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Trodelvy (sacituzumab govitecan-hziy)
sacituzumab govitecan
Black Box Warnings .
Neutropenia
severe, life-threatening, or fatal cases may occur; hold tx if ANC <1500/mm^3 on day 1 of cycle, ANC <1000/mm^3 on day 8 of cycle, or febrile neutropenia; monitor CBC with diff during tx; give primary prophylaxis with G-CSF starting 1st tx cycle in all patients with incr. febrile neutropenia risk; initiate antimicrobial tx immediately if febrile neutropenia
Diarrhea
severe cases may occur; hold tx for severe cases until resolved to Grade 1 or less, and reduce subsequent doses; monitor patients with diarrhea, give fluid and electrolytes as needed; at the onset of diarrhea, evaluate for infectious cases and if negative, promptly initiate loperamide
Adult Dosing .
Dosage forms: INJ
Special Note
- [equivalency or interchangeability info]
- Info: not interchangeable with other irinotecan- or SN-38-containing products
- [drug name clarification]
- Info: nonproprietary name = sacituzumab govitecan-hziy
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing including toxicity-related dose adjustments
breast CA, unresectable locally advanced or metastatic
- [ER/PR-negative HER2-negative disease]
- Dose: 10 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 10 mg/kg/dose; Info: for patients who have received at least 2 systemic tx
- [hormone receptor-positive HER2-negative disease]
- Dose: 10 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 10 mg/kg/dose; Info: for patients who have received endocrine-based tx and at least 2 additional systemic tx
urothelial carcinoma, locally advanced or metastatic
- [indication withdrawn in US]
- Info: drug not shown to improve survival in patients with locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemo and PD-1/PD-L1 inhibitor
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin <1.5x ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- ANC <1500 on day 1 of cycle
- ANC <1000 on day 8 of cycle
- avoid: breastfeeding during tx and x1mo after D/C
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: patients 65 yo and older
- caution: UGT1A1*28 allele carriers
Drug Interactions .
Overview
sacituzumab govitecan
DNA topoisomerase I inhibitor
- UGT1A1 substrate
- hypokalemia
- hypophosphatemia
- myelosuppressive oncologic agent
- prolongs QT interval (conditional)
Contraindicated
- pimozide
- thioridazine
Avoid/Use Alternative
- arsenic trioxide
- atazanavir
- bedaquiline
- belumosudil
- butalbital
- capivasertib
- carbamazepine
- chloramphenicol
- cisapride
- cladribine oral
- crizotinib
- deferiprone
- domperidone
- dronedarone
- efavirenz
- ephedra
- erdafitinib
- eribulin
- fexinidazole
- fosfomycin injection
- fosphenytoin
- ganciclovir
- gemfibrozil
- hydroxychloroquine
- ketoconazole
- lefamulin
- lenvatinib
- lonafarnib
- lopinavir/ritonavir
- lorlatinib
- mitapivat
- mobocertinib
- oxcarbazepine
- penicillamine
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- primaquine
- primidone
- probenecid
- quizartinib
- radium Ra 223 dichloride
- regorafenib
- rifampin
- ritonavir
- ropeginterferon alfa-2b
- sorafenib
- sotalol
- tipranavir
- toremifene
- valganciclovir
- valproic acid
- vandetanib
- ziprasidone
Monitor/Modify Tx
- abiraterone acetate
- acetazolamide
- adagrasib
- albendazole
- albuterol
- albuterol inhaled
- alemtuzumab
- allopurinol
- aloe
- amiloride
- amiodarone
- amphotericin
- anagrelide
- anti-thymocyte globulin
- apalutamide
- apomorphine
- arformoterol inhaled
- artemether/lumefantrine
- asenapine
- asparaginase
- atidarsagene autotemcel
- auranofin
- azathioprine
- azithromycin
- balsalazide
- baricitinib
- benznidazole
- betamethasone
- betibeglogene autotemcel
- brexucabtagene autoleucel
- budesonide
- bumetanide
- cabozantinib
- carfilzomib
- ceritinib
- cetuximab
- chloroquine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cidofovir
- cisplatin
- citalopram
- clarithromycin
- clofazimine
- clomipramine
- clozapine
- colchicine
- copper histidinate
- corticotropin
- cortisone
- cyclophosphamide
- dapsone
- decitabine
- deferasirox
- deflazacort
- degarelix
- desflurane
- desipramine
- deuruxolitinib
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexrazoxane
- dichlorphenamide
- dinutuximab
- disopyramide
- dofetilide
- donepezil
- dordaviprone
- droperidol
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- emapalumab
- encorafenib
- epinephrine
- epirubicin
- erythromycin
- ethacrynic acid
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flecainide
- flucytosine
- fludrocortisone
- fluorouracil
- fluphenazine
- formoterol inhaled
- foscarnet
- fostamatinib
- furosemide
- gentamicin
- gilteritinib
- givinostat
- glasdegib
- goserelin
- haloperidol
- histrelin
- hydrochlorothiazide
- hydrocortisone
- hydroxyurea
- hydroxyzine
- ibutilide
- imipramine
- indapamide
- inotuzumab ozogamicin
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isoflurane
- isoproterenol
- ivosidenib
- leflunomide
- lenalidomide
- leuprolide
- levalbuterol inhaled
- levofloxacin
- levoketoconazole
- licorice
- linezolid
- lofexidine
- lovotibeglogene autotemcel
- lymphocyte immune globulin, anti-thymocyte globulin
- macimorelin
- magnesium citrate
- mannitol
- mercaptopurine
- mesalamine
- mesalamine rectal
- methadone
- methazolamide
- methotrexate
- methylprednisolone
- metolazone
- mifepristone
- motixafortide
- moxifloxacin
- mycophenolate mofetil
- mycophenolic acid
- necitumumab
- neomycin
- nilotinib
- oliceridine
- olodaterol inhaled
- olsalazine
- ondansetron
- osilodrostat
- osimertinib
- pacritinib
- paliperidone
- palonosetron
- pamidronate
- panitumumab
- paromomycin
- pasireotide
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- perphenazine
- polyethylene glycol
- polyethylene glycol/electrolytes
- posaconazole
- prednisolone
- prednisone
- procainamide
- proguanil
- propafenone
- protriptyline
- pyrimethamine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- revumenib
- ribavirin
- ribociclib
- rifabutin
- rituximab
- romidepsin
- rucaparib
- ruxolitinib topical
- salmeterol inhaled
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- selinexor
- selpercatinib
- sevoflurane
- sirolimus
- sirolimus albumin-bound
- sodium benzoate
- sodium phenylacetate
- sodium phenylbutyrate
- sodium polystyrene sulfonate
- sodium thiosulfate
- stiripentol
- streptomycin
- succimer
- sulfasalazine
- sulfate bowel prep
- tafasitamab
- tagraxofusp
- taletrectinib
- telavancin
- teplizumab
- terbutaline
- teriflunomide
- tetrabenazine
- thalidomide
- tobramycin
- tocilizumab
- tofacitinib
- topiramate
- torsemide
- tramadol
- triamcinolone
- triamterene
- triclabendazole
- trifluoperazine
- trifluridine
- trimethoprim
- trimipramine
- triptorelin
- upadacitinib
- vamorolone
- vancomycin
- vemurafenib
- venlafaxine
- vilanterol inhaled
- vinblastine
- vincristine
- vinorelbine
- zidovudine
- ziftomenib
- zonisamide
Adverse Reactions .
Serious Reactions
- neutropenia
- anemia
- thrombocytopenia
- febrile neutropenia
- sepsis
- pneumonia
- UTI
- diarrhea, severe
- nausea, severe
- vomiting, severe
- neutropenic colitis
- intestinal perforation
- intestinal obstruction
- hypersensitivity reaction
- anaphylaxis
- infusion reaction
- pleural effusion
- respiratory failure
- acute kidney injury
- hypokalemia
Common Reactions
- neutropenia
- diarrhea
- nausea
- fatigue
- alopecia
- anemia
- constipation
- hypersensitivity reaction
- vomiting
- appetite decr.
- abdominal pain
- cough
- headache
- rash
- dyspnea
- arthralgia
- back pain
- UTI
- pruritus
- fever
- respiratory infection
- stomatitis
- dizziness
- febrile neutropenia
- insomnia
- edema
- dyspepsia
- hypokalemia
- neuropathy
- xeroderma
- dehydration
- dysgeusia
- extremity pain
- lymphocytes decr.
- glucose incr.
- alk phos incr.
- magnesium decr.
- calcium decr.
- ALT or AST incr.
- phosphate decr.
- albumin decr.
- Plt decr.
- potassium decr.
- sodium decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; CBC with diff during tx; signs/symptoms of infusion reaction during and for at least 30min after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available; possible risk of fetal harm, including teratogenicity and embryo-fetal death, based on drug's mechanism of action
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x6mo after D/C in patients of childbearing potential and during tx and x3mo after D/C in male patients
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: for sacituzumab govitecan: catabolism; CYP450: unknown; Info: active drug SN-38 (UGT1A1 substrate)
Excretion: for sacituzumab govitecan: unknown; Half-life: 23.4h (sacituzumab govitecan), 17.6h (SN-38)
Subclass: Immunotherapy, Antibody-Drug Conjugates ; Immunotherapy, TROP-2 Inhibitors ; Mitosis Inhibitors, Topoisomerase I Inhibitors
Mechanism of Action
for sacituzumab govitecan: antibody-drug conjugate binds to trophoblast cell-surface antigen 2 (TROP-2) expressing cells, releases active drug SN-38 intracellularly, which binds to topoisomerase I-DNA complexes, causing DNA damage and apoptosis
Formulary .
No Formulary Selected
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