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

Co-administration with other medicines

CYP1A2 substrates

(e.g. caffeine)

Interaction	Increase in substrate 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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CYP3A4 or CYP2C19 inducers

(e.g. carbamazepine, St. John’s wort and rifampicin)

Interaction	Decrease in CBD and its active metabolites
Adverse events	Reduced effectiveness of CBD
Dose adjustment	Consider dose increase of Epidyolex

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UGT2B7 substrates

(e.g. lamotrigine, morphine and lorazepam)

Interaction	Increase in substrate levels
Adverse events	Assessed in vitro, not assessed in human clinical trials
Dose adjustment	Consider reduction of substrate dose

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CYP2C19 substrates

(e.g. omeprazole)

Interaction	Increase in substrate levels
Adverse events	Assessed in vitro, not assessed in human clinical trials
Dose adjustment	Consider reduction of substrate dose

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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

Somnolence

Monitor patients for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on Epidyolex to gauge whether it adversely affects their ability to drive or operate machinery.
Suicidal behaviour and ideation

Suicidal behaviour and ideation have been reported in patients treated with AEDs in several indications. Patients should be monitored for signs of suicidal behaviour and ideation and appropriate treatment should be considered. Patients and caregivers should be advised to seek medical advice should any signs of suicidal behaviour and ideation emerge.
Increased seizure frequency

As with other AEDs, a clinically relevant increase in seizure frequency may occur during treatment with Epidyolex, which may require adjustment in dose of Epidyolex and/or concomitant AEDs, or discontinuation of Epidyolex, should the benefit risk be negative.

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References

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

Dosing & monitoring

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

Monitoring1

AED safety information 1

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

Monitoring¹

AED safety information ¹