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Cibinqo
abrocitinib
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; screen for latent TB infection before and during abrocitinib tx; initiate anti-TB tx before abrocitinib tx; avoid use in patients with active, serious infection, including localized infections; weigh risk/benefit in patients with chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx, including TB development in patients with negative TB test; D/C abrocitinib if serious infection develops
Mortality
higher rate of mortality, including sudden cardiovascular death, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; abrocitinib not approved for use in RA patients
Malignancies
malignancies occurred in patients treated with abrocitinib; lymphoma and other malignancies observed in patients treated with JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; abrocitinib not approved for use in RA patients
Major Adverse Cardiovascular Events
major adverse cardiovascular events occurred in patients treated with abrocitinib; higher rate of major adverse cardiovascular events, including cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C abrocitinib in patients that experienced MI or stroke; abrocitinib not approved for use in RA patients
Thrombosis
thrombosis, including DVT, PE, and arterial thrombosis have occurred in patients treated with abrocitinib and other JAK inhibitors for inflammatory conditions; many adverse events were serious, sometimes fatal; higher rate of thrombosis observed in RA patients 50 yo and older with at least 1 cardiovascular risk factor on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid abrocitinib in patients with thrombosis risk; D/C abrocitinib and promptly evaluate patients with thrombosis symptoms; abrocitinib not approved for use in RA patients
Adult Dosing .
Dosage forms: TAB: 50 mg, 100 mg, 200 mg
atopic dermatitis, moderate-severe refractory
- [100-200 mg PO qd]
- Start: 100 mg PO qd, then may incr. to 200 mg PO qd; Info: use lowest effective dose; decr. dose 50% in CYP2C19 poor metabolizers; do not cut/crush/chew tab; see pkg insert for toxicity-related D/C recommendations; D/C if inadequate response with dose incr.
renal dosing
- [see below]
- eGFR 30-59: start 50 mg qd, then may incr. to 100 mg qd; eGFR <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 50 mg, 100 mg, 200 mg
atopic dermatitis, moderate-severe refractory
- [12 yo and older, >25 kg]
- Dose: 100-200 mg PO qd; Start: 100 mg PO qd, then may incr. to 200 mg PO qd; Info: use lowest effective dose; decr. dose 50% in CYP2C19 poor metabolizers; do not cut/crush/chew tab; see pkg insert for toxicity-related D/C recommendations; D/C if inadequate response with dose incr.
renal dosing
- [see below]
- eGFR 30-59: start 50 mg qd, then may incr. to 100 mg qd; eGFR <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- baseline Plt <150,000
- baseline lymphocytes <500
- baseline ANC <1000
- baseline Hgb <8
- eGFR <30
- infection, active
- TB infection, active
- thrombosis risk
- avoid: breastfeeding during tx and x1 day after D/C
- caution: patients >65 yo
- caution: CYP2C19 poor metabolizers
- caution: smokers
- caution: past smokers
- caution: eGFR 30-59
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: residents of area with endemic TB
- caution: residents of area with endemic mycosis
- caution: travelers in area with endemic TB
- caution: travelers in area with endemic mycosis
- caution: herpes zoster history
- caution: HBV infection
- caution: HBV infection history
- caution: HCV infection
- caution: malignancy
- caution: cardiovascular disease
- caution: cardiovascular disease risk
Drug Interactions .
Overview
abrocitinib
JAK inhibitor
- CYP2C9 substrate
- CYP2C19 substrate
- P-gp inhibitor, weak
- antiplatelet effects
- immunomodulatory effects
- thrombogenic effects
Contraindicated
- adenovirus vaccine, live
- anagrelide
- aspirin
- BCG live intravesical
- cangrelor
- caplacizumab
- chikungunya vaccine, live
- cholera vaccine, live
- cilostazol
- clopidogrel
- colchicine
- dengue vaccine, live
- dipyridamole
- eptifibatide
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- prasugrel
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- ticagrelor
- tirofiban
- typhoid vaccine, live
- varicella vaccine, live
- vorapaxar
- yellow fever vaccine, live
Avoid/Use Alternative
- abatacept
- adagrasib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- amiodarone
- anakinra
- anifrolumab
- anti-thymocyte globulin
- apalutamide
- apixaban
- asciminib
- axicabtagene ciloleucel
- azathioprine
- baricitinib
- basiliximab
- belatacept
- belimumab
- blinatumomab
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- canakinumab
- cannabidiol
- cannabis
- cenobamate
- certolizumab pegol
- ciltacabtagene autoleucel
- cladribine oral
- crovalimab
- cyclosporine
- dabigatran
- daratumumab
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dinutuximab
- dupilumab
- eculizumab
- efavirenz
- efgartigimod alfa
- elotuzumab
- elranatamab
- emapalumab
- ensartinib
- epcoritamab
- etanercept
- etrasimod
- everolimus
- fedratinib
- fexinidazole
- fluconazole
- fluorouracil
- fluoxetine
- fluvoxamine
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- ibritumomab tiuxetan
- idecabtagene vicleucel
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- isatuximab
- ixekizumab
- lebrikizumab
- linvoseltamab
- lisocabtagene maraleucel
- loncastuximab tesirine
- lymphocyte immune globulin, anti-thymocyte globulin
- marnetegragene autotemcel
- milk thistle
- mogamulizumab
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- narsoplimab
- natalizumab
- neratinib
- nipocalimab
- nitisinone
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- omeprazole
- pacritinib
- pimecrolimus topical
- polatuzumab vedotin
- pozelimab
- pralsetinib
- rabies vaccine
- ravulizumab
- relugolix
- repotrectinib
- rifampin
- rilonacept
- risankizumab
- ritlecitinib
- rituximab
- rivaroxaban
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- siltuximab
- sirolimus
- spesolimab
- stiripentol
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- teplizumab
- tildrakizumab
- tisagenlecleucel
- tocilizumab
- tofacitinib
- topotecan
- tralokinumab
- tranexamic acid
- ublituximab
- upadacitinib
- ustekinumab
- vaccinia immune globulin
- vedolizumab
- venetoclax
- vilobelimab
- voclosporin
- voriconazole
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- afatinib
- aflibercept
- alprostadil intracavernous
- alprostadil intravenous
- aminocaproic acid
- angiotensin II
- anthrax immune globulin
- anthrax vaccine
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- asparaginase
- atidarsagene autotemcel
- atorvastatin
- avatrombopag
- axitinib
- bazedoxifene
- bevacizumab
- binimetinib
- botulism immune globulin
- brolucizumab
- bromfenac ophthalmic
- C1 esterase inhibitor
- cabozantinib
- calaspargase
- carfilzomib
- celecoxib
- chikungunya vaccine
- chorionic gonadotropin
- citalopram
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- concizumab
- COVID-19 vaccine
- cytomegalovirus immune globulin
- danazol
- darbepoetin alfa
- dasatinib
- deflazacort
- desogestrel (contraceptive)
- desvenlafaxine
- dexamethasone
- diclofenac
- diclofenac ophthalmic
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- digoxin
- diosmin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duloxetine
- ebola vaccine, live
- edoxaban
- eltrombopag
- epirubicin
- epoetin alfa
- epoprostenol
- escitalopram
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- factor XIII concentrate
- faricimab
- fenofibrate
- fenofibric acid
- fenoprofen
- fibrinogen (human)
- fitusiran
- flurbiprofen
- flurbiprofen ophthalmic
- follitropin
- fruquintinib
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B immune globulin
- hepatitis B vaccine
- human papillomavirus vaccine
- ibrutinib
- ibuprofen
- ibuprofen lysine
- icosapent ethyl
- immune globulin
- indomethacin
- influenza H5N1 vaccine
- influenza vaccine
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- Japanese encephalitis vaccine
- ketoprofen
- ketorolac
- ketorolac ophthalmic
- lazertinib
- lenalidomide
- lenvatinib
- levomilnacipran
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- luspatercept
- lusutrombopag
- mavorixafor
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- meningococcal vaccine
- menotropins
- methoxy polyethylene glycol-epoetin beta
- methyl salicylate topical
- methyltestosterone
- milnacipran
- mitomycin
- mitotane
- momelotinib
- morphine
- nabumetone
- naproxen
- necitumumab
- nepafenac ophthalmic
- niacin (vitamin B3)
- nintedanib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- nusinersen
- olaparib
- omega-3-acid
- ospemifene
- oxaprozin
- paroxetine
- pazopanib
- pegaspargase
- penicillin G
- pentoxifylline
- piperacillin
- piroxicam
- pneumococcal vaccine
- poliovirus vaccine
- pomalidomide
- ponatinib
- porfimer
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- prothrombin complex concentrate (human)
- quinidine (antiarrhythmic)
- raloxifene
- ramucirumab
- ranibizumab
- ranolazine
- respiratory syncytial virus vaccine
- Rho(D) immune globulin
- romiplostim
- salsalate
- saw palmetto
- segesterone (contraceptive)
- sertraline
- sipuleucel-T
- smallpox/mpox vaccine, live
- sodium tetradecyl sulfate
- sotatercept
- sulindac
- talazoparib
- tamoxifen
- tenofovir alafenamide
- tenofovir disoproxil
- testosterone
- thalidomide
- tick-borne encephalitis vaccine
- tipranavir
- tivozanib
- tolmetin
- toremifene
- trametinib
- trazodone
- treprostinil
- tretinoin
- typhoid vaccine
- ubrogepant
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- varicella zoster immune globulin
- venlafaxine
- vilazodone
- von Willebrand factor
- vorinostat
- vortioxetine
- willow bark
- ziv-aflibercept
- zopapogene imadenovec
Caution Advised
- armodafinil
- avacopan
- azacitidine
- beclomethasone inhaled
- beclomethasone nasal
- belinostat
- bendamustine
- betamethasone
- bimekizumab
- bortezomib
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- carboplatin
- carmustine
- chlorambucil
- chloramphenicol
- ciclesonide
- cimetidine
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- coccidioides immitis skin test antigen
- copanlisib
- corticotropin
- cortisone
- cyclophosphamide
- cytarabine
- dactinomycin
- danicopan
- darolutamide
- daunorubicin
- decitabine
- dexamethasone ophthalmic
- dicloxacillin
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- docetaxel
- doxorubicin
- duvelisib
- elagolix
- elivaldogene autotemcel
- enasidenib
- enzalutamide
- eribulin
- eslicarbazepine acetate
- esomeprazole
- etoposide
- etravirine
- etuvetidigene autotemcel
- felbamate
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fosphenytoin
- garlic
- givosiran
- glecaprevir
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- icotrokinra
- idarubicin
- idelalisib
- ifosfamide
- iptacopan
- irinotecan
- isoniazid
- ixabepilone
- leflunomide
- lomustine
- lonafarnib
- loteprednol ophthalmic
- luliconazole topical
- mavacamten
- melphalan
- mercaptopurine
- methadone
- methotrexate
- methylprednisolone
- mirikizumab
- mitoxantrone
- modafinil
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- naldemedine
- nelarabine
- osilodrostat
- oxaliplatin
- oxcarbazepine
- ozanimod
- paclitaxel
- pegcetacoplan
- pentostatin
- phenytoin
- pibrentasvir
- pirtobrutinib
- ponesimod
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- regorafenib
- relacorilant
- rilzabrutinib
- romidepsin
- rucaparib
- selinexor
- sibeprenlimab
- siponimod
- sirolimus albumin-bound
- sulfasalazine
- tecovirimat
- temozolomide
- temsirolimus
- teriflunomide
- thioguanine
- thiotepa
- topiramate
- trabectedin
- treosulfan
- triamcinolone
- triclabendazole
- tuberculin purified protein derivative
- vinblastine
- vincristine
- vinorelbine
- vonoprazan
- zanubrutinib
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- tuberculosis
- HBV reactivation
- herpes zoster
- malignancy
- lymphoma
- non-melanoma skin CA
- cardiovascular event
- pulmonary embolism
- DVT
- lymphopenia
- thrombocytopenia
- retinal detachment
- infertility (animal studies)
Common Reactions
- nausea
- nasopharyngitis
- headache
- acne
- herpes simplex
- vomiting
- CPK incr.
- dizziness
- UTI
- hyperlipidemia
Safety/Monitoring .
Monitoring Parameters
Cr, hepatitis panel at baseline; CBC with diff at baseline, 4wk after tx start or dose incr, then periodically if long-term tx; TB test at baseline, then periodically; lipid panel 4wk after tx start; dermatologic exams periodically if incr. skin CA risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; possible risk of embryo-fetal toxicity, including skeletal variations, decr. fetal wt, and death, based on animal data at 11-17x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Pregnancy Exposure Registry at 1-877-311-3770
Lactation
Clinical Summary
avoid breastfeeding during tx and x1 day 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 abrocitinib: liver; CYP450: 2B6, 2C9, 2C19 (primary), 3A4 substrate; Info: active metabolites
Excretion: for abrocitinib: urine (<1% unchanged); Half-life: 3-5h
Subclass: Atopic Dermatitis, Systemic Nonsteroidal Agents ; JAK Inhibitors, Dermatologic
Mechanism of Action
for abrocitinib: exact mechanism of action unknown; selectively inhibits janus-associated kinases (JAK) 1, leading to disruption of cytokine and growth factor signaling pathways
Formulary .
No Formulary Selected
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