Prescribing guide
Fintepla (fenfluramine)REMS certification, echocardiogram schedule, weight-based dosing and prior authorization criteria for Dravet syndromeFor prescribers and their offices treating dravet syndrome: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
Fintepla REMS: certified prescriber and pharmacy, enrolled patient, baseline echocardiogram reported on the Patient Status Form, then prior authorization.
Example PA threshold
Cigna example: age 2 or older, neurologist, at least 2 other ASMs or one of clobazam, Epidiolex or Diacomit tried or concomitant, 1-year approval.
Monitoring
Echocardiogram at baseline, every 6 months and once 3 to 6 months after the last dose, each on a REMS Patient Status Form; blood pressure; weight and growth; somnolence; mood and suicidality.
Support line
UCB ONWARD: Clinical Nurse Educators 1-833-463-7547, Care Coordinators 1-888-964-3649 for enrolled families, copay as little as $0 and no more than $25 per refill for commercial plans, uninsured and echo copay programs, At-Home Echo Program.
Give your patient their plan
A one-page handout for starting Fintepla, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/finteplaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Prescriber certification | Review the Prescribing Information, Prescriber Training and REMS Program Overview, pass the Prescriber Knowledge Assessment and submit the Prescriber Enrollment Form. | FDA REMS page |
| Patient enrollment and counseling | Counsel on VHD and PAH and the echo schedule using the Patient Guide, provide the Patient Guide, and submit the Patient Enrollment Form to the REMS. | FDA REMS page |
| Baseline echocardiogram | Obtain an echo before the first dose, then document the results and the authorization for treatment on the Patient Status Form. | FDA REMS page |
| Pharmacy authorization | Certified outpatient pharmacies contact the REMS before dispensing to verify the prescriber is certified and the patient is enrolled and authorized. Inpatient pharmacies dispense no more than 7 days' supply at discharge. | FDA REMS page |
| Referral to ONWARD | UCB's patient site asks families to sign the Patient Enrollment and the Prescription Authorization and Patient Referral forms before leaving the office; ONWARD then calls from 1-844-669-2731. | Getting Fintepla |
| Specialty pharmacy | ONWARD Care Coordinators connect families with AnovoRx, the ONWARD pharmacy partner, for refills and extra syringes. | ONWARD support |
| Ongoing | Report treatment discontinuation or transfer of care, and report adverse events suggestive of VHD or PAH on the Cardiovascular Adverse Event Reporting Form. | FDA REMS page |
Prior authorization criteria and what to document
One public policy as the example: Cigna, May 1, 2026. Approval approved a year at a time. Renewal needs the patient to be responding, such as reduced seizure severity, frequency or duration, as judged by the prescriber. This version took effect May 1, 2026 and cites the October 2025 label, so it matches the current dosing text. Its header still names Zogenix, the company UCB acquired. Other plans set their own criteria and approval lengths. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 2 years or older | Date of birth on the request | Cigna policy |
| Diagnosis | Seizures associated with Dravet syndrome | Neurology note with the diagnosis | Cigna policy |
| Prior or concomitant ASMs | At least 2 other antiseizure medications (examples: valproic acid, topiramate, clonazepam, levetiracetam, zonisamide), or one of clobazam, Epidiolex or Diacomit | Medication history or current list with dates | Cigna policy |
| Prescriber | Prescribed by or in consultation with a neurologist | Specialty on the request, or the consult note | Cigna policy |
| Continuation | Responding to therapy, such as reduced seizure severity, frequency or duration, as determined by the prescriber; approval 1 year | Seizure diary or progress note | Cigna policy |
Fintepla dosing and titration
| When | Label | Source |
|---|---|---|
| Start and maintenance | 0.1mg/kg twice daily, with or without food. For Dravet syndrome the label calls this the initial starting and maintenance dosage. | FDA label |
| Day 7, if needed | 0.2mg/kg twice daily without stiripentol; 0.15mg/kg twice daily with stiripentol plus clobazam. | FDA label |
| Day 14, if needed | 0.35mg/kg twice daily, maximum 26mg a day, without stiripentol; 0.2mg/kg twice daily, maximum 17mg a day, with stiripentol plus clobazam. Without stiripentol, the dose may be increased every 4 days when faster titration is warranted. | FDA label |
| Dose volume | Weight (kg) x dose (mg/kg) / 2.2mg/mL = mL twice daily, measured with the 3mL or 6mL oral syringe the pharmacy provides. Compatible with gastric and nasogastric feeding tubes. | FDA label |
| Supply | Cartons of one 360mL or one 30mL bottle, 2.2mg/mL. Discard 3 months after first opening or at the Discard After date, whichever is sooner; at 26mg a day a 360mL bottle covers about 30 days. | FDA label |
| Renal and hepatic caps | eGFR 15 to 29: 20mg a day (17mg with stiripentol); not studied below 15. Child-Pugh A: 20mg (13mg with stiripentol); B: 20mg (not recommended with stiripentol); C: 17mg (not recommended with stiripentol). | FDA label |
| Discontinuation | Taper gradually to limit increased seizure frequency and status epilepticus; rapid discontinuation can be considered for a serious adverse reaction. | FDA label |
Monitoring the Fintepla label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Baseline | Echocardiogram for VHD and PAH | Required before initiation; report on the Patient Status Form | FDA label |
| Every 6 months | Echocardiogram | Consider benefit versus risk of continuing for a new valvular abnormality, mild or greater AR or moderate or greater MR with VHD features, or PASP above 35mmHg | FDA label |
| Overdue echo | REMS dispensing authorization | The 2024 assessment plan treats an echo not obtained every 6 months, plus a 3-month grace period, as a reason dispensing is not authorized | FDA letter |
| 3 to 6 months after the last dose | Echocardiogram | Submit the result to the REMS on the Patient Status Form | FDA REMS page |
| Throughout | Weight and growth | Decreased appetite 37% against 8% and weight loss of 7% or more in 19% against 2% in the Dravet trials; consider dose changes if weight falls | FDA label |
| Throughout | Blood pressure | Monitor; rare hypertensive crisis reported in adults on fenfluramine | FDA label |
| Throughout | Somnolence, mood, suicidality, vision | Somnolence, sedation or lethargy 25% against 11%; consider discontinuing for acute visual loss or ocular pain (angle closure glaucoma) | FDA label |
Fintepla drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Stiripentol plus clobazam (with or without valproate) | Raises fenfluramine levels; maximum 0.2mg/kg twice daily and 17mg a day. | FDA label |
| Strong CYP1A2 or CYP2D6 inhibitors | Maximum 20mg a day, or 17mg with stiripentol. If the inhibitor is stopped, consider a gradual increase back toward the usual dose. | FDA label |
| Strong CYP1A2, CYP2B6 or CYP3A inducers | Avoid; if necessary, monitor for reduced efficacy and consider a dose increase within the maximum. If the inducer is stopped, consider a gradual reduction. | FDA label |
| MAOIs | Contraindicated with Fintepla or within 14 days of an MAOI, because of serotonin syndrome. | FDA label |
| Other serotonergic agents | SSRIs, SNRIs, TCAs, trazodone, bupropion, triptans, lithium, tramadol, dextromethorphan, St. John's wort, tryptophan and serotonergic antipsychotics raise the risk of serotonin syndrome; use with caution. | FDA label |
| Cyproheptadine and 5-HT antagonists | Cyproheptadine and potent 5-HT1A, 5-HT1D, 5-HT2A or 5-HT2C antagonists may decrease efficacy; monitor. | FDA label |
| CNS depressants | Alcohol and other CNS depressants could potentiate somnolence and sedation. | FDA label |
| REMS materials | The REMS was last modified May 22, 2026 (S-018), updating the Prescriber Training and Pharmacy Guide to align with the April 2025 labeling changes. | FDA letter |
Why a first fill stalls, and the fix
- The pharmacy cannot get REMS authorizationCertified pharmacies must check with the REMS that the prescriber is certified and the patient is enrolled and authorized before each dispense. A missing Patient Enrollment Form or baseline Patient Status Form stops the shipment. The neurologist's office submits both forms.
- An echocardiogram is overdueThe FDA's 2024 REMS letter lists a missed echocardiogram every 6 months, with a 3-month grace period, as a reason dispensing is not authorized. ONWARD Care Coordinators help find echo locations, and UCB's At-Home Echo Program can send a sonographer to eligible families.
- Prior authorization pending or deniedCigna asks for age 2 or older and a neurologist. It also wants 2 other seizure medicines, or one of clobazam, Epidiolex or Diacomit, tried or taken alongside. The office lists those medicines on the request. Cigna approves 1 year at a time.
- A copay you cannot payWith commercial insurance, eligible families may pay as little as $0 and no more than $25 per refill through the ONWARD Copay Assistance Program. It is not valid with Medicaid, Medicare or other government programs. Our help paying page lists charity funds.
- No insurance at allUCB's ONWARD Support Program was created to help uninsured families get Fintepla if they meet eligibility requirements. A Clinical Nurse Educator answers questions about financial programs at 1-833-463-7547.
- Echocardiogram billsUCB says its ONWARD Echocardiogram Copay Support Program may help with copays, deductibles and coinsurance for echocardiograms. Families who cannot reach an echo facility may qualify for the At-Home Echo Program through their Care Coordinator.
ONWARD (UCB)
- A dedicated Care Coordinator, a nurse trained in Dravet syndrome, who reviews insurance coverage, gives treatment reminders and helps find echocardiogram locations
- Connection to AnovoRx, the ONWARD pharmacy partner, for refills and extra syringes
- Clinical Nurse Educators at 1-833-GO-DS-LGS (1-833-463-7547) for general information about Fintepla and the REMS, who cannot give medical advice
- ONWARD Copay Assistance Program for commercial insurance, as little as $0 and no more than $25 per refill, subject to program limits and annual maximums. Not valid with Medicaid, Medicare or other government programs Cost and copay
- ONWARD Support Program for uninsured families who meet eligibility requirements, and an Echocardiogram Copay Support Program for echo copays, deductibles and coinsurance Financial support info sheet
- At-Home Echo Program, a traveling pediatric or adult sonographer for eligible families who cannot reach an echo facility because of distance or disease-related limits At-Home Echo Program
Questions prescribers' offices ask about Fintepla
What echocardiogram schedule does the Fintepla label require?
Before the first dose, every 6 months during treatment, and once 3 to 6 months after the final dose, per the October 2025 label (sections 2.1, 2.6 and 5.1). Weigh benefit against risk if the echo shows a new valvular abnormality, mild or greater aortic regurgitation or moderate or greater mitral regurgitation with features of VHD, or PASP above 35mmHg. Each result goes to the REMS on a Patient Status Form.
Is the Fintepla REMS still in force?
Yes. The October 2025 label (boxed warning and section 5.2) still restricts Fintepla to the Fintepla REMS, and the FDA's REMS page shows a modification approved May 22, 2026 (S-018) that updated the Prescriber Training and Pharmacy Guide. Prescribers and pharmacies must be certified and patients enrolled; FinteplaREMS.com, 1-877-964-3649.
What is the Fintepla dose in Dravet syndrome?
0.1mg/kg twice daily is both the starting and maintenance dose, per the October 2025 label (section 2.2), increased weekly only if more seizure reduction is needed. The maximum is 0.35mg/kg twice daily (26mg a day) without stiripentol, or 0.2mg/kg twice daily (17mg a day) with stiripentol plus clobazam. Dose volume in mL = weight (kg) x dose (mg/kg) / 2.2mg/mL, given twice daily.
Which interactions change the Fintepla maximum dose?
Stiripentol plus clobazam caps the dose at 17mg a day, and strong CYP1A2 or CYP2D6 inhibitors cap it at 20mg a day (17mg with stiripentol), per the October 2025 label (sections 2.3 and 7.1). Avoid strong CYP1A2, CYP2B6 or CYP3A inducers. MAOIs within 14 days are contraindicated.
What do insurers ask for to approve Fintepla in Dravet syndrome?
The Cigna policy shown here, IP0042 effective May 1, 2026, asks for age 2 or older, a neurologist, and a trial or concomitant use of at least 2 other antiseizure medications or one of clobazam, Epidiolex or Diacomit. Approval is for 1 year, and continuation requires response as determined by the prescriber. The policy cites the October 2025 label.
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Sources
- FINTEPLA- fenfluramine solution: prescribing information, revised 10/2025, Medication Guide, revised 4/2025, and Instructions for Use, revised 10/2025, UCB, Inc., via DailyMed, 2026-10-22.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Fintepla (fenfluramine hydrochloride), NDA #212102, FDA, 2026-05-22.
- Dravet Syndrome Support With ONWARD®, FINTEPLA® (fenfluramine), UCB, Inc., 2026-11-10.
- Getting FINTEPLA for Dravet Syndrome Seizures, FINTEPLA® (fenfluramine), UCB, Inc., 2026-11-10.
- Dravet Syndrome Cost and Copay, FINTEPLA® (fenfluramine), UCB, Inc., 2026-11-10.
- FINTEPLA financial support programs info sheet (US-P-FA-DS-2300283), UCB, Inc., 2023.
- Dravet Syndrome At-Home Echo Test, FINTEPLA® (fenfluramine), UCB, Inc., 2026-11-10.
- Drug Coverage Policy IP0042, Fintepla (Antiseizure Medications, Fintepla), Cigna, 2026-05-01.
- NDA 212102/S-018 supplement approval letter, REMS modification, FDA, 2026-05-22.
- NDA 212102/S-017 supplement approval letter, dose volume calculation, syringe cleaning and pregnancy subsection, FDA, 2025-10-15.
- NDA 212102/S-016 supplement approval letter, valvular heart disease and pulmonary arterial hypertension revisions, FDA, 2025-04-08.
- NDA 212102/S-014 supplement approval letter, REMS modification and assessment plan, FDA, 2024-04-02.
- NDA 212102/S-013 supplement approval letter, aggression added to postmarketing experience, FDA, 2023-12-11.
- NDA 212102/S-007 and S-008 supplement approval letter, corporate name change and removal of controlled substance schedule, FDA, 2023-09-14.
- NDA 212102/S-006 supplement approval letter, hepatic impairment dosing, FDA, 2023-01-03.
- NDA 212102/S-005 supplement approval letter, carcinogenicity data, FDA, 2022-06-15.
- NDA 212102/S-003 supplement approval letter, Lennox-Gastaut syndrome indication and REMS modification, FDA, 2022-03-25.
- Drugs@FDA record for NDA 212102, FINTEPLA, via openFDA, FDA, 2026-11-10.
A reference drawn from the October 22, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 10, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.