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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