Serious Infections, Mortality, Malignancy, Major Adverse Cardiovasculary Events (MACE), and Thrombosis
- Increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Discontinue treatment with CIBINQO 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, with another JAK inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. CIBINQO is not approved for use in RA patients.
- Malignancies have occurred with CIBINQO. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
Major Adverse Cardiovasculary Events (MACE)
- MACE has occurred with CIBINQO. Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients.
- Thrombosis has occurred with CIBINQO. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
- Closely monitor patients for the development of signs and symptoms of infection during and after treatment. If a patient develops a serious or opportunistic infection, discontinue therapy. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with abrocitinibshould be carefully considered prior to reinitiating therapy.
Patient Counseling Information