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      Drugs & Diseases

      ganaxolone (Rx)

      Brand and Other Names:Ztalmy
      • Print

      Dosing & Uses

      AdultPediatricGeriatric

      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

      • Mild (Child-Pugh class A) or moderate (Child- Pugh class B): No dosage adjustment necessary
      • Severe (Child-Pugh class C): Results in elevated drug plasma concentrations; dosage adjustment during titration and maintenance required

      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

      • Mild (Child-Pugh class A) or moderate (Child-Pugh class B): No dosage adjustment necessary
      • Severe (Child-Pugh class C): Results in elevated drug plasma concentrations; dosage adjustment during titration and maintenance required

      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

      Next:

      Interactions

      Interaction Checker

      and ganaxolone

      No Results

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          Serious - Use Alternative

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                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 (203)

                  • 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.

                  • avapritinib

                    avapritinib 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.

                  • brimonidine

                    brimonidine 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.

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                  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%)

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                  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
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                  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.

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                  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

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                  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

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Create Your List of Plans

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  View explanations for tiers and restrictions
                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.
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