What should be frequency of cardiac follow ups for patients with drawet

Cardiac Follow-up Frequency for Patients with Saint Louis Syndrome Taking Low-Dose Fenfluramine:

Patients receiving fenfluramine, even at doses used to treat conditions such as Saint Louis syndrome, require regular cardiac monitoring due to the risk of valvular heart disease and pulmonary arterial hypertension, which have been reported at higher doses but also post-marketing with lower doses SmPC Fintepla.

Before initiating fenfluramine, an echocardiogram should be performed to establish a baseline and to exclude any pre-existing valvular heart disease or pulmonary hypertension SmPC Fintepla.

Subsequent echocardiographic monitoring is recommended every 6 months for the first 2 years of treatment, and then annually thereafter SmPC Fintepla.

If fenfluramine is discontinued for any reason, a final echocardiogram should be conducted 3 to 6 months after cessation of treatment to ensure resolution or persistence of any abnormalities SmPC Fintepla.

Should echocardiographic findings indicate pathological valvular changes during monitoring, follow-up echocardiography should be considered at an earlier timeframe for evaluation SmPC Fintepla. In such cases, the benefit-risk balance of continuing fenfluramine treatment should be reassessed collaboratively by the prescriber, caregiver, and cardiologist SmPC Fintepla.

In instances where the echocardiogram findings suggest pulmonary arterial hypertension, further urgent echocardiographic evaluation within 3 months is warranted, and treatment decisions, including possible cessation of fenfluramine, should be based on these findings and in line with the European Society of Cardiology and European Respiratory Society guidelines SmPC Fintepla.

This monitoring frequency is supported by the drug’s summary of product characteristics, reflecting accumulated safety data to ensure early detection and management of serious cardiac adverse effects SmPC Fintepla.