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Rinvoq
upadacitinib
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; most infections occur in combo w/ immunosuppressants; screen for latent TB infection before and during upadacitinib tx; initiate anti-TB tx before upadacitinib tx; weigh risk/benefit in pts w/ chronic or recurrent infection; monitor closely for infection s/sx during and after tx, incl. TB development in pts w/ negative TB test; D/C upadacitinib if serious infection develops
Mortality
higher rate of mortality, incl. sudden cardiovascular death, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study
Malignancies
lymphoma and other malignancies observed w/ upadacitinib; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA pts treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers
Major Adverse Cardiovascular Events
higher rate of major adverse cardiovascular events, incl. cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C upadacitinib in pts that experienced MI or stroke
Thrombosis
thrombosis, incl. DVT, PE, and arterial thrombosis occurred in pts treated w/ upadacitinib and other JAK inhibitors for inflammatory conditions; many adverse events were serious, sometimes fatal; higher rate of thrombosis observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid upadacitinib in pts w/ thrombosis risk; D/C upadacitinib and promptly evaluate pts w/ thrombosis sx
Adult Dosing .
Dosage forms: ER TAB: 15 mg, 30 mg, 45 mg
Special Note
- [formulation clarification]
- Info: Rinvoq not interchangeable w/ Rinvoq LQ; do not substitute on a mg to mg basis
rheumatoid arthritis, moderate-severe
- [15 mg PO qd]
- Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
psoriatic arthritis
- [15 mg PO qd]
- Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
ankylosing spondylitis
- [15 mg PO qd]
- Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
axial spondyloarthritis, non-radiographic
- [15 mg PO qd]
- Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
atopic dermatitis, moderate-severe refractory
- [<65 yo]
- Start: 15 mg PO qd; Info: may incr. to 30 mg PO qd if inadequate response; see pkg insert for toxicity-related dose adjustments; use lowest effective dose; do not cut/crush/chew tab; D/C if inadequate response w/ dose incr.
- [65 yo and older]
- Dose: 15 mg PO qd; Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
ulcerative colitis, moderate-severe
- [induction tx]
- Dose: 45 mg PO qd x8wk; Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
- [maintenance tx]
- Dose: 15 mg PO qd; Info: may incr. to 30 mg PO qd for refractory, severe, or extensive dz; see pkg insert for toxicity-related dose adjustments; use lowest effective dose; do not cut/crush/chew tab; D/C tx if inadequate response w/ dose incr.
Crohn dz, moderate-severe
- [induction tx]
- Dose: 45 mg PO qd x12wk; Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
- [maintenance tx]
- Dose: 15 mg PO qd; Info: may incr. to 30 mg PO qd for refractory, severe, or extensive dz; see pkg insert for toxicity-related dose adjustments; use lowest effective dose; do not cut/crush/chew tab; D/C tx if inadequate response w/ dose incr.
giant cell arteritis
- [15 mg PO qd]
- Info: give w/ tapering corticosteroid course; see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
renal dosing
- [Crohn dz or ulcerative colitis induction tx]
- eGFR 15-30: 30 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [atopic dermatitis or Crohn dz or ulcerative colitis maintenance tx]
- eGFR 15-30: 15 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [all other indications]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [Crohn dz or ulcerative colitis induction tx]
- Child-Pugh Class A or B: 30 mg qd; Child-Pugh Class C: avoid use
- [Crohn dz or ulcerative colitis maintenance tx]
- Child-Pugh Class A or B: 15 mg qd; Child-Pugh Class C: avoid use
- [all other indications]
- Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: ER TAB: 15 mg, 30 mg
Special Note
- [formulation clarification]
- Info: Rinvoq not interchangeable w/ Rinvoq LQ; do not substitute on a mg to mg basis
psoriatic arthritis
- [2 yo and older, >30 kg]
- Dose: 15 mg PO qd; Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
atopic dermatitis, moderate-severe refractory
- [12 yo and older, >40 kg]
- Start: 15 mg PO qd; Info: may incr. to 30 mg PO qd if inadequate response; see pkg insert for toxicity-related dose adjustments; use lowest effective dose; do not cut/crush/chew tab; D/C if inadequate response w/ dose incr.
polyarticular juvenile idiopathic arthritis
- [2 yo and older, >30 kg]
- Dose: 15 mg PO qd; Info: see pkg insert for toxicity-related dose adjustments; do not cut/crush/chew tab
renal dosing
- [atopic dermatitis]
- eGFR 15-30: 15 mg qd; eGFR <15: avoid use
- HD/PD: not defined
- [all other indications]
- eGFR >15: no adjustment; eGFR <15: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- baseline Hgb <8
- baseline lymphocytes <500
- baseline ANC <1000
- eGFR <15 (atopic dermatitis, Crohn dz, or ulcerative colitis use)
- hepatic impairment, Child-Pugh Class C
- thrombosis risk
- infection, active
- avoid: breastfeeding during tx and x6 days after D/C
- caution: pts of childbearing potential
- caution: elderly pts
- caution: eGFR 15-30 (atopic dermatitis, Crohn dz, or ulcerative colitis use)
- caution: hepatic impairment, Child-Pugh Class A-B (Crohn dz or ulcerative colitis use)
- caution: opportunistic infection hx
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection risk
- caution: TB infection, latent
- caution: TB infection risk
- caution: lung dz hx, chronic
- caution: herpes zoster hx
- caution: HBV infection
- caution: HBV infection hx
- caution: HCV infection
- caution: smokers
- caution: past smokers
- caution: cardiovascular dz
- caution: cardiovascular dz risk
- caution: malignancy
- caution: GI perforation risk
- caution: diabetes mellitus
Drug Interactions .
Overview
upadacitinib
JAK inhibitor
- CYP3A4 substrate
- CYP2D6 inhibitor, weak
- CYP3A4 inducer, minor
- GI mucosal injury/bleeding risk
- immunosuppressive effects
- myelosuppressive effects
- thrombogenic effects
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- dengue vaccine, live
- eliglustat
- influenza nasal vaccine, live
- measles/mumps/rubella vaccine, live
- rotavirus vaccine, live
- smallpox vaccine, live
- talimogene laherparepvec
- thioridazine
- typhoid vaccine, live
- varicella vaccine, live
- yellow fever vaccine, live
Avoid/Use Alternative
- abatacept
- abrocitinib
- adalimumab
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- apalutamide
- azathioprine
- baricitinib
- basiliximab
- belatacept
- belimumab
- bimekizumab
- blinatumomab
- brodalumab
- butalbital
- canakinumab
- carbamazepine
- certolizumab pegol
- chloramphenicol
- cladribine oral
- codeine
- cyclosporine
- deferiprone
- deucravacitinib
- deuruxolitinib
- dihydrocodeine
- dupilumab
- eculizumab
- emapalumab
- encorafenib
- enzalutamide
- etanercept
- etrasimod
- everolimus
- fedratinib
- fexinidazole
- fosphenytoin
- ganciclovir
- golimumab
- grapefruit
- guselkumab
- inebilizumab
- infliximab
- ivosidenib
- ixekizumab
- loncastuximab tesirine
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- lymphocyte immune globulin, anti-thymocyte globulin
- methadone
- mirikizumab
- mitotane
- momelotinib
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- ocrelizumab
- ofatumumab
- pacritinib
- pentobarbital
- phenobarbital
- phenytoin
- pimecrolimus topical
- pimozide
- pozelimab
- primaquine
- primidone
- propafenone
- rabies vaccine
- radium Ra 223 dichloride
- ravulizumab
- rifabutin
- rifampin
- rilonacept
- risankizumab
- ritlecitinib
- rituximab
- ropeginterferon alfa-2b
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- siltuximab
- sirolimus
- spesolimab
- St. John's wort
- tacrolimus
- talquetamab
- teplizumab
- tildrakizumab
- tocilizumab
- tofacitinib
- tralokinumab
- tramadol
- tranexamic acid
- ustekinumab
- vaccinia immune globulin
- valganciclovir
- vedolizumab
- vilobelimab
- voclosporin
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- adagrasib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- afatinib
- aflibercept
- albendazole
- alendronate
- allopurinol
- alteplase
- aminocaproic acid
- anacaulase topical
- anagrelide
- angiotensin II
- anthrax immune globulin
- anthrax vaccine
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- antithrombin
- apixaban
- aprepitant
- argatroban
- arsenic trioxide
- asciminib
- asenapine
- asparaginase
- aspirin
- atazanavir
- atidarsagene autotemcel
- auranofin
- avapritinib
- avatrombopag
- axicabtagene ciloleucel
- axitinib
- azacitidine
- balsalazide
- bazedoxifene
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- betamethasone
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- binimetinib
- bivalirudin
- bortezomib
- bosutinib
- botulism immune globulin
- brentuximab vedotin
- brexucabtagene autoleucel
- brolucizumab
- bromelain
- busulfan
- C1 esterase inhibitor
- cabazitaxel
- cabozantinib
- calaspargase
- cangrelor
- capecitabine
- caplacizumab
- carboplatin
- carfilzomib
- carmustine
- celecoxib
- ceritinib
- chikungunya vaccine
- chlorambucil
- chorionic gonadotropin
- cidofovir
- cilostazol
- ciltacabtagene autoleucel
- cinacalcet
- cisplatin
- citalopram
- cladribine injection
- clarithromycin
- clofarabine
- clopidogrel
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- cobicistat
- colchicine
- concizumab
- copanlisib
- corticotropin
- cortisone
- COVID-19 vaccine
- crizotinib
- cyclophosphamide
- cysteamine
- cytarabine
- cytomegalovirus immune globulin
- dabigatran
- dacarbazine
- dactinomycin
- dalteparin
- danazol
- danshen
- dapsone
- daratumumab
- darbepoetin alfa
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- defibrotide
- deflazacort
- desipramine
- desogestrel (contraceptive)
- desvenlafaxine
- dexamethasone
- dexrazoxane
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- dimethyl fumarate
- dinutuximab
- diosmin
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- dipyridamole
- diroximel fumarate
- docetaxel
- donepezil
- dostarlimab
- doxorubicin
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duloxetine
- duvelisib
- ebola vaccine, live
- edoxaban
- eflornithine
- elivaldogene autotemcel
- elranatamab
- eltrombopag
- enfortumab vedotin
- enoxaparin
- entrectinib
- epcoritamab
- epirubicin
- epoetin alfa
- eptifibatide
- eribulin
- erlotinib
- escitalopram
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- etelcalcetide
- ethanol
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- etoposide
- evening primrose oil
- exagamglogene autotemcel
- factor XIII concentrate
- fam-trastuzumab deruxtecan
- faricimab
- fenofibrate
- fenofibric acid
- fenoprofen
- fenugreek
- fitusiran
- flecainide
- floxuridine
- flucytosine
- fludarabine
- fludrocortisone
- fluorouracil
- fluoxetine
- fluphenazine
- flurbiprofen
- fluvoxamine
- follitropin
- fondaparinux
- foscarnet
- fostamatinib
- fruquintinib
- galantamine
- garlic
- gefitinib
- gemcitabine
- gemtuzumab ozogamicin
- ginkgo
- givinostat
- glasdegib
- glofitamab
- Haemophilus b vaccine
- heparin
- hepatitis A vaccine
- hepatitis B immune globulin
- hepatitis B vaccine
- human papillomavirus vaccine
- hydrocortisone
- hydroxychloroquine
- hydroxyurea
- ibandronate
- ibritumomab tiuxetan
- ibrutinib
- ibuprofen
- ibuprofen lysine
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- iloperidone
- iloprost inhaled
- imatinib
- imetelstat
- immune globulin
- indomethacin
- influenza H5N1 vaccine
- influenza vaccine
- inotuzumab ozogamicin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iohexol
- iomeprol
- iopamidol
- irinotecan
- isatuximab
- itraconazole
- ixabepilone
- Japanese encephalitis vaccine
- ketoconazole
- ketoprofen
- ketorolac
- lazertinib
- leflunomide
- lenalidomide
- lenvatinib
- levoketoconazole
- levomilnacipran
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- linezolid
- lisocabtagene maraleucel
- lomustine
- lonafarnib
- lovotibeglogene autotemcel
- lumateperone
- lurbinectedin
- luspatercept
- lusutrombopag
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- magnesium salicylate
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- melphalan
- meningococcal vaccine
- menotropins
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyl salicylate topical
- methylprednisolone
- methyltestosterone
- metoprolol
- midostaurin
- mifepristone
- milnacipran
- mitomycin
- mitoxantrone
- mogamulizumab
- monomethyl fumarate
- mosunetuzumab
- nabumetone
- naproxen
- nattokinase
- necitumumab
- nefazodone
- nelarabine
- nelfinavir
- niacin (vitamin B3)
- nilotinib
- nintedanib
- niraparib
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone acetate (hormone replacement)
- norgestimate (contraceptive)
- norgestimate (hormone replacement)
- norgestrel (contraceptive)
- nortriptyline
- nusinersen
- obecabtagene autoleucel
- obinutuzumab
- olaparib
- oliceridine
- olsalazine
- ospemifene
- oxaliplatin
- oxaprozin
- paclitaxel
- palbociclib
- panobinostat
- paroxetine
- pazopanib
- pegaspargase
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- penicillamine
- penicillin G
- pentamidine
- pentosan polysulfate sodium
- pentostatin
- pentoxifylline
- piperacillin
- piroxicam
- pirtobrutinib
- plasminogen, human
- pneumococcal vaccine
- polatuzumab vedotin
- poliovirus vaccine
- pomalidomide
- ponatinib
- porfimer
- posaconazole
- pralatrexate
- pralsetinib
- prasugrel
- prednisolone
- prednisone
- procarbazine
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- proguanil
- propranolol
- prothrombin complex concentrate (human)
- pyridostigmine
- pyrimethamine
- quizartinib
- raloxifene
- ramucirumab
- ranibizumab
- regorafenib
- respiratory syncytial virus vaccine
- resveratrol
- reteplase
- Rho(D) immune globulin
- ribavirin
- ribociclib
- risedronate
- ritonavir
- rivaroxaban
- rivastigmine
- romidepsin
- romiplostim
- rucaparib
- sacituzumab govitecan
- salsalate
- saw palmetto
- segesterone (contraceptive)
- selinexor
- selpercatinib
- selumetinib
- sertraline
- sipuleucel-T
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sodium tetradecyl sulfate
- sorafenib
- sotatercept
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- sulindac
- sunitinib
- tafasitamab
- tagraxofusp
- talazoparib
- tamoxifen
- tarlatamab
- tazemetostat
- teclistamab
- temozolomide
- temsirolimus
- tenecteplase
- teriflunomide
- testosterone
- thalidomide
- thioguanine
- thiotepa
- ticagrelor
- tick-borne encephalitis vaccine
- tipranavir
- tirofiban
- tisagenlecleucel
- tisotumab vedotin
- tivozanib
- tolmetin
- topotecan
- toremifene
- tovorafenib
- trabectedin
- trametinib
- trastuzumab
- trazodone
- treosulfan
- treprostinil
- tretinoin
- triamcinolone
- trifluridine
- trimethoprim
- tucatinib
- typhoid vaccine
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vandetanib
- varicella zoster immune globulin
- venetoclax
- venlafaxine
- vilazodone
- vinblastine
- vincristine
- vinorelbine
- vinpocetine
- von Willebrand factor
- vorapaxar
- voriconazole
- vorinostat
- vortioxetine
- warfarin
- willow bark
- zanubrutinib
- zidovudine
- ziv-aflibercept
Caution Advised
- avacopan
- beclomethasone inhaled
- beclomethasone nasal
- berotralstat
- bosentan
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- cenobamate
- ciprofloxacin
- clobetasol ophthalmic
- clofazimine
- conivaptan
- crovalimab
- dabrafenib
- danicopan
- darunavir
- dexamethasone ophthalmic
- difluprednate ophthalmic
- diltiazem
- dronedarone
- efavirenz
- efgartigimod alfa
- elotuzumab
- erythromycin
- etravirine
- fingolimod
- fluconazole
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- fosamprenavir
- hydrocortisone ophthalmic
- iptacopan
- isavuconazonium
- lebrikizumab
- lefamulin
- lenacapavir
- letermovir
- lorlatinib
- loteprednol ophthalmic
- mavacamten
- mitapivat
- modafinil
- mometasone implant
- mometasone inhaled
- mometasone nasal
- nadofaragene firadenovec intravesical
- nafcillin
- netupitant
- nirogacestat
- ozanimod
- pegcetacoplan
- perphenazine
- pexidartinib
- ponesimod
- prednisolone ophthalmic
- repotrectinib
- rifapentine
- rozanolixizumab
- siponimod
- sotorasib
- sutimlimab
- tuberculin purified protein derivative
- ublituximab
- verapamil
- zilucoplan
Adverse Reactions .
Serious Reactions
- cardiovascular death risk
- cardiovascular event risk
- infection, severe
- opportunistic infection
- viral reactivation
- HBV reactivation
- malignancy
- lymphoma
- non-melanoma skin CA
- pulmonary embolism
- DVT
- arterial thrombosis
- neutropenia
- lymphopenia
- anemia
- GI perforation
- anaphylaxis
- angioedema
- eczema herpeticum
- retinal detachment
Common Reactions
- URI
- acne
- herpes simplex
- CPK incr.
- anemia
- fever
- headache
- ALT or AST incr.
- neutropenia
- rash
- herpes zoster
- folliculitis
- pneumonia
- bronchitis
- gastroenteritis (Crohn dz use)
- hypercholesterolemia
- nausea
- cough
- abdominal pain
- hypersensitivity rxn
- influenza
- fatigue
- lymphopenia
- weight incr.
- myalgia (atopic dermatitis use)
- medication residue in stool
Safety/Monitoring .
Monitoring Parameters
Atopic Dermatitis or Crohn dz or Ulcerative Colitis: Cr, hepatitis panel, pregnancy test at baseline; CBC w/ diff, LFTs, TB test at baseline, then periodically; lipid panel 12wk after tx start; dermatologic exams if incr. skin CA risk
All Other Indications: hepatitis panel, pregnancy test at baseline; CBC w/ diff, LFTs, TB test at baseline, then periodically; lipid panel 12wk after tx start; dermatologic exams if incr. skin CA risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; possible risk of teratogenicity based on animal data at >0.6x MRHD
Pregnancy Registry
report any suspected fetal exposure to Rinvoq/Rinvoq LQ pregnancy surveillance program at 1-800-633-9110
Individuals of Reproductive Potential
obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and x4wk after D/C in pts of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x6 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: unknown; CYP450: 2D6, 3A4 (primary) substrate
Excretion: urine (24% unchanged), feces (38% unchanged); Half-life: 8-14h
Subclass: Atopic Dermatitis, Systemic Nonsteroidal Agents ; DMARDs, JAK Inhibitors ; Inflammatory Bowel Disease (IBD) ; JAK Inhibitors, Dermatologic ; Psoriasis, Systemic Agents ; Spondyloarthropathies
Mechanism of Action
inhibits janus-associated kinases (JAK) 1, 2, and 3, leading to disruption of cytokine and growth factor signaling pathways
Formulary .
No Formulary Selected
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