Is Fintepla a controlled substance?
Yes, Fintepla is a Schedule IV controlled substance which means it is recognized as having some potential for abuse, although this is lower than substances classified in Schedule III. It is also subject to certain prescription restrictions. In addition, Fintepla is available only through a restricted program called the Fintepla REMS because it is associated with a higher risk of valvular heart disease and pulmonary arterial hypertension.
Fintepla (fenfluramine) is approved for the treatment of seizures associated with Dravet syndrome or Lennox-Gastault syndrome. Dravet syndrome is a rare and life-threatening form of epilepsy that is characterized by severe and unrelenting seizures that are often unresponsive to treatment. Lennox-Gastaut syndrome is a severe form of epilepsy that usually starts during infancy or early childhood and affected children experience multiple types of seizures such as atonic, tonic, and atypical absence seizures.
What does a Schedule IV controlled substance mean?
Substances in Schedule IV have a low potential for abuse relative to substances in Schedule III. The prescription for Schedule IV substances also has to meet certain requirements and the prescription cannot be refilled more than 6 months after the date the prescription was issued.
Examples of Schedule IV substances include: alprazolam (Xanax), carisoprodol (Soma), clonazepam (Klonopin), diazepam (Valium), fenfluramine (Fintepla), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), and triazolam (Halcion).
What is the Fintepla REMS?
The Fintepla REMS is a safety program that aims to manage two heart-related safety concerns associated with the use of Fintepla, namely valvular heart disease and pulmonary arterial hypertension. REMS stands for Risk Evaluation and Mitigation Strategy, and REMS programs aim to ensure the potential benefits of a drug, in this case Fintepla, outweigh its risks.
There are several restrictions associated with Fintepla including:
- Only certified health care providers can prescribe Fintepla
- Only certified pharmacies can dispense Fintepla
- Patients who take Fintepla need to be educated on the risks of developing problems with heart valves or high blood pressure in the arteries of the lungs and the signs and symptoms to look out for
- Patient’s taking Fintepla need to enrol in the Fintepla REMS and their details recorded
The Fintepla REMS program helps to support the long-term safety and safe use of Fintepla.
- Fintepla (fenfluramine) 06/2022 Zogenix, Inc. https://www.drugs.com/pro/fintepla.html
- FINTEPLA® (fenfluramine) oral solution, CIV FDA access data https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212102s000lbl.pdf
- FDA Approves New Therapy for Dravet Syndrome. June 25 2020. US Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-dravet-syndrome
- What is the FINTEPLA REMS (Risk Evaluation and Mitigation Strategy)? https://www.finteplarems.com/
- Approved Risk Evaluation and Mitigation Strategies (REMS) Fintepla (fenfluramine hydrochloride) 25 March 2022 https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=400
- FDA Approves New Therapy for Dravet Syndrome US FDA 25 June 2020 https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-dravet-syndrome
- Fintepla (fenfluramine) Oral Solution Now FDA Approved for Treatment of Seizures Associated with Lennox-Gastaut Syndrome (LGS) March 28, 2022. https://www.drugs.com/newdrugs/fintepla-fenfluramine-oral-solution-now-fda-approved-seizures-associated-lennox-gastaut-syndrome-lgs-5811.html
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