Resources

Guidance and support

Resources for patients and caregivers

Take advantage of our expanding collection of resources. Families can learn how to get access to treatment with DIACOMIT, read about Dravet syndrome, discover new ways of helping their child navigate life, and find support groups to connect with other families affected by Dravet syndrome.

Dravet syndrome communities and resources
Getting access to treatment with DIACOMIT

Not actual patients

Building a support system

Managing a rare disease like Dravet syndrome can cause caregivers and families to feel lonely and isolated. Seeking support and community from friends, family, or other caregivers can help when times are difficult or when they need a reminder of their successes.

Dravet syndrome resources:

Getting access to treatment

DIACOMIT is now available through our specialty pharmacy and covered by most insurance plans. Learn more:

Patient Access Insights video

Resource library

Downloadable materials for healthcare practices

Find quick links to valuable resources for doctors, nurses, and office staff.

About DIACOMIT
DIACOMIT access forms
About Dravet syndrome
DIACOMIT background and clinical data

Not an actual HCP

About DIACOMIT:

Drug interactions card

Access training video

Patient enrollment form | VA patient enrollment form

Sample letter of appeal

Sample letter of medical necessity

About Dravet syndrome:

“Navigating Life with Dravet Syndrome” information booklet

DIACOMIT background and clinical data:

Posters

Publications

Chiron C. Stiripentol for the treatment of seizures associated with Dravet syndrome. Expert Rev Neurother. 2019:19(4):301-310. doi: 10.1080/14737175.2019.1593142. Epub 2019 Apr 2.

Chiron C, Marchand MC, Tran A, et al. Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial. STICLO study group. Lancet. 2000;356(9242):1638-1642. doi: 10.1016/s0140-6736(00)03157-3.

Cross JH, Caraballo RH, Nabbout R, Vigevano F, Guerrini R, Lagae L. Dravet syndrome: treatment options and management of prolonged seizures. Epilepsia. 2019;60(3):S39-S48. doi: 10.1111/epi.16334.

Wirrell EC, Laux L, Donner E, et al. Optimizing the diagnosis and management of Dravet syndrome: recommendations from a North American Consensus Panel. Pediatr Neurol. 2017;68(3):18-34. doi: 10.1016/j.pediatrneurol.2017.01.025. Epub 2017 Feb 4.

Wirrell EC, Laux L, Franz DN, et al. Stiripentol in Dravet syndrome: results of a retrospective U.S. study. Epilepsia. 2013;54(9):1595-1604. doi: 10.1111/epi.12303. Epub 2013 Jul 12.

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^®.