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Opzelura
ruxolitinib topical
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death in patients treated with oral JAK inhibitors for inflammatory conditions; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections reported in patients treated with oral JAK inhibitors for inflammatory conditions; serious lower respiratory tract infections and viral reactivation, including herpes zoster, reported with topical ruxolitinib; consider screening for latent and active TB infection before tx; avoid use in patients with active, serious infection, including localized infections; weigh risk/benefit before tx in patients with chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx; D/C topical ruxolitinib if serious infection or sepsis 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 an oral JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; topical ruxolitinib not approved for use in RA patients
Malignancies
non-melanoma skin CA occurred in patients treated with topical ruxolitinib; lymphoma and other malignancies observed in patients treated with oral JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated with an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients with known malignancy, patients who develop a malignancy during tx, or patients who are current or past smokers; topical ruxolitinib not approved for use in RA patients
Major Adverse Cardiovascular Events
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 an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients who are current or past smokers or patients with other cardiovascular risk factors; D/C topical ruxolitinib in patients that experienced MI or stroke; topical ruxolitinib not approved for use in RA patients
Thrombosis
thromboembolic events observed with topical ruxolitinib tx; incr. incidence of thrombosis, including DVT, PE, and arterial thrombosis, reported in patients treated with oral 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 treated with an oral JAK inhibitor (tofacitinib) vs. TNF blockers; avoid topical ruxolitinib in patients at incr. thrombosis risk; D/C topical ruxolitinib and promptly evaluate patients with thrombosis symptoms; topical ruxolitinib not approved for use in RA patients
Adult Dosing .
Dosage forms: CREAM: 1.5%
mild-moderate atopic dermatitis, short-term tx or intermittent long-term tx
- [apply bid]
- Max: 60 g/wk,100 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
vitiligo, non-segmental
- [apply bid]
- Max: 60 g/wk,100 g/2wk; Info: tx area should not exceed 10% BSA; reassess if unsatisfactory response in 24wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: CREAM: 1.5%
mild-moderate atopic dermatitis, short-term tx or intermittent long-term tx
- [2-11 yo]
- Dose: apply bid; Max: 60 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
- [12 yo and older]
- Dose: apply bid; Max: 60 g/wk,100 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
vitiligo, non-segmental
- [12 yo and older]
- Dose: apply bid; Max: 60 g/wk,100 g/2wk; Info: tx area should not exceed 10% BSA; reassess if unsatisfactory response in 24wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- thrombosis risk
- avoid: breastfeeding during tx and x4wk after D/C
- caution: infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: herpes zoster history
- caution: HBV infection
- caution: HBV infection history
- caution: HCV infection
- caution: malignancy
- caution: cardiovascular disease
- caution: cardiovascular disease risk
- caution: smokers
- caution: past smokers
Drug Interactions .
Overview
ruxolitinib topical
JAK inhibitor topical
- CYP3A4 substrate
- immunomodulatory effects
- myelosuppressive effects
- thrombogenic effects
Contraindicated
- BCG live intravesical
- talimogene laherparepvec
Avoid/Use Alternative
- abatacept
- abrocitinib
- adagrasib
- adalimumab
- aldesleukin
- alemtuzumab
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- deucravacitinib
- deuruxolitinib
- dinutuximab
- dupilumab
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- emapalumab
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- rozanolixizumab
- ruxolitinib
- sarilumab
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- siltuximab
- sirolimus
- spesolimab
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- tacrolimus
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- tofacitinib
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- upadacitinib
- ustekinumab
- vaccinia immune globulin
- valganciclovir
- vedolizumab
- vilobelimab
- voclosporin
- voriconazole
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aflibercept
- albendazole
- allopurinol
- aminocaproic acid
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- aprepitant
- arsenic trioxide
- asciminib
- asparaginase
- atidarsagene autotemcel
- auranofin
- avacopan
- avatrombopag
- axitinib
- azacitidine
- balsalazide
- bazedoxifene
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- berotralstat
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- binimetinib
- bortezomib
- bosutinib
- botulism immune globulin
- brolucizumab
- busulfan
- C1 esterase inhibitor
- cabazitaxel
- cabozantinib
- calaspargase
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- celecoxib
- chlorambucil
- chorionic gonadotropin
- cidofovir
- ciprofloxacin
- cisplatin
- cladribine injection
- clofarabine
- clofazimine
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- coagulation factor XIII A-subunit
- colchicine
- concizumab
- conivaptan
- copanlisib
- copper histidinate
- crizotinib
- cyclophosphamide
- cytarabine
- cytomegalovirus immune globulin
- dacarbazine
- dactinomycin
- danazol
- dapsone
- darbepoetin alfa
- darunavir
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- deflazacort
- desogestrel (contraceptive)
- dexamethasone
- dexrazoxane
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- diltiazem
- docetaxel
- dostarlimab
- doxorubicin
- dronedarone
- drospirenone (contraceptive)
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- duvelisib
- eflornithine
- elivaldogene autotemcel
- eltrombopag
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- entrectinib
- epirubicin
- epoetin alfa
- eribulin
- erythromycin
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- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
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- etoposide
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- exagamglogene autotemcel
- factor XIII concentrate
- fam-trastuzumab deruxtecan
- faricimab
- fenofibrate
- fenofibric acid
- fenoprofen
- fibrinogen (human)
- fitusiran
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- fluconazole
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- flurbiprofen
- follitropin
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- foscarnet
- fosfomycin injection
- fostamatinib
- fruquintinib
- gemcitabine
- givinostat
- glasdegib
- hepatitis B immune globulin
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- idarubicin
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- immune globulin
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- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iodixanol
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- iothalamate meglumine
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- ivosidenib
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- lazertinib
- lefamulin
- leflunomide
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- lenvatinib
- letermovir
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- levonorgestrel (hormone replacement)
- lifileucel
- linezolid
- lomustine
- lovotibeglogene autotemcel
- lurbinectedin
- luspatercept
- lusutrombopag
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- mefenamic acid
- megestrol
- meloxicam
- melphalan
- menotropins
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
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- nabumetone
- naproxen
- necitumumab
- nelarabine
- netupitant
- nilotinib
- nintedanib
- niraparib
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- norethindrone (contraceptive)
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- norgestrel (contraceptive)
- olaparib
- olsalazine
- ospemifene
- oxaliplatin
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- palbociclib
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- peginterferon alfa 2a
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- pentamidine
- pentostatin
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- pirtobrutinib
- pomalidomide
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- porfimer
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- progesterone vaginal (hormone replacement)
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- romidepsin
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- rucaparib
- sacituzumab govitecan
- salsalate
- segesterone (contraceptive)
- selinexor
- sipuleucel-T
- sirolimus albumin-bound
- sodium tetradecyl sulfate
- sotatercept
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- sulindac
- tagraxofusp
- talazoparib
- tamoxifen
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- temozolomide
- temsirolimus
- teriflunomide
- testosterone
- thalidomide
- thioguanine
- thiotepa
- tivozanib
- tolmetin
- topotecan
- toremifene
- trabectedin
- trametinib
- trastuzumab
- treosulfan
- tretinoin
- trifluridine
- trimethoprim
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vancomycin
- varicella zoster immune globulin
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- von Willebrand factor
- vorinostat
- zanubrutinib
- zidovudine
- ziv-aflibercept
- zopapogene imadenovec
Caution Advised
- beclomethasone inhaled
- beclomethasone nasal
- betamethasone
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- clobetasol ophthalmic
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- danicopan
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- hydrocortisone
- hydrocortisone ophthalmic
- icotrokinra
- iptacopan
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- narsoplimab
- ozanimod
- pegcetacoplan
- ponesimod
- prednisolone
- prednisolone ophthalmic
- prednisone
- regorafenib
- siponimod
- triamcinolone
- tuberculin purified protein derivative
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- viral reactivation
- HBV reactivation
- herpes zoster
- thrombocytopenia
- anemia
- neutropenia
- lymphopenia
- leukopenia
- non-melanoma skin CA
- thromboembolism
Common Reactions
- URI
- application site reaction
- nasopharyngitis
- headache
- fever
- WBC decr.
- UTI
Safety/Monitoring .
Monitoring Parameters
CBC with diff; dermatologic exams periodically during tx and after tx D/C; signs/symptoms of serious infection during and after tx D/C; consider HBV, HCV, TB screening at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; no known risk of teratogenicity, though risk of fetal death based on animal data with PO route at 0.7x MRHD; risk of decr. fetal weight based on animal data with PO route at 0.7x and 22x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Pregnancy Exposure Registry at 1-855-463-3463 or www.opzelura.pregnancy.incyte.com
Lactation
Clinical Summary
avoid breastfeeding during tx and x4wk 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 ruxolitinib: liver; CYP450: 2C9, 3A4 (primary) substrate; Info: active metabolites; systemic absorption varies with application area and site, tx duration, and patient-specific factors
Excretion: for ruxolitinib: urine 74%, feces 22%; Half-life: 116h
Subclass: Atopic Dermatitis, Topical Nonsteroidal Agents ; Cosmetic, Dermatologic ; JAK Inhibitors, Dermatologic ; Organ Transplant Anti-Rejection Agents
Mechanism of Action
for ruxolitinib: exact mechanism of action unknown; inhibits janus-associated kinases (JAK) 1 and 2, leading to disruption of cytokine and growth factor signaling pathways
Formulary .
No Formulary Selected
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