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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 patients 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 patients w/ chronic or recurrent infection, serious or opportunistic infection history, underlying conditions predisposing to infections, and in patients exposed to TB, incl. residing or traveling to areas of endemic TB or mycoses; monitor closely for active TB infection during tx, incl. patients w/ baseline negative latent TB screening
Mortality
higher rate of mortality, incl. sudden cardiovascular death, observed in RA patients 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 patients
Malignancies
malignancies, incl. non-melanoma skin CA observed in patients treated w/ ritlecitinib; lymphoma and other malignancies observed in patients treated w/ oral JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients w/ known malignancy, patients who develop a malignancy during tx, or patients who are current or past smokers; periodic skin exams recommended for patients 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 patients 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 patients who are current or past smokers or patients w/ other cardiovascular risk factors; D/C ritlecitinib in patients that experienced MI or stroke
Thrombosis
thromboembolic events observed w/ ritlecitinib; higher rate of thrombosis observed in RA patients 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; avoid ritlecitinib in patients at incr. thrombosis risk; D/C ritlecitinib and promptly evaluate patients w/ thrombosis symptoms
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