Dosing & monitoring

Epidyolex offers flexible dosing to help optimise treatment response for your patients. There is a recommended dosage range for maintenance dosing and new Epidyolex patients will need to undergo a titration to reach their maintenance dosage.1

 

Recommended Epidyolex starting dosage and titrating for patients1

 

Week 1 Recommended starting dosage
5 mg/kg/day
(2.5 mg/kg twice daily)
Week 2 Recommended maintenance dosage
10 mg/kg/day
(5 mg/kg twice daily)
Based on individual clinical response and tolerability Dose increased to a maximum recommended dosage of
20 mg/kg/day
(10 mg/kg twice daily)
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Based on individual clinical response and tolerability, dosage titrations should be increased in weekly increments of 2.5 mg/kg administered twice daily (5 mg/kg/day). Any dose increases above 10 mg/kg/day, to maximum recommended dose of 20 mg/kg/day, should be made considering individual benefit and risk and with adherence to the full monitoring schedule.

Epidyolex dose adjustment for special populations1

 

Hepatic Impairment

Moderate

Severe

Starting Dosage

2.5 mg/kg/day
(1.25 mg/kg twice daily)

1 mg/kg/day
(0.5 mg/kg twice daily)

Maintenance Dosage

5 mg/kg/day
(2.5 mg/kg twice daily)

2 mg/kg/day
(1 mg/kg twice daily)

Maximum Dosage

10 mg/kg/day
(5 mg/kg twice daily)

4 mg/kg/day*
(2 mg/kg twice daily)

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* Higher doses of Epidyolex may be considered in patients with severe hepatic impairment where the potential benefits outweigh the risks.

 

Epidyolex does not require dose adjustment in patients with:1

 

  • Mild hepatic impairment
  • Mild, moderate or severe renal impairment

Co-administration of Epidyolex with commonly prescribed anti-epileptic drugs (AEDs)1

Epidyolex can interact with some commonly prescribed AEDs, which should be monitored and may require dose adjustment.

 

Clobazam

Interaction Increase in both CBD and clobazam active metabolites
Adverse events Increased incidence of somnolence and transaminase elevations vs. placebo
Dose adjustment Consider reduction of Epidyolex or clobazam dose
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Valproate

Interaction No effect on CBD or its metabolites and no effect on valproic acid exposure
Adverse events Increase in incidence of transaminase elevations, diarrhoea and events of decreased appetite
Dose adjustment Discontinuation or reduction of valproate and/or Epidyolex*


*If clinically significant increases of transaminases occur, CBD and/or concomitant valproate should be reduced or discontinued in all patients until a recovery of transaminase elevations are observed

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Stiripentol

Interaction Minor decrease in CBD active metabolite and increase in stiripentol levels
Adverse events Clinical importance has not been studied. Patients should be closely monitored for adverse drug reactions.
Dose adjustment N/A
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Phenytoin

Interaction Increase in phenytoin level
Adverse events Assessed in vitro, not assessed in human clinical trials
Dose adjustment Consider reduction of phenytoin dose
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Lamotrigine

Interaction Interaction unknown; lamotrigine levels may increase
Adverse events Assessed in vitro, not assessed in human clinical trials
Dose adjustment N/A
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CBD, cannabidiol

 

Monitoring1

Prior to starting treatment with Epidyolex, obtain serum transaminases (ALT and AST) and total bilirubin levels.

 

Routine monitoring schedule

Pre-treatment
Test 1
Month 1
Test 2
Month 3
Test 3
Month 6
Test 4
Ongoing
As clinically indicated

Upon changes in Epidyolex dose above 10 mg/kg/day or changes in medicinal products that are known to impact the liver, this monitoring schedule should be restarted.

 

Patients with identified baseline elevations of ALT or AST and patients who are taking valproate are recommended to undergo intensified monitoring:

 

 

 

Intensified monitoring schedule

Prior to treatment
Test 1
2 weeks
Test 2
Month 1
Test 3
Month 2
Test 4
Month 3
Test 5
Month 6
Test 6
Ongoing
As clinically indicated

Upon changes in cannabidiol dose above 10 mg/kg/day or changes in medicinal products that are known to impact the liver, this monitoring schedule should be restarted.

 

If a patient develops clinical signs and symptoms suggestive of hepatic dysfunction, serum transaminases and total bilirubin should be promptly measured and treatment with Epidyolex should be interrupted or discontinued, as appropriate.

AED safety information 1

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References

 

1. Epidyolex Summary of Product Characteristics (Date accessed: April 2021).