irinotecan liposomal (Rx)

Brand and Other Names:Onivyde
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

liposomal dispersion for injection

  • 43mg/10mL single-dose vial

Pancreatic Cancer

Indicated, in combination with fluorouracil and leucovorin, for metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy

Administer irinotecan liposomal prior to leucovorin and fluorouracil

70 mg/m² IV infused over 90 min q2wk

Premedicate with a corticosteroid and an antiemetic agent 30 min before irinotecan liposomal infusion (see Administration)

Dosage Modifications

Patients known to be homozygous for the UGT1A1*28 allele: 50 mg/m² IV infused over 90 min q2wk; increase dose to 70 mg/m² as tolerated in subsequent cycles

Serum bilirubin >ULN: No recommended dose

Interstitial lung disease: Discontinue drug

Anaphylactic reaction: Discontinue drug

Grade 3 or 4 adverse reactions

  • Withhold dose
  • Upon recovery to ≤grade 1, resume dose at:
    • First occurrence: Resume dose at 50 mg/m² or 43 mg/m² (patients homozygous for UGT1A1*28 without previous increase to 70 mg/m²)
    • Second occurrence: Resume dose at 43 mg/m² or 35 mg/m² (patients homozygous for UGT1A1*28 without previous increase to 70 mg/m²)
    • Third occurrence: Discontinue drug
  • Diarrhea
    • Withhold dose
    • Initiate loperamide for late-onset diarrhea of any severity
    • Administer IV or SC atropine 0.25-1 mg (unless clinically contraindicated) for early-onset diarrhea of any severity
    • Upon recovery to ≤grade 1, resume dose as described above

Dosing Considerations

Limitations of use: Not indicated as a single agent

Do not substitute irinotecan liposomal for other drugs containing irinotecan

Small Cell Lung Cancer (Orphan)

Orphan designation for treatment of small cell lung cancer

Sponsor

  • Ipsen Bioscience, Inc; 650 East Kendall Street; Cambridge, Massachusetts 02142

Safety and efficacy not established

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Interactions

Interaction Checker

and irinotecan liposomal

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      Serious - Use Alternative

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            Contraindicated (11)

            • carbamazepine

              carbamazepine will decrease the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Contraindicated.

            • clozapine

              irinotecan liposomal, clozapine. Either increases toxicity of the other by Other (see comment). Contraindicated. Comment: Concomitant administration increases risk of agranulocytosis.

              clozapine, irinotecan liposomal. Either increases toxicity of the other by Other (see comment). Contraindicated. Comment: Concomitant administraiton increases risk of agranulocytosis.

            • cobicistat

              cobicistat will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. UGT1A1 inhibitors decrease irinotecan metabolism

            • conivaptan

              conivaptan will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • darunavir

              darunavir will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • fosamprenavir

              fosamprenavir will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • indinavir

              indinavir will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Contraindicated.

            • itraconazole

              itraconazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Contraindicated during and 2 weeks after itraconazole treatment. Strong CYP3A4 Inhibitors may increase the serum concentration of SN-38 (active metabolite for irinotecan products).

            • lopinavir

              lopinavir will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • rifampin

              rifampin will decrease the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Contraindicated.

            • ritonavir

              ritonavir will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Contraindicated.

            Serious - Use Alternative (64)

            • abametapir

              abametapir will increase the level or effect of irinotecan liposomal 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.

            • adenovirus types 4 and 7 live, oral

              irinotecan liposomal decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

            • apalutamide

              apalutamide will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • armodafinil

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

            • atazanavir

              atazanavir will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

              atazanavir will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • bosentan

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

            • carbamazepine

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

            • chloramphenicol

              chloramphenicol will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • cimetidine

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

            • clarithromycin

              clarithromycin will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

              clarithromycin will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • clobazam

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

            • crizotinib

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

            • dasabuvir

              dasabuvir will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • efavirenz

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

            • eliglustat

              eliglustat increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the P-gp substrate and titrate to clinical effect.

            • enzalutamide

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

            • erdafitinib

              erdafitinib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

            • erythromycin base

              erythromycin base will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • eslicarbazepine acetate

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

            • etravirine

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

            • fexinidazole

              fexinidazole will decrease the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Avoid or Use Alternate Drug. Coadministration may decrease plasma concentrations of CYP2B6 substrates owing to fexinidazole inducing CYP2B6.

              fexinidazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fosphenytoin

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

            • gemfibrozil

              gemfibrozil will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • idelalisib

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

            • indinavir

              indinavir will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

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

            • influenza virus vaccine quadrivalent, adjuvanted

              irinotecan liposomal decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • influenza virus vaccine trivalent, adjuvanted

              irinotecan liposomal decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

            • isoniazid

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

            • ivosidenib

              ivosidenib will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

              ketoconazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • lasmiditan

              lasmiditan increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • mifepristone

              mifepristone will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • milk thistle

              milk thistle will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • mitotane

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

            • modafinil

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

            • nafcillin

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

            • nefazodone

              nefazodone will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

              nefazodone will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • nelfinavir

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

            • nevirapine

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

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of irinotecan liposomal by decreasing metabolism. Avoid or Use Alternate Drug. UGT1A1 inhibitors decrease irinotecan metabolism

            • oxcarbazepine

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

            • palifermin

              palifermin increases toxicity of irinotecan liposomal by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • phenobarbital

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

            • phenytoin

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

            • posaconazole

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

            • primidone

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

            • rifabutin

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

            • rifampin

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

            • rifapentine

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

            • ritonavir

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

            • saquinavir

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

            • sertraline

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

            • tepotinib

              tepotinib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • tetracycline

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

            • ticagrelor

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

            • tipranavir

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

            • tucatinib

              tucatinib will increase the level or effect of irinotecan liposomal 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.

            • verapamil

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

            • voriconazole

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

            • voxelotor

              voxelotor will increase the level or effect of irinotecan liposomal 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.

            • zileuton

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

            Monitor Closely (85)

            • amiodarone

              amiodarone will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              amiodarone will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • apalutamide

              apalutamide will decrease the level or effect of irinotecan liposomal by increasing elimination. Use Caution/Monitor. Apalutamide induces UGT and weakly induces BCRP and may decrease systemic exposure of drugs that are substrates of both UGT and BCRP.

            • aprepitant

              aprepitant will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • atorvastatin

              atorvastatin will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • belzutifan

              belzutifan will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • berotralstat

              berotralstat will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • bevacizumab

              bevacizumab, irinotecan liposomal. Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of diarrhea and neutropenia during concomitant administration of bevacizumab and irinotecan.

            • bicalutamide

              bicalutamide will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • bosutinib

              bosutinib increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • cenobamate

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

            • ceritinib

              ceritinib will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • cholera vaccine

              irinotecan liposomal decreases effects of cholera vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • clotrimazole

              clotrimazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • cyclosporine

              cyclosporine will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              cyclosporine will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • dabrafenib

              dabrafenib will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • dengue vaccine

              irinotecan liposomal 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.

            • denosumab

              irinotecan liposomal, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • desipramine

              desipramine will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dexamethasone

              dexamethasone will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • diltiazem

              diltiazem will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              dronedarone will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • duvelisib

              duvelisib will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Coadministration with duvelisib increases AUC of a sensitive CYP3A4 substrate which may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitor for signs of toxicities of the coadministered sensitive CYP3A substrate.

            • elagolix

              elagolix will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              elagolix decreases levels of irinotecan liposomal 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.

            • eluxadoline

              eluxadoline increases levels of irinotecan liposomal by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered BCRP substrates.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, irinotecan liposomal. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • erythromycin base

              erythromycin base will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • fedratinib

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

            • fingolimod

              irinotecan liposomal increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • fluconazole

              fluconazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fluvoxamine

              fluvoxamine will increase the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor.

            • fostamatinib

              fostamatinib will increase the level or effect of irinotecan liposomal by Other (see comment). Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp/BCRP substrate drugs. Monitor for toxicities of P-gp/BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.

            • fostemsavir

              fostemsavir will increase the level or effect of irinotecan liposomal by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • hydroxyurea

              irinotecan liposomal, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

            • imatinib

              imatinib will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of irinotecan liposomal 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.

              istradefylline will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • ivacaftor

              ivacaftor increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Ivacaftor and its M1 metabolite has the potential to inhibit P-gp; may significantly increase systemic exposure to sensitive P-gp substrates with a narrow therapeutic index.

            • ketoconazole

              ketoconazole will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • lapatinib

              lapatinib will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              lapatinib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • lemborexant

              lemborexant will decrease the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Modify Therapy/Monitor Closely. Monitor CYP2B6 substrate for adequate clinical response. Consider increasing the CYP2B6 substrate dose according to specific prescribing recommendations.

            • lomitapide

              lomitapide increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing dose when used concomitantly with lomitapide.

            • lonafarnib

              lonafarnib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • lorlatinib

              lorlatinib will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lumacaftor/ivacaftor

              lumacaftor/ivacaftor, irinotecan liposomal. affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor. In vitro studies suggest that lumacaftor may induce and ivacaftor may inhibit CYP2B6 substrates. .

            • meningococcal group B vaccine

              irinotecan liposomal decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

            • mifepristone

              mifepristone will increase the level or effect of irinotecan liposomal by affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor.

            • nicardipine

              nicardipine will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nifedipine

              nifedipine will decrease the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • ofatumumab SC

              ofatumumab SC, irinotecan liposomal. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • olaparib

              irinotecan liposomal and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

            • osimertinib

              osimertinib will increase the level or effect of irinotecan liposomal by Other (see comment). Modify Therapy/Monitor Closely. Osimertinib is an inhibitor of BCRP transport. Caution if coadministered with sensitive BCRP substrates.

            • pentobarbital

              pentobarbital will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ponatinib

              ponatinib increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              ponatinib increases levels of irinotecan liposomal by Other (see comment). Use Caution/Monitor.

            • ranolazine

              ranolazine will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • regorafenib

              regorafenib will increase the level or effect of irinotecan liposomal by decreasing metabolism. Use Caution/Monitor. Regorafenib may inhibit UGT1A1-mediated metabolism of irinotican and its metabolite

              regorafenib will increase the level or effect of irinotecan liposomal by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

            • ribociclib

              ribociclib will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. UGT1A1 inhibitors decrease irinotecan metabolism

            • rifampin

              rifampin will decrease the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • rolapitant

              rolapitant will increase the level or effect of irinotecan liposomal by Other (see comment). Use Caution/Monitor. Oral rolapitant (BCRP inhibitor) may increase plasma concentrations of BCRP substrates and may result in potential adverse reactions. Monitor possible adverse reactions if concomitant use of BCRP substrates and rolapitant can not be avoided.

            • rucaparib

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

            • sarecycline

              sarecycline will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • schisandra

              schisandra will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • simvastatin

              simvastatin will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • siponimod

              siponimod and irinotecan liposomal 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.

            • sipuleucel-T

              irinotecan liposomal decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sirolimus

              sirolimus will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • sorafenib

              sorafenib increases levels of irinotecan liposomal by Other (see comment). Use Caution/Monitor. Comment: Competition for UGT1A1 pathway.

            • stiripentol

              stiripentol, irinotecan liposomal. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

              stiripentol will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • tacrolimus

              tacrolimus will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tazemetostat

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

            • tecovirimat

              tecovirimat will decrease the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • teniposide

              teniposide will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tesamorelin

              tesamorelin will decrease the level or effect of irinotecan liposomal by altering metabolism. Use Caution/Monitor. Avoid combo. Consider discontinuation of tesamelin at least 2 weeks before initiating irinotecan therapy.

            • tolvaptan

              tolvaptan will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, irinotecan liposomal. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, irinotecan liposomal. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

            • trazodone

              trazodone will decrease the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • tucatinib

              tucatinib will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • vemurafenib

              vemurafenib increases levels of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • verapamil

              verapamil will increase the level or effect of irinotecan liposomal by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            Minor (7)

            • haloperidol

              haloperidol will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • iloperidone

              iloperidone increases levels of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4.

            • metronidazole

              metronidazole will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • netupitant/palonosetron

              netupitant/palonosetron will increase the level or effect of irinotecan liposomal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • valerian

              valerian will increase the level or effect of irinotecan liposomal by decreasing metabolism. Minor/Significance Unknown. UGT1A1 inhibitors decrease irinotecan metabolism

            • vitamin A

              vitamin A, irinotecan liposomal. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

            • vitamin E

              vitamin E, irinotecan liposomal. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.

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            Adverse Effects

            >10%

            Diarrhea, grades 1-4 (59%)

            Fatigue/asthenia, grades 1-4 (56%)

            Vomiting, grades 1-4 (52%)

            Nausea, grades 1-4 (51%)

            Decreased appetite, grades 1-4 (44%)

            Late diarrhea, grades 1-4 (43%)

            Stomatitis, grades 1-4 (32%)

            Early diarrhea, grades 1-4 (30%)

            Lymphopenia, grades 3-4 (27%)

            Pyrexia, grades 1-4 (23%)

            Fatigue/asthenia, grades 3-4 (21%)

            Neutropenia, grades 3-4 (20%)

            Weight loss, grades 1-4 (17%)

            Alopecia, grades 1-4 (14%)

            Diarrhea, grades 3-4 (13%)

            Vomiting, grades 3-4 (11%)

            1-10%

            Early diarrhea, grades 3-4 (9%)

            Nausea, grades 3-4 (8%)

            Dehydration (4-8%)

            Anemia, grades 3-4 (6%)

            Increased ALT, grades 3-4 (6%)

            Hyponatremia, grades 3-4 (5%)

            Cholinergic reactions, other than diarrhea (4.5%)

            Decreased appetite, grades 3-4 (4%)

            Stomatitis, grades 3-4 (4%)

            Hypophosphatemia, grades 3-4 (4%)

            Late diarrhea, grades 3-4 (3%)

            Sepsis (3-4%)

            Neutropenic fever/neutropenic sepsis (3%)

            Gastroenteritis (3%)

            IV catheter-related infection (3%)

            Infusion reactions (3%)

            Pyrexia, grades 3-4 (2%)

            Weight loss, grades 3-4 (2%)

            Thrombocytopenia, grades 3-4 (2%)

            Hypoalbuminemia, grades 3-4 (2%)

            Hypokalemia, grades 3-4 (2%)

            Hypocalcemia, grades 3-4 (1%)

            Alopecia, grades 3-4 (1%)

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            Warnings

            Black Box Warnings

            Neutropenic sepsis

            • Fatal neutropenic sepsis occurred in 0.8% of patients receiving irinotecan liposomal
            • Severe or life-threatening neutropenic fever or sepsis occurred in 3% and severe or life-threatening neutropenia occurred in 20% of patients receiving irinotecan liposomal in combination with fluorouracil and leucovorin
            • Withhold drug for absolute neutrophil count <1500/mm³ or neutropenic fever
            • Monitor blood cell counts periodically during treatment

            Diarrhea

            • Severe diarrhea occurred in 13% of patients receiving irinotecan liposomal in combination with fluorouracil and leucovorin
            • Do not administer to patients with bowel obstruction
            • Withhold for diarrhea of grade 2-4 severity (see Dosage Modifications)
            • Administer loperamide for late-onset diarrhea of any severity
            • Administer atropine, if not contraindicated, for early-onset diarrhea of any severity

            Contraindications

            Hypersensitivity

            Cautions

            Can cause severe or life-threatening neutropenia and fatal neutropenic sepsis (see Black Box Warnings)

            Can cause severe and life-threatening diarrhea; do not administer to patients with bowel obstruction (see Black Box Warnings)

            Can cause severe and fatal interstitial lung disease; withhold drug in patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation

            Severe hypersensitivity reactions may occur, including anaphylaxis; permanently discontinue if a severe hypersensitivity reaction occurs

            Based on animal data with irinotecan HCl and the mechanism of action of irinotecan liposomal, can cause fetal harm when administered to a pregnant woman (see Pregnancy)

            Strong CYP3A4 inducers are known to substantially decrease systemic exposure to irinotecan or its active metabolite, SN-38

            Strong CYP3A4 or UGT1A1 inhibitors have shown to increase systemic exposure to irinotecan or its active metabolite, SN-38

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            Pregnancy

            Pregnancy

            Based on animal data with irinotecan HCl and the mechanism of action of irinotecan liposomal, can cause fetal harm when administered to a pregnant woman

            Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the final dose

            Embryotoxicity and teratogenicity were observed following treatment with irinotecan HCl, at doses resulting in irinotecan exposures lower than those achieved with irinotecan liposomal 70 mg/m² in humans, when administered to pregnant rats and rabbits during organogenesis

            Male reproductive recommendations

            • Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment and for 4 months after the final dose

            Lactation

            Unknown if distributed in human breast milk

            Because of the potential for serious adverse reactions in breastfed infants from irinotecan liposomal, advise a nursing woman not to breastfeed during treatment with and for 1 month after the final 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

            Binds to topoisomerase-1

            Topoisomerase-1 relieves torsional strain in DNA by inducing single-strand breaks

            Irinotecan and its active metabolite SN-38 bind reversibly to the topoisomerase-1 DNA complex and prevent re-ligation of the single-strand breaks, leading to exposure time-dependent double-strand DNA damage and cell death

            Absorption

            Peak plasma concentration: 37.2 mcg/mL; 5.4 ng/mL (SN-38)

            AUC: 1364 h·mcg/mL; 620 h·mcg/mL (SN-3

            Distribution

            Vd: 4.1 L; 95% remains encapsulated

            Metabolism

            Metabolism of irinotecan liposome has not been evaluated

            Irinotecan is subject to extensive metabolic conversion by various enzyme systems, including esterases to form the active metabolite SN-38, and UGT1A1 mediating glucuronidation of SN-38 to form the inactive glucuronide metabolite SN-38G

            Irinotecan can also undergo CYP3A4-mediated oxidative metabolism to several inactive oxidation products, one of which can be hydrolyzed by carboxylesterase to release SN-38

            Elimination

            Half-life: 25.8 hr; 67.8 hr (SN-38)

            Clearance: 0.2 L/hr

            Excretion: 11-20% urine (SN-38 <1%); 25-50% cumulative biliary and urinary (parent drug and metabolites over 48 hr

            Pharmacogenomics

            Homozygous for UGT1A1*28 allele

            • Individuals who are homozygous for the UGT1A1*28 allele are at increased risk for neutropenia from irinotecan HCL
            • In clinical trials, patients homozygous for the UGT1A1*28 allele (N=7) were initiated on irinotecan liposomal (Onivyde) at a reduced dose of 50 mg/m² in combination with 5-fluorouracil/leucovorin
            • The frequency of grade 3 or 4 neutropenia in these patients (2 of 7 [28.6%]) was similar to the frequency in patients not homozygous for the UGT1A1*28 allele who received a starting dose of irinotecan liposomal of 70 mg/m² (30 of 110 [27.3%])
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            Administration

            IV Compatibilities

            Dextrose 5% water

            0.9% NaCl

            IV Preparation

            Withdraw the calculated volume for dose from the vial

            Dilute in 500 mL D5W or 0.9% NaCl and mix diluted solution by gentle inversion

            Protect diluted solution from light

            Administer diluted solution within 4 hr of preparation when stored at room temperature or within 24 hr of preparation when stored under refrigerated conditions

            IV Administration

            Allow diluted solution to come to room temperature prior to administration if stored under refrigeration

            Premedicate with a corticosteroid and an antiemetic 30 minutes before administering irinotecan liposomal

            Infuse diluted solution IV over 90 minutes

            Do not use in-line filters

            Discard unused portion

            Storage

            Cytotoxic drug; follow applicable special handling and disposal procedures

            Unopened vials

            • Store vials refrigerated at 2-8ºC (36-46°F)
            • Do not freeze
            • Protect from light

            Diluted solution

            • Administer diluted solution within 4 hr of preparation when stored at room temperature or within 24 hr of preparation when stored under refrigerated conditions (2-8ºC [36-46ºF])
            • Protect diluted solution from light
            • Allow diluted solution to come to room temperature prior to administration
            • Do not freeze
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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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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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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.