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Overview: Fintepla is used to treat certain types of seizures. It may work by blocking certain signals that come from nerves and cause seizures. Common side effects include weight loss, sleepiness, and increased blood pressure. Serious side effects can include heart problems, suicidal thoughts and behaviors, and glaucoma.

Uses

What is Fintepla used for?

Fintepla (fenfluramine) is commonly used to treat certain types of seizures in people with epilepsy.

Fintepla may also be used for other conditions as determined by your health care provider.

How does Fintepla work (mechanism of action)?

The exact way that Fintepla works for seizures is unknown. Fintepla may block certain signals from nerves. Seizures are caused by electrical activity in the brain that is not normal. Fintepla may interfere with the abnormal electrical activity of the brain.

How is Fintepla supplied (dosage forms)?

Brands and other names

  • Fintepla

Dosage forms and strengths

  • 2.2 mg/mL oral solution

How should I store Fintepla?

Fintepla should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Fintepla?

The most common side effects of Fintepla are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Loss of appetite
  • Weight loss (see below)
  • Sleepiness or tiredness (see below)
  • Diarrhea
  • Constipation
  • General feeling of being unwell, tired, or not having your usual energy
  • Feeling unusually weak or tired
  • Falling or trouble with balance or coordination
  • Trouble walking
  • Increased blood pressure (hypertension) (see below)
  • Drooling or increased saliva
  • Fever
  • Nose or throat infection, sore throat, or common cold symptoms
  • Vomiting

There may be other side effects of Fintepla that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Fintepla?

While less common, the most serious side effects of Fintepla are described below, along with what to do if they happen.

Severe Allergic Reactions. Fintepla may cause allergic reactions, which can be serious. Stop taking Fintepla and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Problems. Fintepla can cause certain heart problems, such as heart valve disease (valvular heart disease) and pulmonary arterial hypertension. Your health care provider should check your heart regularly before, during, and after your treatment. Call your health care provider if you have any of the following symptoms.

  • Trouble breathing
  • Chest pain or pressure
  • Dizziness or fainting
  • Fatigue
  • Fluid retention in your abdomen, legs, or feet
  • Fast or abnormal heartbeat

Weight Loss. Fintepla can cause you to lose your appetite or lose weight. Your health care provider should monitor your weight regularly while you are taking Fintepla. Talk to your health care provider if you have a loss of appetite or are losing weight.

Suicidal Thoughts and Actions. Fintepla may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Withdrawal Reactions. If you stop Fintepla suddenly, it could lead to certain seizures that will not stop (status epilepticus) and may be life-threatening. Do not stop taking Fintepla without talking to your health care provider. Your health care provider can tell you how to stop Fintepla to reduce the risk of withdrawal reactions. Call your health care provider right away or go to the nearest emergency room if you have seizures.

Serotonin Syndrome. Serotonin syndrome is when there is too much of a substance called serotonin in your body. Fintepla can cause serotonin syndrome when it is taken alone or with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help if you have any of the following symptoms of serotonin syndrome.

  • Sweating, fever, or flushing
  • Confusion
  • Feeling agitated or restless
  • Seeing or hearing unusual things
  • Dizziness
  • Fast or racing heartbeat
  • Nausea, vomiting, or diarrhea
  • Muscle twitching, stiffness, or tremor
  • Seizures

Increased Blood Pressure (Hypertension). Fintepla may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry vision or other vision changes
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling like your heart is skipping beats

Glaucoma. Fintepla may increase pressure inside the eye and cause or worsen narrow-angle glaucoma, which can lead to blindness. Tell your health care provider right away if you have any of the following symptoms of glaucoma.

  • Loss of vision
  • Eye pain or redness
  • Severe headache or vomiting
  • Seeing bright, colorful circles around lights (vision halos)

Warnings & Precautions

Who should not use Fintepla?

Allergies to Ingredients. People who are allergic to any of the following should not take Fintepla.

  • Fenfluramine
  • Fintepla
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Fintepla.

Drug Interactions. Fintepla should not be taken while you are using certain other medicines. Before taking Fintepla, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details.

What should I know about Fintepla before using it?

Do not take Fintepla unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Fintepla with other people, even if they have the same condition as you. It may harm them.

Keep Fintepla out of the reach of children.

Fintepla is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including heart tests, while taking Fintepla. If you have any questions about this program, you can go to www.fintepla.com or call 877-964-3649.

Fintepla can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Fintepla affects you.

Do not stop taking Fintepla without talking to your health care provider. Stopping Fintepla suddenly can cause seizures that will not stop (status epilepticus). If you need to stop taking Fintepla, your health care provider will give you instructions on how to stop the medicine.

Use an accurate measuring device to measure your dose. A household spoon is not an accurate measuring device and may cause you to take the wrong dose. Ask your pharmacist what measuring device to use.

What should I tell my health care provider before using Fintepla?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Fintepla is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems
  • Weight loss
  • A mental health condition, such as depression, mood problems, thoughts of suicide, or suicide attempts
  • Kidney problems
  • Liver problems

Other Medicines and Supplements. Fintepla may interact with other medicines and supplements. Before taking Fintepla, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Fintepla could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take Fintepla while you are pregnant or trying to get pregnant. If you become pregnant while taking Fintepla, you can sign up for the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334 or at www.aedpregnancyregistry.org. This registry collects safety information about the use of antiepileptic medicines during pregnancy.

Breastfeeding. It is not known if Fintepla passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take Fintepla while breastfeeding.

How can I get more information about Fintepla?

For more information about Fintepla, you can visit the drugmaker’s website at www.fintepla.com or call them at 844-599-2273.

Interactions

Does Fintepla interact with foods or drinks?

There are no known interactions between Fintepla and foods or drinks.

It is unknown if drinking alcohol will affect Fintepla. The risk of sleepiness may increase if you drink alcohol while taking Fintepla.

Does Fintepla interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Fintepla.

  • A monoamine oxidase inhibitor (MAOI) within the past 14 days, which is a medicine usually used for depression or Parkinson’s disease
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, or medicines for anxiety
  • A selective serotonin reuptake inhibitor (SSRI), such as fluoxetine, paroxetine, or sertraline, which is a medicine commonly used for anxiety and depression
  • A serotonin and norepinephrine reuptake inhibitor (SNRI), such as duloxetine or venlafaxine, which is a medicine commonly used for anxiety and depression
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • Trazodone, which is a medicine commonly used for depression
  • Stiripentol (Diacomit), which is a medicine used for seizures
  • Clobazam (Onfi, Sympazan), which is a medicine used for seizures
  • Tryptophan, which is a supplement that may be used to help the body make proteins and certain brain-signaling chemicals
  • Lithium, which is a medicine for certain mental health conditions
  • An antipsychotic, which is a medicine for certain mental health conditions
  • St. John’s wort, which is a supplement that may be used to treat depression
  • Dextromethorphan, which is a medicine used to treat cough
  • Tramadol, which is a medicine used to treat pain
  • Cyproheptadine, which is an antihistamine

Some other medicines may alter the blood levels of Fintepla. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Fintepla. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Fintepla?

If you or someone else has used too much Fintepla, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Fintepla?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses. 

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