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Opzelura
ruxolitinib topical
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death in pts treated w/ oral JAK inhibitors for inflammatory conditions; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections reported in pts treated w/ oral JAK inhibitors for inflammatory conditions; serious lower respiratory tract infections and viral reactivation, incl. herpes zoster, reported w/ topical ruxolitinib; consider screening for latent and active TB infection before tx; avoid use in pts w/ active, serious infection, incl. localized infections; weigh risk/benefit before tx in pts w/ chronic or recurrent infection; monitor closely for infection s/sx during and after tx; D/C topical ruxolitinib if serious infection or sepsis 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/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; topical ruxolitinib not approved for use in RA pts
Malignancies
non-melanoma skin CA occurred in pts treated w/ topical ruxolitinib; 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; topical ruxolitinib not approved for use in RA pts
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 topical ruxolitinib in pts that experienced MI or stroke; topical ruxolitinib not approved for use in RA pts
Thrombosis
thromboembolic events observed w/ topical ruxolitinib tx; incr. incidence of thrombosis, incl. DVT, PE, and arterial thrombosis, reported in pts treated w/ oral 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 treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; avoid topical ruxolitinib in pts at incr. thrombosis risk; D/C topical ruxolitinib and promptly evaluate pts w/ thrombosis sx; topical ruxolitinib not approved for use in RA pts
Adult Dosing .
Dosage forms: CRM: 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 pts; 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: CRM: 1.5%
mild-moderate atopic dermatitis, short-term tx or intermittent long-term tx
- [12 yo and older]
- Dose: apply bid; Max: 60 g/wk,100 g/2wk; Info: for immunocompetent pts; 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]