What is it?
First and only FDA-approved prescription cannabidiol (CBD)
What is it used for?
Seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC)
Mechanism of action for the reduction of seizures is unknown.
How is it dosed and taken?
Titrated dosing given orally or via feeding tube (non PVC) twice daily, administered consistently with or without food.
LGS or Dravet syndrome:
Initial dose: 5mg/kg/day (2.5mg/kg twice daily)
Recommended dosing: 10 to 15mg/kg/day (5 to 7.5mg/kg twice daily) increased in weekly increments of 5mg/kg/day (2.5mg/kg twice daily)
Maximum dosing: 20mg/kg/day (10mg/kg twice daily)
TSC:
Initial dose: 5mg/kg/day (2.5mg/kg twice daily)
Recommended dosing: 10 to 20mg/kg/day (5 to 10mg/kg twice daily) increased in weekly increments of 5mg/kg/day (2.5mg/kg twice daily)
Maximum dosing: 25mg/kg/day (12.5mg/kg twice daily)
If rapid titration is necessary, dose may be increased no more frequently than every other day.
Dose adjustment and a slower titration is recommended in patients with moderate to severe hepatic impairment.
Should not be stopped suddenly due to the risk of increased frequency of seizures and status epilepticus.
Recommended lab work:
Transaminase and bilirubin levels prior to starting treatment, at month 1, month 3 and month 6 then periodically thereafter.
Patients on valproate or are at increased risk of elevated transaminase levels and/or hepatocellular injury.
If levels are elevated, consider a dose reduction or discontinuation of Epidiolex or other medications known to increase transaminase levels such as valproate and/or clobazam.
Common side effects (> 10% and greater than placebo): transaminase elevations, somnolence, fatigue, malaise, asthenia, decreased appetite, diarrhea, vomiting, pyrexia, rash, insomnia and infections.
Other important side effects to be aware of: suicidal behavior and ideation
Potential interactions to consider:
Several potential drug-drug interactions to consider, most commonly run into potential drug-drug interactions with other anticonvulsant medications:
Clobazam, diazepam, & valproate
Recommended to counsel patient or caregiver on signs/symptoms to watch for and recommend lab work as appropriate.
Strawberry flavored but does not contain strawberry.
Compatible with a ketogenic diet.
Federal law no longer considers Epidiolex to be a controlled substance. It had originally been federally scheduled as a CV. Now it is federally non-controlled. There are a handful of states that have it scheduled as a controlled substance.
https://www.drugtopics.com/view/dea-deschedules-antiepileptic-cbd-oral-solution-epidiolex
| Controlled Status | State |
| CIV | Louisiana |
| CV | Florida |
| CV | Georgia |
| CV | Idaho |
| CV | Maryland |
| CV | Montana |
| CV | Nebraska |
| CV | North Dakota |
| CV | Puerto Rico |