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Cibinqo
abrocitinib
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; screen for latent TB infection before and during abrocitinib tx; initiate anti-TB tx before abrocitinib tx; avoid use in patients with active, serious infection, including localized infections; weigh risk/benefit in patients with chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx, including TB development in patients with negative TB test; D/C abrocitinib if serious infection 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 another JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; abrocitinib not approved for use in RA patients
Malignancies
malignancies occurred in patients treated with abrocitinib; lymphoma and other malignancies observed in patients treated with JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated with another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; abrocitinib not approved for use in RA patients
Major Adverse Cardiovascular Events
major adverse cardiovascular events occurred in patients treated with abrocitinib; 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 another JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; D/C abrocitinib in patients that experienced MI or stroke; abrocitinib not approved for use in RA patients
Thrombosis
thrombosis, including DVT, PE, and arterial thrombosis have occurred in patients treated with abrocitinib and other 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 on another JAK inhibitor (tofacitinib) vs. TNF blockers; avoid abrocitinib in patients with thrombosis risk; D/C abrocitinib and promptly evaluate patients with thrombosis symptoms; abrocitinib not approved for use in RA patients
Adult Dosing .
Dosage forms: TAB: 50 mg, 100 mg, 200 mg
atopic dermatitis, moderate-severe refractory
- [100-200 mg PO qd]
- Start: 100 mg PO qd, then may incr. to 200 mg PO qd; Info: use lowest effective dose; decr. dose 50% in CYP2C19 poor metabolizers; do not cut/crush/chew tab; see pkg insert for toxicity-related D/C recommendations; D/C if inadequate response with dose incr.
renal dosing
- [see below]
- eGFR 30-59: start 50 mg qd, then may incr. to 100 mg qd; eGFR <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 50 mg, 100 mg, 200 mg
atopic dermatitis, moderate-severe refractory
- [12 yo and older, >25 kg]
- Dose: 100-200 mg PO qd; Start: 100 mg PO qd, then may incr. to 200 mg PO qd; Info: use lowest effective dose; decr. dose 50% in CYP2C19 poor metabolizers; do not cut/crush/chew tab; see pkg insert for toxicity-related D/C recommendations; D/C if inadequate response with dose incr.
renal dosing
- [see below]
- eGFR 30-59: start 50 mg qd, then may incr. to 100 mg qd; eGFR <30: avoid use
- HD/PD: avoid use
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined