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Litfulo
ritlecitinib
Black Box Warnings .
Serious Infections
incr. risk of serious bacterial, fungal, viral, and opportunistic infection, incl. TB, leading to hospitalization or death; serious appendicitis, COVID-19 infection, incl. pneumonia, sepsis and multi-dermatomal herpes zoster reported w/ ritlecitinib; Interrupt tx if serious infection occurs, and tx infection until resolved before resuming ritlecitinib; avoid use in pts w/ active, serious infection, incl. active TB; screen for latent TB infection and initiate anti-TB tx before ritlecitinib tx start; weigh risk/benefit before tx in pts w/ chronic or recurrent infection, serious or opportunistic infection hx, underlying conditions predisposing to infections, and in pts exposed to TB, incl. residing or traveling to areas of endemic TB or mycoses; monitor closely for active TB infection during tx, incl. pts w/ baseline negative latent TB screening
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/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; ritlecitinib not approved for use in RA pts
Malignancies
malignancies, incl. non-melanoma skin CA observed in pts treated w/ ritlecitinib; lymphoma and other malignancies observed in pts treated w/ oral JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA pts treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in pts w/ known malignancy, pts who develop a malignancy during tx, or pts who are current or past smokers; periodic skin exams recommended for pts w/ incr. risk
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/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in pts who are current or past smokers or pts w/ other cardiovascular risk factors; D/C ritlecitinib in pts that experienced MI or stroke
Thrombosis
thromboembolic events observed w/ ritlecitinib; higher rate of thrombosis observed in RA pts 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; avoid ritlecitinib in pts at incr. thrombosis risk; D/C ritlecitinib and promptly evaluate pts w/ thrombosis sx
Adult Dosing .
Dosage forms: CAP: 50 mg
alopecia areata, severe
- [50 mg PO qd]
- Info: do not crush, split, chew cap; interrupt tx if lymphocytes <500; D/C if Plt <50,000
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: CAP: 50 mg
alopecia areata, severe
- [12 yo and older]
- Dose: 50 mg PO qd; Info: do not crush, split, chew cap; interrupt tx if lymphocytes <500; D/C if Plt <50,000
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
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
- infection, active
- TB infection, active
- thrombosis risk
- HBV infection
- HCV infection
- lymphocytes <500
- Plt <100,000
- avoid: breastfeeding during tx and x14h after D/C
- caution: pts >65 yo
- caution: infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: infection hx, serious
- caution: opportunistic infection hx
- caution: TB infection, latent
- caution: TB infection risk
- caution: residents of area w/ endemic TB
- caution: travelers in area w/ endemic TB
- caution: residents of area w/ endemic mycosis
- caution: travelers in area w/ endemic mycosis
- caution: herpes zoster hx
- caution: HBV infection hx
- caution: malignancy
- caution: cardiovascular dz
- caution: cardiovascular dz risk
- caution: smokers
- caution: past smokers
Drug Interactions .
Overview
ritlecitinib
JAK inhibitor
- CYP3A4 substrate
- CYP1A2 inhibitor, weak
- CYP3A4 inhibitor, weak
- immunosuppressive effects
- thrombogenic effects
Contraindicated
- adenovirus vaccine, live
- BCG live intravesical
- chikungunya vaccine, live
- cholera vaccine, live
- cisapride
- dengue vaccine, live
- fezolinetant
- 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
- abatacept
- abrocitinib
- adalimumab
- afamitresgene autoleucel
- aldesleukin
- alemtuzumab
- alprazolam
- anakinra
- anifrolumab
- anti-thymocyte globulin
- apalutamide
- axicabtagene ciloleucel
- azathioprine
- baricitinib
- basiliximab
- belatacept
- belimumab
- blinatumomab
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- butalbital
- canakinumab
- carbamazepine
- certolizumab pegol
- ciltacabtagene autoleucel
- cladribine oral
- codeine
- colchicine
- crovalimab
- cyclosporine
- daratumumab
- deucravacitinib
- deuruxolitinib
- dinutuximab
- dupilumab
- eculizumab
- efgartigimod alfa
- eliglustat
- elotuzumab
- elranatamab
- emapalumab
- encorafenib
- enzalutamide
- epcoritamab
- etanercept
- etrasimod
- everolimus
- fedratinib
- fosphenytoin
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- hydrocodone
- ibritumomab tiuxetan
- idecabtagene vicleucel
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- isatuximab
- ivosidenib
- ixekizumab
- lebrikizumab
- lisocabtagene maraleucel
- loncastuximab tesirine
- lumacaftor/ivacaftor
- lymphocyte immune globulin, anti-thymocyte globulin
- meperidine
- methadone
- mitotane
- mogamulizumab
- mosunetuzumab
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- oxycodone
- pacritinib
- pentobarbital
- phenobarbital
- phenytoin
- pimecrolimus topical
- pimozide
- polatuzumab vedotin
- pozelimab
- pralsetinib
- primidone
- propafenone
- rabies vaccine
- ravulizumab
- rifabutin
- rifampin
- rilonacept
- risankizumab
- rituximab
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- ruxolitinib topical
- sarilumab
- satralizumab
- secukinumab
- siltuximab
- simvastatin
- sirolimus
- spesolimab
- St. John's wort
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teplizumab
- tildrakizumab
- tisagenlecleucel
- tizanidine
- tocilizumab
- tofacitinib
- tralokinumab
- tranexamic acid
- ublituximab
- upadacitinib
- ustekinumab
- vaccinia immune globulin
- vedolizumab
- vilobelimab
- voclosporin
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- aflibercept
- alfentanil
- aminocaproic acid
- aminophylline
- amiodarone
- angiotensin II
- anthrax immune globulin
- anthrax vaccine
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- asciminib
- asparaginase
- atidarsagene autotemcel
- avanafil
- avapritinib
- avatrombopag
- axitinib
- bazedoxifene
- bendamustine
- bevacizumab
- binimetinib
- botulism immune globulin
- brigatinib
- brolucizumab
- C1 esterase inhibitor
- cabozantinib
- caffeine citrate
- calaspargase
- capivasertib
- carfilzomib
- celecoxib
- chikungunya vaccine
- chorionic gonadotropin
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- concizumab
- COVID-19 vaccine
- cytomegalovirus immune globulin
- danazol
- darbepoetin alfa
- deflazacort
- desogestrel (contraceptive)
- dexamethasone
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- diphtheria/tetanus vaccine
- diphtheria/tetanus/pertussis vaccine
- disopyramide
- docetaxel
- dofetilide
- domperidone
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- ebola vaccine, live
- eltrombopag
- entrectinib
- epirubicin
- epoetin alfa
- erythromycin
- 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
- felodipine
- fenofibrate
- fenofibric acid
- fenoprofen
- fentanyl
- finerenone
- fitusiran
- flibanserin
- flurbiprofen
- follitropin
- fruquintinib
- gepirone
- Haemophilus b vaccine
- hepatitis A vaccine
- hepatitis B immune globulin
- hepatitis B vaccine
- human papillomavirus vaccine
- ibrutinib
- ibuprofen
- immune globulin
- indomethacin
- infigratinib
- influenza H5N1 vaccine
- influenza vaccine
- iohexol
- iopamidol
- ivabradine
- ixabepilone
- Japanese encephalitis vaccine
- ketoprofen
- ketorolac
- lazertinib
- lemborexant
- lenalidomide
- lenvatinib
- levoketoconazole
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lomitapide
- lonafarnib
- lovastatin
- lumateperone
- lurasidone
- lurbinectedin
- luspatercept
- lusutrombopag
- mavacamten
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- meningococcal vaccine
- menotropins
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- midazolam
- mobocertinib
- momelotinib
- nabumetone
- naproxen
- necitumumab
- nifedipine
- nimodipine
- nintedanib
- nisoldipine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone acetate (hormone replacement)
- norgestimate (contraceptive)
- norgestimate (hormone replacement)
- norgestrel (contraceptive)
- olaparib
- oliceridine
- ospemifene
- oxaprozin
- pazopanib
- pegaspargase
- pemigatinib
- piroxicam
- pneumococcal vaccine
- poliovirus vaccine
- pomalidomide
- ponatinib
- porfimer
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- prothrombin complex concentrate (human)
- quinidine (antiarrhythmic)
- raloxifene
- ramucirumab
- ranibizumab
- red yeast rice
- respiratory syncytial virus vaccine
- Rho(D) immune globulin
- ribociclib
- romiplostim
- salsalate
- segesterone (contraceptive)
- selpercatinib
- selumetinib
- sipuleucel-T
- sirolimus albumin-bound
- smallpox/mpox vaccine, live
- sodium tetradecyl sulfate
- sotatercept
- sufentanil
- sulindac
- tadalafil
- tamoxifen
- temsirolimus
- testosterone
- thalidomide
- theophylline
- tick-borne encephalitis vaccine
- tivozanib
- tolmetin
- tolvaptan
- toremifene
- trametinib
- tretinoin
- typhoid vaccine
- ubrogepant
- vadadustat
- valoctocogene roxaparvovec
- vamorolone
- vardenafil
- varicella zoster immune globulin
- venetoclax
- vinblastine
- vincristine
- vinorelbine
- von Willebrand factor
- vorinostat
- warfarin
- zanubrutinib
- ziv-aflibercept
Caution Advised
- alosetron
- avacopan
- azacitidine
- beclomethasone inhaled
- beclomethasone nasal
- belinostat
- betamethasone
- bimekizumab
- bortezomib
- bosentan
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- busulfan
- cabazitaxel
- carboplatin
- cariprazine
- carmustine
- cenobamate
- chlorambucil
- cisplatin
- cladribine injection
- clobetasol ophthalmic
- clofarabine
- cobimetinib
- conivaptan
- copanlisib
- corticotropin
- cortisone
- cyclophosphamide
- cytarabine
- dabrafenib
- dactinomycin
- danicopan
- daridorexant
- daunorubicin
- decitabine
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dihydroergotamine
- dimethyl fumarate
- diroximel fumarate
- doxorubicin
- duvelisib
- efavirenz
- elivaldogene autotemcel
- eplerenone
- ergotamine
- eribulin
- etoposide
- etravirine
- fexinidazole
- fingolimod
- floxuridine
- fludarabine
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluorouracil
- fluticasone furoate
- fluticasone propionate
- gemcitabine
- hydrocortisone
- hydrocortisone ophthalmic
- hydroxyurea
- idarubicin
- idelalisib
- ifosfamide
- iptacopan
- irinotecan
- leflunomide
- lifileucel
- lomustine
- lopinavir/ritonavir
- lorlatinib
- loteprednol ophthalmic
- melphalan
- mercaptopurine
- methotrexate
- methylergonovine
- methylprednisolone
- mirikizumab
- mitapivat
- mitoxantrone
- modafinil
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- nafcillin
- nelarabine
- omacetaxine mepesuccinate
- oxaliplatin
- ozanimod
- paclitaxel
- palovarotene
- panobinostat
- pegcetacoplan
- pentostatin
- pexidartinib
- pirfenidone
- pirtobrutinib
- ponesimod
- prednisolone
- prednisolone ophthalmic
- prednisone
- procarbazine
- quizartinib
- regorafenib
- repotrectinib
- rifapentine
- roflumilast
- roflumilast topical
- romidepsin
- selinexor
- siponimod
- sirolimus topical
- sotorasib
- sulfasalazine
- teclistamab
- temozolomide
- teriflunomide
- thioguanine
- thiotepa
- topotecan
- triamcinolone
- triazolam
- tuberculin purified protein derivative
- verapamil
- vorasidenib
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- viral reactivation
- HBV reactivation
- herpes zoster
- thrombocytopenia
- lymphopenia
- malignancy
- non-melanoma skin CA
- pulmonary embolism
- acute MI
- cardiovascular death risk
- hypersensitivity rxn, severe
- anaphylaxis
Common Reactions
- headache
- diarrhea
- acne
- rash
- urticaria
- folliculitis
- fever
- atopic dermatitis
- dizziness
- ALT or AST elevated
Safety/Monitoring .
Monitoring Parameters
hepatitis panel at baseline; CBC w/ diff at baseline, then 4wk after tx start, then periodically; LFTs, TB test at baseline, then periodically; dermatologic exams 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 and malformation based on animal data at 49x MRHD and 55x MRHD, respectively
Pregnancy Reporting
report pregnancy to Pfizer at 1-877-390-2940
Lactation
Clinical Summary
avoid breastfeeding during tx and x14h 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: liver; CYP450: 1A2, 2C8, 2C9, 3A4 substrate
Excretion: urine 66% (4% unchanged), feces 20%; Half-life: 1.3-2.3h
Subclass: Cosmetic, Dermatologic ; JAK Inhibitors, Dermatologic ; TEC Kinase Inhibitors
Mechanism of Action
exact mechanism of action unknown; inhibits janus-associated kinase (JAK) 3, preventing cytokine-induced STAT protein phosphorylation; inhibits tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family, preventing immune receptor signaling
Formulary .
No Formulary Selected
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