For US Healthcare Professionals Only
For your patients ≥2 years of age experiencing seizures associated with Dravet syndrome or Lennox-Gastaut syndrome (LGS)

Resources for prescribers

Resources for healthcare providers (HCPs) who are ready to prescribe FINTEPLA

The following resources can be used to provide you and your office with key information on prescribing FINTEPLA.

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Dosing FINTEPLA

FINTEPLA® dosing and titration flashcard.

FINTEPLA Dosing and Titration Flashcard

Provides prescribers with the recommended starting doses and titration schedules for FINTEPLA

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About echocardiograms

Echocardiography: What you need to know.

Echocardiography: What You Need to Know

Provides prescribers with an overview of the REMS-required monitoring with echocardiograms for patients taking FINTEPLA

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Echocardiogram assessment sheet.

Echocardiogram Assessment Sheet

Provides cardiologists and echocardiography technicians with information on monitoring for FINTEPLA patients

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ONWARD™ is here for you and your staff.

FINTEPLA® Patient Authorization and Patient Referral form.

Patient Authorization and Patient Referral Form

By completing and submitting this form, you can provide the first prescription and enroll the patient in ONWARD

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Prescribing FINTEPLA® brochure.

Prescribing FINTEPLA

Provides prescribers with an overview of getting patients started on FINTEPLA

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ONWARD™ backgrounder for prescribers.

ONWARD Backgrounder for Prescribers

Provides prescribers with a brief overview of how ONWARD can guide their staff and caregivers

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ONWARD™ backgrounder for office staff.

ONWARD Backgrounder for Office Staff

Provides details on support for the office staff, including dedicated Field Specialists, accessible resources, and the ONWARD Provider Portal

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Financial assistance and copay info for HCPs.

Financial Assistance and Copay Info for HCPs

Provides an overview of the financial assistance programs available for FINTEPLA and associated echocardiograms

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Learn from your peers who have experience treating patients with FINTEPLA.

James Wheless, MD

Shares Dravet syndrome clinical trial data and a patient case from his practice

Video of James Wheless, MD, Professor and Chief of Pediatric Neurology at Le Bonheur Children's Hospital.

Steven Wolf, MD

Shares information about the impact of Dravet syndrome and critical considerations for optimizing seizure treatment

Video of Steven Wolf, MD, Director of Pediatric Epilepsy at Boston Children's Health Physicians.

James Wheless, MD

Shares cardiovascular safety data and his clinical experience treating patients with FINTEPLA

Video of James Wheless, MD, Professor and Chief of Pediatric Neurology at Le Bonheur Children's Hospital.

Steven Wolf, MD

Shares best practices regarding cardiovascular monitoring for patients taking FINTEPLA

Video of Steven Wolf, MD, Director of Pediatric Epilepsy at Boston Children's Health Physicians.

Scott Perry, MD, and
Kelly Knupp, MD

Discuss challenges in treating Dravet syndrome

Video of Scott Perry, MD, from Cook Children's Center and Kelly Knupp, MD, from Children's Hospital Colorado.

Important contact information

Icon with REMS for FINTEPLA® REMS.

FINTEPLA REMS

For more information about the FINTEPLA REMS, or to access FDA-mandated REMS forms, please call 1-877-964-3649 or visit FinteplaREMS.com.

Icon of a prescription pad with a pencil on it for FINTEPLA® prescriptions.

FINTEPLA prescriptions

If you have questions about a patient’s prescription or about refills, contact AnovoRx at 1-844-288-5007 (8:00 AM to 5:00 PM Central Time, Monday through Friday) or send a fax to 1-855-813-2039.

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ONWARD

To learn more about financial assistance programs and their eligibility criteria, call ONWARD at 1-888-964-3649.

Frequently asked questions1

For what patient age range is FINTEPLA approved?

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

Which seizure types were evaluated in the Dravet syndrome clinical studies for FINTEPLA?

In the randomized, double-blind, placebo-controlled trials of FINTEPLA in Dravet syndrome, convulsive seizure types assessed included tonic, clonic, generalized tonic-clonic (GTC), tonic-atonic, secondarily GTC, hemiclonic, and focal with observable motor signs.

Which seizure types were evaluated in the LGS clinical study for FINTEPLA?

In the randomized, double-blind, placebo-controlled trial of FINTEPLA in LGS, the primary endpoint was the change in frequency of the following seizure types that were confirmed by The Epilepsy Study Consortium to have resulted in a drop, fall, or injury: generalized tonic-clonic (GTC), secondarily GTC, tonic, atonic, and tonic-atonic.

Is FINTEPLA compatible with the ketogenic diet?

Patients on a ketogenic diet were included in the clinical studies. FINTEPLA is compatible with a ketogenic diet and contains no ingredient made from gluten-containing grain (wheat, barley, or rye) and not more than 0.1% of carbohydrates, which is solely derived from the cherry flavor.

Do my patients need a cardiology consultation in order to get an echocardiogram?

Most patients do not need to have a cardiology consultation in order to get an echocardiogram, which can be ordered as a screening test, just like other screening procedures. However, certain epilepsy centers require that an epileptologist refer a patient to a cardiologist in order to get an echocardiogram.

Where can I find information about financial assistance programs for patients taking FINTEPLA?

UCB is committed to making FINTEPLA affordable and accessible for patients through financial assistance programs. Patients may pay as little as $0 in out-of-pocket costs for FINTEPLA and echocardiograms. Most families will not pay more than $25 in out-of-pocket copays for FINTEPLA.* For more information about these financial assistance programs, including eligibility criteria, call 1-833-GO-DS-LGS (1-833-463-7547).

*Subject to eligibility; individual out-of-pocket costs may vary. See full Terms and Conditions.

What if my patient is not able to access an echo facility?

UCB strives to make the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) as accessible as possible. That’s why UCB has established a network of sonographers who can travel directly to eligible patients who are unable to access an echocardiogram (echo) facility due to their geographic location or disease-related limitations. Full eligibility Terms and Conditions apply.*

*Eligibility Terms and Conditions: The At-home Echo Program is intended to assist certain eligible patients who have been prescribed FINTEPLA to obtain an echocardiogram assessment in accordance with the product labeling and the FINTEPLA REMS, as required by the US Food and Drug Administration. To be eligible for the program, a patient (or their caregiver) must attest that they are unable to safely access a qualified healthcare provider’s office for an echocardiogram due to their geographic location or disease-related limitations. Participating patients, caregivers, and/or healthcare providers may not submit any claims for reimbursement to any third-party payer for echocardiograms provided through the program. The program may be amended or canceled at any time without notice.

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Ready to get patients started on FINTEPLA?

By completing and submitting this form, you can provide the first prescription and enroll the patient in ONWARD.

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Connect with your Key Account Manager

Your Key Account Manager is available to provide additional information and answer questions.

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Reference

1. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc.

Important Safety Information See more

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 >35 mm Hg).

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 VHD and PAH, how to recognize signs and symptoms of VHD and PAH, 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

In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2).

Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients.

To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1‑844-599-2273 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.