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Inlexzo
gemcitabine intravesical
Adult Dosing .
Dosage forms: INSERT: 225 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing
non-muscle invasive bladder CA in situ, BCG-unresponsive
- [225 mg intravesically q3wk for up to 6mo, then q12wk for up to 18mo]
- Info: for patients w/ or w/o papillary tumors; maintain adequate fluids intake of 1500 mL/day; remove insert after each 3wk indwelling period
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
- bladder perforation
- pregnancy 1st trimester
- avoid: breastfeeding during tx and x1wk after D/C
- avoid: urine contact w/ skin during indwelling period
- caution: MRI, concurrent
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
gemcitabine
pyrimidine analog
- cytidine deaminase substrate
- immunomodulatory effects
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- chloramphenicol
- cladribine oral
- deferiprone
- dexrazoxane
- fexinidazole
- ganciclovir
- palifermin
- penicillamine
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- valganciclovir
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- asenapine
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- cedazuridine
- chikungunya vaccine
- cidofovir
- clozapine
- colchicine
- COVID-19 vaccine
- cyclophosphamide
- dapsone
- deferasirox
- deuruxolitinib
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- everolimus
- exagamglogene autotemcel
- filgrastim (G-CSF)
- flucytosine
- fluphenazine
- foscarnet
- fostamatinib
- givinostat
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydroxychloroquine
- hydroxyurea
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- Japanese encephalitis vaccine
- leflunomide
- linezolid
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- lymphocyte immune globulin, anti-thymocyte globulin
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- mycophenolate mofetil
- mycophenolic acid
- olsalazine
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pentamidine
- pneumococcal vaccine
- poliovirus vaccine
- proguanil
- pyrimethamine
- respiratory syncytial virus vaccine
- ribavirin
- rifabutin
- rituximab
- ruxolitinib topical
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- sirolimus
- smallpox/mpox vaccine, live
- stiripentol
- succimer
- sulfasalazine
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tocilizumab
- tofacitinib
- trimethoprim
- typhoid vaccine
- upadacitinib
- valproic acid
- vancomycin
- zidovudine
Adverse Reactions .
Serious Reactions
- UTI
- hematuria
- pneumonia
- urinary tract pain
Common Reactions
- urinary frequency
- UTI
- dysuria
- micturition urgency
- urinary tract pain
- hematuria
- bladder irritation
- Hgb decr.
- lipase incr.
- lymphocytes decr.
- Cr incr.
- potassium incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; bladder eval prior to intravesical instillation
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; risk of fetal harm, incl. teratogenicity, in 1st trimester based on animal data at 0.002x and 0.005x recommended human dose w/ systemically absorbed gemcitabine and drug's mechanism of action; risk of fetal harm low in 2nd and 3rd trimesters based on limited human data w/ systemically absorbed gemcitabine
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 x1wk after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: intracellular; CYP450: unknown; Info: active metabolite
Excretion: urine; Half-life: unknown
Subclass: Antimetabolites, Pyrimidine Analogs
Mechanism of Action
inhibits DNA synthesis
Formulary .
No Formulary Selected
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