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Important Safety Information Full Prescribing Information

About DIACOMIT®

Safety information about DIACOMIT®

Most common adverse reactions, occurring in ≥10% of patients treated with DIACOMIT® and more frequently than placebo, include:

  • Somnolence (67%)
  • Decreased appetite (45%)
  • Agitation (27%)
  • Ataxia (27%)
  • Decreased weight (27%)
  • Hypotonia (24%)
  • Nausea (15%)
  • Tremor (15%)
  • Dysarthria (12%)
  • Insomnia (12%)

Adverse reactions in 5% or more of DIACOMIT®-treated patients and more frequently than on placebo in patients with Dravet syndrome (STICLO France and STICLO Italy)

Adverse Reactions Pooled Total
DIACOMIT®
(50 mg/kg/day)
n=33
%
Placebo
n=31
%
Gastrointestinal disorders
Nausea 15 3
Vomiting 9 0
Salivary hypersecretion 6 0
General disorders and administration site conditions
Fatigue 9 3
Pyrexia 6 3
Infections and infestations
Bronchitis 6 0
Nasopharyngitis 6 0
Investigations
Decreased weight 27 6
Increased weight 6 3
Metabolism and nutrition disorders
Decreased appetite 46 10
Nervous system disorders
Somnolence 67 23
Ataxia 27 23
Hypotonia 18 13
Tremor 15 10
Dysarthria 12 0
Psychiatric disorders
Agitation 27 16
Insomnia 12 7
Aggression 9 0

There were 2 patients in whom adverse reactions led to discontinuation of DIACOMIT® treatment: one patient had an adverse reaction of status epilepticus; the second patient had drowsiness, impaired balance and sialorrhea.

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.

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®.