Precautions of Abrocitinib

1. Serious Infections

Avoid use of Cibinqo in patients with active, serious infection including localized infections.

Consider the risks and benefits of treatment prior to initiating Cibinqo in patients:

with chronic or recurrent infection  x who have been exposed to tuberculosis

with a history of a serious or an opportunistic infection

who have resided or traveled in areas of endemic tuberculosis or endemic mycoses

with underlying conditions that may predispose them to infection

Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Cibinqo. If a patient develops a serious or opportunistic infection, discontinue Cibinqo. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with Cibinqo should be carefully considered prior to reinitiating therapy with Cibinqo.

2. Mortality

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Cibinqo.

3. Malignancy and Lymphoproliferative Disorders

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Cibinqo, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

4. Major Adverse Cardiovascular Events

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Cibinqo, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue Cibinqo in patients that have experienced a myocardial infarction or stroke.

5. Thrombosis

Avoid Cibinqo in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue Cibinqo and evaluate and treat patients appropriately.

from FDA，2023.12