Cannabidiol

EPIDIOLEX

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Pronunciation: kan-a-bi-DYE-ol

Cannabidiol ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Cannabidiol ballicule

Cannabidiol EPIDIOLEX mascot mnemonic cartoon — Visual mnemonic: Cannabidiol mascot
**“Cannabis B.I.D. oil”**

What it isCannabinoid modulating several non-CB1 targets; Dravet, Lennox-Gastaut, and tuberous-sclerosis seizures.

Why this oneProvides a standardized prescription product for epilepsies often self-treated with unregulated cannabis extracts.

What limits itHepatotoxicity is amplified by valproate; monitor liver tests. It raises exposure to clobazam’s active metabolite.

Pearls

Approved from age 1 year
No adequate evidence for other epilepsies or nonprescription cannabis products

Cannabidiol molecular structure (skeletal formula) — Molecular structure: Cannabidiol

Cannabidiol prescription history

Animated chart of estimated U.S. prescriptions per year, Antiseizure meds (1869–2026). Cannabidiol enters in 2018 (estimated).

FDA-approved for

Dravet/Lennox-Gastaut/TSC seizures (2018)

Off-label

anxiety (limited evidence)

Principal riskHepatotoxicity, especially with valproate

Classes and tags

Clinical profile

Therapeutic safety burden2 / 4

Overdose danger2 / 4

Weight-gain liability1 / 4

Sedation liability1 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilitySedation, dizziness and agent-specific rash, behavioral, hepatic, hematologic or teratogenic toxicity.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

FDA dosing	Population	Start	Target	Max
Seizures associated with Lennox-Gastaut syndrome	Patients 1 year and older	2.5 mg/kg PO BID (5 mg/kg/day)	5 mg/kg BID (10 mg/kg/day) after one week	10 mg/kg BID (20 mg/kg/day)
Seizures associated with Dravet syndrome	Patients 1 year and older	2.5 mg/kg PO BID (5 mg/kg/day)	5 mg/kg BID (10 mg/kg/day) after one week	10 mg/kg BID (20 mg/kg/day)
Seizures associated with tuberous sclerosis complex	Patients 1 year and older	2.5 mg/kg PO BID (5 mg/kg/day)	12.5 mg/kg BID (25 mg/kg/day)	12.5 mg/kg BID (25 mg/kg/day) recommended maintenance

Titration Weekly increments of 2.5 mg/kg BID (5 mg/kg/day) as tolerated; if more rapid titration warranted, no more often than every other day

Renal Undefined

Hepatic Mild: no adjustment. Moderate: start 1.25 mg/kg BID; maintenance 2.5–5 mg/kg BID (LGS/DS) or 6.25 mg/kg BID (TSC). Severe: start 0.5 mg/kg BID; maintenance 1–2 mg/kg BID (LGS/DS) or 2.5 mg/kg BID (TSC). Slower titration may be needed

Strong CYP3A4/CYP2C19 inducer: consider dose increase up to 2-fold. Valproate/clobazam increase transaminase elevations; lower starting dose of oral everolimus recommended

Instructions

Obtain ALT, AST and total bilirubin before starting
Dose consistently with respect to meals (food affects levels)
Measure with provided 1 mL / 5 mL oral syringes, not a household spoon
Enteral OK via silicone NG/G-tubes; flush with water ~5× tube priming volume; do not use PVC or polyurethane tubes
Discard unused solution 12 weeks after first opening
Taper to discontinue; avoid abrupt stop

Available strengths

sol 100 mg/mL

Cautions

Hepatic injury — dose-related transaminase elevations, higher with valproate/clobazam; check LFTs at 1, 3 and 6 months
Somnolence and sedation
Suicidal behavior and ideation
Hypersensitivity reactions (contains sesame seed oil)
Withdrawal of AEDs — taper gradually

Adverse reactions

Somnolence
Decreased appetite
Diarrhea
Transaminase elevations
Fatigue, malaise, asthenia
Rash
Insomnia, sleep disorder, poor quality sleep
Infections
Pyrexia (TSC)
Vomiting (TSC)

Pregnancy No adequate human data; animal data show developmental toxicity — may cause fetal harm; pregnancy registries available

Lactation No data on presence in human milk or effects on infant/milk production — weigh breastfeeding benefits vs maternal need

Cost

Cannabidiol (EPIDIOLEX)

Strength		#/mo	generic $/unit	CostPlus
100 mg/mL	sol	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Cannabidiol is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2041 est.

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