Abrocitinib (Oral)

Serious InfectionsPatients treated with abrocitinib may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infection reported with abrocitinib were herpes simplex, herpes zoster, and pneumonia.If a serious or opportunistic infection develops, discontinue abrocitinib and control the infection.Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:Active tuberculosis, which may present with pulmonary or extrapulmonary disease. 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.Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized disease.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.Avoid use of abrocitinib in patients with an active, serious infection including localized infections. The risks and benefits of treatment with abrocitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MortalityIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Abrocitinib is not approved for use in RA patients.MalignanciesMalignancies were reported in patients treated with abrocitinib. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risks.Major Adverse Cardiovascular EventsMajor adverse cardiovascular events were reported in patients treated with abrocitinib. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue abrocitinib in patients that have experience a myocardial infarction or stroke.ThrombosisDeep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with abrocitinib. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thro..