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.

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).

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.

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.

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

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

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.

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.