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Adstiladrin (nadofaragene firadenovec-vncg)
nadofaragene firadenovec intravesical
Adult Dosing .
Dosage forms: SUSPENSION
Special Note
- [drug name clarification]
- Info: nonproprietary name = nadofaragene firadenovec-vncg
- [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
non-muscle invasive bladder CA in situ, BCG-refractory
- [75 mL intravesically q3mo]
- Info: for high-risk patients with or without papillary tumors; consider cystectomy if complete response not achieved after 3mo or disease recurs
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to interferon alfa
- avoid: handling drug (immunocompromised individuals)
- caution: immunocompromised patients
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
nadofaragene firadenovec intravesical
gene therapy
- immunomodulatory infective agent
Avoid/Use Alternative
- infliximab
Monitor/Modify Tx
- mitomycin
Caution Advised
- abatacept
- abrocitinib
- acalabrutinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- atidarsagene autotemcel
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- baricitinib
- basiliximab
- belatacept
- belimumab
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- blinatumomab
- bortezomib
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- budesonide
- budesonide rectal
- busulfan
- cabazitaxel
- canakinumab
- carboplatin
- carfilzomib
- carmustine
- certolizumab pegol
- chlorambucil
- ciltacabtagene autoleucel
- cisplatin
- cladribine injection
- cladribine oral
- clofarabine
- copanlisib
- corticotropin
- cortisone
- crovalimab
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- danicopan
- daratumumab
- daunorubicin
- deflazacort
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dexamethasone
- dimethyl fumarate
- dinutuximab
- diroximel fumarate
- docetaxel
- doxorubicin
- dupilumab
- duvelisib
- eculizumab
- efgartigimod alfa
- elivaldogene autotemcel
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- epirubicin
- eribulin
- etanercept
- etoposide
- etrasimod
- etuvetidigene autotemcel
- everolimus
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- fruquintinib
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocortisone
- hydroxyurea
- ibritumomab tiuxetan
- ibrutinib
- icotrokinra
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- inebilizumab
- inotuzumab ozogamicin
- iptacopan
- irinotecan
- isatuximab
- ixabepilone
- ixekizumab
- lebrikizumab
- leflunomide
- lenalidomide
- lifileucel
- linvoseltamab
- lisocabtagene maraleucel
- lomustine
- loncastuximab tesirine
- lymphocyte immune globulin, anti-thymocyte globulin
- melphalan
- mercaptopurine
- methotrexate
- methylprednisolone
- mirikizumab
- mitoxantrone
- mogamulizumab
- momelotinib
- monomethyl fumarate
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- narsoplimab
- natalizumab
- nelarabine
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxaliplatin
- ozanimod
- paclitaxel
- pacritinib
- pegcetacoplan
- peginterferon alfa 2a
- pentostatin
- pimecrolimus topical
- pirtobrutinib
- polatuzumab vedotin
- ponesimod
- pozelimab
- prednisolone
- prednisone
- procarbazine
- ravulizumab
- regorafenib
- rilonacept
- rilzabrutinib
- risankizumab
- ritlecitinib
- rituximab
- romidepsin
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- selinexor
- sibeprenlimab
- siltuximab
- siponimod
- sirolimus
- sirolimus albumin-bound
- spesolimab
- sulfasalazine
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- temozolomide
- temsirolimus
- teplizumab
- teriflunomide
- thioguanine
- thiotepa
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- trabectedin
- tralokinumab
- triamcinolone
- ublituximab
- upadacitinib
- ustekinumab
- vamorolone
- vedolizumab
- venetoclax
- vilobelimab
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- disseminated adenovirus infection risk (immunocompromised patients)
- hematuria
Common Reactions
- instillation site discharge
- fatigue
- bladder spasm
- urinary urgency
- hematuria
- rigors
- dysuria
- fever
- glucose incr.
- triglycerides incr.
- Cr incr.
- phosphate decr.
- Hgb decr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
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
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for nadofaragene firadenovec: other; CYP450: unknown
Excretion: for nadofaragene firadenovec: unknown; Half-life: unknown
Subclass: Gene Therapy, Interferons
Mechanism of Action
for nadofaragene firadenovec: delivers copy of human interferon alfa-2b (IFNa2b) gene via adenoviral vector to bladder urothelium, leading to transient local expression of IFNa2b protein
Formulary .
No Formulary Selected
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