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 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:
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 the medicine safely. If you have any questions, 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.
Your healthcare provider may need to make changes to your dose if your weight decreases. In some cases, treatment may need to be stopped.
3. Sleepiness, sedation, and lack of energy (lethargy). These are both serious and common side effects. 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.
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.
