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U.S. FDA Approval of Opzelura(ruxolitinib)Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis(AD)
U.S. Food and Drug Administration(FDA)has approved Opzelura(ruxolitinib)cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Invasive fungal infections, including candidiasis and pneumocystosis.
Bacterial, viral, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA.
No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider eva luating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.
Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.
MORTALITY
Higher rate of all-cause mortality, including sudden cardiovascular death, has been observed in patients treated with oral Janus kinase inhibitors for inflammatory conditions.
MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. Patients who are current or past smokers are at additional increased risk. Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate.
MAJOR ADVERSE CARDIOVASCULAR EVENTS(MACE)
Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. Consider the benefits and risks for the individual patient pr |
