Active Ingredient: Cannabidiol
Cannabidiol is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.
For this indication, competent medicine agencies globally authorize below treatments:
For:
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, over the duration of 1 week. Afterwards, oral, 12.5 milligrams cannabidiol per kilogram of body weight, 2 times daily. The maximum allowed total dose is 25 milligrams cannabidiol per kilogram of body weight daily.
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 dose of 5 mg/kg twice daily (10 mg/kg/day) and the clinical response and tolerability should be assessed. 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 12.5 mg/kg twice daily (25 mg/kg/day).
Any dose increases above 10 mg/kg/day, up to the maximum recommended dose of 25 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.
Dosage recommendations:
| TSC | |
|---|---|
| Starting dose – first week | 2.5 mg/kg taken twice daily (5 mg/kg/day) |
| Second week | 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 dose | 12.5 mg/kg twice daily (25 mg/kg/day) |
The calculated dose should be rounded to the nearest graduated increment.
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.
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.
Clinical trials of cannabidiol in the treatment of TSC 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.
There is no relevant use of cannabidiol in children aged below 1 month. The safety and efficacy of cannabidiol in children aged 1 month to 2 years have not yet been established.
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.
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.
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