Drug Detail:Fintepla (Fenfluramine)
Generic Name: fenfluramine 2.2mg in 1mL
Dosage Form: oral solution
Drug Class: CNS stimulants Miscellaneous anticonvulsants
Assessments Prior to Initiating FINTEPLA
Prior to starting treatment with FINTEPLA, obtain an echocardiogram assessment to evaluate for valvular heart disease and pulmonary arterial hypertension [see Dosage and Administration (2.6) and Warnings and Precautions (5.1)].
Dosing Information
FINTEPLA is to be administered orally and may be taken with or without food.
Dravet Syndrome
- The initial starting and maintenance dosage for patients with Dravet Syndrome is 0.1 mg/kg twice daily, which can be increased weekly based on efficacy and tolerability. Table 1 provides the recommended titration schedule, if needed.
- Patients with Dravet Syndrome not on concomitant stiripentol who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).
- Patients with Dravet Syndrome taking concomitant stiripentol plus clobazam who are tolerating FINTEPLA at 0.1 mg/kg twice daily and require further reduction of seizures may benefit from a dosage increase up to a maximum recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1)].
Lennox-Gastaut Syndrome
- The initial starting dosage for patients with Lennox-Gastaut syndrome is 0.1 mg/kg twice daily, which should be increased weekly based on tolerability. Table 1 provides the recommended titration schedule.
- Patients with Lennox-Gastaut syndrome not on concomitant stiripentol who are tolerating FINTEPLA should be titrated to the recommended maintenance dosage of 0.35 mg/kg twice daily (maximum daily dosage of 26 mg).
- Patients with Lennox-Gastaut syndrome taking concomitant stiripentol plus clobazam who are tolerating FINTEPLA should be titrated to the recommended maintenance dosage of 0.2 mg/kg twice daily (maximum daily dosage of 17 mg) [see Drug Interactions (7.1)].
| Without concomitant stiripentol* | With concomitant stiripentol plus clobazam | |||
|---|---|---|---|---|
| Weight-based Dosage | Maximum Total Daily Dosage† | Weight-based Dosage | Maximum Total Daily Dosage† | |
|
||||
| Initial Dosage‡ | 0.1 mg/kg twice daily | 26 mg | 0.1 mg/kg twice daily | 17 mg |
| Day 7 | 0.2 mg/kg twice daily | 26 mg | 0.15 mg/kg twice daily | 17 mg |
| Day 14§ | 0.35 mg/kg twice daily | 26 mg | 0.2 mg/kg twice daily | 17 mg |
Dosage Modifications for Patients with Concomitant Use of Strong CYP1A2 or CYP2D6 Inhibitors (DS and LGS)
For patients with concomitant use of FINTEPLA with a strong CYP1A2 or CYP2D6 inhibitor, a maximum total daily dosage of 20 mg without concomitant stiripentol and 17 mg with concomitant stiripentol plus clobazam is recommended [see Drug Interactions (7.1)].
Dosage Modifications for Patients with Severe Renal Impairment (DS and LGS)
For patients with severe renal impairment (estimated glomerular filtration rate (eGFR) 15 to 29 mL/min/1.73m2), a maximum total daily dosage of 20 mg without concomitant stiripentol and 17 mg with concomitant stiripentol plus clobazam is recommended [see Use in Specific Populations (8.6)].
Dosage Modifications for Patients with Mild, Moderate, and Severe Hepatic Impairment (DS and LGS)
See Table 2 for dosage adjustments and recommendations for patients with hepatic impairment [see Use in Specific Populations (8.7)].
| Hepatic Impairment Classification | Without concomitant stiripentol* | With concomitant stiripentol plus clobazam |
|---|---|---|
| Maximum total daily dosage | Maximum total daily dosage | |
|
||
| Mild (Child-Pugh A) |
20 mg | 13 mg* |
| Moderate (Child-Pugh B) |
20 mg | Use not recommended |
| Severe (Child-Pugh C) |
17 mg | Use not recommended |
Assessments During and After Administration of FINTEPLA
To evaluate for valvular heart disease and pulmonary arterial hypertension, obtain an echocardiogram assessment every 6 months during treatment with FINTEPLA, and 3 to 6 months after the final dose of FINTEPLA [see Warnings and Precautions (5.1)].
Administration Instructions
A calibrated measuring device (either a 3 mL or 6 mL oral syringe) will be provided by the pharmacy and is recommended to measure and administer the prescribed dose accurately [see How Supplied/Storage and Handling (16.1)]. A household teaspoon or tablespoon is not an adequate measuring device and should not be used.
Discard any unused FINTEPLA oral solution remaining after 3 months of first opening the bottle or the "Discard After" date on the bottle, whichever is sooner.
FINTEPLA is compatible with commercially available gastric and nasogastric feeding tubes.
