of the reach of children and pets.

Ingredients

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).

Manufacturer

UCB.

Popular FAQ

How long does it take Fintepla to work?

On average, it takes 3 to 4 weeks for Fintepla to start working according to trials that investigated the use of Fintepla in children and adolescents with Dravet syndrome and children and adults with Lennox-Gastault seizures. Once a reduction in seizure frequency was observed, it generally persisted for the entire treatment period. Continue reading

Is Fintepla a controlled substance?

Yes, Fintepla is a Schedule IV controlled substance which means it is recognized as having some potential for abuse, although this is lower than substances classified in Schedule III. It is also subject to certain prescription restrictions. In addition, Fintepla is available only through a restricted program called the Fintepla REMS because it is associated with a higher risk of valvular heart disease and pulmonary arterial hypertension. Continue reading

What type of epilepsy is Diacomit used to treat?

Diacomit (stiripentol) is an oral anticonvulsant used with clobazam (Onfi) for seizures associated with Dravet syndrome in patients 6 months of age and older, weighing at least 7 kg (15.4 lbs), and taking the benzodiazepine clobazam (Onfi). Diacomit is not used alone to treat Dravet Syndrome, a rare, genetic form of epilepsy. It usually begins in infancy, often during a fever due to illness or vaccination. Continue reading

How is Fintepla injected/administered?

Fintepla is administered orally and is available as a cherry-flavored solution that may be taken with or without food. The dosage of Fintepla is calculated based on a patient’s weight and the usual starting dose is 0.1 mg/kg twice daily. Continue reading