Move your patients forward with profound seizure reduction

Dravet syndrome Study 1: FINTEPLA vs placebo (N=117)

Reduction in convulsive seizure frequency from baseline

FINTEPLA 0.7 mg/kg/day reduced monthly convulsive seizures by a median of 79.4% from baseline over 14 weeks1

  • The placebo-adjusted percent reduction in monthly convulsive seizure frequency was 70.0% for FINTEPLA 0.7 mg/kg/day (P<.001) and 31.7% for FINTEPLA 0.2 mg/kg/day (P=.043)
  • A reduction in convulsive seizures was observed within 3 to 4 weeks of starting FINTEPLA, and the effect remained generally consistent over the 14-week treatment period

Reduction in Convulsive Seizure Frequency From Baseline (Study 1)1

The most commonly used concomitant ASMs were valproate (61%), clobazam (59%), and topiramate (25%).

Proportion of patients with ≥50% or ≥75% reduction in convulsive seizure frequency

Among patients taking FINTEPLA 0.7 mg/kg/day over 14 weeks

  • More than half of patients had a profound (≥75%) reduction

*P value vs placebo.

  • 7 in 10 patients had a clinically meaningful (≥50%) reduction

*P value vs placebo.

FINTEPLA extended the length of seizure-free intervals

Among patients taking FINTEPLA 0.7 mg/kg/day over 14 weeks

  • 50% of patients taking FINTEPLA 0.7 mg/kg/day over 14 weeks achieved a seizure-free (0 seizures) interval lasting at least 21 days vs 8 days in the placebo group
  • At baseline, patients in Study 1 had a mean of 1.5 seizures per day and 41 seizures per month1

*P value vs placebo.

With FINTEPLA, seizure freedom is within reach

8% of patients taking FINTEPLA 0.7 mg/kg/day reported no convulsive seizures during the entire 14 weeks vs 0% in the placebo group

Results from a post hoc analysis

  • 25% of patients taking FINTEPLA 0.7 mg/kg/day had no more than a single seizure during the 14-week treatment period vs 13.2% taking 0.2 mg/kg/day vs 0% in the placebo group1
  • Because these results were obtained in a post hoc analysis, no conclusions of efficacy should be made

Open-label extension (OLE) study

Results from a long-term OLE study of FINTEPLA in patients with Dravet syndrome

OLE study results

94% of patients who completed either Study 1 or Study 2 opted to participate in a long-term, flexible-dose OLE study that evaluated the long-term safety and antiseizure activity of FINTEPLA1

  • All patients in the OLE study were started at a dose of 0.2 mg/kg/day and were subsequently titrated up to their maintenance dose
  • The results of this open-label, uncontrolled study are exploratory; therefore, no conclusions of efficacy should be made

The number of patients assessed at each time point is shown in the figure. The decrease in patient number is primarily due to staggered entry into the study.

Dravet syndrome Study 2: FINTEPLA + stiripentol vs placebo (N=85)

  • All patients in this study were receiving stiripentol and either clobazam, valproate, or both
Reduction in convulsive seizure frequency from baseline

FINTEPLA 0.4 mg/kg/day reduced monthly convulsive seizures by 63.1% from baseline1

  • The placebo-adjusted percent reduction in monthly convulsive seizure frequency was 59.5% (P<.001)

Reduction in Convulsive Seizure Frequency From Baseline (Study 2)1

Proportion of patients with a profound (≥75%) reduction in convulsive seizure frequency

The majority of patients (53.5%) taking FINTEPLA 0.4 mg/kg/day over 15 weeks experienced a 50% or greater reduction in monthly convulsive seizures

  • More than one-third of patients experienced a ≥75% reduction in convulsive seizures

Proportion of Patients Achieving ≥50% or ≥75% Reduction in Convulsive Seizures From Baseline (Study 2)

Review FINTEPLA Study Designs

Learn how FINTEPLA was studied across a wide range of patients and seizure types.

See study designs

View FINTEPLA Efficacy in LGS

See clinical study data supporting the efficacy and use of FINTEPLA in LGS.

Efficacy in LGS

Steven Wolf, MD, Director of Pediatric Epilepsy at Boston Children’s Health Physicians of New York and Connecticut

Physician insight: Impact of Dravet syndrome and FINTEPLA treatment

Hear about profound seizure reduction and clinical study results.

Miller’s family discusses his journey with Dravet syndrome

The Dravet syndrome patient journey with FINTEPLA

Hear about one patient’s treatment experience

References

1. Data on file. Zogenix Inc; 2. Sullivan J, Scheffer IE, Lagae L, et al. Fenfluramine HCl (Fintepla®) provides long-term clinically meaningful reduction in seizure frequency: analysis of an ongoing open-label extension study. Epilepsia. 2020;61(11):2396-2404. doi:10.1111/epi.16722

Indications & Important Safety Information See more

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.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION

  • There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension.
  • Echocardiogram assessments are required before, during, and after treatment with FINTEPLA.
  • FINTEPLA is available only through a restricted program called the FINTEPLA REMS.

CONTRAINDICATIONS

FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome.

WARNINGS AND PRECAUTIONS

Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH.

Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA.

The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35mmHg).

FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of valvular heart disease and pulmonary arterial hypertension, how to recognize signs and symptoms of valvular heart disease and pulmonary arterial hypertension, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at www.FinteplaREMS.com or by telephone at 1-877-964-3649.

Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed.

Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery.

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior.

Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered.

Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John’s Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA.

Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain.

ADVERSE REACTIONS

The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus.

The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting.

DRUG INTERACTIONS

Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer.

Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg.

USE IN SPECIFIC POPULATIONS

Administration to patients with hepatic impairment is not recommended.

To report SUSPECTED ADVERSE REACTIONS, contact Zogenix Inc. at 1-866-964-3649 (1-866-Zogenix) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning, for additional Important Safety Information on FINTEPLA.