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Calquence
acalabrutinib
Adult Dosing .
Dosage forms: TAB: 100 mg
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; consider holding tx x3-7 days before and after surgery if bleeding risk
mantle cell lymphoma
- [previously untreated dz]
- Dose: 100 mg PO q12h; Info: for pts ineligible for autologous HSCT; part of multi-drug chemo regimen; do not cut/crush/chew tab
- [previously treated dz]
- Dose: 100 mg PO q12h; Info: do not cut/crush/chew tab
CLL/SLL
- [100 mg PO q12h]
- Info: for previously untreated dz, may use w/ obinutuzumab starting 28 days after tx start; do not cut/crush/chew tab
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class C
- avoid: breastfeeding during tx and for at least 2wk after D/C
- caution: pts of childbearing potential
- caution: pts 65 yo and older
- caution: bleeding risk
- caution: arrhythmia hx
- caution: infection, acute
- caution: HTN
- caution: cardiac dz risk
Drug Interactions .
Overview
acalabrutinib
kinase inhibitor
- CYP3A4 substrate
- BCRP inhibitor
- antiplatelet effects
- immunosuppressive oncologic agent
- myelosuppressive oncologic agent
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- adagrasib
- alpelisib
- apalutamide
- atazanavir
- butalbital
- carbamazepine
- ceritinib
- chloramphenicol
- cladribine oral
- clarithromycin
- cobicistat
- deferiprone
- dexrazoxane
- encorafenib
- enoxaparin
- enzalutamide
- etrasimod
- fexinidazole
- fondaparinux
- fosamprenavir
- fosphenytoin
- ganciclovir
- grapefruit
- idelalisib
- itraconazole
- ivosidenib
- ketoconazole
- levoketoconazole
- lonafarnib
- lumacaftor/ivacaftor
- mifepristone
- mitotane
- nefazodone
- nelfinavir
- pacritinib
- palifermin
- pazopanib
- penicillamine
- pentobarbital
- phenobarbital
- phenytoin
- pimecrolimus topical
- posaconazole
- primaquine
- primidone
- rabies vaccine
- radium Ra 223 dichloride
- ribociclib
- rifabutin
- rifampin
- ritonavir
- ropeginterferon alfa-2b
- St. John's wort
- tipranavir
- topotecan
- tucatinib
- valganciclovir
- voriconazole
Monitor/Modify Tx
- abrocitinib
- ado-trastuzumab emtansine
- afatinib
- albendazole
- alemtuzumab
- allopurinol
- alprazolam
- alteplase
- amiodarone
- amlodipine
- anacaulase topical
- anagrelide
- anthrax vaccine
- anti-thymocyte globulin
- antithrombin
- apixaban
- aprepitant
- argatroban
- asciminib
- asenapine
- asparaginase
- aspirin
- atidarsagene autotemcel
- atorvastatin
- auranofin
- avacopan
- avapritinib
- axitinib
- azathioprine
- balsalazide
- baricitinib
- belumosudil
- benznidazole
- berberine
- berotralstat
- betibeglogene autotemcel
- bevacizumab
- bicalutamide
- binimetinib
- bivalirudin
- bosentan
- brentuximab vedotin
- bromelain
- bromfenac ophthalmic
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- capivasertib
- caplacizumab
- carfilzomib
- celecoxib
- cenobamate
- chikungunya vaccine
- chlorzoxazone
- cidofovir
- cilostazol
- cimetidine
- ciprofloxacin
- citalopram
- clofazimine
- clopidogrel
- clotrimazole oropharyngeal
- clozapine
- colchicine
- collagenase clostridium histolyticum
- conivaptan
- COVID-19 vaccine
- cranberry
- crizotinib
- cyclophosphamide
- cyclosporine
- cysteamine
- dabigatran
- dabrafenib
- dalteparin
- danazol
- danshen
- dapsone
- daridorexant
- darunavir
- dasatinib
- deferasirox
- defibrotide
- desvenlafaxine
- deuruxolitinib
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- diflunisal
- diltiazem
- dimethyl fumarate
- diosmin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dipyridamole
- diroximel fumarate
- dronedarone
- duloxetine
- duvelisib
- ebola vaccine, live
- edoxaban
- efavirenz
- efbemalenograstim alfa
- eflapegrastim (G-CSF)
- elivaldogene autotemcel
- entrectinib
- epoprostenol
- eptifibatide
- erlotinib
- erythromycin
- escitalopram
- ethanol
- ethinyl estradiol (contraceptive)
- etodolac
- etravirine
- evening primrose oil
- everolimus
- exagamglogene autotemcel
- fedratinib
- fenoprofen
- fenugreek
- filgrastim (G-CSF)
- flibanserin
- fluconazole
- flucytosine
- fluoxetine
- fluphenazine
- flurbiprofen
- flurbiprofen ophthalmic
- fluvastatin
- fluvoxamine
- fosaprepitant
- foscarnet
- fostamatinib
- fruquintinib
- garlic
- gefitinib
- gemtuzumab ozogamicin
- gepotidacin
- ginkgo
- givinostat
- givosiran
- glecaprevir
- goldenseal
- grazoprevir
- Haemophilus b vaccine
- heparin
- hepatitis A vaccine
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrocortisone
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- iloperidone
- iloprost inhaled
- imatinib
- indomethacin
- influenza H5N1 vaccine
- influenza vaccine
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- isavuconazonium
- isoniazid
- istradefylline
- ivacaftor
- Japanese encephalitis vaccine
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- kratom
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- leflunomide
- lenacapavir
- lenvatinib
- letermovir
- levomilnacipran
- lifileucel
- linezolid
- lomitapide
- lopinavir/ritonavir
- lorlatinib
- lovastatin
- lovotibeglogene autotemcel
- lumateperone
- lurasidone
- lymphocyte immune globulin, anti-thymocyte globulin
- magnesium salicylate
- maribavir
- mavacamten
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- meningococcal vaccine
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methyl salicylate topical
- milnacipran
- mitapivat
- modafinil
- monomethyl fumarate
- mycophenolate mofetil
- mycophenolic acid
- nabumetone
- nafcillin
- naproxen
- nattokinase
- nepafenac ophthalmic
- netupitant
- niacin (vitamin B3)
- nicardipine
- nilotinib
- nintedanib
- nirogacestat
- nusinersen
- olsalazine
- omega-3-acid
- osilodrostat
- oxaliplatin
- oxaprozin
- palbociclib
- paroxetine
- pegaspargase
- pegfilgrastim (G-CSF)
- peginterferon alfa 2a
- peginterferon beta 1a
- penicillin G
- pentamidine
- pentosan polysulfate sodium
- pentoxifylline
- peppermint
- pexidartinib
- pibrentasvir
- piperacillin
- piroxicam
- pirtobrutinib
- pitavastatin
- plasminogen, human
- pneumococcal vaccine
- poliovirus vaccine
- ponatinib
- porfimer
- pralsetinib
- prasugrel
- pravastatin
- proguanil
- pyrimethamine
- quercetin
- ramucirumab
- ranibizumab
- ranolazine
- regorafenib
- remdesivir
- repotrectinib
- respiratory syncytial virus vaccine
- resveratrol
- reteplase
- revakinagene taroretcel
- ribavirin
- rifapentine
- riociguat
- ritlecitinib
- rituximab
- rivaroxaban
- rosuvastatin
- rucaparib
- ruxolitinib topical
- salsalate
- sargramostim (GM-CSF)
- sarilumab
- satralizumab
- saw palmetto
- selpercatinib
- selumetinib
- sertraline
- simvastatin
- sipuleucel-T
- sirolimus
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sorafenib
- sotatercept
- sotorasib
- spironolactone
- stiripentol
- succimer
- sulfasalazine
- sulindac
- sunitinib
- talazoparib
- tenecteplase
- tenofovir alafenamide
- tenofovir disoproxil
- teplizumab
- teriflunomide
- thalidomide
- ticagrelor
- tick-borne encephalitis vaccine
- tirofiban
- tisotumab vedotin
- tivozanib
- tocilizumab
- tofacitinib
- tolmetin
- tolvaptan
- tovorafenib
- trametinib
- trazodone
- treosulfan
- treprostinil
- trimethoprim
- trofinetide
- typhoid vaccine
- ubrogepant
- upadacitinib
- vadadustat
- valproic acid
- vandetanib
- venlafaxine
- verapamil
- vilazodone
- viloxazine
- vinpocetine
- vonoprazan
- vorapaxar
- vortioxetine
- voxelotor
- warfarin
- willow bark
- xanomeline
- zanubrutinib
- zidovudine
- zileuton
- ziv-aflibercept
Caution Advised
- abatacept
- adalimumab
- anakinra
- anifrolumab
- armodafinil
- artemether/lumefantrine
- basiliximab
- beclomethasone inhaled
- beclomethasone nasal
- belatacept
- belimumab
- belzutifan
- betamethasone
- bexarotene
- bimekizumab
- brigatinib
- brodalumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- canakinumab
- certolizumab pegol
- clobazam
- clobetasol ophthalmic
- corticotropin
- cortisone
- crovalimab
- danicopan
- darolutamide
- deflazacort
- deucravacitinib
- dexamethasone
- dexamethasone ophthalmic
- dicloxacillin
- difluprednate ophthalmic
- dupilumab
- echinacea
- eculizumab
- efgartigimod alfa
- elafibranor
- elagolix
- emapalumab
- enasidenib
- eslicarbazepine acetate
- etanercept
- felbamate
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- ginseng, Asian
- glycerol phenylbutyrate
- golimumab
- griseofulvin
- guselkumab
- hydrocortisone ophthalmic
- inebilizumab
- infliximab
- iptacopan
- ixekizumab
- lebrikizumab
- loteprednol ophthalmic
- meropenem
- methylprednisolone
- mirikizumab
- mitoxantrone
- mobocertinib
- mometasone implant
- mometasone inhaled
- mometasone nasal
- nadofaragene firadenovec intravesical
- natalizumab
- nevirapine
- nipocalimab
- ocrelizumab
- odevixibat
- ofatumumab
- olutasidenib
- omaveloxolone
- oxcarbazepine
- ozanimod
- pegcetacoplan
- perampanel
- pioglitazone
- ponesimod
- pozelimab
- prednisolone
- prednisolone ophthalmic
- prednisone
- ravulizumab
- rilonacept
- risankizumab
- rozanolixizumab
- rufinamide
- secukinumab
- seladelpar
- siltuximab
- siponimod
- somatropin
- spesolimab
- sutimlimab
- suzetrigine
- tacrolimus
- tazemetostat
- tecovirimat
- telotristat ethyl
- tezepelumab
- tildrakizumab
- topiramate
- tralokinumab
- triamcinolone
- tuberculin purified protein derivative
- ublituximab
- ustekinumab
- vaborbactam
- vamorolone
- vedolizumab
- vemurafenib
- vilobelimab
- vinblastine
- voclosporin
- vorasidenib
- zilucoplan
Adverse Reactions .
Serious Reactions
- hemorrhage, severe
- thrombocytopenia
- anemia
- neutropenia
- lymphopenia
- infection, serious
- pneumonia
- opportunistic infection
- HBV reactivation
- EBV reactivation
- CMV infection
- PML
- second primary malignancy
- skin CA
- atrial fibrillation
- ventricular arrhythmia
- hepatotoxicity
Common Reactions
- infection
- anemia
- headache
- neutropenia
- diarrhea
- thrombocytopenia
- URI
- fatigue
- rash
- musculoskeletal pain
- ecchymosis
- hemorrhage
- lymphocytosis, transient
- pneumonia
- nausea
- hyperuricemia
- LFTs incr.
- arthralgia
- second primary malignancy
- UTI
- myalgia
- dizziness
- abdominal pain
- constipation
- HSV infection
- vomiting
- atrial fibrillation
- HTN
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; AST/ALT, bilirubin at baseline, then periodically; CBC w/ diff regularly; HR; s/sx bleeding
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, incl. decr. fetal wt and delayed skeletal ossification, based on animal data at 2x or greater systemic exposure, risk of dystocia at 2x or greater systemic exposure
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 1wk after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 2wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver primarily; CYP450: 3A4 substrate; Info: active metabolite
Excretion: feces 84% (<2% unchanged), urine 12% (<2% unchanged); Half-life: 1h (parent drug), 3.5h (active metabolite)
Subclass: Kinase Inhibitors, BTK Inhibitors
Mechanism of Action
forms covalent bond w/ cysteine residue (C481) at Bruton tyrosine kinase (BTK) active site, irreversibly inhibiting BTK activity, incl. B-cell antigen receptor and cytokine receptor pathways, leading to inhibition of malignant B-cell proliferation and tumor growth
Formulary .
No Formulary Selected
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