Seizure disorders:

Indications for EPIDIOLEX:

Treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).

Adults and Children:

<2yrs: not established. Use calibrated measuring device. ≥2yrs: initially 2.5mg/kg twice daily; may increase to 5mg/kg twice daily after 1 week. May further increase in weekly increments of 2.5mg/kg twice daily (or no sooner than every other day) as tolerated; max 10mg/kg twice daily. Hepatic impairment (moderate): initially 1.25mg/kg twice daily up to 2.5mg/kg twice daily; max 5mg/kg twice daily; (severe): initially 0.5mg/kg twice daily up to 1mg/kg twice daily; max 2mg/kg twice daily.

Warnings/Precautions:

Risk of hepatocellular injury. Obtain ALT/AST and total bilirubin prior to, at 1 month, 3 months, and 6 months after initiation, and periodically thereafter; also obtain levels within 1 month after dose adjustments or concomitant drugs known to impact the liver. Evaluate and consider more frequent monitoring if elevated liver enzymes at baseline. Interrupt or discontinue if hepatic dysfunction occurs; discontinue if ALT/AST elevations >3×ULN and bilirubin >2×ULN, or sustained ALT/AST elevations >5×ULN. Monitor for somnolence and sedation. Monitor for emergence or worsening of depression, suicidal thoughts/behavior or any unusual changes in mood/behavior. Discontinue if hypersensitivity reactions occur. Withdraw gradually. Avoid abrupt cessation. Moderate or severe hepatic impairment. Elderly. Pregnancy. Nursing mothers.

Pharmacologic Class:

Cannabinoid.

Interactions:

Potentiated by moderate or strong CYP3A4 or CYP2C19 inhibitors: consider reducing Epidiolex dose. Antagonized by strong CYP3A4 or CYP2C19 inducers: consider increasing Epidiolex dose. May potentiate UGT1A9 (eg, diflunisal, propofol, fenofibrate), UGT2B7 (eg, gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 or CYP2C9 (eg, phenytoin) substrates: consider reducing dose of these. May affect CYP1A2 (eg, theophylline, caffeine) or CYP2B6 (eg, bupropion, efavirenz) substrates: consider adjusting dose of these. Potentiates sensitive CYP2C19 substrates (eg, diazepam, clobazam): consider reducing dose of substrate. Increased transaminase elevations with concomitant valproate and/or clobazam; monitor more frequently, consider discontinuation or dose adjustment. May increase risk of somnolence and sedation with concomitant CNS depressants, alcohol; monitor.

Adverse Reactions:

Somnolence, sedation, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, asthenia, rash, insomnia, sleep disorders, poor quality sleep, infections; hypersensitivity reactions.

Note:

Enroll pregnant patients exposed to Epidiolex in the North American Antiepileptic Drug pregnancy registry by calling (888) 233-2334.

Generic Availability:

NO

How Supplied:

Oral soln—100mL (w. dosing syringes + adapter)