Epidiolex

CANNABIDIOL

Manufacturer: Jazz Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Epidiolex (cannabidiol) is used for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older. The precise mechanisms by which Epidiolex exerts its anticonvulsant effect in humans are unknown. Key clinical findings indicate its efficacy in reducing seizure frequency. Important safety information includes the risk of hepatocellular injury, somnolence, and sedation. The recommended starting dosage is 2.5 mg/kg twice daily, with possible increases to a maximum of 10-12.5 mg/kg twice daily based on condition and response. Special population considerations include dose adjustments for patients with hepatic impairment, and cautious use in elderly patients due to potential decreased hepatic, renal, or cardiac function.

Key Clinical Findings and Indications

Treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex
Efficacy in reducing seizure frequency in clinical trials
Unknown precise mechanisms of anticonvulsant effect

Important Safety Information

Warning

Risk of hepatocellular injury, somnolence, and sedation

Contraindications

Hypersensitivity to cannabidiol or any of the ingredients in the product

Adverse Reactions

Somnolence, decreased appetite, diarrhea, transaminase elevations, fatigue, malaise, asthenia, rash, insomnia, sleep disorder, poor quality sleep, infections

Dosing Recommendations

General Guidance

Dose adjustment recommended for patients with moderate or severe hepatic impairment

Lennox-Gastaut syndrome or Dravet syndrome

Adult Dose

2.5 mg/kg twice daily, increasing to 5 mg/kg twice daily after one week, with possible further increases to 10 mg/kg twice daily

Pediatric Dose

Same as adult dose

Tuberous sclerosis complex

Adult Dose

2.5 mg/kg twice daily, increasing weekly by 2.5 mg/kg twice daily to 12.5 mg/kg twice daily

Pediatric Dose

Same as adult dose

Special Population Considerations

Pregnancy

No adequate data on developmental risks associated with use in pregnant women
Administration of cannabidiol to pregnant animals produced evidence of developmental toxicity

Nursing Mothers

Pediatric Use

Safety and effectiveness established in patients 1 year of age and older
Use in pediatric patients below 1 year of age has not been established

Geriatric Use

Clinical trials did not include sufficient number of patients aged above 55 years
Dose selection should be cautious, usually starting at the low end of the dosing range