Diacomit

(Stiripentol)

The active ingredient in Diacomit is stiripentol. While the exact mechanism of action in the treatment of seizures is not fully understood, Diacomit is thought to work by enhancing the activity of gamma-aminobutyric acid (GABA). GABA is a neurotransmitter that helps calm brain signals, thereby reducing the likelihood of seizures. It may also indirectly affect other antiepileptic drugs (AEDs) by inhibiting cytochrome P450 activity, which can increase the blood levels of these medications.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labelling, Instructions for Use, and Medication Guide before using Diacomit. However, the following is a synopsis of the general guidelines for the use of Diacomit:

• Diacomit is taken by mouth as capsules or oral suspension.
• It is used as adjunctive therapy, typically with clobazam and valproate.
• The dose is based on body weight and is usually given in two or three divided doses per day.
• Diacomit should be taken with food to reduce stomach upset.
• Diacomit capsules should be swallowed whole and not crushed or opened.
• Oral suspension should be measured using the provided dosing device.
• Pediatric dosing is calculated in mg/kg/day and adjusted by the healthcare provider.
• Caregivers should follow dosing instructions carefully and not change doses without medical advice.
• Missed doses should be taken as soon as remembered, unless it is close to the next dose.

Some mild or most common side effects of Diacomit seen in clinical trials include:

• Loss of appetite.
• Weight loss.
• Drowsiness.
• Fatigue.
• Ataxia or unsteady movement.
• Nausea.
• Tremor.
• Low muscle strength (hypotonia).

Some individuals may experience serious side effects while using Diacomit. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe drowsiness or difficulty waking.
• Worsening seizure frequency or status epilepticus.
• Signs of infection, such as fever or sore throat.
• Unusual bruising or bleeding.
• Suicidal thoughts or changes in mood.
• Severe adverse reactions, including swelling or trouble breathing.
• Low white blood cell (neutropenia) or platelet counts.

These are not all of the possible side effects of Diacomit. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the U.S. Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Diacomit, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of blood disorders.
• Liver disease.
• Phenylketonuria, as the oral suspension contains phenylalanine.
• Depression or suicidal thoughts.
• Feeding or growth concerns.

Diacomit should not be used in individuals with:

• Known hypersensitivity to stiripentol or any inactive ingredients.
• Certain metabolic conditions related to phenylalanine intolerance when using oral suspension.

Some patients may see a reduction in seizure frequency within a few weeks of starting Diacomit. Full benefit may take several weeks as doses are adjusted and stabilised.

When Diacomit is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Clobazam, as Diacomit increases clobazam levels and may increase sedation.
• Valproate, which may increase the risk of side effects.
• Carbamazepine, which may have altered blood levels.
• Phenytoin, which may increase toxicity.
• Phenobarbital, which may increase sedation.
• Theophylline, which may increase theophylline levels due to enzyme inhibition.
• Other CNS depressants, which may increase drowsiness.

Diacomit is available as:

• Capsules.
• Oral suspension.
• Doses are individualised based on weight and given as mg/kg/day in divided doses.

The oral suspension contains phenylalanine and should be used cautiously in patients with phenylketonuria (PKU).

It should be stored at room temperature, away from the reach of children or pets.

Diacomit is manufactured by Biocodex.

No, there is no generic version of Diacomit currently available.

Do not stop Diacomit suddenly. Stopping abruptly may increase seizure risk. Your healthcare provider will guide any dose reductions or discontinuation.

Diacomit may cause harm to an unborn baby. Effective contraception should be used during treatment and continued for at least 5 days after the last dose. Talk to your healthcare provider immediately if pregnancy occurs.

Lactation is not recommended during treatment with Diacomit and should be avoided for at least 5 days after the final dose, as stiripentol may pass into breast milk and cause serious side effects in a nursing infant.