Abrocitinib is an oral medication approved for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

FDA drug label recommends a lower abrocitinib dosage regimen for people with significantly reduced CYP2C19 function, while EMA and Health Canada drug labels do not require dose adjustment.

Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue abrocitinib if serious or opportunistic infection occurs. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative latent TB test. Higher rate of all-cause mortality, including sudden cardiovascular death, thrombosis, pulmonary embolism, MACE, and malignancies with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. Abrocitinib is not approved for use in RA patients.

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213871s000lbl.pdf
• https://www.ema.europa.eu/en/documents/product-information/cibinqo-epar-product-information_en.pdf