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Avgemsi
gemcitabine
Adult Dosing .
Dosage forms: INJ
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing incl. toxicity-related dose adjustments
ovarian CA, advanced
- [1000 mg/m^2/dose IV x1 on days 1, 8 of 21-day cycle]
- Info: for platinum-refractory dz; use w/ carboplatin
breast CA, metastatic
- [1250 mg/m^2/dose IV x1 on days 1, 8 of 21-day cycle]
- Info: for anthracycline-refractory dz; use w/ paclitaxel
non-small cell lung CA, locally advanced or metastatic
- [1000 mg/m^2/dose IV x1 on days 1, 8, 15 of 28-day cycle]
- Alt: 1250 mg/m^2/dose IV x1 on days 1, 8 of 21-day cycle; Info: use w/ cisplatin
pancreatic CA, locally advanced or metastatic
- [1000 mg/m^2/dose IV x1 on days 1, 8, 15 of 28-day cycle, starting cycle 2]
- Start: 1000 mg/m^2/dose IV x1 on days 1, 8, 15, 22, 29, 36, 43 of 56-day cycle for cycle 1
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- XRT w/in 7 days
- pregnancy 1st trimester
- avoid: breastfeeding during tx and for at least 7 days after D/C
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: pts of childbearing potential
- caution: male pts of reproductive potential
- caution: elderly pts
- caution: XRT hx
- caution: renal impairment
- caution: hepatic impairment
- caution: hepatic metastases
- caution: alcoholism
- caution: myelosuppression
Drug Interactions .
Overview
gemcitabine
pyrimidine analog
- cytidine deaminase substrate
- CNT3 inhibitor
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
Avoid/Use Alternative
- adenovirus vaccine, live
- cedazuridine
- chikungunya vaccine, live
- chloramphenicol
- cholera vaccine, live
- cladribine oral
- deferiprone
- dengue vaccine, live
- dexrazoxane
- fexinidazole
- ganciclovir
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- palifermin
- penicillamine
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- rotavirus vaccine, live
- smallpox vaccine, live
- typhoid vaccine, live
- valganciclovir
- varicella vaccine, live
- yellow fever vaccine, live
Monitor/Modify Tx
- albendazole
- alemtuzumab
- allopurinol
- anthrax vaccine
- anti-thymocyte globulin
- asenapine
- atidarsagene autotemcel
- auranofin
- azathioprine
- balsalazide
- baricitinib
- benznidazole
- betibeglogene autotemcel
- 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
- iloperidone
- 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
- neutropenia
- thrombocytopenia
- anemia
- hemorrhage
- infection, severe
- pneumonitis, interstitial
- pulmonary fibrosis
- ARDS
- hepatic failure
- hemolytic uremic syndrome
- thrombotic microangiopathy
- renal failure
- capillary leak syndrome
- posterior reversible encephalopathy syndrome
- vasculitis
- radiation recall rxn
- skin rxn, severe
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- drug rxn w/ eosinophilia and systemic sx
- acute generalized exanthematous pustulosis
- anaphylaxis
Common Reactions
- nausea
- vomiting
- proteinuria
- fever
- hematuria
- rash
- neutropenia
- dyspnea
- peripheral edema
- diarrhea
- influenza-like sx
- hemorrhage
- infection
- BUN or Cr elevated
- alopecia
- edema
- stomatitis
- somnolence
- paresthesia
- LFTs elevated
- alk phos elevated
- anemia
- thrombocytopenia
- injection site rxn
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; BUN/Cr, LFTs at baseline, then periodically; CBC w/ diff prior to each dose
Look/Sound-Alike Drug Names
gemcitabine confused with: gemtuzumab ozogamicin
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; risk of fetal harm low in 2nd and 3rd trimesters based on limited human data; possible risk of decr. birth wt and pancytopenia based on limited human data w/ cytarabine
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x6mo after D/C in pts of childbearing potential and during tx and x3mo after D/C in male pts
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 7 days 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 (<10% unchanged); Half-life: 0.5-10h (parent drug), 1.7-19.4h (metabolite)
Subclass: Antimetabolites, Pyrimidine Analogs
Mechanism of Action
inhibits DNA synthesis
Formulary .
No Formulary Selected
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