Indications for: OPZELURA
For short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients whose disease is not adequately controlled with topical ℞ therapies or when those therapies are not advisable.
Limitations of Use:
Not recommended for use with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants (eg, azathioprine, cyclosporine).
Adults and Children:
<12yrs: not established. ≥12yrs: Apply a thin layer twice daily to affected area(s) of up to 20% body surface area. Max: 60g per week.
Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.
Not for ophthalmic, oral, or intravaginal use. Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Consider evaluating for latent or active TB infection prior to therapy. Monitor closely if new infection, active TB, reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection, or sepsis occurs. Increased rate of all-cause mortality, MACE, and thrombosis. Cardiovascular risk factors. Consider the risks/benefits esp. in patients with known malignancy or smokers. Perform periodic skin exams during and after treatment. Consider the risks/benefits in those with a known history of thrombocytopenia, anemia, and neutropenia; discontinue if significant signs/symptoms occur. Perform CBC monitoring as clinically indicated. Pregnancy. Nursing mothers: not recommended (during and for 4 weeks after the last dose).
Janus kinase (JAK) inhibitor.
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); avoid.
Nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, urticaria, folliculitis, tonsillitis, rhinorrhea; malignancy (eg, lymphomas), non-melanoma skin cancers, increased lipid parameters (total cholesterol, LDL, triglycerides).
Generic Drug Availability: