glasdegib (Rx)

Brand and Other Names:Daurismo
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 25mg
  • 100mg

Acute Myeloid Leukemia

Indicated, in combination with low-dose cytarabine, for newly diagnosed acute myeloid leukemia (AML) in adults aged ≥75 years or who have comorbidities that preclude use of intensive induction chemotherapy

100 mg PO qDay on days 1-28 of each 28-day cycle; administer in combination with cytarabine 20 mg SC BID on days 1-10

For patients without unacceptable toxicity, treat for a minimum of 6 cycles to allow time for clinical response

Dosage Modifications

QT prolongation (≥2 separate ECGs)

  • QTc >480 to 500 ms
    • Assess electrolyte levels and supplement as clinically indicated
    • Review and adjust concomitant medications with known QTc interval-prolonging effects
    • Monitor ECGs at least weekly for 2 weeks following QTc prolongation resolution to ≤480 ms
  • QT >500 ms
    • Assess electrolyte levels and supplement as clinically indicated
    • Review and adjust concomitant medications with known QTc interval-prolonging effects
    • Interrupt glasdegib dosing; resume at reduced dose of 50 mg qDay when QTc interval returns to within 30 ms of baseline or ≤480 ms
    • Monitor ECGs at least weekly for 2 weeks following QTc prolongation resolution
    • Consider re-escalating glasdegib dose to 100 mg qDay if other etiology identified for QTc prolongation
  • QTc prolongation with life-threatening arrhythmia
    • Discontinue permanently

Hematologic toxicity

  • Platelets <10 Gi/L or neutrophil count <0.5 Gi/L for >42 days in absence of disease: Discontinue glasdegib and cytarabine permanently

Nonhematologic toxicity

  • Grade 3
    • Interrupt glasdegib and/or cytarabine until symptoms reduce to mild or return to baseline
    • Resume glasdegib at the same dose level, or reduce dose to 50 mg
    • Resume cytarabine at the same dose level, or reduce dose to 15 mg or 10 mg
    • If toxicity recurs, discontinue glasdegib and cytarabine
    • If toxicity attributed only to glasdegib, cytarabine may be continued
  • Grade 4
    • Discontinue glasdegib and cytarabine permanently

Strong or moderate CYP3A4 inducers

  • Avoid; coadministration may decrease glasdegib plasma concentrations, thereby reducing efficacy
  • May increase glasdegib dose if coadministration with moderate CYP3A4 inducers cannot be avoided
  • Glasdegib dose adjustment if coadministration with moderate CYP3A4 inducer
    • If taking 100 mg/day: Increase to 200 mg PO qDay
    • If taking 50 mg/day: Increase to 100 mg PO qDay
    • After moderate CYP3A4 inducer discontinued for 7 days, resume previous glasdegib dose

Renal impairment

  • Mild-to-severe (eGFR 15-89 mL/min): No dosage modifications recommended
  • Monitor patients with severe renal impairment (eGFR 15-29 mL/min) for increased risk of adverse effects including QTc prolongation owing to increased serum levels

Hepatic impairment

  • Not studied

Dosing Considerations

Limitations of use: Not studied in patients with severe renal impairment or moderate-to-severe hepatic impairment

Conduct pregnancy testing in females of reproductive potential before initiating

Monitoring

  • Assess complete blood cell counts, electrolytes, renal function, and hepatic function before initiating and at least once weekly for the first month
  • Monitor electrolytes and renal function once monthly for the duration of therapy
  • Obtain serum creatine kinase levels before initiating and as indicated clinically thereafter (eg, if muscle symptoms are reported)
  • Monitor ECG) before initiating, ~1 week after initiation, and then once monthly for the next 2 months to assess for QTc prolongation; repeat ECG if abnormal; certain patients may require more frequent and ongoing ECG monitoring

Safety and efficacy not established

See adult dosing

Of the total number of patients in clinical trials, 98% were aged ≥65 years and 60% were aged ≥75 years

There were insufficient patients younger than age 65 years to determine differences in adverse reactions reported from patients older than 65 years

Next:

Interactions

Interaction Checker

and glasdegib

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            Contraindicated (1)

            • lefamulin

              lefamulin will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            Serious - Use Alternative (152)

            • abametapir

              abametapir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • alfuzosin

              alfuzosin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • amiodarone

              amiodarone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • amobarbital

              amobarbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • anagrelide

              anagrelide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • apalutamide

              apalutamide will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • apomorphine

              apomorphine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • arformoterol

              arformoterol and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • aripiprazole

              aripiprazole and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • arsenic trioxide

              arsenic trioxide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • artemether

              artemether and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • artemether/lumefantrine

              artemether/lumefantrine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • asenapine

              asenapine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • atazanavir

              atazanavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • atomoxetine

              atomoxetine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • azithromycin

              azithromycin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • bedaquiline

              bedaquiline and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • belzutifan

              belzutifan will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • bosentan

              bosentan will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • butabarbital

              butabarbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • butalbital

              butalbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • carbamazepine

              carbamazepine will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • ceritinib

              ceritinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • chloramphenicol

              chloramphenicol will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • chloroquine

              chloroquine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • chlorpromazine

              chlorpromazine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ciprofloxacin

              ciprofloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • citalopram

              citalopram and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • clarithromycin

              clarithromycin will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

              clarithromycin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • clofazimine

              clofazimine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • clozapine

              clozapine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • cobicistat

              cobicistat will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • conivaptan

              conivaptan will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • crizotinib

              crizotinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • dabrafenib

              dabrafenib will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • darunavir

              darunavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • dasatinib

              dasatinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • degarelix

              degarelix and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • desflurane

              desflurane and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • disopyramide

              disopyramide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • dofetilide

              dofetilide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • dolasetron

              dolasetron and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • donepezil

              donepezil and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • doxepin

              doxepin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • dronedarone

              dronedarone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • droperidol

              droperidol and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • efavirenz

              efavirenz will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

              efavirenz and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • eliglustat

              eliglustat and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • encorafenib

              encorafenib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • entrectinib

              glasdegib and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • enzalutamide

              enzalutamide will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • eribulin

              eribulin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • erythromycin base

              erythromycin base and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • erythromycin lactobionate

              erythromycin lactobionate and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • erythromycin stearate

              erythromycin stearate and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • escitalopram

              escitalopram and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • etravirine

              etravirine will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • ezogabine

              ezogabine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • fexinidazole

              fexinidazole and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

            • fingolimod

              fingolimod and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • flecainide

              flecainide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • fluconazole

              fluconazole and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • fluoxetine

              fluoxetine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • formoterol

              formoterol and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • gemifloxacin

              gemifloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • gemtuzumab

              gemtuzumab and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • goserelin

              goserelin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • granisetron

              granisetron and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • grapefruit

              grapefruit will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • haloperidol

              haloperidol and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • histrelin

              histrelin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and glasdegib both increase QTc interval. Avoid or Use Alternate Drug.

            • ibutilide

              ibutilide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • idelalisib

              idelalisib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • iloperidone

              iloperidone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • imatinib

              imatinib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • indacaterol, inhaled

              indacaterol, inhaled and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • indinavir

              indinavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • inotuzumab

              inotuzumab and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • isoniazid

              isoniazid will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • ivosidenib

              ivosidenib will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • ketoconazole

              ketoconazole will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • lapatinib

              lapatinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • lenvatinib

              lenvatinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • leuprolide

              leuprolide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • levofloxacin

              levofloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • lofexidine

              lofexidine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • lopinavir

              lopinavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

              lopinavir and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • lorlatinib

              lorlatinib will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • methadone

              methadone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • mifepristone

              mifepristone will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

              mifepristone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • mitotane

              mitotane will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • moxifloxacin

              moxifloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • nafcillin

              nafcillin will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • nefazodone

              nefazodone will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • nelfinavir

              nelfinavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • nilotinib

              nilotinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ofloxacin

              ofloxacin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • olanzapine

              olanzapine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ondansetron

              ondansetron and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • osimertinib

              osimertinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • paliperidone

              paliperidone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • panobinostat

              panobinostat and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pasireotide

              pasireotide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pazopanib

              pazopanib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pentamidine

              pentamidine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pentobarbital

              pentobarbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • phenobarbital

              phenobarbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • phenytoin

              phenytoin will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • pimavanserin

              pimavanserin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pimozide

              pimozide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • pitolisant

              glasdegib and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • posaconazole

              posaconazole will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • primaquine

              primaquine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • primidone

              primidone will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • procainamide

              procainamide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • propafenone

              propafenone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • quetiapine

              quetiapine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • quinidine

              quinidine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • quinine

              quinine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ranolazine

              ranolazine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ribociclib

              ribociclib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • rifabutin

              rifabutin will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • rifampin

              rifampin will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • rifapentine

              rifapentine will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • risperidone

              risperidone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • ritonavir

              ritonavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • romidepsin

              romidepsin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • saquinavir

              saquinavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

              saquinavir and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • secobarbital

              secobarbital will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • sorafenib

              sorafenib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • sotalol

              sotalol and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • St John's Wort

              St John's Wort will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of glasdegib with strong CYP3A inducers.

            • stiripentol

              stiripentol, glasdegib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stiripentol may either inhibit or induce CYP3A4. Monitor glasdegib for decreased efficacy or increased risk of adverse effects, including QTc interval prolongation. Dosage adjustment may be needed.

            • sunitinib

              sunitinib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • telavancin

              telavancin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • tetrabenazine

              tetrabenazine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • thioridazine

              thioridazine and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • tipranavir

              tipranavir will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • toremifene

              toremifene and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • trazodone

              trazodone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • triptorelin

              triptorelin and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • tucatinib

              tucatinib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • vandetanib

              vandetanib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • vemurafenib

              vemurafenib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • voriconazole

              voriconazole will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

              voriconazole and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • voxelotor

              voxelotor will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            • ziprasidone

              ziprasidone and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            Monitor Closely (19)

            • albuterol

              albuterol and glasdegib both increase QTc interval. Use Caution/Monitor.

            • cenobamate

              cenobamate will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • dengue vaccine

              glasdegib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

            • deutetrabenazine

              deutetrabenazine and glasdegib both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • elagolix

              elagolix decreases levels of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • fedratinib

              fedratinib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • fostemsavir

              glasdegib and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • istradefylline

              istradefylline will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • itraconazole

              itraconazole will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Consider alternate therapies that are not strong CYP3A inhibitors or monitor for increased risk of adverse effects, including QTc interval prolongation.

            • osilodrostat

              osilodrostat and glasdegib both increase QTc interval. Use Caution/Monitor.

            • ozanimod

              ozanimod and glasdegib both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • ribociclib

              ribociclib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • selpercatinib

              selpercatinib increases toxicity of glasdegib by QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and glasdegib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of glasdegib by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of glasdegib by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias. .

            • tazemetostat

              tazemetostat will decrease the level or effect of glasdegib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • voclosporin

              voclosporin, glasdegib. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            Minor (0)

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              Adverse Effects

              >10% (All Grades Glasdegib with Cytarabine)

              Increased creatinine (96%)

              Hyponatremia (11-54%)

              Anemia (43%)

              Hemorrhage (36%)

              Fatigue (36%)

              Hypomagnesemia (33%)

              Febrile neutropenia (31%)

              Thrombocytopenia (30%)

              Edema (30%)

              Musculoskeletal pain (30%)

              Nausea (29%)

              Increased AST (28%)

              Increased blood bilirubin (25%)

              Increased ALT (24%)

              Increased alkaline phosphatase (23%)

              Mucositis (21%)

              Decreased appetite (21%)

              Dysgeusia (21%)

              Constipation (20%)

              Rash (20%)

              Abdominal pain (19%)

              Pneumonia (19%)

              Renal insufficiency (19%)

              Pyrexia (18%)

              Diarrhea (18%)

              Vomiting (18%)

              Dizziness (18%)

              Hyperkalemia (16%)

              Increased CPK (16%)

              Muscle spasm (15%)

              Decreased platelet count (15%)

              Hypokalemia (15%)

              Weight decreased (13%)

              Atrial arrhythmia (13%)

              Chest pain (12%)

              Headache (12%)

              >10% (Glasdegib with Cytarabine Grade ≥3)

              Anemia (41%)

              Febrile neutropenia (31%)

              Thrombocytopenia (30%)

              Pneumonia (15%)

              Decreased platelet count (15%)

              Fatigue (14%)

              Dyspnea (11%)

              Decreased WBC count (11%)

              1-10% (Glasdegib with Cytarabine Grade ≥3)

              Hyponatremia (7%)

              Hemorrhage (6%)

              Hyponatremia (6%)

              Renal insufficiency (5%)

              Diarrhea (4%)

              Atrial arrhythmia (4%)

              Increased blood bilirubin (4%)

              Musculoskeletal pain (2%)

              Vomiting (2%)

              Rash (2%)

              Mucositis (1%)

              Pyrexia (1%)

              Chest pain (1%)

              Nausea (1%)

              Constipation (1%)

              Decreased appetite (1%)

              Increased creatinine (1%)

              Increased AST (1%)

              Hyperkalemia (1%)

              1-10% (Glasdegib with Cytarabine)

              <10%

              • Dental disorders: Loose teeth, toothache
              • Skin and subcutaneous tissue disorders: Alopecia
              • Cardiac disorders: QT prolongation
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              Warnings

              Black Box Warnings

              Embryo-fetal toxicity

              • Can cause embryo-fetal death or severe birth defects when administered to pregnant women; it is embryotoxic, fetotoxic, and teratogenic in animals
              • Conduct pregnancy testing in females of reproductive potential before initiating
              • Advise females of reproductive potential to use effective contraception during treatment and for at least 30 days after last dose
              • Advise males of the potential risk of exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential during treatment and for at least 30 days after last dose

              Contraindications

              None

              Cautions

              Based on mechanism of action and findings from animal studies, can cause embryo-fetal death or severe birth defects when administered to pregnant women (see Black Box Warnings and Pregnancy)

              Development of QTc prolongation and ventricular arrhythmias reported, including ventricular fibrillation and ventricular tachycardia; more frequent ECG monitoring advised in patients with congenital long QT syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval (see Drug Interactions)

              Drug interaction overview

              • Glasdegib primarily metabolized by CYP3A
              • Strong CYP3A inhibitors
                • Coadministration may increase glasdegib plasma concentrations and increase risk for QT prolongation
              • Strong or moderate CYP3A inducers
                • Avoid; coadministration may decrease glasdegib plasma concentrations, thereby reducing efficacy
                • May increase glasdegib dose if coadministration with moderate CYP3A4 inducers cannot be avoided
              • Prolonged QTc
                • Associated with concentration-dependent QTc prolongation
                • Avoid coadministration with QTc prolonging drugs
                • If unavoidable, monitor for increased risk of QTc interval prolongation
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              Pregnancy

              Pregnancy

              Based on its mechanism of action and findings in animal embryo-fetal developmental toxicity studies, glasdegib can cause fetal harm when administered to pregnant women

              Animal studies

              • Exposure 3-4 times that of humans: Resulted in embryo-fetal lethality (eg, increased postimplantation loss and decreased numbers of live fetuses) in rats and rabbits
              • Exposure 0.6 times that of humans: Fetal developmental abnormalities and malformations consisting of craniofacial malformations; malformed limbs, paws/digits, trunk, and tail; dilation of brain; malpositioned/malformed eyes; misshapen head; small tongue; absent palate, teeth, and viscera; diaphragmatic hernia; edema; heart defects; rib and vertebral abnormalities; malformed or absent structures in the appendicular skeleton

              Infertility

              • Males: Based on findings in repeat-dose animal toxicity studies in rats, may impair fertility in males of reproductive potential; some effects on male reproductive organs did not recover

              Contraception

              • Females of reproductive potential
                • Use effective contraception during treatment and for at least 30 days after last dose
                • Do not donate blood during treatment and for at least 30 days after last dose
              • Males
                • Unknown if present in semen
                • Advise males of the potential risk of exposure through semen and to use effective contraception, including a condom, even after a vasectomy, to avoid drug exposure to a pregnant partner or a female partner of reproductive potential during treatment for at least 30 days after last dose
                • Advise males to not donate sperm or blood during treatment and for at least 30 days after last dose

              Lactation

              • No data are available on the presence in human milk, effects on the breastfed child, or effect on milk production
              • Advise women not to breastfeed or provide breast milk to infants or children during treatment and for at least 30 days after last dose

              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

              Inhibits the smoothen (SMO) receptor, a transmembrane protein involved in hedgehog (Hh) signal transduction, thereby disrupting the Hh pathway

              SMO inhibition of Hh signaling impacts tumor biology by disrupting the regulation of cancer stem cell survival; this may inhibit development of drug resistance and prevent relapse

              Absorption

              Bioavailability: 77%

              Peak plasma time: 1.3-1.8 hr

              Peak plasma concentration: 1,252 ng/mL

              AUC: 17,210 ng·hr/mL

              Steady-state: Achieved by 8 days of daily dosing

              Effect of food: High-fat, high-calorie meal reduced glasdegib’s AUC (16%) and peak plasma concentration (31%)

              Distribution

              Protein bound: 91%

              Vd: 188 L

              Metabolism

              Primary metabolic pathway: CYP3A4

              Minor metabolic pathways: CYP2C8 and UGT1A9

              Elimination

              Half-life: 17.4 hr

              Clearance: 6.45 L/hr

              Excretion: Urine (49% [17% unchanged]); feces (42%] 20% unchanged])

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              Administration

              Oral Administration

              Administer with or without food

              Swallow tablet whole; do not split or crush

              Administer at about the same time each day

              Missed or vomited dose

              • Vomited dose: Do not replace dose; wait until the next scheduled dose is due
              • Missed dose or not taken at usual time: Administer dose as soon as possible and at least 12 hr before the next scheduled dose; return to normal schedule the following day
              • Do not administer 2 doses within 12 hr

              Storage

              Store at 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F)

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              Patient Handout

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

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              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.
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              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
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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.