Pharmacology
The elimination half life of fenfluramine
What is 20 hours?
Doses used in Study 1
What is 0.7 mg/kg/day and 0.2 mg/kg/day?
The initial starting dose without concomitant stiripentol
What is 0.1 mg/kg twice daily?
The 2 most common adverse reactions that occurred in patients treated with Fintepla (incidence at least 10% and greater than placebo)
What is decreased appetite and somnolence/sedation/lethargy?
The contraindications of Fintepla
What is
- Hypersensitivity to fenfluramine or any of the excipients in Fintepla
- Concomitant use of, or within 14 days of the administration on MAOIs because of an increased risk of serotonin syndrome
Time to maximum plasma concentration at steady state
What is 4 to 5 hours?
AEDs used in Study 2
What are stiripentol, clobazam, and valproate?
Maximum daily dose for patients taking concomitant stiripentol
What is 0.2 mg/kg twice daily?
Echocardiograms should be completed post-treatment in this timeframe
What is 3-6 months?
The flavor of Fintepla oral solution
What is cherry?
The Mechanism of Action of fenfluramine is believed to be
What is increasing the extracellular levels of serotonin through interaction with serotonin transporter proteins, and exhibit agonist activity at serotonin 5HT-2 receptors.
Minimum number of convulsive seizure that patients were required to have for inclusion in both Study 1 and Study 2 while on stable AED therapy
What is 6?
When discontinuing Fintepla, the dose should be _____
What is decreased gradually?
In clinical trials of up to 3 years, the number of patients receiving Fintepla that developed pulmonary arterial hypertension or valvular heart disease
What is zero?
The number of patients with Dravet Syndrome treated with Fintepla in controlled and uncontrolled trials for more than 2 years
What is 138?
The percentage of fenfluramine metabolized to nonfenfluramine prior to elimination
What is 75%?
Change in convulsive seizure frequency during the treatment period in patients with Dravet Syndrome for both doses in Study 1
What is 79.4% for 0.7 mg/kg/day and 30.4% for 0.2 mg/kg/day?
For patients not on concomitant stiripentol in whom a rapid titration is warranted, the dose may be increased this often
What is every 4 days?
By the end of the controlled studies, the percentage of patients treated with Fintepla had a measured decrease in weight of 7% or greater from their baseline weight
What is 19%?
The controlled substance schedule of Fintepla
What is schedule IV?
Change of AUC and Cmax of fenfluramine when a single 0.7 mg/kg dose of Fintepla was coadministered with a single dose of stiripentol, clobazam, and valproic acid combination
What is 69% and 18%?
The amount of time until a reduction in convulsive seizures was observed
What is 3 to 4 weeks?
Discard any unused Fintepla unused oral solution remaining after this amount of time of first opening the bottle or the "Discard After" date on the bottle, whichever is sooner
What is 3 months?
The Fintepla REMs phone number
What is 1-877-964-3649?
The maximum daily dosage in mg for patients not on concomitant stiripentol and on concomitant stiripentol, respectively
What is 26 mg and 17 mg?