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Important Safety Information Full Prescribing Information

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WEBSITE TERMS OF USE

Navigation of this site is regulated by the conditions of use described in the present document.
These conditions may be modified at any time by Biocodex, without any prior warning; therefore, we invite you to consult them regularly.

1. IMPORTANT NOTICE

The information given by the company on this site is no substitute for a medical opinion. Biocodex thus declines any responsibility regarding interpretation and use of the information given. We strongly recommend you to consult a doctor or a pharmacist before using any of our drugs.

2. SITE CONTENTS

This site aims at providing general information on the organization, activity and products of Biocodex. It was conceived and implemented in accordance with the Public Health Code. Thus, information regarding the drugs mentioned is no advertisement and does not constitute any particular recommendation on the part of Biocodex with regard to their use.

3. INTELLECTUAL PROPERTY

The domain names, the company logo and all texts and drug names given on this site are the exclusive property of Biocodex, 7 avenue Gallieni, Gentilly Cedex - 94257 (France), SA (public company) with a capital of EUR 4,200,000 registered with the Créteil Register of Companies under the number B 562 064 600.

4. PROTECTION AND SAFETY OF DATA

The site is hosted by Biocodex IT Department, which has implemented a system to protect against intrusion and acts of piracy. However, the safety of the internet cannot be fully guaranteed. Therefore, Biocodex accepts no responsibility for information which could be used for malevolent purposes.

5. TECHNICAL INFORMATIONS

The website follows the World Wide Web Consortium recommendations (www.w3c.org). During its development, the site was successfully tested on the latest version of several web browsers such as Internet Explorer and Firefox. The minimal recommended screen resolution is 1024x768. We cannot guarantee the proper distribution of the information on web browsers or other resolutions, other than the ones already cited above. For technical questions, please contact the webmaster at the following email address: webadmin@biocodex.fr

Biocodex head office: 7, avenue Gallieni - 94257 Gentilly Cedex - France

A simplified joint stock company of EUR 4,284,000 - registered number 562 064 600 (Trade and Companies registry of Créteil)

Head of publications: Mr. François Hublot, Chairman’s Permanent Representative

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®.