Medicinal Products

DIACOMIT 500 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Stiripentol
laboratory: Biocodex

Powder for oral solution
Box of 60
All forms

Indication

Diacom it is indicated in combination with sodium valproate and clobazam in the treatment of generalized tonicoclonic seizures in patients with severe myoclonic epilepsy of the infant (EMSN, Dravet syndrome) and insufficiently controlled by the combination clobazam / valproate of sodium.

Dosage DIACOMIT 500 mg Powder for oral solution Sachets Box of 60

Diacomit should only be administered under the supervision of a pediatrician or pediatric neurologist experienced in the diagnosis and treatment of infant and child epilepsy.

Dosage

The dose of stiripentol is calculated in milligrams per kilogram of body weight.

The daily dose can be administered in two or three doses.

Stiripentol treatment with clobazam and sodium valproate should be initiated with a gradual dose increase for three days to the recommended dose of 50 mg / kg / day. This dose is recommended based on available clinical trial data and was the only one evaluated in the pivotal studies of Diacomit (see section 5.1 ).

There is no clinical evidence to support the safety of stiripentol at a daily dose above 50 mg / kg / day. There are no clinical data to support the use of stiripentol monotherapy for the treatment of Dravet syndrome.

Children under three years old

The pivotal studies of stiripentol were conducted in children aged 3 years and older with an MSN. The decision to administer stiripentol in a child under 3 years of age with an EMSN should be made on a case-by-case basis, taking into account potential clinical benefits and risks. In this population, tiripentol should be added to treatment only after clinical confirmation of the diagnosis of EMSN (see section 5.1 ). Data on the administration of stiripentol in children under 12 months of age are limited. In these children, the use of stiripentol will be done under close supervision of the doctor.

Patients aged 18 and over

Long-term follow-up has failed to collect sufficient data from adults to confirm maintenance of the eff ect in this population. Treatment should be continued as long as the effectiveness is observed.

Dose adjustment of other antiepileptics combined with stiripentol

Despite the lack of comprehensive pharmacological data on potential drug interactions, the following recommendations for dose modification of other stiripentol-associated antiepileptic drugs are based on clinical experience.

- Clobazam

In pivotal studies, the dose of clobazam at the time of initiation of stiripentol was 0.5 mg / kg / day administered usually twice daily. This daily dose was reduced by 25% per week in case of clinical signs of adverse effects or overdose of cl obazam (somnolence, hypotonia and irritability in young children). Joint administration of stiripentol in children with Dravet syndrome increased the plasma concentration of clobazam by approximately two to three times and norclobazam by approximately fifty-fold.

- Sodium valproate

The drug interaction potential between stiripentol and sodium valproate is considered moderate. Therefore, no change in the dosage of sodium valproate is necessary in combination with stiripentol, except for reasons of clinical tolerance. In pivotal studies, the daily dose of sodium valproate was reduced by approximately 30% per week in case of digestive side effects such as anorexia and weight loss.

Anomalies of biological examinations

In the event of abnormal blood counts or liver function parameters, the clinical decision whether to continue stiripentol administration or dose adjustment with clobazam and sodium valproate should be made. on a case-by-case basis, taking into account the possible clinical benefits and risks (see section Warnings and precautions for use ).

Effect of formulation

The sachet form has a C max slightly higher than that of the capsules, the two forms are therefore not bioequivalent. If replacement of one form with another is necessary, it is recommended that this be done under clinical supervision, in the event that tolerance problems occur (see section 5.2. Pharmacokinetic properties ).

Hepatic or renal failure

Stiripentol is not recommended in patients with impaired hepatic and / or renal function (see Warnings and Precautions ).

Administration mode

The powder should be added to a glass of water and taken immediately after mixing during the meal.
Stiripentol should always be administered with food because it rapidly degrades in an acidic environment (eg exposure to gastric acidity if the child is fasting).

Stiripentol should not be administered with milk or dairy products (yogurts, white cheeses, etc.), a soft drink, fruit juice, or foods and beverages containing caffeine or theophylline.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition . History of psychosis in the form of delusional episodes.

Diacomit side effects

Summary of the safety profile

The most common side effects with Diacomit (seen in more than 1 patient in 10) are: anorexia, weight loss, insomnia, drowsiness, ataxia, hypotonia, and dystonia.

Tabulated list of adverse effects

The classification of adverse events by frequency is as follows: very common (≥ 1/10), common (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to <1/100), rare (≥ 1/10 000 to <1/1000), very rare (<1 / 10, 000), undetermined (can not be estimated from the available data). In each frequency group, the adverse effects are presented in order of decreasing severity.

Device class or organ

(MedDRA Terminology)

Very frequent

frequent

Uncommon

few

Blood and lymphatic system disorders

Neutropenia Severe persistent neutropenia usually disappears spontaneously after discontinuation of Diacomit.

Thrombocytopenia *

Metabolism and nutrition disorders

Anorexia, decreased appetite, weight loss (especially when combined with sodium valproate)

Psychiatric disorders

Insomnia

Aggressiveness, irritability, behavioral disorders, hyperexcitability behavior, sleep disorders

Nervous system disorders

Drowsiness, ataxia, hypotonia, dystonia

hyperkinesia

Eye disorders

Diplopia (when co-administered with carbamazepine)

Gastrointestinal disorders

Nausea, vomiting

Skin and subcutaneous tissue disorders

Photosensitivity, rash, skin allergy, urticaria

General disorders and anomalies at the site of administration

Tired

investigations

Increase of the GT γ

(especially in case of association

to the

carbamazepine and sodium valproate).

Abnormal liver function tests

Particular adverse effects

Many of the side effects described above are often due to increased plasma concentrations of other anticonvulsant medications (see Warnings and Precautions and Interactions with Other Drugs and Other Forms of Interactions sections). may decrease as a result of a dose reduction of these products.

* Thrombocytopenia data are derived from both clinical and post-marketing surveillance data.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V *.

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