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The approval of FINTEPLA as a treatment choice for Dravet syndrome signals an important milestone for many families. Whether your child has just been diagnosed or your family has been living with Dravet syndrome for some time, you know that selecting the right treatment means understanding and weighing all options.

In clinical studies, FINTEPLA was proven to significantly reduce seizures caused by Dravet syndrome in patients 2 years of age and older.a To help you learn more about FINTEPLA, see below for answers to commonly asked questions.

When you’re ready, talk to your healthcare provider to decide if FINTEPLA is right for you or your child.

aYour child’s results may vary.

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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.

How is FINTEPLA taken?

FINTEPLA is a liquid that is taken by mouth (or administered orally) and can be taken with or without food. Read the Instructions for Use at the end of the FINTEPLA Medication Guide for information on the right way to take FINTEPLA.

How can my child get on FINTEPLA?

FINTEPLA is available only through the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) program. In the past, some adults who took fenfluramine, the active ingredient in FINTEPLA, developed problems with their heart valves or high blood pressure in the arteries of their lungs. The FINTEPLA REMS program is designed to help manage these potential safety concerns.

Before your child receives FINTEPLA, your healthcare provider will check their heart valves and lung artery pressure with a test called an echocardiogram (echo), which is an ultrasound picture of the heart. After enrolling in the REMS and reviewing your child’s echo results, you and your healthcare provider will decide to begin or continue with FINTEPLA.

Did children in the FINTEPLA clinical studies develop problems with the heart valves or high blood pressure in the arteries of the lungs?

Of the 341 children who have taken FINTEPLA in clinical trials to date, none have developed problems with the valves in the heart or blood pressure in the arteries of the lungs. This includes some children who have been treated for up to 3 years. However, the FINTEPLA REMS program can help identify these potential problems early before symptoms begin to develop.

Is financial assistance available for FINTEPLA?

Zogenix is committed to making FINTEPLA affordable and accessible for all patients and sponsors several financial assistance programs including the Zogenix Co-pay Support Program and the Zogenix Patient Support Program.

For more information about these financial assistance programs, please call Zogenix Central at 1-888-ZOGENIX (1-888-964-3649).

Can FINTEPLA be taken with other anti-seizure medications?

During clinical studies, children were on their current treatment plans including other antiepileptic drugs or treatments such as vagal nerve stimulation or ketogenic diet while taking FINTEPLA. If you have additional questions about taking these medicines with FINTEPLA, speak with your healthcare provider.

Can FINTEPLA be taken with cannabidiol (CBD)?

Yes. FINTEPLA can be taken with commercially available CBD. If you have additional questions, speak with your healthcare provider.

Can FINTEPLA be taken while on a ketogenic diet?

Yes. There are no restrictions for use of FINTEPLA while on a ketogenic diet. In fact, children on a ketogenic diet were included in the FINTEPLA clinical trials. Remember to discuss with your healthcare provider all treatments you may be taking, including the ketogenic diet.

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Important Safety InformationIndication

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.
  • 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.

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 of 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 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.

  1. 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.
  1. 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.
  2. 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.

  1. 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:

Before taking FINTEPLA, tell your healthcare provider about all of your medical conditions, including if you:

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?

What should I avoid while taking FINTEPLA?

What are the possible side effects of FINTEPLA?

FINTEPLA may cause serious side effects, including:

  • See “FINTEPLA can cause serious side effects” above,
    • 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.