Fintepla

FINTEPLA- fenfluramine solution
UCB, Inc.

1 INDICATIONS AND USAGE

FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 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)].

2.2 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)].

Table 1: FINTEPLA Recommended Titration Schedule *

	Without concomitant stiripentol *		With concomitant stiripentol plus clobazam
	Weight-based Dosage	Maximum Total Daily Dosage †	Weight-based Dosage	Maximum Total Daily Dosage †
* For patients not on concomitant stiripentol in whom a more rapid titration is warranted, the dose may be increased every 4 days. † For maximum dosage with concomitant use of strong CYP1A2 or CYP2D6 inhibitors, in patients with severe renal impairment, or in patients with hepatic impairment see Dosage and Administration 2.3, 2.4, 2.5. ‡ For patients with Dravet Syndrome, dosage may be increased based on clinical response to the maximum recommended dosage, as needed. § For patients with Lennox-Gastaut syndrome, dosage should be increased as tolerated to the recommended maintenance dosage (i.e., Day 14).
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

2.3 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)].

2.4 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)].

2.5 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)].

Table 2: FINTEPLA Dosage Modifications and Recommendations for Patients with Hepatic Impairment

​ Hepatic Impairment Classification	Without concomitant stiripentol *	With concomitant stiripentol plus clobazam
	Maximum total daily dosage	Maximum total daily dosage
* titrate as recommended [see Dosage and Administration (2.2)]
​ 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