leniolisib (Rx)

Brand and Other Names:Joenja

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 70mg

Activated Phosphoinositide 3-kinase Delta Syndrome

Indicated for treatment of immune dysregulation in activated phosphoinositide 3-kinase delta syndrome (APDS), formerly known as PASLI (p110 delta-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency) disease, in adults and pediatric patients aged ≥12 years

<45 kg: No recommended dose

≥45 kg: 70 mg PO q12hr

Dosage Modifications

Hepatic impairment

  • Extensively (60%) metabolized by the liver; effect of hepatic impairment on pharmacokinetics of leniolisib has not been studied
  • Moderate-to-severe: Not recommended

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiating

Dosage Forms & Strengths

tablet

  • 70mg

Activated Phosphoinositide 3-kinase Delta Syndrome

Indicated for treatment of immune dysregulation in activated phosphoinositide 3-kinase delta syndrome (APDS), formerly known as PASLI (p110 delta-activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency) disease, in adults and pediatric patients aged ≥12 years

<12 years: Safety and efficacy not established

≥12 years and ≥45 kg: 70 mg PO q12hr

<45 kg: No recommended dose

Dosage Modifications

Hepatic impairment

  • Extensively (60%) metabolized by the liver; effect of hepatic impairment on pharmacokinetics of leniolisib has not been studied
  • Moderate-to-severe: Not recommended

Dosing Considerations

Verify pregnancy status in females of reproductive potential before initiating

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Interactions

Interaction Checker

and leniolisib

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (1)

            • fezolinetant

              leniolisib will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors

            Serious - Use Alternative (150)

            • alosetron

              leniolisib will increase the level or effect of alosetron by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • alpelisib

              leniolisib will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • ambrisentan

              leniolisib will increase the level or effect of ambrisentan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • amobarbital

              amobarbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • apalutamide

              apalutamide will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • armodafinil

              armodafinil will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • atazanavir

              atazanavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • atogepant

              leniolisib will increase the level or effect of atogepant by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • atorvastatin

              leniolisib will increase the level or effect of atorvastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • belzutifan

              belzutifan will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • bendamustine

              leniolisib will increase the level or effect of bendamustine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • bexarotene

              bexarotene will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • bosentan

              bosentan will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              leniolisib will increase the level or effect of bosentan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • butabarbital

              butabarbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • butalbital

              butalbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • carbamazepine

              carbamazepine will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • caspofungin

              leniolisib will increase the level or effect of caspofungin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • cenobamate

              cenobamate will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • chloramphenicol

              chloramphenicol will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • chlorothiazide

              leniolisib will increase the level or effect of chlorothiazide by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • cimetidine

              leniolisib will increase the level or effect of cimetidine by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • clarithromycin

              clarithromycin will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clomipramine

              leniolisib will increase the level or effect of clomipramine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • clozapine

              leniolisib will increase the level or effect of clozapine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • cobicistat

              cobicistat will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • conivaptan

              conivaptan will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • dabrafenib

              dabrafenib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • darunavir

              darunavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • daunorubicin

              leniolisib will increase the level or effect of daunorubicin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • digoxin

              leniolisib will increase the level or effect of digoxin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • dipyridamole

              leniolisib will increase the level or effect of dipyridamole by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • doxorubicin

              leniolisib will increase the level or effect of doxorubicin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • duloxetine

              leniolisib will increase the level or effect of duloxetine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • duvelisib

              duvelisib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • efavirenz

              efavirenz will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • elagolix

              elagolix will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              leniolisib will increase the level or effect of elagolix by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • elbasvir/grazoprevir

              leniolisib will increase the level or effect of elbasvir/grazoprevir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • eluxadoline

              leniolisib will increase the level or effect of eluxadoline by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • enalapril

              leniolisib will increase the level or effect of enalapril by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • encorafenib

              encorafenib, leniolisib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Encorafenib, an inhibitor and inducer of CYP3A4, may either increase or decrease leniolisib systemic exposure .

            • enzalutamide

              enzalutamide will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin base

              leniolisib will increase the level or effect of erythromycin base by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • erythromycin ethylsuccinate

              leniolisib will increase the level or effect of erythromycin ethylsuccinate by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • erythromycin lactobionate

              leniolisib will increase the level or effect of erythromycin lactobionate by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • erythromycin stearate

              leniolisib will increase the level or effect of erythromycin stearate by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ethinylestradiol

              leniolisib will increase the level or effect of ethinylestradiol by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • etravirine

              etravirine will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ezetimibe

              leniolisib will increase the level or effect of ezetimibe by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • fexofenadine

              leniolisib will increase the level or effect of fexofenadine by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • fluvastatin

              leniolisib will increase the level or effect of fluvastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • fluvoxamine

              leniolisib will increase the level or effect of fluvoxamine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • fosphenytoin

              fosphenytoin will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • glecaprevir/pibrentasvir

              leniolisib will increase the level or effect of glecaprevir/pibrentasvir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • glyburide

              leniolisib will increase the level or effect of glyburide by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • grapefruit

              grapefruit will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • imatinib

              leniolisib will increase the level or effect of imatinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • indinavir

              indinavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • irinotecan

              leniolisib will increase the level or effect of irinotecan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • itraconazole

              itraconazole will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ivosidenib

              ivosidenib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ketoconazole

              ketoconazole will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lapatinib

              leniolisib will increase the level or effect of lapatinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • ledipasvir/sofosbuvir

              leniolisib will increase the level or effect of ledipasvir/sofosbuvir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • leflunomide

              leniolisib will increase the level or effect of leflunomide by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • lenvatinib

              leniolisib will increase the level or effect of lenvatinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • letermovir

              leniolisib will increase the level or effect of letermovir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • levoketoconazole

              levoketoconazole will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lonafarnib

              lonafarnib will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lopinavir

              lopinavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lorlatinib

              lorlatinib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lovastatin

              leniolisib will increase the level or effect of lovastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mavacamten

              mavacamten will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • methotrexate

              leniolisib will increase the level or effect of methotrexate by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • mexiletine

              leniolisib will increase the level or effect of mexiletine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • mifepristone

              mifepristone will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mitapivat

              mitapivat will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mitotane

              mitotane will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • mitoxantrone

              leniolisib will increase the level or effect of mitoxantrone by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • mobocertinib

              mobocertinib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • modafinil

              modafinil will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nafcillin

              nafcillin will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nelfinavir

              nelfinavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nirmatrelvir/ritonavir

              nirmatrelvir/ritonavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • nitrofurantoin

              leniolisib will increase the level or effect of nitrofurantoin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • olanzapine

              leniolisib will increase the level or effect of olanzapine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • olmesartan

              leniolisib will increase the level or effect of olmesartan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • olutasidenib

              olutasidenib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • osimertinib

              leniolisib will increase the level or effect of osimertinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • ozanimod

              leniolisib will increase the level or effect of ozanimod by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • paclitaxel

              leniolisib will increase the level or effect of paclitaxel by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • pantoprazole

              leniolisib will increase the level or effect of pantoprazole by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • pazopanib

              leniolisib will increase the level or effect of pazopanib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • penicillin G benzathine

              leniolisib will increase the level or effect of penicillin G benzathine by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • pentobarbital

              pentobarbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pexidartinib

              pexidartinib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenobarbital

              phenobarbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenytoin

              phenytoin will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pirfenidone

              leniolisib will increase the level or effect of pirfenidone by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration, decrease pirfenidone dose

            • pitavastatin

              leniolisib will increase the level or effect of pitavastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • pomalidomide

              leniolisib will increase the level or effect of pomalidomide by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration, decrease pomalidomide dose

            • posaconazole

              posaconazole will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pravastatin

              leniolisib will increase the level or effect of pravastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • primidone

              primidone will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ramelteon

              leniolisib will increase the level or effect of ramelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • rasagiline

              leniolisib will increase the level or effect of rasagiline by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration, decrease rasagiline dose

            • repaglinide

              leniolisib will increase the level or effect of repaglinide by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • revefenacin

              leniolisib will increase the level or effect of revefenacin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • rifabutin

              rifabutin will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifapentine

              rifapentine will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • riluzole

              leniolisib will increase the level or effect of riluzole by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • rimegepant

              leniolisib will increase the level or effect of rimegepant by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • riociguat

              leniolisib will increase the level or effect of riociguat by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • ritonavir

              ritonavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ropinirole

              leniolisib will increase the level or effect of ropinirole by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. If unable to avoid coadministration, decrease ropinirole dose

            • rosuvastatin

              leniolisib will increase the level or effect of rosuvastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • rucaparib

              rucaparib will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • saquinavir

              saquinavir will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • secobarbital

              secobarbital will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • selexipag

              leniolisib will increase the level or effect of selexipag by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • selumetinib

              leniolisib will increase the level or effect of selumetinib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • simvastatin

              leniolisib will increase the level or effect of simvastatin by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • sofosbuvir

              leniolisib will increase the level or effect of sofosbuvir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • sotorasib

              sotorasib will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • St John's Wort

              St John's Wort will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • stiripentol

              stiripentol, leniolisib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Stiripentol, an inhibitor and inducer of CYP3A4, may either increase or decrease leniolisib systemic exposure .

            • sulbactam/durlobactam

              leniolisib will increase the level or effect of sulbactam/durlobactam by Other (see comment). Avoid or Use Alternate Drug. Sulbactam is predicted to have active secretion by OATP1 as a significant portion of total clearance; therefore, inhibition of OAT1 may increase sulbactam plasma concentrations

            • sulfasalazine

              leniolisib will increase the level or effect of sulfasalazine by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • talazoparib

              leniolisib will increase the level or effect of talazoparib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • tasimelteon

              leniolisib will increase the level or effect of tasimelteon by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • telmisartan

              leniolisib will increase the level or effect of telmisartan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • telotristat ethyl

              telotristat ethyl will decrease the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • tenofovir AF

              leniolisib will increase the level or effect of tenofovir AF by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • tenofovir DF

              leniolisib will increase the level or effect of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • theophylline

              leniolisib will increase the level or effect of theophylline by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • tizanidine

              leniolisib will increase the level or effect of tizanidine by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid leniolisib with CYP1A2 substrates that have a narrow therapeutic index

            • topotecan

              leniolisib will increase the level or effect of topotecan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • troglitazone

              leniolisib will increase the level or effect of troglitazone by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • tucatinib

              tucatinib will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ubrogepant

              leniolisib will increase the level or effect of ubrogepant by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • valsartan

              leniolisib will increase the level or effect of valsartan by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, an OATP1B1 and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            • velpatasvir

              leniolisib will increase the level or effect of velpatasvir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • vemurafenib

              leniolisib will increase the level or effect of vemurafenib by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates

            • voriconazole

              voriconazole will increase the level or effect of leniolisib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • voxilaprevir

              leniolisib will increase the level or effect of voxilaprevir by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP, OATP1B1, and OATP1B3 inhibitor, may increase systemic exposure of these substrates

            Monitor Closely (20)

            • adenovirus types 4 and 7 live, oral

              leniolisib decreases effects of adenovirus types 4 and 7 live, oral by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • BCG vaccine live

              leniolisib decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • cholera vaccine

              leniolisib decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • dengue vaccine

              leniolisib decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • Ebola Zaire vaccine

              leniolisib decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • influenza virus vaccine quadrivalent, intranasal

              leniolisib decreases effects of influenza virus vaccine quadrivalent, intranasal by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • measles (rubeola) vaccine

              leniolisib decreases effects of measles (rubeola) vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • measles mumps and rubella vaccine, live

              leniolisib decreases effects of measles mumps and rubella vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • measles, mumps, rubella and varicella vaccine, live

              leniolisib decreases effects of measles, mumps, rubella and varicella vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • poliovirus vaccine live oral trivalent

              leniolisib decreases effects of poliovirus vaccine live oral trivalent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • rotavirus oral vaccine, live

              leniolisib decreases effects of rotavirus oral vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • rubella vaccine

              leniolisib decreases effects of rubella vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • smallpox (vaccinia) and monkeypox vaccine, live, nonreplicating

              leniolisib decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • smallpox (vaccinia) vaccine, attenuated

              leniolisib decreases effects of smallpox (vaccinia) vaccine, attenuated by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • smallpox (vaccinia) vaccine, live

              leniolisib decreases effects of smallpox (vaccinia) vaccine, live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • typhoid polysaccharide vaccine

              leniolisib decreases effects of typhoid polysaccharide vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • typhoid vaccine live

              leniolisib decreases effects of typhoid vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • varicella virus vaccine live

              leniolisib decreases effects of varicella virus vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • yellow fever vaccine

              leniolisib decreases effects of yellow fever vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            • zoster vaccine live

              leniolisib decreases effects of zoster vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.

            Minor (0)

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              Adverse Effects

              >10%

              ANC 500-1500 cells/microL (33%)

              Headache (24%)

              Sinusitis (19%)

              Atopic dermatitis (14%)

              1-10%

              Tachycardia (10%)

              Diarrhea (10%)

              Fatigue (10%)

              Pyrexia (10%)

              Back pain (10%)

              Neck pain (10%)

              Alopecia (10%)

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              Warnings

              Contraindications

              None

              Cautions

              Based on findings in animals, may cause fetal harm when administered to pregnant females

              Drug interaction overview

              • Substrate of CYP3A4
              • Inhibitor of CYP1A2, BCRP, OATP1B1, OATP1B3
              • Vaccines
                • Caution, monitor
                • Live, attenuated vaccinations may be less effective if administered during leniolisib treatment
              • Strong CYP3A4 inhibitors
                • Avoid coadministration
                • Leniolisib exposure was increased 2-fold when coadministered with itraconazole, a strong CYP3A4 inhibitor
              • Strong and moderate CYP3A4 inducers
                • Avoid coadministration
                • Strong and moderate CYP3A4 inducers may reduce leniolisib systemic exposure and thus reduced leniolisib efficacy
              • Sensitive CYP1A2 substrates
                • Avoid coadministration
                • Coadministration may increase CYP1A2 systemic exposure
                • Avoid with CYP1A2 substrates that have a narrow therapeutic index
              • BCRP, OATP1B1, and OAP1B3 substrates
                • Avoid coadministration
                • Effect of leniolisib on BCRP, OATP1B1, and OATP1B3 substrates has not been studied clinically
                • Owing to possible increase in systemic exposure of these substrates, avoid concomitant use
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              Pharmacology

              Mechanism of Action

              Inhibits phosphoinositide 3-kinase (PI3K) delta by blocking the active binding site of PI3K-delta; this inhibits the signaling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells

              Absorption

              Peak plasma time: 1 hr

              Steady-state reached: ~2-3 days

              Distribution

              Protein bound: 94.5%

              Vd: 28.5 L

              Metabolism

              60% metabolized by liver, with CYP3A4 being the most predominant enzyme involved (94.5%) with minor contribution of CYP3A5, CYP1A2, and CYP2D6

              Elimination

              Terminal half-life: ~10 hr

              Excretion: Feces 67%; urine 25.5% (6.32% unchanged leniolisib)

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              Administration

              Oral Administration

              May take with or without food

              Missed or vomited dose

              • Dose missed by >6 hr: Wait and take next dose at the usual time
              • Vomited dose
                • ≤1 hr after administration: Take as soon as possible
                • >1 hr after administration: Wait and take the next dose at the usual time

              Storage

              Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

              Do not refrigerate

              Store and dispense in original container

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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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              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.