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Onivyde
irinotecan liposomal
Black Box Warnings .
Severe Neutropenia
severe and life-threatening cases, incl. fatal neutropenic sepsis and fatal neutropenic fever, have occurred when used in combo w/ fluorouracil, leucovorin w/ or w/o oxaliplatin; withhold tx if ANC <1500 or neutropenic fever; monitor CBC w/ diff during tx
Severe Diarrhea
severe and life-threatening cases have occurred when used in combo w/ fluorouracil, leucovorin w/ or w/o oxaliplatin; do not admin. to pts w/ bowel obstruction; withhold tx for grades 2-4 diarrhea; admin. loperamide for late diarrhea of any severity; admin. atropine, if not contraindicated, for early diarrhea of any severity
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: not interchangeable w/ other irinotecan- or SN-38-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
pancreatic CA, metastatic
- [first-line tx]
- Dose: 50 mg/m^2/dose IV x1 on day 1 of 14-day cycle; Info: part of multi-drug chemo regimen
- [progressive dz]
- Dose: 70 mg/m^2/dose IV x1 on day 1 of 14-day cycle; Info: start 50 mg/m^2/dose in UGT1A1*28 homozygous allele carriers, may incr. to 70 mg/m^2/dose in subsequent cycles; for pts w/ dz progression after gemcitabine-based tx; part of multi-drug chemo regimen
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: no adjustment; moderate-severe impairment: not defined, caution advised if bilirubin >ULN
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- GI obstruction
- ANC <1500
- pregnancy 1st trimester
- avoid: breastfeeding during tx and x1mo after D/C
- avoid: food w/ lactose
- avoid: high-fat diet
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: female pts of reproductive potential
- caution: male pts of reproductive potential
- caution: Asian pts (risk of incr. drug levels or neutropenia)
- caution: UGT1A1*28 homozygous allele carriers
- caution: pneumotoxic agent use, concurrent
- caution: XRT hx
- caution: bilirubin >ULN
- caution: lung dz
Drug Interactions .
Overview
irinotecan
DNA topoisomerase I inhibitor
- CYP3A4 substrate
- UGT1A1 substrate
- BCRP substrate
- OATP1B1 substrate
- fluid/electrolyte loss
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- atazanavir
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- itraconazole
- ketoconazole
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adagrasib
- apalutamide
- belumosudil
- bosentan
- butalbital
- capivasertib
- carbamazepine
- cenobamate
- ceritinib
- chloramphenicol
- cladribine oral
- clarithromycin
- cobicistat
- dabrafenib
- darunavir
- deferiprone
- dexrazoxane
- efavirenz
- encorafenib
- enzalutamide
- etrasimod
- etravirine
- fexinidazole
- fosphenytoin
- ganciclovir
- gemfibrozil
- idelalisib
- ivosidenib
- lenvatinib
- levoketoconazole
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- magnesium citrate
- mavacamten
- mifepristone
- mitapivat
- mitotane
- modafinil
- nafcillin
- nefazodone
- nelfinavir
- pacritinib
- palifermin
- panitumumab
- penicillamine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimecrolimus topical
- polyethylene glycol
- polyethylene glycol/electrolytes
- posaconazole
- primaquine
- primidone
- probenecid
- rabies vaccine
- radium Ra 223 dichloride
- regorafenib
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- ritonavir
- ropeginterferon alfa-2b
- sodium phosphate rectal
- sodium picosulfate
- sotorasib
- St. John's wort
- sulfate bowel prep
- tipranavir
- tucatinib
- valganciclovir
- voriconazole
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- aprepitant
- asciminib
- asenapine
- atidarsagene autotemcel
- auranofin
- avacopan
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- berotralstat
- betibeglogene autotemcel
- brigatinib
- capmatinib
- chikungunya vaccine
- cidofovir
- ciprofloxacin
- clofazimine
- clozapine
- colchicine
- conivaptan
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cyclosporine
- danazol
- danicopan
- dapsone
- darolutamide
- deferasirox
- deuruxolitinib
- diltiazem
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dronedarone
- duvelisib
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elacestrant
- elivaldogene autotemcel
- eltrombopag
- enasidenib
- erythromycin
- everolimus
- exagamglogene autotemcel
- febuxostat
- fedratinib
- filgrastim (G-CSF)
- fluconazole
- flucytosine
- fluphenazine
- fosamprenavir
- foscarnet
- fostamatinib
- futibatinib
- gilteritinib
- givinostat
- glecaprevir
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- iloperidone
- imatinib
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isavuconazonium
- Japanese encephalitis vaccine
- lazertinib
- lefamulin
- leflunomide
- lenacapavir
- leniolisib
- letermovir
- linezolid
- lovotibeglogene autotemcel
- lumateperone
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- momelotinib
- mycophenolate mofetil
- mycophenolic acid
- netupitant
- nilotinib
- nirogacestat
- olsalazine
- osimertinib
- oteseconazole
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pibrentasvir
- pirtobrutinib
- pneumococcal vaccine
- poliovirus vaccine
- pretomanid
- pyrimethamine
- resmetirom
- respiratory syncytial virus vaccine
- ribavirin
- rituximab
- rucaparib
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selpercatinib
- sipuleucel-T
- sirolimus
- smallpox/mpox vaccine, live
- sparsentan
- stiripentol
- succimer
- sulfasalazine
- telmisartan
- teplizumab
- teriflunomide
- thalidomide
- ticagrelor
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- turmeric
- typhoid vaccine
- upadacitinib
- vadadustat
- valproic acid
- vanzacaftor/tezacaftor/deutivacaftor
- verapamil
- vimseltinib
- voxilaprevir
- zidovudine
Caution Advised
- abatacept
- abrocitinib
- adalimumab
- anakinra
- anifrolumab
- armodafinil
- artemether/lumefantrine
- atracurium
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belzutifan
- betamethasone
- bexarotene
- bimekizumab
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- cisatracurium
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- danshen
- deflazacort
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- dicloxacillin
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- dupilumab
- echinacea
- eculizumab
- efgartigimod alfa
- elafibranor
- elagolix
- emapalumab
- eslicarbazepine acetate
- etanercept
- felbamate
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- garlic
- ginkgo
- ginseng, Asian
- glycerol phenylbutyrate
- golimumab
- griseofulvin
- guselkumab
- hydrocortisone
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- meropenem
- methylprednisolone
- midostaurin
- mirikizumab
- mitoxantrone
- mobocertinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- natalizumab
- nevirapine
- ocrelizumab
- ofatumumab
- olutasidenib
- omaveloxolone
- oxcarbazepine
- ozanimod
- pancuronium
- pegcetacoplan
- perampanel
- pioglitazone
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- rilonacept
- risankizumab
- ritlecitinib
- rocuronium
- rolapitant
- rozanolixizumab
- rufinamide
- secukinumab
- siltuximab
- siponimod
- somatropin
- spesolimab
- succinylcholine
- sutimlimab
- suzetrigine
- tacrolimus
- tafamidis
- tazemetostat
- tecovirimat
- telotristat ethyl
- tezepelumab
- tildrakizumab
- topiramate
- tovorafenib
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vaborbactam
- vamorolone
- vecuronium
- vedolizumab
- vemurafenib
- vilobelimab
- vinblastine
- voclosporin
- vorasidenib
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- anaphylaxis
- angioedema
- neutropenia
- infection, severe
- febrile neutropenia
- neutropenic sepsis
- diarrhea, severe
- interstitial lung dz
- acute renal failure
- embolism
- GI obstruction
- cerebrovascular event
- hemorrhage
- thrombocytopenia
Common Reactions
- anemia
- diarrhea
- lymphopenia
- fatigue
- asthenia
- nausea
- neutropenia
- thrombocytopenia
- vomiting
- appetite decr.
- stomatitis
- abdominal pain
- weight decr.
- alopecia
- fever
- musculoskeletal pain
- peripheral edema
- dehydration
- embolism
- hemorrhage
- rash
- dyspnea
- sepsis
- cholinergic rxn
- hypokalemia
- ALT or AST incr.
- alk phos incr.
Safety/Monitoring .
Monitoring Parameters
CBC w/ diff on day 1 and 8 of each cycle, and more frequently if clinically indicated; consider UGT1A1 genotyping before tx start if progressive dz
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; risk of teratogenicity and embryo-fetal death in 1st trimester based on animal data w/ irinotecan and drug's mechanism of action; inadequate human and animal data available in 2nd and 3rd trimesters
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x7mo after D/C in female pts and by using condoms during tx and x4mo after D/C in male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and x1mo after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 3A4 substrate; UGT: 1A1 substrate; Info: active metabolite
Excretion: urine (11-20% unchanged), bile; Half-life: 25.8h (parent drug), 67.8h (active metabolite)
Subclass: Mitosis Inhibitors, Topoisomerase I Inhibitors
Mechanism of Action
binds to topoisomerase I-DNA complexes, preventing religation of single-strand breaks
Formulary .
No Formulary Selected
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