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Xeloda
capecitabine
Black Box Warnings .
Serious Adverse Reactions Or Death In Patients With Complete DPD Deficiency
test for genetic variants of dihydropyrimidine dehydrogenase (DPYD) prior to initiating unless immediate treatment necessary; avoid use in patients with certain homozygous or compound heterozygous DPYD variants resulting in complete DPD deficiency
Warfarin Drug Interaction
monitor PT/INR frequently in patients receiving concomitant warfarin and adjust warfarin dose accordingly; incr. PT/INR, bleeding, and death reported in patients with and without liver metastases; events occurred several days to months after starting capecitabine and within 1mo after capecitabine D/C
Adult Dosing .
Dosage forms: TAB: 150 mg, 500 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments
stage III colon CA, adjuvant tx
- [monotherapy]
- Dose: 1250 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Max: 8 cycles; Info: give after meals; do not cut/crush/chew tab
- [combo with oxaliplatin-containing regimen]
- Dose: 1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Max: 8 cycles; Info: give after meals; do not cut/crush/chew tab
rectal CA, locally advanced, perioperative tx
- [combo with XRT]
- Dose: 825 mg/m^2/dose PO bid; Info: give after meals; do not cut/crush/chew tab
- [chemo combo tx without XRT]
- Dose: 1250 mg/m^2/dose PO bid; Info: give after meals; do not cut/crush/chew tab
colorectal CA, unresectable or metastatic
- [monotherapy]
- Dose: 1250 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: give after meals; do not cut/crush/chew tab
- [combo with oxaliplatin]
- Dose: 1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: give after meals; do not cut/crush/chew tab
breast CA, advanced or metastatic
- [monotherapy]
- Dose: 1000-1250 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for paclitaxel- and anthracycline-resistant disease; give after meals; do not cut/crush/chew tab
- [combo with docetaxel]
- Dose: 1000-1250 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for anthracycline-resistant disease; give after meals; do not cut/crush/chew tab
- [combo with lapatinib (off-label)]
- Dose: 1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for patients with HER2-positive disease who have received prior tx, including anthracycline, taxane, and trastuzumab; give after meals; do not cut/crush/chew tab
- [combo with neratinib (off-label)]
- Dose: 750 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for patients with HER2-positive disease who have received 2 or more anti-HER2 based regimens; give after meals; do not cut/crush/chew tab
gastric CA
- [unresectable or metastatic disease]
- Dose: 625 mg/m^2/dose PO bid on days 1-21 of 21-day cycle for up to 8 cycles; Alt: 850-1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: part of multi-drug chemo regimen; give after meals; do not cut/crush/chew tab
- [HER2-positive metastatic disease, first-line tx]
- Dose: 1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for patients with gastric or gastroesophageal junction adenocarcinoma; part of multi-drug chemo regimen; give after meals; do not cut/crush/chew tab
esophageal CA
- [unresectable or metastatic disease]
- Dose: 625 mg/m^2/dose PO bid on days 1-21 of 21-day cycle for up to 8 cycles; Alt: 850-1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: part of multi-drug chemo regimen; give after meals; do not cut/crush/chew tab
- [HER2-positive metastatic disease, first-line tx]
- Dose: 1000 mg/m^2/dose PO bid on days 1-14 of 21-day cycle; Info: for patients with gastroesophageal junction adenocarcinoma; part of multi-drug chemo regimen; give after meals; do not cut/crush/chew tab
pancreatic CA, adjuvant tx
- [830 mg/m^2/dose PO bid on days 1-21 of 28-day cycle]
- Max: 6 cycles; Info: give with gemcitabine; give after meals; do not cut/crush/chew tab
renal dosing
- [adjust dose amount]
- CrCl 30-50: decr. usual dose by 25%; CrCl <30: decr. usual dose, amount not defined
- HD/PD: not defined
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
- hypersensitivity to fluorouracil, severe
- dihydropyrimidine dehydrogenase (DPD) deficiency, complete
- pregnancy 1st trimester
- baseline ANC <1500
- baseline Plt <100,000
- avoid: breastfeeding during tx and x1wk after D/C
- caution: pregnancy 2nd trimester
- caution: pregnancy 3rd trimester
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
- caution: elderly patients
- caution: dihydropyrimidine dehydrogenase (DPD) deficiency, partial
- caution: nephrotoxic agent use, concurrent
- caution: renal impairment
- caution: hepatic impairment
- caution: CAD
- caution: bone marrow depression
Drug Interactions .
Overview
capecitabine
pyrimidine analog
- cytidine deaminase substrate
- CYP2C9 inhibitor, weak
- cardiotoxic effects
- immunomodulatory effects
- myelosuppressive oncologic agent
- nephrotoxicity
Contraindicated
- adenovirus vaccine, live
- chikungunya vaccine, live
- cholera vaccine, live
- cidofovir
- 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
- aldesleukin
- allopurinol
- amikacin
- amikacin inhaled
- bosentan
- bumetanide
- cedazuridine
- chloramphenicol
- cladribine oral
- clofarabine
- deferiprone
- dexrazoxane
- epirubicin
- fexinidazole
- foscarnet
- ganciclovir
- gentamicin
- idarubicin
- leucovorin
- levomefolate
- mannitol
- methadone
- methotrexate
- palifermin
- penicillamine
- pentamidine
- polymyxin B
- primaquine
- rabies vaccine
- radium Ra 223 dichloride
- ropeginterferon alfa-2b
- streptomycin
- streptozocin
- tenofovir disoproxil
- tobramycin
- tobramycin inhaled
- valganciclovir
Monitor/Modify Tx
- acyclovir
- adalimumab
- adefovir dipivoxil
- ado-trastuzumab emtansine
- aficamten
- albendazole
- alectinib
- alemtuzumab
- aliskiren
- alogliptin
- amiloride
- amphotericin
- anagrelide
- anthrax immune globulin
- anthrax vaccine
- anti-thymocyte globulin
- asciminib
- aspirin
- atidarsagene autotemcel
- auranofin
- avelumab
- axitinib
- azathioprine
- azilsartan medoxomil
- balsalazide
- baricitinib
- benazepril
- benznidazole
- betibeglogene autotemcel
- bevacizumab
- bezlotoxumab
- binimetinib
- bleomycin
- bortezomib
- bosutinib
- botulism immune globulin
- cabozantinib
- candesartan cilexetil
- captopril
- carboplatin
- carfilzomib
- celecoxib
- certolizumab pegol
- chikungunya vaccine
- chlorothiazide
- chlorthalidone
- cilostazol
- cisplatin
- clindamycin
- clozapine
- cobimetinib
- colchicine
- colistimethate
- copper histidinate
- COVID-19 vaccine
- creatine
- cyclophosphamide
- cyclosporine
- cytomegalovirus immune globulin
- dabrafenib
- dapsone
- daunorubicin
- deferasirox
- deferoxamine
- deuruxolitinib
- diclofenac
- diclofenac topical
- diflunisal
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- doxorubicin
- dronedarone
- ebola vaccine, live
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- enalapril
- enalaprilat
- encorafenib
- entrectinib
- etanercept
- ethacrynic acid
- etodolac
- etuvetidigene autotemcel
- everolimus
- exagamglogene autotemcel
- fam-trastuzumab deruxtecan
- fenoprofen
- filgrastim (G-CSF)
- flucytosine
- fluorouracil
- fluphenazine
- flurbiprofen
- fluvastatin
- fosfomycin injection
- fosinopril
- fosphenytoin
- fostamatinib
- furosemide
- givinostat
- glimepiride
- golimumab
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrochlorothiazide
- hydroxocobalamin IV
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- ibuprofen lysine
- ifosfamide
- imatinib
- immune globulin
- indapamide
- indomethacin
- infliximab
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irbesartan
- itraconazole
- Japanese encephalitis vaccine
- ketoprofen
- ketorolac
- lapatinib
- leflunomide
- lenvatinib
- lifileucel
- linagliptin
- linezolid
- lisinopril
- lithium
- lomustine
- lonafarnib
- losartan
- lovotibeglogene autotemcel
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- magnesium citrate
- magnesium salicylate
- margetuximab
- mavacamten
- meclofenamate
- mefenamic acid
- meloxicam
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- metolazone
- mirdametinib
- mitomycin
- mitoxantrone
- mobocertinib
- moexipril
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- naproxen
- neomycin
- nusinersen
- olmesartan medoxomil
- olsalazine
- osimertinib
- oxaliplatin
- oxaprozin
- pamidronate
- paromomycin
- pazopanib
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- pentostatin
- perindopril
- pertuzumab
- phenytoin
- pioglitazone
- piroxicam
- plazomicin
- pneumococcal vaccine
- poliovirus vaccine
- polyethylene glycol
- polyethylene glycol/electrolytes
- ponatinib
- proguanil
- propafenone
- pyrimethamine
- quinapril
- ramipril
- ramucirumab
- respiratory syncytial virus vaccine
- Rho(D) immune globulin
- ribavirin
- rifabutin
- ripretinib
- rituximab
- rosiglitazone
- ruxolitinib topical
- salsalate
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- saxagliptin
- selumetinib
- sirolimus
- sitagliptin
- smallpox/mpox vaccine, live
- sorafenib
- sparsentan
- spironolactone
- stiripentol
- succimer
- sulfasalazine
- sulfate bowel prep
- sulindac
- sunitinib
- tacrolimus
- telavancin
- telmisartan
- temsirolimus
- tenofovir alafenamide
- teplizumab
- teriflunomide
- thalidomide
- tick-borne encephalitis vaccine
- tiopronin
- tivozanib
- tocilizumab
- tofacitinib
- tolmetin
- torsemide
- trabectedin
- trametinib
- trandolapril
- trastuzumab
- triamterene
- trimethoprim
- typhoid vaccine
- upadacitinib
- vaccinia immune globulin
- valacyclovir
- valproic acid
- valsartan
- vancomycin
- vandetanib
- voclosporin
- warfarin
- willow bark
- zanidatamab
- zenocutuzumab
- zidovudine
- ziv-aflibercept
- zoledronic acid
- zongertinib
- zonisamide
Caution Advised
- folic acid (vitamin B9)
Adverse Reactions .
Serious Reactions
- cardiotoxicity
- diarrhea, severe
- GI toxicity, severe
- enterocolitis, necrotizing
- GI hemorrhage
- dehydration
- nephrotoxicity
- renal failure
- Stevens-Johnson syndrome
- toxic epidermal necrolysis
- hand-foot syndrome
- neutropenia
- lymphopenia
- thrombocytopenia
- anemia
- sepsis
- hypersensitivity reaction
- hyperbilirubinemia
- hepatotoxicity
- toxic leukoencephalopathy
- angioedema
- cutaneous lupus erythematosus
- keratitis
Common Reactions
- hand-foot syndrome
- diarrhea
- nausea
- anemia
- stomatitis
- abdominal pain
- vomiting
- hyperbilirubinemia
- fatigue
- dermatitis
- constipation
- fever
- lymphopenia
- neutropenia
- anorexia
- headache
- dizziness
- edema
- ocular irritation
- asthenia
- lethargy
- alopecia
- dyspnea
- dyspepsia
- pain
- rash
- dysgeusia
- GI disorders
- peripheral neuropathy
- insomnia
- dehydration
- conjunctivitis
- arthralgia
- venous thrombosis
- cough
- skin discoloration
- thrombocytopenia
- epistaxis
- chest pain
- GI hemorrhage
- ileus
Safety/Monitoring .
Monitoring Parameters
pregnancy test, dihydropyrimidine dehydrogenase (DPYD) genotyping at baseline; CBC with diff at baseline, then before each cycle; Cr at baseline, then as clinically indicated; LFTs; signs/symptoms of skin reaction
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 1st trimester, weigh risk/benefit in 2nd and 3rd trimesters; no human data available; risk of teratogenicity and embryo-fetal toxicity in 1st trimester based on animal data at 0.2x recommended human dose and risk of fetal death at 0.6x recommended human dose; risk of fetal harm low in 2nd and 3rd trimesters based on limited human data with fluorouracil
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: for capecitabine: liver, tissues; CYP450: none
Excretion: for capecitabine: urine 95.5% (3% unchanged), feces 2.6%; Half-life: 45min
Subclass: Antimetabolites, Pyrimidine Analogs
Mechanism of Action
for capecitabine: prodrug converted to fluorouracil, which inhibits DNA and RNA synthesis
Formulary .
No Formulary Selected
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