This website is intended for a US audience

Important Safety Information Full Prescribing Information

Ordering and Support

As of April 29, 2019, all patients will require a new prescription for DIACOMIT®. DIACOMIT® has partnered with US Bioservices, an independent specialty pharmacy, as the exclusive dispensary of DIACOMIT®.

E-prescribe by choosing the US Bioservices Texas location in your e-prescribe software, or fax prescriptions to (833) 871‑4137(833) 871‑4137

  • Please include the patient’s insurance information and clinical documentation to facilitate prior authorization

US Bioservices will work with the patient/caregiver and payer to determine insurance eligibility and coverage. The support team will provide updates regarding order progress and will reach out if additional information is required. You can call US Bioservices at (833) 248‑0467(833) 248‑0467 (Monday through Friday, 7 AM to 7 PM CST) if you have questions or need information about submitted prescriptions.

DIACOMIT® support services

For help navigating access and affordability challenges, please call (833) 248‑0467(833) 248‑0467 (Monday through Friday, 7 AM to 7 PM CST)

Healthcare providers:

  • Comprehensive verification of patient health insurance coverage, including benefits and eligibility
  • Communication of a health insurance plan’s prior authorization requirements and assistance in gaining approval for DIACOMIT®
  • Appeals assistance for patients with a denial from a health insurance plan
  • Coordination of product shipment

Insured patients:

  • Assistance in paying for out‑of‑pocket costs for DIACOMIT® for eligible patients*
  • Temporary prescription for 30 days (and possible refill) at no cost for new patients awaiting approval from an insurance plan, or a 30‑day fill for patients experiencing a lapse in healthcare insurance coverage
  • Assistance with prior authorization requirements or access

Uninsured patients:

  • Medication may be provided at no cost through our Patient Assistance Program (PAP), pending eligibility
*For patients with private, commercial insurance only. Not available for those with government insurance such as Medicare and Medicaid. Please note that restrictions may apply for any support.
IMPORTANT SAFETY INFORMATION AND INDICATION
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.

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 powder for suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT powder for suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT powder for 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 http://www.aedpregnancyregistry.org). This can be done by calling the toll free number 1‑888‑233‑23341‑888‑233‑2334, and must be done by patients themselves or their caregiver.

To report suspected adverse reactions, contact BIOCODEX at 1‑866‑330‑30501‑866‑330‑3050 or FDA at 1‑800‑FDA‑10881‑800‑FDA‑1088 or www.fda.gov/medwatch

Please see full prescribing information for DIACOMIT®.