Diacomit Side Effects Center

Last updated on RxList: 7/20/2022
Diacomit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Diacomit?

Diacomit (stiripentol) is an antiepileptic drug (AED) indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.

What Are Side Effects of Diacomit?

Common side effects of Diacomit include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Diacomit

The dosage of Diacomit is 50 mg/kg/day, administered by mouth in 2 or 3 divided doses.

What Drugs, Substances, or Supplements Interact with Diacomit?

Diacomit may interact with theophylline, caffeine, sertraline, thiotepa, midazolam, triazolam, quinidine, diazepam, clopidogrel, carbamazepine, methotrexate, prazosin, glyburide, clobazam, rifampin, phenytoin, phenobarbital, and other CNS depressants, including alcohol. Tell your doctor all medications and supplements you use.

Diacomit During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before taking Diacomit; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as Diacomit, during pregnancy. It is unknown if Diacomit passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Diacomit (stiripentol) Capsules, for Oral Use And Diacomit (Stiripentol) Powder, for Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Diacomit Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • severe drowsiness;
  • significant weight loss;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

Common side effects may include:

  • nausea, loss of appetite;
  • weight loss;
  • drowsiness;
  • agitation;
  • problems with balance or muscle movement;
  • tremor, slurred speech;
  • muscle weakness; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Diacomit Professional Information

SIDE EFFECTS

The following serious or otherwise clinically significant adverse reactions are described elsewhere in the labeling:

  • Somnolence [see WARNINGS AND PRECAUTIONS]
  • Decreased Appetite and Decreased Weight [see WARNINGS AND PRECAUTIONS]
  • Neutropenia and Thrombocytopenia [see WARNINGS AND PRECAUTIONS]
  • Withdrawal Symptoms [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Phenylketonuria [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug, and may not reflect the rates observed in practice.

During its development for the treatment of seizures associated with Dravet syndrome, DIACOMIT was administered to 55 healthy male volunteers and 438 patients with Dravet syndrome, including 310 patients treated for 12 months or more. The conditions and duration of exposure varied greatly, and included single- and multiple-dose clinical pharmacology studies in healthy male volunteers, 2 randomized, double-blind, placebo-controlled, 12-week studies in patients with Dravet syndrome (Study 1 and Study 2), and open-label long-term studies.

In Study 1 and Study 2, 33 patients received DIACOMIT and 31 patients received placebo for a treatment duration of 8 weeks [see Clinical Studies]. Adverse reactions from these trials are presented below. Approximately 53% of patients were female and the mean age was 9.2 years. All patients were taking clobazam and valproate.

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, balance impaired and sialorrhea.

The most common adverse reactions, occurring in at least 10% of DIACOMIT-treated patients and more frequently than on placebo, included somnolence (67%), decreased appetite (45%), agitation (27%), ataxia (27%), weight decreased (27%), hypotonia (24%), nausea (15%), tremor (15%), dysarthria (12%), and insomnia (12%).

Table 3 lists the adverse reactions that occurred in 5% or more of DIACOMIT-treated patients and at a rate greater than in patients on placebo in the 2 randomized, double-blind, placebocontrolled, clinical trials in patients with Dravet syndrome (Study 1 and Study 2).

Table 3. Adverse Reactions in 5% or More of DIACOMIT-Treated Patients and More Frequently than on Placebo in Patients with Dravet Syndrome (Study 1 and Study 2)

Adverse Reactions Study 1 and 2 – Pooled Total
DIACOMIT
(50mg/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
  Weight decreased 27 6
  Weight increased 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

Adverse Reactions In Pediatric Patients 6 Months To Less Than 2 Years Of Age

In five open-label studies including pediatric patients 6 months to less than 2 years of age with Dravet syndrome, a total of 106 patients received DIACOMIT, with 81 patients exposed for at least 6 months, and 69 patients exposed for at least 1 year. Adverse reactions in pediatric patients with Dravet syndrome who were 6 months to less than 2 years of age were similar to those seen in patients in Study 1 and Study 2.

DRUG INTERACTIONS

Effect Of DIACOMIT On Other Drugs

CYP1A2, CYP2B6, CYP3A4, CYP2C8, CYP2C19, P-Glycoprotein (P-gp) And Breast Cancer Resistance Protein (BCRP) Substrates

In vitro data show that stiripentol is both an inhibitor and inducer of CYP1A2, CYP2B6, and CYP3A4. Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT.

Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with DIACOMIT.

Clobazam

Co-administration of DIACOMIT (which inhibits CYP 3A4 and 2C19) with clobazam results in increased plasma concentrations of clobazam (a substrate of CYP3A4) and norclobazam, the active metabolite of clobazam (a substrate of CYP2C19) [see CLINICAL PHARMACOLOGY]. This may increase the risk of clobazam-related adverse reactions. Consider a reduction in dosage of clobazam if adverse reactions are experienced when co-administered with DIACOMIT [see WARNINGS AND PRECAUTIONS].

Effect Of Other Drugs On DIACOMIT

Induction-based interactions leading to decreases in DIACOMIT concentrations are possible when co-administered with a potent CYP1A2, CYP3A4, or CYP2C19 inducer, such as rifampin, phenytoin, phenobarbital and carbamazepine, as these enzymes all metabolize stiripentol. Concomitant use of strong inducers with DIACOMIT should be avoided, or dosage adjustments should be made.

CNS Depressants And Alcohol

Concomitant use of DIACOMIT with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Diacomit (Stiripentol)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer

© Diacomit Patient Information is supplied by Cerner Multum, Inc. and Diacomit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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