Important safety information

Fintepla is a medicine which is prescribed to treat the seizures that patients with Dravet syndrome can experience. Fintepla is used with other drugs to treat seizures in Dravet syndrome patients aged 2 years of age and older.

Echocardiogram checks

Before a doctor can prescribe Fintepla they must first arrange for the patient’s heart to be checked with an echocardiogram test (often known as an ECHO), which is an ultrasound picture of the heart. Your treating doctor will arrange for a cardiologist (a doctor who specialises in the heart and blood vessels) to perform the ECHO. Echocardiogram monitoring will be conducted every 6 months for the first 2 years and annually thereafter.

An ECHO is a non-invasive test that uses sound waves (an ultrasound) to create pictures of the heart. An ECHO is done with an ultrasound device, similar to the ones used for women during pregnancy. During an ECHO, the cardiologist will check that the valves in the heart are working properly and that the pressure in the artery between the heart and the lungs is not too high. The test uses a few different tools:

  • Electrodes: A sonographer will place a few of these stick-on patches onto the chest to record the heart’s activity
  • Transducer: The person doing the ECHO test will move this wand-like device around the chest. It sends ultrasound waves into the chest
  • Ultrasound gel: This is spread onto the transducer. It helps the sound waves from the transducer reach the heart
  • Ultrasound computer: This machine turns the sound waves into pictures of the heart

The controlled access programme (CAP)

Fintepla (fenfluramine) is part of a controlled access programme (CAP), which means it can only be prescribed by doctors with experience in the treatment of epilepsy and certain doctors who have performed specific training. The controlled access programme has been put in place as part of the requirements for the medicine being approved for use in Europe.

When your doctor gives you a prescription for Fintepla, they will also provide their unique prescriber’s identification code (called a CAP ID) which your pharmacist will need to be able to dispense the medicine. Your doctor will either write their CAP ID onto your prescription or provide it to you separately at the same time as your prescription.

The pharmacist will not be able to dispense Fintepla to you without your doctor's CAP ID.

Because of this, the supply may take slightly longer than normal, so you should hand your prescription to the pharmacist at least 3 working days before you need the medicine.

This website is intended for patients in Europe who have been prescribed Fintepla and their caregivers

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you or the person you care for may experience. See the What to look out for section for how to report side effects.

Fintepla is a medicine which is prescribed to treat the seizures that patients with Dravet syndrome can experience. Fintepla is used with other drugs to treat seizures in Dravet syndrome patients aged 2 years of age and older.

Dravet syndrome is a rare form of epilepsy which usually starts when a child is less than 1 year old. Patients who suffer from it often have very frequent and severe seizures. You can learn more about Dravet syndrome here.