Prescribing Information

DIACOMIT® for Dravet syndrome The only FDA-approved treatment for children as young as 6 months* * 15 lb or more and taking clobazam

Not actual patient and caregiver

For patients and caregivers

For healthcare providers

For TREATMENT access

Earlier Access to Effective Dravet Seizure Treatment

A Dravet syndrome diagnosis is difficult to receive. With seizures that usually develop during the first year of life, and developmental and cognitive issues that unfold over a lifetime, the treatment path can be a difficult one to walk for patients, their caregivers, and their healthcare providers.

DIACOMIT (stiripentol) is an effective, FDA-approved treatment designed specifically to treat seizures associated with Dravet syndrome. In July 2022, DIACOMIT was approved for patients 6 months and older (weighing 15 lb or more) taking clobazam.¹ There are no clinical data to support the use of DIACOMIT as a monotherapy.

DIACOMIT is now the only treatment specifically for Dravet seizures available for children as young as 6 months.  This means more children will have access to effective treatment closer to the time of their Dravet syndrome diagnosis.

At Biocodex, we are dedicated to providing treatment, education, and support to the entire Dravet syndrome community. We’re partners on the path every step of the way.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.
 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

No contraindications are listed.

WARNINGS & PRECAUTIONS

Somnolence

DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

Decreased Appetite and Decreased Weight

DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored.

Neutropenia and Thrombocytopenia

DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

Risks in Patients with Phenylketonuria (PKU)

DIACOMIT for oral suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT for oral suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT for oral suspension. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

ADVERSE REACTIONS

The most common adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia.

PREGNANCY

There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at www.aedpregnancyregistry.org). This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver.

To report suspected adverse reactions, contact Biocodex at 1-866-330-3050 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for DIACOMIT®.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

DIACOMIT (stiripentol) capsules for oral use or powder for oral suspension are indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.