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Important Safety Information Full Prescribing Information

Specifically for Dravet syndrome1

DIACOMIT® is an original anti‑epileptic drug resulting from BIOCODEX’s research program.2,3 Its chemical structure is not related to any other known anticonvulsant and its active substance is stiripentol.4

DIACOMIT® is to be used as an add‑on therapy to clobazam for seizures associated with Dravet syndrome when these are not adequately controlled.1

DIACOMIT® is the first anti‑epileptic drug with 2 double‑blind, placebo-controlled trials demonstrating efficacy in Dravet syndrome.1

FDA approved in August 2018 after 18 years of compassionate use for Dravet syndrome1,5

December 5, 2001

DIACOMIT® was designated as an orphan drug by the European Medicines Agency (EMA) for use in severe myoclonic epilepsy in infancy (SMEI)6

January 4, 2007

Conditional marketing authorization was granted for Europe6

October 30, 2008

DIACOMIT® was designated as an orphan medicine in the US7

September 28, 2012

Marketing authorization was granted for Japan8

December 21, 2012

Marketing authorization was granted for Canada9,10

January 8, 2014

Conditional approval was switched to full European marketing authorization for use in conjunction with valproate and clobazam as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with SMEI/Dravet syndrome whose seizures are not adequately controlled with clobazam and valproate alone6

August 20, 2018

FDA approval was granted for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam11

References:

1. DIACOMIT® (stiripentol) prescribing information. Beauvais, France: BIOCODEX; 2018. 2. European Medicines Agency. EPAR – Scientific Discussion: Diacomit. Published 2007. https://www.ema.europa.eu/en/documents/scientific-discussion/diacomit-epar-scientific-discussion_en.pdf. Accessed March 12, 2019. 3. Brigo F, Igwe SC, Bragazzi NL. Antiepileptic drugs for the treatment of infants with severe myoclonic epilepsy. Cochrane Database Syst Rev. 2017;5:CD010483. doi:10.1002/14651858.CD010483.pub4. 4. US Food and Drug Administration. Center for Drug Evaluation and Research Clinical Review: DIACOMIT, stiripentol. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000MedR.pdf. Accessed March 12, 2019. 5. Data on file, BIOCODEX; 2019. 6. European Medicines Agency. EPAR summary for the public. Diacomit. https://www.ema.europa.eu/documents/overview/diacomit-epar-summary-public_en.pdf. Updated June 2014. Accessed March 12, 2019. 7. US Food and Drug Administration. Search orphan drug designations and approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=266108. Accessed March 12, 2019. 8. Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2012. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html. Accessed March 12, 2019. 9. Canadian Agency for Drugs and Technologies in Health. Common Drug Review: Clinical Review Report on Diacomit (stiripentol). https://www.cadth.ca/sites/default/files/cdr/clinical/sr0360_diacomit_cl_report.pdf. Accessed March 12, 2019. 10. Government of Canada. Summary Basis of Decision - Diacomit - Health Canada. Published February 21, 2013. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00181. Accessed March 12, 2019. 11. US Food and Drug Administration. Drug Trial Snapshot: DIACOMIT. https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm. Accessed March 12, 2019.

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®.