Your first 90 days
Your first 90 days on Diacomit 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.
Diacomit is approved as an add-on to clobazam, and that pairing shapes the first weeks. The dose is set by weight, every dose goes with a meal, and sleepiness was the most common side effect in the trials. Blood counts are checked before the first dose and again every 6 months. This page walks parents, guardians and caregivers through that stretch. It draws on the FDA label, Biocodex's own Diacomit pages and one insurer's written rules.
What has to happen before the first bottle ships
Diacomit has no REMS, so the first shipment waits mainly on a blood count, a medicine review, an insurance approval and one specialty pharmacy. These are the 7 things in the way, in order.
Clobazam as part of treatment
The label approves Diacomit for patients who are taking clobazam.
- It says there are no clinical data to support using Diacomit on its own in Dravet syndrome.FDA label
A blood count
The label asks for blood counts before starting, because Diacomit can lower a type of white blood cell and platelets.
- The same blood test then repeats every 6 months for as long as treatment continues.FDA label
Capsules or powder
Diacomit comes as 250mg and 500mg capsules and as 250mg and 500mg powder packets.
- The powder contains phenylalanine, which matters for anyone with phenylketonuria (PKU), and the capsules do not contain it.FDA label
A full medicine list
Diacomit raises blood levels of clobazam and can change levels of other medicines.
- Some seizure medicines, such as phenytoin, phenobarbital and carbamazepine, can lower Diacomit levels.
- The Medication Guide says to tell the healthcare provider about every medicine, vitamin and herbal supplement.
- It also says to keep a list to show the provider and pharmacist.FDA label
The insurance approval
Plans such as Cigna require prior authorization before they will cover Diacomit.
- Cigna's policy asks for a patient 6 months or older who weighs 7kg (15 pounds) or more.
- It asks that Diacomit is prescribed by a neurologist or in consultation with one.
- It also asks that the patient takes clobazam, or cannot take it because of side effects.Cigna policy
One specialty pharmacy
Biocodex says Diacomit is available only at PANTHERx Rare Pharmacy, a national specialty pharmacy.
- PANTHERx manages the prescription process and delivers Diacomit directly to the home.Accessing Diacomit
Help paying, from Biocodex
Biocodex lists 4 patient programs, including a $0 copay per prescription for eligible patients with commercial insurance.
- The copay program is not available for government plans such as Medicare or Medicaid.Accessing Diacomit
The days that matter
Counted from the first dose, with the blood count the label asks for every 6 months and the yearly insurance renewal. 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.Baseline blood count
A blood count before the first dose, to record white blood cells and platelets.
- The label does not set an exact number of days ahead.
Insurance approval and shipment
The plan reviews the prior authorization while PANTHERx checks coverage and savings.
- Biocodex says Diacomit can be delivered in as little as 24 hours, because no REMS is required.
First dose, 50mg/kg a day in 2 or 3 doses
The dose is set by weight, and each dose is taken during a meal.
- The label's trials began at the full 50mg/kg a day with no gradual build-up.
- The neurologist sets the schedule and the number of doses a day.
First refill, timing depends on the dose
The label lists bottles of 60 capsules and cartons of 60 powder packets.
- How long a supply lasts depends on the dose the neurologist prescribes.
Blood count, then every 6 months
The label repeats the blood count every 6 months during treatment.
- In its trials, 13% of tested patients had neutrophil counts drop from normal to low, and 13% had platelet counts do the same.
Insurance renewal
Cigna approves Diacomit for a year at a time, then asks for renewal.
- 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 Diacomit 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 April 27, 2026, read from the FDA's label database today. FDA label
- April 2026
The FDA approved a new section listing side effects reported since approval, and its one entry is pneumonia.FDA letter
- July 2022
The FDA approved Diacomit for patients 6 months and older who weigh 7kg (15 pounds) or more and take clobazam. Biocodex said the 2018 approval had covered children 2 years and older.Biocodex press release
- August 2018
Diacomit capsules and powder for oral suspension were first approved on August 20, 2018.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.
- Two or three times a day, by weight
The label's dose is 50mg/kg a day, given as 25mg/kg twice a day or 16.67mg/kg three times a day.
- The highest total dose on the label is 3,000mg a day.FDA label
- Twice a day only for the smallest children
For babies under 1 year, and for children under 10kg (about 22 pounds), the label limits dosing to twice a day.
- From 10kg and 1 year of age, it allows either 2 or 3 doses a day.FDA label
- Always during a meal
The label says both capsules and powder are taken during a meal.
- The Instructions for Use say a child must eat food right after taking the powder mixture.FDA label
- Capsules stay whole
The label says capsules must be swallowed whole with a glass of water.
- It also says capsules should not be broken or opened.FDA label
- Mixing the powder
Each dose of powder is mixed into 100mL of water in a small cup and taken right away.
- Another 25mL of water is then stirred into the cup and drunk, so no medicine is left behind.FDA label
- Powder is never mixed ahead
The Instructions for Use say not to open a packet until it is needed.
- They also say not to store the mixture, because it must be taken right after mixing.FDA label
- Doses that do not match the strengths
When the exact dose cannot be made from 250mg and 500mg units, the label rounds to the nearest possible dose.
- It says this is usually within 50mg to 150mg of the 50mg/kg a day target.FDA label
- Missed doses
The label says a missed dose is taken as soon as possible.
- If it is almost time for the next dose, the missed one is skipped, and doses are never doubled.FDA label
- Never stop suddenly
The Medication Guide says not to stop Diacomit without first talking to the healthcare provider.
- Stopping a seizure medicine suddenly can bring more seizures or seizures that do not stop.
- The label withdraws Diacomit gradually when treatment ends, to limit that risk.FDA label
- Clobazam and sleepiness
In the label's studies, Diacomit raised clobazam levels about 2 times and its active breakdown product about 5 times.
- If sleepiness occurs, the label tells prescribers to consider lowering clobazam by 25% at first.FDA label
- Valproate and appetite
Everyone in the label's 2 trials also took clobazam and valproate.
- The label says lowering valproate by 30% per week can, in some cases, ease the loss of appetite and weight.
- The prescriber decides whether to change any other medicine or dose.FDA label
- Alcohol and other sedating medicines
The Medication Guide says not to drink alcohol or take other medicines that cause sleepiness or dizziness without first talking to the healthcare provider.
- Taken together with Diacomit, they can make sleepiness or dizziness worse.
- The Medication Guide also says not to drive, use heavy machinery or do other dangerous activities until it is known how Diacomit affects the patient.FDA label
- Other medicines and supplements
The label says Diacomit can change levels of medicines such as diazepam, clopidogrel, carbamazepine, midazolam, sertraline and theophylline.
- It says to avoid strong inducers such as rifampin, phenytoin, phenobarbital and carbamazepine, or to adjust doses.FDA label
- Phenylketonuria (PKU)
Each 250mg powder packet contains 1.40mg of phenylalanine, and each 500mg packet contains 2.80mg.
- The label asks prescribers to count phenylalanine from all sources for a patient with PKU.
- Diacomit capsules do not contain phenylalanine, according to the label.FDA label
- Kidney and liver problems
Diacomit has not been formally studied in people with kidney or liver impairment.
- The label does not recommend it for patients with moderate or severe impairment of either organ.FDA label
- Pregnancy and breastfeeding
There are no adequate human data in pregnancy, and animal studies showed harm.
- The label encourages enrolling in the North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334.
- It is not known whether Diacomit passes into breast milk.FDA label
- Storage
The label stores Diacomit in a dry place at room temperature, 68 to 77 degrees Fahrenheit.
- It stays in the original package to protect it from light, out of the 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.
Sleepiness and drowsiness
Sleepiness affected 67% of patients on Diacomit in the label's trials, against 23% on placebo, and everyone also took clobazam.
- The Medication Guide calls it a serious and common side effect and says to call the healthcare provider right away.FDA label
Eating less or losing weight
Decreased appetite affected 46% on Diacomit against 10% on placebo, and weight fell in 27% against 6%.
- Nausea and vomiting were also more frequent on Diacomit than on placebo.
- The Medication Guide says children should have their weight and growth checked often.FDA label
Low white blood cells and platelets
The Medication Guide says low white blood cell counts may cause serious infections, and low platelet counts may cause serious bleeding problems.
- The blood counts before starting and every 6 months are how the prescriber watches for both.
- The Medication Guide says to call the healthcare provider right away about these side effects.FDA label
Mood and behavior changes
Thoughts about suicide or dying, attempts to commit suicide, new or worse depression, anxiety or irritability, agitation, panic attacks, trouble sleeping, aggression, acting on dangerous impulses, or an extreme increase in activity and talking.
- The Medication Guide says to call the healthcare provider right away, especially if these are new, worse or worrying.FDA label
Other common side effects
Agitation, loss of control of body movements, low muscle tone, nausea, tremor, trouble saying words clearly and trouble sleeping.
- The Medication Guide says to tell the healthcare provider about any side effect that bothers or does not go away.FDA label
More seizures after a sudden stop
The label says abrupt withdrawal may raise the risk of more frequent seizures and of status epilepticus, a seizure that does not stop.
- It tells families not to stop Diacomit without consulting the healthcare provider first.FDA label
Too much Diacomit
If too much is taken, the Medication Guide says to call the healthcare provider or go to the nearest hospital emergency room right away.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.
- Prior authorization pending or deniedCigna asks for age 6 months or older and a weight of 7kg (15 pounds) or more. It asks that Diacomit is prescribed by a neurologist or in consultation with one. It also asks that the patient takes clobazam, or cannot take it because of side effects. The neurologist's office documents each of these points on the request.Cigna policy
- The prescription went to a regular pharmacyBiocodex says Diacomit is available only through PANTHERx Rare Pharmacy. The neurologist's office can fax a Patient Enrollment Form to PANTHERx or send it an electronic prescription.Access, HCP page
- The pharmacy is missing informationBiocodex asks offices to include the diagnosis code, the patient's weight, the formulation and quantity, and clear dosing instructions. It also asks for insurance cards, medical records and a medicine list that shows clobazam use and dose.Access, HCP page
- Insurance approval is taking too longBiocodex's Quick Start Program can supply up to 60 days of Diacomit at no cost. It is for newly eligible patients who face delays in getting access to treatment.Accessing Diacomit
- Insurance changed or lapsedBiocodex's Bridge Program can supply up to 60 days of Diacomit at no cost. It is for patients already on Diacomit whose insurance coverage changes or lapses.Accessing Diacomit
- A copay you cannot payBiocodex's Copay Program offers a $0 copay per prescription for eligible patients with commercial insurance. It is not available for government plans such as Medicare or Medicaid. Our help paying page lists charity funds that may assist with costs.Accessing Diacomit
- No insurance, or not enoughBiocodex's Long-Term Patient Assistance Program provides Diacomit at no cost for eligible patients who are uninsured or underinsured. The Biocodex By Your Side team at 833-248-0467 can explain eligibility.Accessing Diacomit
Cigna prior authorization policy, May 1, 2026
- Dravet syndrome, patient 6 months of age or older who weighs 7kg (15 pounds) or more
- Taking clobazam at the same time
- Or unable to take clobazam because of side effects, as determined by the prescriber
- 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 July 2022 label. The April 2026 label revision added pneumonia to side effects reported since approval and did not change the indication or dosing. The label itself covers only patients who are taking clobazam with Diacomit. Other health plans set their own criteria and their own 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.
- Delivery to the home from PANTHERx Rare Pharmacy, the only pharmacy that dispenses Diacomit
- Support with insurance coverage and eligibility for savings, and outreach to the prescriber for refills when needed
- Pharmacists on call 24/7 and translation services in more than 100 languages
- A Rapid Refill program for scheduling refills online or by mobile, which requires opting in, plus shipment tracking and vacation planning
- Dosing supplies by request: 10mL and 35mL oral syringes and 100mL dosing cups
- Copay Program: $0 copay per prescription for eligible patients with commercial insurance. Not available for government plans such as Medicare or Medicaid
- Quick Start Program: up to 60 days of Diacomit at no cost for newly eligible patients experiencing delays in getting access to treatment
- Bridge Program: up to 60 days of Diacomit at no cost for patients on Diacomit with changes or lapses in insurance coverage
- Long-Term Patient Assistance Program: Diacomit at no cost for eligible patients who are uninsured or underinsured
Details as the drugmaker publishes them. Accessing Diacomit
Five questions for the pharmacist or the support line
- How many capsules or packets make up each dose, and which strengths are we using?
- How long will this supply last at my child's dose, and when should we reorder?
- My child takes clobazam and valproate. What should we watch for?
- Do any of my child's other medicines or supplements interact with Diacomit?
- Can we get a 100mL dosing cup for mixing the powder?
Questions people ask in the first weeks
What dose of Diacomit is used for Dravet syndrome?
The label's dose is 50mg/kg a day, given as 25mg/kg twice a day or 16.67mg/kg three times a day. Babies under 1 year and children under 10kg (about 22 pounds) are limited to twice a day. The highest total dose on the label is 3,000mg a day.
Does Diacomit have to be taken with clobazam?
The label approves Diacomit for patients who are taking clobazam. It says there are no clinical data to support Diacomit on its own in Dravet syndrome. Valproate is not part of the approved use, although everyone in the 2 trials took it.
How often are blood tests needed on Diacomit?
The label asks for blood counts before the first dose and then every 6 months. In its trials, 13% of tested patients on Diacomit had neutrophil counts drop from normal to low, and 13% had platelet counts do the same. No patient on placebo had either drop during the trials.
What is the difference between Diacomit capsules and powder?
Both come in 250mg and 500mg strengths and are taken during a meal. Capsules are swallowed whole with water, while powder is mixed in 100mL of water and taken right away. The powder contains phenylalanine, which matters in PKU, and the capsules do not.
Does Diacomit have a boxed warning or a REMS?
No. The label has no boxed warning and lists no contraindications, and Biocodex says no REMS program is required. Its warnings cover sleepiness, decreased appetite and weight, low blood counts, stopping too quickly, phenylalanine in the powder, and suicidal behavior and ideation.
How well did Diacomit work in the trials?
In the label's 2 trials, 71% and 67% of patients on Diacomit had their convulsive seizures cut by more than half. On placebo, the matching figures were 5% and 9% of patients. Treatment lasted 2 months, and everyone also took clobazam and valproate.
What does Diacomit cost with insurance?
Biocodex's Copay Program offers a $0 copay per prescription for eligible patients with commercial insurance. It is not available for government plans such as Medicare or Medicaid. The Biocodex By Your Side team at 833-248-0467 can explain the other programs.
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Sources
- DIACOMIT- stiripentol capsule; DIACOMIT- stiripentol powder, for suspension: prescribing information, revised 4/2026, Medication Guide, issued 07/2022, and Instructions for Use, approved 7/2022, Biocodex, Inc., via DailyMed, April 27, 2026.
- Accessing DIACOMIT® (stiripentol), Biocodex, Inc., November 11, 2026.
- DIACOMIT® (stiripentol) Access and Coverage I HCP Site, Biocodex, Inc., November 11, 2026.
- DIACOMIT® Patient Enrollment Form (BBD-00421-052025), Biocodex, Inc., May 1, 2025.
- Drug Coverage Policy IP0409, Diacomit (Antiseizure Medications, Diacomit), Cigna, May 1, 2026.
- NDA 206709/S-006 and NDA 207223/S-006 supplement approval letter, postmarketing experience subsection adding pneumonia, FDA, April 15, 2026.
- Antiseizure Drug DIACOMIT Now Approved for Children as Young as 6 Months, Biocodex, Inc., via BioSpace, September 21, 2022.
- Drugs@FDA records for NDA 206709 and NDA 207223, DIACOMIT, via openFDA, FDA, November 11, 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.