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Uses
Side effects
Interactions
Precautions
- EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older
- The most common adverse reactions (10% or more for EPIDIOLEX and greater than placebo) are: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections.
- Moderate or strong inhibitors of CYP3A4 or CYP2C19: Consider dose reduction of EPIDIOLEX.
- Strong inducer of CYP3A4 or CYP2C19: Consider dose increase of EPIDIOLEX.
- Consider a dose reduction of substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, and CYP2C19 (e.g., clobazam).
- Substrates of CYP1A2 and CYP2B6 may also require dose adjustment.
- Hepatocellular Injury: EPIDIOLEX can cause transaminase elevations. Concomitant use of valproate and higher doses of EPIDIOLEX increase the risk of transaminase elevations. See Full Prescribing Information for serum transaminase and bilirubin monitoring recommendations.
- Somnolence and Sedation: Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX.
- Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and thoughts
- Hypersenstivity Reactions: Advise patients to seek immediate medical care. Discontinue and do not restart EPIDIOLEX if hypersensitivity occurs.
- Withdrawal of Antiepileptic Drugs: EPIDIOLEX should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.
