ganaxolone (Rx)

Brand and Other Names:Ztalmy
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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

  • 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

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Interactions

Interaction Checker

and ganaxolone

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              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 (199)

              • 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.

              • 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.

              • 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

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              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
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              • 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.

              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.