Fintepla

What is Fintepla?

• Fintepla is a prescription medicine used to treat the 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.

Description

FINTEPLA oral solution contains 2.2 mg/mL fenfluramine, equivalent to 2.5 mg/mL of the hydrochloride salt.

The active ingredient, fenfluramine hydrochloride, is designated chemically as N-ethyl-α-methyl-3-(trifluoromethyl)phenethylamine hydrochloride.

The structural formula is:

Fenfluramine hydrochloride is a white to off-white crystalline solid. The pKa of fenfluramine is 10.2.

FINTEPLA is a clear, colorless solution, pH 5.

FINTEPLA contains the following 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), and contains not more than 0.1% of carbohydrates, which is solely derived from the cherry flavor.

Mechanism of Action

The precise mechanism by which fenfluramine exerts its therapeutic effects in the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome is unknown. Fenfluramine and the metabolite, norfenfluramine, exhibit agonist activity at serotonin 5-HT2 receptors. There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine and norfenfluramine, and valvular heart disease and pulmonary arterial hypertension.

What is the most important information I should know about Fintepla?

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:

• 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 to your lips and skin (cyanosis)

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 (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.

• 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:

• 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 suddenly can 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.

Who should not take Fintepla?

Do not take Fintepla if you:

• are allergic to fenfluramine or any of the ingredients in Fintepla. See the end of this Medication Guide 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.

What should I tell my healthcare provider before taking Fintepla?

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.
  • 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 at the end of this Medication Guide 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 “What is the most important information I should know about Fintepla?”
• 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 to include:
  • 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 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.

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 FDA at 1-800-FDA-1088.

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.

You can ask your pharmacist or healthcare provider for information about Fintepla that is written for health professionals.

How should I store Fintepla?

• Store Fintepla at room temperature between 68°F to 77°F (20°C and 25°C).
• Do not refrigerate or freeze.
• Store the Fintepla 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 Fintepla and all medicines out of the reach of children.

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).

Label

PRINCIPAL DISPLAY PANEL – NDC: 3376-322-30 – 30 ML CARTON LABEL

PRINCIPAL DISPLAY PANEL – NDC: 43376-322-36 – 360 ML BOTTLE LABEL