Indications for EPIDIOLEX:
Treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC).
Adults and Children:
<1yr: not established. Use calibrated measuring device. May be given via nasogastric or gastrotomy tubes, if needed. ≥1yr: LGS or DS: 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. TSC: initially 2.5mg/kg twice daily; increase in weekly increments of 2.5mg/kg twice daily (or no sooner than every other day) as tolerated, to maintenance dose of 12.5mg/kg twice daily. Moderate to severe hepatic impairment: see full labeling.
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.
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 CYP1A2 (eg, theophylline, caffeine, tizanidine), UGT1A9 (eg, diflunisal, propofol, fenofibrate), UGT2B7 (eg, gemfibrozil, lamotrigine, morphine, lorazepam), CYP2C8 or CYP2C9 (eg, phenytoin) substrates: consider reducing dose of these. May affect CYP2B6 (eg, bupropion, efavirenz) substrates: consider adjusting dose of these. Potentiates sensitive CYP2C19 substrates (eg, diazepam, clobazam): consider reducing dose of substrate. Monitor with stiripentol. Increased transaminase elevations with concomitant valproate and/or clobazam; monitor more frequently, consider discontinuation or dose adjustment of these drugs. May increase risk of somnolence and sedation with concomitant clobazam, CNS depressants, alcohol; monitor.
Somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, asthenia, rash, insomnia, sleep disorders, poor quality sleep, infections, pyrexia, vomiting; hypersensitivity reactions.
Enroll pregnant patients exposed to Epidiolex in the North American Antiepileptic Drug pregnancy registry by calling (888) 233-2334.
Generic Drug Availability:
Oral soln—100mL (w. dosing syringes + adapter)