Seizures associated with Lennox-Gastaut syndrome or Dravet syndrome

Active Ingredient: Cannabidiol

Indication for Cannabidiol

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Adjunct intent

Cannabidiol is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.

For this indication, competent medicine agencies globally authorize below treatments:

2.5 mg/kg twice daily the first week, 5 mg/kg twice daily the second week and thereafter 7.5-10 mg/kg twice daily

For:

Dosage regimens

Oral, 2.5 milligrams cannabidiol per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, oral, 5 milligrams cannabidiol per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, oral, 7.5 milligrams cannabidiol per kilogram of body weight, 2 times daily, over the duration of 1 week. Afterwards, oral, 10 milligrams cannabidiol per kilogram of body weight, 2 times daily. The maximum allowed total dose is 20 milligrams cannabidiol per kilogram of body weight daily.

Detailed description

The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily (5 mg/kg/day) for one week. After one week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day) up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day).

Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.

Dosage recommendations:

 LGS and DS
Starting dose – first week2.5 mg/kg taken twice daily (5 mg/kg/day)
Second weekMaintenance dose
5 mg/kg twice daily (10 mg/kg/day)
Further titration as applicable (incremental steps) weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day)
Maximal recommended dose10 mg/kg twice daily (20 mg/kg/day)

The calculated dose should be rounded to the nearest graduated increment.

Discontinuation

If cannabidiol has to be discontinued, the dose should be decreased gradually. In clinical trials, cannabidiol discontinuation was achieved by reducing the dose by approximately 10% per day for 10 days. A slower or faster down titration may be required, as clinically indicated, at the discretion of the prescriber.

Missed doses

In the case of one or more missed doses, the missed doses should not be compensated. Dosing should be resumed at the existing treatment schedule. In the case of more than 7 days' missed doses, re-titration to the therapeutic dose should be made.

Elderly

Clinical trials of cannabidiol in the treatment of LGS and DS did not include a sufficient number of patients aged above 55 years to determine whether or not they respond differently from younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other concurrent therapy.

Paediatric population

There is no relevant use of cannabidiol in children aged below 6 months. The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established. No data are available.

Dose adjustments of other medicinal products used in combination with cannabidiol

A physician experienced in treating patients who are on concomitant antiepileptic drugs (AEDs) should evaluate the need for dose adjustments of cannabidiol or of the concomitant medicinal product(s) to manage potential drug interactions.

Dosage considerations

Food may increase cannabidiol levels and therefore it should be taken consistently either with or without food, including the ketogenic diet. When taken with food, a similar composition of food should be considered, if possible.

Active ingredient

Cannabidiol

Cannabidiol is indicated for the treatment of seizures associated with Lennoxโ€‘Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Read more about Cannabidiol

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