Epidiolex

Adult Dosing .

Dosage forms:  SOL: 100 mg per mL

Restricted Distribution in US

[1-833-426-4243 or www.epidiolexhcp.com for more info]

seizures, Dravet syndrome

[5 mg/kg/dose PO bid]

Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Max: 20 mg/kg/day; Info: for more rapid titration from 10 mg/kg/day to 20 mg/kg/day may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

seizures, Lennox-Gastaut syndrome

[5 mg/kg/dose PO bid]

Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Max: 20 mg/kg/day; Info: for more rapid titration from 10 mg/kg/day to 20 mg/kg/day may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

seizures, tuberous sclerosis complex

[12.5 mg/kg/dose PO bid]

Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Info: for more rapid titration may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

renal dosing

[see below]

renal impairment: no adjustment

HD/PD: not defined

hepatic dosing

[Dravet or Lennox-Gastaut syndrome]

Child-Pugh Class B: start 1.25 mg/kg/dose bid, incr. to 2.5-5 mg/kg/dose bid; Child-Pugh Class C: start 0.5 mg/kg/dose bid, incr. to 1-2 mg/kg/dose bid; Info: consider slower titration

[tuberous sclerosis complex]

Child-Pugh Class B: start 1.25 mg/kg/dose bid, incr. to 6.25 mg/kg/dose bid; Child-Pugh Class C: start 0.5 mg/kg/dose bid, incr. to 2.5 mg/kg/dose bid; Info: consider slower titration

Peds Dosing .

Dosage forms:  SOL: 100 mg per mL

Restricted Distribution in US

[1-833-426-4243 or www.epidiolexhcp.com for more info]

seizures, Dravet syndrome

[1 yo and older]

Dose: 5 mg/kg/dose PO bid; Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Max: 20 mg/kg/day; Info: for more rapid titration from 10 mg/kg/day to 20 mg/kg/day may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

seizures, Lennox-Gastaut syndrome

[1 yo and older]

Dose: 5 mg/kg/dose PO bid; Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Max: 20 mg/kg/day; Info: for more rapid titration from 10 mg/kg/day to 20 mg/kg/day may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

seizures, tuberous sclerosis complex

[1 yo and older]

Dose: 12.5 mg/kg/dose PO bid; Start: 2.5 mg/kg/dose PO bid x1wk, then may incr. by 5 mg/kg/day qwk; Info: for more rapid titration may incr. no more frequently than qod; give consistently w/ or w/o food; taper dose gradually to D/C

renal dosing

[see below]

renal impairment: no adjustment

HD/PD: not defined

hepatic dosing

[Dravet or Lennox-Gastaut syndrome]

Child-Pugh Class B: start 1.25 mg/kg/dose bid, incr. to 2.5-5 mg/kg/dose bid; Child-Pugh Class C: start 0.5 mg/kg/dose bid, incr. to 1-2 mg/kg/dose bid; Info: consider slower titration

[tuberous sclerosis complex]

Child-Pugh Class B: start 1.25 mg/kg/dose bid, incr. to 6.25 mg/kg/dose bid; Child-Pugh Class C: start 0.5 mg/kg/dose bid, incr. to 2.5 mg/kg/dose bid; Info: consider slower titration