Your first 90 days
Your first 90 days on Fintepla for Dravet syndrome
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Fintepla cannot be picked up at an ordinary pharmacy counter. The prescriber, the pharmacy and the patient are all enrolled in a safety program, and a heart ultrasound comes before the first dose. After that, the dose is measured by weight with a syringe, and the heart checks repeat every 6 months. This page walks parents, guardians and caregivers through those first weeks. It draws on the FDA label, the FDA's REMS page, UCB's own Fintepla pages and one insurer's written rules.
What has to happen before the first bottle ships
Fintepla has a REMS, so the first bottle waits on enrollment forms, a baseline echocardiogram reported to the program and an insurance approval. These are the 6 things in the way, in order.
Enrollment in the Fintepla REMS
The label says Fintepla is available only through the Fintepla REMS.
- Prescribers and pharmacies must be certified, and every patient must be enrolled.
- The prescriber completes the Patient Enrollment Form with the family and goes over a Patient Guide about heart warning signs.FDA REMS page
Two forms at the neurologist's office
UCB's Fintepla site asks families to sign the Patient Enrollment form and the Prescription Authorization and Patient Referral form before leaving the office.
- A call from ONWARD at 1-844-669-2731 follows in the next few days.Getting Fintepla
A heart ultrasound before the first dose
The label requires an echocardiogram before starting, to look for heart valve disease and high blood pressure in the lungs.
- The prescriber reports the result and the go-ahead to the REMS on a Patient Status Form.
- Without that form, the pharmacy cannot get permission to send Fintepla.FDA REMS page
A full medicine list
Stiripentol plus clobazam lowers the highest Fintepla dose, and so do strong blockers of the liver enzymes CYP1A2 or CYP2D6.
- Medicines called MAOIs must be stopped at least 14 days before Fintepla.
- Antidepressants, dextromethorphan cough medicine and St. John's wort raise the risk of serotonin syndrome.FDA label
The insurance approval
Plans such as Cigna require prior authorization.
- Cigna's policy asks for a child 2 or older and a neurologist.
- It also asks that 2 other seizure medicines were tried or are still taken, or one of clobazam, Epidiolex or Diacomit.Cigna policy
Help paying, from UCB
UCB's ONWARD program assigns each enrolled family a Care Coordinator who checks coverage and helps find echocardiogram locations.
- ONWARD also runs a copay program for commercial insurance and programs for uninsured families and for echocardiogram costs.ONWARD support
The days that matter
Counted from the first dose, with the weekly dose steps the label allows, the bottle's 3-month limit and the 6-month heart ultrasound. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.REMS and referral forms
The family signs the Patient Enrollment form and the prescription authorization and referral form.
- ONWARD calls from 1-844-669-2731 in the days that follow.
Baseline echocardiogram
A heart ultrasound before the first dose, reported to the REMS on a Patient Status Form.
- The label does not set an exact number of days ahead.
Insurance approval and shipment
The plan reviews the prior authorization while the certified pharmacy checks that the REMS has authorized the patient.
- UCB names AnovoRx as the ONWARD pharmacy partner for refills and extra syringes.
First dose, 0.1mg/kg twice a day
The dose is set by weight and measured with the 3mL or 6mL oral syringe from the pharmacy.
- For Dravet syndrome, the label calls this both the starting dose and the maintenance dose.
Possible first increase
If more seizure control is needed and the dose is tolerated, the label's table moves to 0.2mg/kg twice a day.
- With stiripentol plus clobazam, the step is 0.15mg/kg twice a day.
- The neurologist decides whether to raise it.
Highest step on the label's table
The table's top dose is 0.35mg/kg twice a day, capped at 26mg a day.
- With stiripentol plus clobazam, it is 0.2mg/kg twice a day, capped at 17mg a day.
First refill, timing depends on the dose
At the highest dose of 26mg a day, a 360mL bottle lasts about 30 days.
- At lower doses the bottle lasts longer, but the label says to throw it away 3 months after opening.
Three months after opening the first bottle
Any liquid left 3 months after first opening, or past the bottle's Discard After date, is thrown away.
- The label says whichever comes first.
Echocardiogram, then every 6 months
The label repeats the heart ultrasound every 6 months during treatment.
- The prescriber sends each result to the REMS on a new Patient Status Form so shipments can continue.
Insurance renewal
Cigna approves Fintepla a year at a time.
- Renewal asks that the patient is responding, such as fewer, shorter or milder seizures, as judged by the prescriber.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Fintepla label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated October 22, 2026, read from the FDA's label database today. FDA label
- October 2025
The dosing section gained a formula for turning the weight-based dose into milliliters. The syringe cleaning steps in the Instructions for Use were updated, and the pregnancy section added general information on epilepsy risks in pregnancy.FDA letter
- April 2025
The FDA approved revisions to the boxed warning and the heart valve and lung pressure warning, also reflected in the Medication Guide. The current text says cases have been reported since approval, although none occurred in trials of up to 3 years.FDA letter
- December 2023
Aggression was added to the list of side effects reported since approval.FDA letter
- September 2023
The label switched to UCB's name and address after UCB acquired Zogenix. It also dropped the controlled substance listing, because fenfluramine was removed from federal drug schedules in December 2022.FDA letter
- January 2023
Dose limits for people with mild, moderate or severe liver impairment were added, based on a study the FDA had required.FDA letter
- June 2022
Results from long-term cancer studies in rats and mice were added to the nonclinical toxicology section.FDA letter
- March 2022
Fintepla was approved for seizures in Lennox-Gastaut syndrome for patients 2 and older, and the REMS materials were updated to match.FDA letter
- June 2020
Fintepla was first approved on June 25, 2020, for seizures associated with Dravet syndrome, under the original maker, Zogenix.Drugs@FDA record
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Twice a day, by weight
The label doses Fintepla in milligrams per kilogram of body weight, twice a day, with or without food.
- The pharmacy label shows the volume in milliliters for each dose, worked out from the 2.2mg/mL strength.FDA label
- Only the syringe from the pharmacy
The label says a household teaspoon or tablespoon is not an adequate measuring device.
- The pharmacy supplies 2 reusable 3mL or 6mL oral syringes and fits an adapter into the bottle.
- Leave the adapter in place.FDA label
- Giving the dose
The Instructions for Use say to place the syringe tip against the inside of the cheek and push the plunger gently.
- Squirting it into the back of the throat may cause choking.
- Fintepla can also go through gastric and nasogastric feeding tubes.FDA label
- Cleaning the syringe
Rinse the syringe and plunger with cold water after each use and let them air dry.
- The Instructions for Use say not to use detergent or a dishwasher.FDA label
- The 3-month bottle limit
Any unused Fintepla is thrown away 3 months after the bottle is first opened, or after the Discard After date, whichever comes first.
- If the date is near, the Instructions for Use say to contact the pharmacy or prescriber.FDA label
- Missed doses
The label and Medication Guide do not give a missed dose instruction for Fintepla.
- The neurologist or the pharmacist can say what to do, and ONWARD's nurse educators can give general information.FDA label
- Never stop suddenly
The Medication Guide says not to stop Fintepla without first talking to the healthcare provider.
- Stopping a seizure medicine suddenly can bring more seizures or seizures that do not stop.
- The label lowers the dose gradually when treatment ends.FDA label
- Medicines that change the dose
With stiripentol plus clobazam, the label caps Fintepla at 0.2mg/kg twice a day and 17mg a day.
- With a strong CYP1A2 or CYP2D6 blocker, the cap is 20mg a day.
- The label says to avoid strong CYP1A2, CYP2B6 or CYP3A inducers.FDA label
- Serotonin medicines and supplements
MAOIs within 14 days are not allowed with Fintepla.
- The label also warns about SSRIs, SNRIs, tricyclics, trazodone, lithium, tramadol, triptans, dextromethorphan, tryptophan and St. John's wort.
- Cyproheptadine may make Fintepla work less well.FDA label
- Weight, growth and blood pressure
Decreased appetite affected about 37% of patients in the Dravet trials against 8% on placebo.
- The label asks for regular weight checks and careful growth monitoring in children.
- It also asks the prescriber to check blood pressure during treatment.FDA label
- Kidney and liver problems
Severe kidney disease lowers the highest dose to 20mg a day, or 17mg with stiripentol.
- Any degree of liver impairment also lowers it.
- With stiripentol plus clobazam, the label does not recommend Fintepla in moderate or severe liver impairment.FDA label
- Pregnancy
There are no human data on Fintepla in pregnancy, and animal studies showed harm.
- The label encourages enrolling in the North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334.
- Seizure medicines are not stopped abruptly in pregnancy.FDA label
- Storage
Room temperature, 68 to 77 degrees Fahrenheit, and never refrigerated or frozen.
- Keep the bottle and syringe together in a clean place, out of reach of children.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of heart or lung problems
Shortness of breath, tiredness or weakness with activity, lightheadedness or fainting, or swollen ankles or feet.
- Chest pain, a fluttering or irregular heartbeat, or bluish lips or skin also count.
- The Medication Guide says to call the healthcare provider right away.FDA label
Serotonin syndrome
Agitation, hallucinations, a fast heartbeat, tight muscles, high temperature, trouble walking, or nausea, vomiting and diarrhea.
- The label calls it potentially life-threatening, especially with other serotonin medicines, and the Medication Guide says to call right away.FDA label
Eye pain or vision changes
Red eyes, eye pain, blurred or decreased vision, or halos around lights.
- Fenfluramine can trigger angle closure glaucoma, and the label says to consider stopping Fintepla if vision drops suddenly or the eye hurts.FDA label
Eating less, losing weight or sleeping more
Decreased appetite, weight loss, sleepiness and low energy were among the most common Dravet side effects.
- In the trials, 19% on Fintepla lost 7% or more of their body weight, against 2% on placebo.
- The prescriber may change the dose.FDA label
Mood and behavior changes
New or worse depression, anxiety, irritability, aggression or thoughts of self-harm.
- The label says all seizure medicines carry this risk and asks caregivers and families to report behaviors of concern right away.
- Aggression has been reported since approval.FDA label
Seizures that do not stop
Status epilepticus was among the most common Dravet side effects in the label's trials.
- It affected 12% of the group also taking stiripentol, against 2% on placebo.
- Follow the seizure rescue plan from the neurologist and seek emergency care as directed.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.FDA REMS page
- 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.FDA letter
- 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.Cigna policy
- 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.Cost and copay
- 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.Financial support info sheet
- 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.Financial support info sheet
Cigna prior authorization policy, May 1, 2026
- Dravet syndrome, patient 2 years of age or older
- Tried or currently taking at least 2 other seizure medicines, such as valproic acid, topiramate, clonazepam, levetiracetam or zonisamide
- Or tried or currently taking one of clobazam, Epidiolex (cannabidiol) or Diacomit (stiripentol)
- Prescribed by or in consultation with a neurologist
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. ONWARD support
Five questions for the pharmacist or the support line
- How many milliliters is each dose, and which syringe size do we use?
- When does this bottle reach its 3-month discard date, and when should we order the next one?
- My child takes these medicines. Do any of them change the highest Fintepla dose or raise the risk of serotonin syndrome?
- Which cough medicines and supplements should we check with you first?
- Can we get extra syringes, and who do we call if the adapter is missing?
Questions people ask in the first weeks
What dose of Fintepla is used for Dravet syndrome?
The label starts at 0.1mg/kg twice a day and calls that the maintenance dose too. If more seizure control is needed, it can rise weekly to as much as 0.35mg/kg twice a day, capped at 26mg a day. With stiripentol plus clobazam, the cap is 0.2mg/kg twice a day and 17mg a day.
How often does my child need an echocardiogram on Fintepla?
The label requires one before the first dose, one every 6 months during treatment and one 3 to 6 months after the last dose. Each result goes to the REMS on a Patient Status Form. UCB's At-Home Echo Program can help eligible families who cannot reach an echo facility.
Is the Fintepla REMS still required?
Yes. The current label still says Fintepla is available only through the Fintepla REMS. The FDA's REMS page shows the program was last modified on May 22, 2026, to update training materials, not to remove it.
Why does Fintepla have a boxed warning?
Fenfluramine can cause heart valve disease and high blood pressure in the arteries of the lungs. The label says no trial patient developed either over up to 3 years, but cases have been reported since approval. That is why the heart ultrasounds are required.
How long does a bottle of Fintepla last?
It depends on the child's weight and dose. At the highest dose of 26mg a day, a 360mL bottle lasts about 30 days. Any liquid left 3 months after first opening is thrown away, even if the bottle is not empty.
How soon might Fintepla reduce seizures?
In the label's Dravet trials, fewer convulsive seizures were seen within 3 to 4 weeks of starting. The effect stayed generally steady over the 14 or 15 week treatment period. Each child responds differently, and the neurologist tracks progress.
What does Fintepla cost with insurance?
UCB's ONWARD Copay Assistance Program lets eligible commercially insured families pay as little as $0 and no more than $25 per refill. It excludes Medicaid, Medicare and other government programs. A Clinical Nurse Educator at 1-833-463-7547 can explain the options.
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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, October 22, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Fintepla (fenfluramine hydrochloride), NDA #212102, FDA, May 22, 2026.
- Dravet Syndrome Support With ONWARD®, FINTEPLA® (fenfluramine), UCB, Inc., November 10, 2026.
- Getting FINTEPLA for Dravet Syndrome Seizures, FINTEPLA® (fenfluramine), UCB, Inc., November 10, 2026.
- Dravet Syndrome Cost and Copay, FINTEPLA® (fenfluramine), UCB, Inc., November 10, 2026.
- FINTEPLA financial support programs info sheet (US-P-FA-DS-2300283), UCB, Inc., January 1, 2023.
- Dravet Syndrome At-Home Echo Test, FINTEPLA® (fenfluramine), UCB, Inc., November 10, 2026.
- Drug Coverage Policy IP0042, Fintepla (Antiseizure Medications, Fintepla), Cigna, May 1, 2026.
- NDA 212102/S-018 supplement approval letter, REMS modification, FDA, May 22, 2026.
- NDA 212102/S-017 supplement approval letter, dose volume calculation, syringe cleaning and pregnancy subsection, FDA, October 15, 2025.
- NDA 212102/S-016 supplement approval letter, valvular heart disease and pulmonary arterial hypertension revisions, FDA, April 8, 2025.
- NDA 212102/S-014 supplement approval letter, REMS modification and assessment plan, FDA, April 2, 2024.
- NDA 212102/S-013 supplement approval letter, aggression added to postmarketing experience, FDA, December 11, 2023.
- NDA 212102/S-007 and S-008 supplement approval letter, corporate name change and removal of controlled substance schedule, FDA, September 14, 2023.
- NDA 212102/S-006 supplement approval letter, hepatic impairment dosing, FDA, January 3, 2023.
- NDA 212102/S-005 supplement approval letter, carcinogenicity data, FDA, June 15, 2022.
- NDA 212102/S-003 supplement approval letter, Lennox-Gastaut syndrome indication and REMS modification, FDA, March 25, 2022.
- Drugs@FDA record for NDA 212102, FINTEPLA, via openFDA, FDA, November 10, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing neurologist. Found an error? Use the report link in the footer and it will be checked against the source.