Your Health, We Care
Hypersensitivity reactions such as angioedema have been reported in subjects receiving Deucravacitinib. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue Deucravacitinib.
Deucravacitinib may increase the risk of infections.
Avoid use of Deucravacitinib in patients with an active or serious infection.
Consider the risks and benefits of treatment prior to initiating Deucravacitinib in patients:
• with chronic or recurrent infection
• who have been exposed to tuberculosis
• with a history of a serious or an opportunistic infection
• 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 Deucravacitinib. A patient who develops a new infection during treatment with Deucravacitinib should undergo prompt and complete diagnostic testing; appropriate antimicrobial therapy should be initiated; and the patient should be closely monitored. Interrupt Deucravacitinib if a patient develops a serious infection. Do not resume Deucravacitinib until the infection resolves or is adequately treated.
Deucravacitinib is not recommended for use in patients with active hepatitis B or hepatitis C.
Consider anti-TB therapy prior to initiation of Deucravacitinib in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients receiving Deucravacitinib for signs and symptoms of active TB during treatment.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Deucravacitinib, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with Deucravacitinib.
Treatment with Deucravacitinib was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to treatment with placebo. Discontinue Deucravacitinib if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
from FDA，2022.09
