Dosing & Uses
Dosage Forms & Strengths
oral suspension
- 50mg/mL (110mL/bottle)
- Controlled substance schedule pending
Seizures
Indicated for seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients aged ≥2 yr
Dosage increased based on tolerability and no more frequently than q7days
Dose must be taken with food
Titration schedule (weight >28 kg)
- Days 1-7: 150 mg PO TID
- Days 8-14: 300 mg PO TID
- Days 15-21: 450 mg PO TID
- Days 22 and thereafter: 600 mg PO TID
Dosage Modifications
Renal impairment
- Not studied; however, renal excretion is a minor pathway of elimination and is unlikely to result in clinically significant increases in ganaxolone exposures
Hepatic impairment
- Not studied; ganaxolone undergoes clearance via the hepatic route, and therefor hepatic impairment is likely to increase ganaxolone exposures
Dosing Considerations
Before initiating, assess risk of suicidal thoughts or behaviors with risk of untreated illness
Dosage Forms & Strengths
oral suspension
- 50mg/mL (110mL/bottle)
- Controlled substance schedule pending
Seizures
Indicated for seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients aged ≥2 yr
Dosage increased based on tolerability and no more frequently than q7days
Dose must be taken with food
Titration schedule (weight ≤28 kg)
- Days 1-7: 6 mg/kg PO TID
- Days 8-14: 11 mg/kg PO TID
- Days 15-21: 16 mg/kg PO TID
- Days 22 and thereafter: 21 mg/kg PO TID
Titration schedule (weight >28 kg)
- Days 1-7: 150 mg PO TID
- Days 8-14: 300 mg PO TID
- Days 15-21: 450 mg PO TID
- Days 22 and thereafter: 600 mg PO TID
Dosage Modifications
Renal impairment
- Not studied; however, renal excretion is a minor pathway of elimination and is unlikely to result in clinically significant increases in ganaxolone exposures
Hepatic impairment
- Not studied; ganaxolone undergoes clearance via the hepatic route, and therefor hepatic impairment is likely to increase ganaxolone exposures
Dosing Considerations
Before initiating, assess risk of suicidal thoughts or behaviors with risk of untreated illness
CDD is largely a disease of pediatric and young adult patients; clinical studies did not include patients aged ≥65 years
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (37)
- amobarbital
amobarbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- apalutamide
apalutamide will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- armodafinil
armodafinil will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- belzutifan
belzutifan will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- bexarotene
bexarotene will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- bosentan
bosentan will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- butabarbital
butabarbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- butalbital
butalbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- carbamazepine
carbamazepine will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- cenobamate
cenobamate will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- dabrafenib
dabrafenib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- efavirenz
efavirenz will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- elagolix
elagolix will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- encorafenib
encorafenib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- enzalutamide
enzalutamide will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- etravirine
etravirine will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- fosphenytoin
fosphenytoin will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- ivosidenib
ivosidenib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- lorlatinib
lorlatinib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- mitapivat
mitapivat will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- mitotane
mitotane will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- mobocertinib
mobocertinib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- modafinil
modafinil will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- nafcillin
nafcillin will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- pentobarbital
pentobarbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- pexidartinib
pexidartinib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- phenobarbital
phenobarbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- phenytoin
phenytoin will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- primidone
primidone will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- rifabutin
rifabutin will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- rifampin
rifampin will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- rifapentine
rifapentine will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- secobarbital
secobarbital will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- sotorasib
sotorasib will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
- St John's Wort
St John's Wort will decrease the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of ganaxolone with moderate or strong CYP3A4 inducers. If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight.
Monitor Closely (201)
- acetaminophen/phenyltoloxamine
acetaminophen/phenyltoloxamine and ganaxolone both increase sedation. Use Caution/Monitor.
- acrivastine
acrivastine and ganaxolone both increase sedation. Use Caution/Monitor.
- alfentanil
alfentanil and ganaxolone both increase sedation. Use Caution/Monitor.
- alprazolam
alprazolam and ganaxolone both increase sedation. Use Caution/Monitor.
- amisulpride
amisulpride and ganaxolone both increase sedation. Use Caution/Monitor.
- amitriptyline
amitriptyline and ganaxolone both increase sedation. Use Caution/Monitor.
- amobarbital
amobarbital and ganaxolone both increase sedation. Use Caution/Monitor.
- amoxapine
amoxapine and ganaxolone both increase sedation. Use Caution/Monitor.
- arbaclofen
arbaclofen and ganaxolone both increase sedation. Use Caution/Monitor.
- aripiprazole
aripiprazole and ganaxolone both increase sedation. Use Caution/Monitor.
- asenapine
asenapine and ganaxolone both increase sedation. Use Caution/Monitor.
- asenapine transdermal
asenapine transdermal and ganaxolone both increase sedation. Use Caution/Monitor.
- baclofen
baclofen and ganaxolone both increase sedation. Use Caution/Monitor.
- benzhydrocodone/acetaminophen
benzhydrocodone/acetaminophen and ganaxolone both increase sedation. Use Caution/Monitor.
- brexanolone
brexanolone and ganaxolone both increase sedation. Use Caution/Monitor.
- brexpiprazole
brexpiprazole and ganaxolone both increase sedation. Use Caution/Monitor.
- brivaracetam
brivaracetam and ganaxolone both increase sedation. Use Caution/Monitor.
- brompheniramine
brompheniramine and ganaxolone both increase sedation. Use Caution/Monitor.
- buprenorphine
buprenorphine and ganaxolone both increase sedation. Use Caution/Monitor.
- buprenorphine buccal
buprenorphine buccal and ganaxolone both increase sedation. Use Caution/Monitor.
- buprenorphine subdermal implant
buprenorphine subdermal implant and ganaxolone both increase sedation. Use Caution/Monitor.
- buprenorphine transdermal
buprenorphine transdermal and ganaxolone both increase sedation. Use Caution/Monitor.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and ganaxolone both increase sedation. Use Caution/Monitor.
- bupropion
bupropion and ganaxolone both increase sedation. Use Caution/Monitor.
- buspirone
buspirone and ganaxolone both increase sedation. Use Caution/Monitor.
- butabarbital
butabarbital and ganaxolone both increase sedation. Use Caution/Monitor.
- butalbital
butalbital and ganaxolone both increase sedation. Use Caution/Monitor.
- butorphanol
butorphanol and ganaxolone both increase sedation. Use Caution/Monitor.
- calcium/magnesium/potassium/sodium oxybates
calcium/magnesium/potassium/sodium oxybates and ganaxolone both increase sedation. Use Caution/Monitor.
- carbinoxamine
carbinoxamine and ganaxolone both increase sedation. Use Caution/Monitor.
- cariprazine
cariprazine and ganaxolone both increase sedation. Use Caution/Monitor.
- carisoprodol
carisoprodol and ganaxolone both increase sedation. Use Caution/Monitor.
- chloral hydrate
chloral hydrate and ganaxolone both increase sedation. Use Caution/Monitor.
- chlordiazepoxide
chlordiazepoxide and ganaxolone both increase sedation. Use Caution/Monitor.
- chlorpheniramine
chlorpheniramine and ganaxolone both increase sedation. Use Caution/Monitor.
- chlorpromazine
chlorpromazine and ganaxolone both increase sedation. Use Caution/Monitor.
- chlorzoxazone
chlorzoxazone and ganaxolone both increase sedation. Use Caution/Monitor.
- citalopram
citalopram and ganaxolone both increase sedation. Use Caution/Monitor.
- clemastine
clemastine and ganaxolone both increase sedation. Use Caution/Monitor.
- clobazam
clobazam and ganaxolone both increase sedation. Use Caution/Monitor.
- clomipramine
clomipramine and ganaxolone both increase sedation. Use Caution/Monitor.
- clonazepam
clonazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- clonidine
clonidine and ganaxolone both increase sedation. Use Caution/Monitor.
- clorazepate
clorazepate and ganaxolone both increase sedation. Use Caution/Monitor.
- clozapine
clozapine and ganaxolone both increase sedation. Use Caution/Monitor.
- codeine
codeine and ganaxolone both increase sedation. Use Caution/Monitor.
- cyclobenzaprine
cyclobenzaprine and ganaxolone both increase sedation. Use Caution/Monitor.
- cyproheptadine
cyproheptadine and ganaxolone both increase sedation. Use Caution/Monitor.
- dantrolene
dantrolene and ganaxolone both increase sedation. Use Caution/Monitor.
- daridorexant
daridorexant and ganaxolone both increase sedation. Use Caution/Monitor.
- desflurane
desflurane and ganaxolone both increase sedation. Use Caution/Monitor.
- desipramine
desipramine and ganaxolone both increase sedation. Use Caution/Monitor.
- desvenlafaxine
desvenlafaxine and ganaxolone both increase sedation. Use Caution/Monitor.
- deutetrabenazine
deutetrabenazine and ganaxolone both increase sedation. Use Caution/Monitor.
- dexbrompheniramine
dexbrompheniramine and ganaxolone both increase sedation. Use Caution/Monitor.
- dexchlorpheniramine
dexchlorpheniramine and ganaxolone both increase sedation. Use Caution/Monitor.
- dexmedetomidine
dexmedetomidine and ganaxolone both increase sedation. Use Caution/Monitor.
- diazepam
diazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- dimenhydrinate
dimenhydrinate and ganaxolone both increase sedation. Use Caution/Monitor.
- diphenhydramine
diphenhydramine and ganaxolone both increase sedation. Use Caution/Monitor.
- diphenoxylate hcl
diphenoxylate hcl and ganaxolone both increase sedation. Use Caution/Monitor.
- doxepin
doxepin and ganaxolone both increase sedation. Use Caution/Monitor.
- doxylamine
doxylamine and ganaxolone both increase sedation. Use Caution/Monitor.
- droperidol
droperidol and ganaxolone both increase sedation. Use Caution/Monitor.
- duloxetine
duloxetine and ganaxolone both increase sedation. Use Caution/Monitor.
- efavirenz
efavirenz and ganaxolone both increase sedation. Use Caution/Monitor.
- entacapone
entacapone and ganaxolone both increase sedation. Use Caution/Monitor.
- escitalopram
escitalopram and ganaxolone both increase sedation. Use Caution/Monitor.
- esketamine intranasal
esketamine intranasal and ganaxolone both increase sedation. Use Caution/Monitor.
- estazolam
estazolam and ganaxolone both increase sedation. Use Caution/Monitor.
- eszopiclone
eszopiclone and ganaxolone both increase sedation. Use Caution/Monitor.
- ethanol
ethanol and ganaxolone both increase sedation. Use Caution/Monitor.
- ethosuximide
ethosuximide and ganaxolone both increase sedation. Use Caution/Monitor.
- ethotoin
ethotoin and ganaxolone both increase sedation. Use Caution/Monitor.
- ezogabine
ezogabine and ganaxolone both increase sedation. Use Caution/Monitor.
- felbamate
felbamate and ganaxolone both increase sedation. Use Caution/Monitor.
- fentanyl
fentanyl and ganaxolone both increase sedation. Use Caution/Monitor.
- fentanyl intranasal
fentanyl intranasal and ganaxolone both increase sedation. Use Caution/Monitor.
- fentanyl iontophoretic transdermal system
fentanyl iontophoretic transdermal system and ganaxolone both increase sedation. Use Caution/Monitor.
- fentanyl transdermal
fentanyl transdermal and ganaxolone both increase sedation. Use Caution/Monitor.
- fentanyl transmucosal
fentanyl transmucosal and ganaxolone both increase sedation. Use Caution/Monitor.
- flibanserin
flibanserin and ganaxolone both increase sedation. Use Caution/Monitor.
- fluoxetine
fluoxetine and ganaxolone both increase sedation. Use Caution/Monitor.
- fluphenazine
fluphenazine and ganaxolone both increase sedation. Use Caution/Monitor.
- flurazepam
flurazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- fluvoxamine
fluvoxamine and ganaxolone both increase sedation. Use Caution/Monitor.
- fosphenytoin
fosphenytoin and ganaxolone both increase sedation. Use Caution/Monitor.
- gabapentin
gabapentin and ganaxolone both increase sedation. Use Caution/Monitor.
- gabapentin enacarbil
gabapentin enacarbil and ganaxolone both increase sedation. Use Caution/Monitor.
- gepirone
gepirone and ganaxolone both increase sedation. Use Caution/Monitor.
- guanfacine
guanfacine and ganaxolone both increase sedation. Use Caution/Monitor.
- haloperidol
haloperidol and ganaxolone both increase sedation. Use Caution/Monitor.
- hydrocodone
hydrocodone and ganaxolone both increase sedation. Use Caution/Monitor.
- hydromorphone
hydromorphone and ganaxolone both increase sedation. Use Caution/Monitor.
- hydroxyzine
hydroxyzine and ganaxolone both increase sedation. Use Caution/Monitor.
- iloperidone
iloperidone and ganaxolone both increase sedation. Use Caution/Monitor.
- imipramine
imipramine and ganaxolone both increase sedation. Use Caution/Monitor.
- isocarboxazid
isocarboxazid and ganaxolone both increase sedation. Use Caution/Monitor.
- isoflurane
isoflurane and ganaxolone both increase sedation. Use Caution/Monitor.
- ketamine
ketamine and ganaxolone both increase sedation. Use Caution/Monitor.
- lamotrigine
lamotrigine and ganaxolone both increase sedation. Use Caution/Monitor.
- lasmiditan
lasmiditan and ganaxolone both increase sedation. Use Caution/Monitor.
- lemborexant
lemborexant and ganaxolone both increase sedation. Use Caution/Monitor.
- lenacapavir
lenacapavir will increase the level or effect of ganaxolone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- levetiracetam
levetiracetam and ganaxolone both increase sedation. Use Caution/Monitor.
- levomilnacipran
levomilnacipran and ganaxolone both increase sedation. Use Caution/Monitor.
- levorphanol
levorphanol and ganaxolone both increase sedation. Use Caution/Monitor.
- lorazepam
lorazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- loxapine
loxapine and ganaxolone both increase sedation. Use Caution/Monitor.
- loxapine inhaled
loxapine inhaled and ganaxolone both increase sedation. Use Caution/Monitor.
- loxicodegol
loxicodegol and ganaxolone both increase sedation. Use Caution/Monitor.
- lurasidone
lurasidone and ganaxolone both increase sedation. Use Caution/Monitor.
- maprotiline
maprotiline and ganaxolone both increase sedation. Use Caution/Monitor.
- meclizine
meclizine and ganaxolone both increase sedation. Use Caution/Monitor.
- meperidine
meperidine and ganaxolone both increase sedation. Use Caution/Monitor.
- mephobarbital
mephobarbital and ganaxolone both increase sedation. Use Caution/Monitor.
- meprobamate
meprobamate and ganaxolone both increase sedation. Use Caution/Monitor.
- metaxalone
metaxalone and ganaxolone both increase sedation. Use Caution/Monitor.
- methadone
methadone and ganaxolone both increase sedation. Use Caution/Monitor.
- methocarbamol
methocarbamol and ganaxolone both increase sedation. Use Caution/Monitor.
- methohexital
methohexital and ganaxolone both increase sedation. Use Caution/Monitor.
- methsuximide
methsuximide and ganaxolone both increase sedation. Use Caution/Monitor.
- midazolam
midazolam and ganaxolone both increase sedation. Use Caution/Monitor.
- milnacipran
milnacipran and ganaxolone both increase sedation. Use Caution/Monitor.
- mirtazapine
mirtazapine and ganaxolone both increase sedation. Use Caution/Monitor.
- molindone
molindone and ganaxolone both increase sedation. Use Caution/Monitor.
- morphine
morphine and ganaxolone both increase sedation. Use Caution/Monitor.
- nalbuphine
nalbuphine and ganaxolone both increase sedation. Use Caution/Monitor.
- nefazodone
nefazodone and ganaxolone both increase sedation. Use Caution/Monitor.
- nitrous oxide
nitrous oxide and ganaxolone both increase sedation. Use Caution/Monitor.
- nortriptyline
nortriptyline and ganaxolone both increase sedation. Use Caution/Monitor.
- olanzapine
olanzapine and ganaxolone both increase sedation. Use Caution/Monitor.
- oliceridine
oliceridine and ganaxolone both increase sedation. Use Caution/Monitor.
- opium tincture
opium tincture and ganaxolone both increase sedation. Use Caution/Monitor.
- orphenadrine
orphenadrine and ganaxolone both increase sedation. Use Caution/Monitor.
- oxazepam
oxazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- oxycodone
oxycodone and ganaxolone both increase sedation. Use Caution/Monitor.
- oxymorphone
oxymorphone and ganaxolone both increase sedation. Use Caution/Monitor.
- paliperidone
paliperidone and ganaxolone both increase sedation. Use Caution/Monitor.
- paregoric
paregoric and ganaxolone both increase sedation. Use Caution/Monitor.
- paroxetine
paroxetine and ganaxolone both increase sedation. Use Caution/Monitor.
- pentazocine
pentazocine and ganaxolone both increase sedation. Use Caution/Monitor.
- pentobarbital
pentobarbital and ganaxolone both increase sedation. Use Caution/Monitor.
- perampanel
perampanel and ganaxolone both increase sedation. Use Caution/Monitor.
- perphenazine
perphenazine and ganaxolone both increase sedation. Use Caution/Monitor.
- phenelzine
phenelzine and ganaxolone both increase sedation. Use Caution/Monitor.
- pheniramine
pheniramine and ganaxolone both increase sedation. Use Caution/Monitor.
- pimavanserin
pimavanserin and ganaxolone both increase sedation. Use Caution/Monitor.
- pimozide
pimozide and ganaxolone both increase sedation. Use Caution/Monitor.
- pomalidomide
pomalidomide and ganaxolone both increase sedation. Use Caution/Monitor.
- pregabalin
pregabalin and ganaxolone both increase sedation. Use Caution/Monitor.
- prochlorperazine
prochlorperazine and ganaxolone both increase sedation. Use Caution/Monitor.
- promazine
promazine and ganaxolone both increase sedation. Use Caution/Monitor.
- promethazine
promethazine and ganaxolone both increase sedation. Use Caution/Monitor.
- propofol
propofol and ganaxolone both increase sedation. Use Caution/Monitor.
- protriptyline
protriptyline and ganaxolone both increase sedation. Use Caution/Monitor.
- pyrilamine
pyrilamine and ganaxolone both increase sedation. Use Caution/Monitor.
- quazepam
quazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- quetiapine
quetiapine and ganaxolone both increase sedation. Use Caution/Monitor.
- ramelteon
ramelteon and ganaxolone both increase sedation. Use Caution/Monitor.
- remifentanil
remifentanil and ganaxolone both increase sedation. Use Caution/Monitor.
- remimazolam
remimazolam and ganaxolone both increase sedation. Use Caution/Monitor.
- reserpine
reserpine and ganaxolone both increase sedation. Use Caution/Monitor.
- risperidone
risperidone and ganaxolone both increase sedation. Use Caution/Monitor.
- samidorphan
samidorphan and ganaxolone both increase sedation. Use Caution/Monitor.
- scopolamine
scopolamine and ganaxolone both increase sedation. Use Caution/Monitor.
- secobarbital
secobarbital and ganaxolone both increase sedation. Use Caution/Monitor.
- sertraline
sertraline and ganaxolone both increase sedation. Use Caution/Monitor.
- sevoflurane
sevoflurane and ganaxolone both increase sedation. Use Caution/Monitor.
- sodium oxybate
sodium oxybate and ganaxolone both increase sedation. Use Caution/Monitor.
- sufentanil
sufentanil and ganaxolone both increase sedation. Use Caution/Monitor.
- sufentanil SL
sufentanil SL and ganaxolone both increase sedation. Use Caution/Monitor.
- suvorexant
suvorexant and ganaxolone both increase sedation. Use Caution/Monitor.
- tapentadol
tapentadol and ganaxolone both increase sedation. Use Caution/Monitor.
- tasimelteon
tasimelteon and ganaxolone both increase sedation. Use Caution/Monitor.
- temazepam
temazepam and ganaxolone both increase sedation. Use Caution/Monitor.
- tetrabenazine
tetrabenazine and ganaxolone both increase sedation. Use Caution/Monitor.
- thalidomide
thalidomide and ganaxolone both increase sedation. Use Caution/Monitor.
- thioridazine
thioridazine and ganaxolone both increase sedation. Use Caution/Monitor.
- thiothixene
thiothixene and ganaxolone both increase sedation. Use Caution/Monitor.
- tiagabine
tiagabine and ganaxolone both increase sedation. Use Caution/Monitor.
- tizanidine
tizanidine and ganaxolone both increase sedation. Use Caution/Monitor.
- tolcapone
tolcapone and ganaxolone both increase sedation. Use Caution/Monitor.
- topiramate
topiramate and ganaxolone both increase sedation. Use Caution/Monitor.
- tramadol
tramadol and ganaxolone both increase sedation. Use Caution/Monitor.
- tranylcypromine
tranylcypromine and ganaxolone both increase sedation. Use Caution/Monitor.
- trazodone
trazodone and ganaxolone both increase sedation. Use Caution/Monitor.
- triazolam
triazolam and ganaxolone both increase sedation. Use Caution/Monitor.
- trifluoperazine
trifluoperazine and ganaxolone both increase sedation. Use Caution/Monitor.
- trimipramine
trimipramine and ganaxolone both increase sedation. Use Caution/Monitor.
- triprolidine
triprolidine and ganaxolone both increase sedation. Use Caution/Monitor.
- valbenazine
valbenazine and ganaxolone both increase sedation. Use Caution/Monitor.
- valerian
valerian and ganaxolone both increase sedation. Use Caution/Monitor.
- venlafaxine
venlafaxine and ganaxolone both increase sedation. Use Caution/Monitor.
- vigabatrin
vigabatrin and ganaxolone both increase sedation. Use Caution/Monitor.
- vilazodone
vilazodone and ganaxolone both increase sedation. Use Caution/Monitor.
- vortioxetine
vortioxetine and ganaxolone both increase sedation. Use Caution/Monitor.
- zaleplon
zaleplon and ganaxolone both increase sedation. Use Caution/Monitor.
- ziconotide
ziconotide and ganaxolone both increase sedation. Use Caution/Monitor.
- ziprasidone
ziprasidone and ganaxolone both increase sedation. Use Caution/Monitor.
- zolpidem
zolpidem and ganaxolone both increase sedation. Use Caution/Monitor.
Minor (26)
- atazanavir
atazanavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- chloramphenicol
chloramphenicol, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- clarithromycin
clarithromycin, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- cobicistat
cobicistat, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- conivaptan
conivaptan, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- darunavir
darunavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- grapefruit
grapefruit, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- idelalisib
idelalisib, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- indinavir
indinavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- isoniazid
isoniazid, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- itraconazole
itraconazole, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- ketoconazole
ketoconazole, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- levoketoconazole
levoketoconazole, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- lonafarnib
lonafarnib, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- lopinavir
lopinavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- mifepristone
mifepristone, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- nefazodone
nefazodone, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- nelfinavir
nelfinavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- posaconazole
posaconazole, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- ritonavir
ritonavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- rucaparib
rucaparib, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- saquinavir
saquinavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- stiripentol
stiripentol, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- tipranavir
tipranavir, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
- voriconazole
voriconazole, ganaxolone. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.
Adverse Effects
>10%
Somnolence (38%)
Pyrexia (18%)
1-10%
Upper respiratory tract infection (10%)
Sedation (6%)
Salivary hypersecretion (6%)
Seasonal allergy (6%)
Bronchitis (4%)
Influenza (4%)
Gail disturbance (4%)
Nasal congestion (4%)
Warnings
Contraindications
None
Cautions
Somnolence and sedation observed early during treatment and are generally dose-related; caution if coadministered with CNS depressants; advise patient not to drive or operate machinery until they have gained sufficient experience to gauge whether ganaxolone adversely affects their ability to drive
Antiepileptic drugs may increase risk of suicidal thoughts or behavior in patients taking these drugs for any indication; monitor for emergence or worsening of depression; if suicidal thoughts and behavior emerge during treatment, consider whether these symptoms may be related to illness being treated
Ganaxolone can be abused or lead to dependence
Ganaxolone, like other antiepileptic drugs, should be withdrawn gradually owing to risk of increased seizure frequency and status epilepticus; because of a serious adverse event, rapid discontinuation can be considered
Drug interaction overview
- CYP3A4 substrate
-
CYP3A4 inducers
- Avoid coadministration with moderate or strong CYP3A4 inducers
- If coadministration unavoidable, consider increasing ganaxolone dose; however, do not exceed maximum daily dose for weight
- In patients on a stable ganaxolone dosage who are initiating or increasing the dosages of enzyme-inducing antiepileptic drugs (eg, carbamazepine, phenytoin, phenobarbital, primidone), ganaxolone dose may need to be increased (not to exceed maximum daily dose)
-
CYP3A4 inhibitors
- Not clinically significant
- Coadministration with itraconazole, a strong CYP3A4 inhibitor, increased ganaxolone AUC by 17% in healthy subjects (peak plasma concentration was unchanged)
- Changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant
-
CNS depressants and alcohol
- Caution
- Coadministration with CNS depressants, including alcohol, may increase risk of somnolence and sedation
Pregnancy & Lactation
Pregnancy
Data are unavailable regarding use in pregnant females to inform a drug-associated risk of adverse developmental outcomes
Based on animal data, may cause fetal harm
Encourage females who are taking ganaxolone during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting www.aedpregnancyregistry.org/
Animal studies
- Adverse effects on development observed in mice (fetal malformations) and rats (neurobehavioral and growth impairment) following exposure during organogenesis (mouse) or throughout gestation and lactation (rat) at maternal exposures lower than that in human adults at the maximum recommended human dose (MRHD) of 1800 mg
- Additionally, neuronal death observed in rats exposed to ganaxolone during brain development that begins during the third trimester of pregnancy in humans and continues during the first few years after birth
Lactation
Excreted in human milk
Following a single oral dose of ganaxolone (300 mg), ganaxolone exposures (AUC0-24 h) in human milk were ~4 times higher than those in maternal plasma, resulting in an estimated daily dose in the infant of <1% of maternal dose
Effects on milk production and breastfed infants are unknown
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for ganaxolone, and any potential adverse effects on the breastfed child from ganaxolone, or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Precise mechanism by which ganaxolone exerts its therapeutic effects on seizures associated with CDD is unknown
Ganaxolone is a positive allosteric modulator of GABAA receptors; exhibits antiseizure and antianxiety activity via its effects on synaptic and extrasynaptic GABAA receptors
Absorption
Peak plasma time: 2-3 hr
Effect of food H4
Administered with food in clinical efficacy study; efficacy is unknown when administered in fasted state
When administered with a high-fat meal, peak plasma concentration and AUC increased by 3- and 2-fold, respectively, when compared to administration under fasted conditions
Distribution
Protein bound: 99% (in serum)
Metabolism
Metabolized by CYP3A4/5, CYP2B6, CYP2C19, and CYP2D6
Elimination
Half-life: 34 hr
Excretion: 55% feces (2% unchanged); 18% urine
Administration
Oral Administration
Must be administered with food
Shake bottle thoroughly for at least 1 minute, and then wait for 1 minutes before measuring and administering each dose
Measure dose with oral syringe; household teaspoon or tablespoon are not adequate measuring devices and should not be used
Discontinuation
- Decrease dose gradually when discontinuing treatment
- As with all antiepileptic drugs, avoid abrupt discontinuation, when possible, to minimize risk of increased seizure frequency and status epilepticus
Storage
Refrigerate at 15-30ºC (59-86ºF)
Store in product’s original bottle in an upright position
Keep cap tightly closed
Use within 30 days of first opening bottle, or before “Discard After” date on the bottle, whichever is sooner, then discard any remainder
Images
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
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