Atopic dermatitis:
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 or 100g per 2 weeks. Discontinue therapy when signs/symptoms resolve. Reevaluate if no improvement within 8 weeks.
Boxed Warning:
Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.
OPZELURA Warnings/Precautions:
Not for intraocular, 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. Screen for viral hepatitis before starting therapy. In rheumatoid arthritis patients age ≥50yrs with ≥1 CV risk factor treated with an oral JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), malignancies (esp. lymphomas, lung cancers), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). 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).
OPZELURA Classification:
Janus kinase (JAK) inhibitor.
OPZELURA Interactions:
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); avoid.
Adverse Reactions:
Atopic dermatitis: nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, urticaria, folliculitis, tonsillitis, rhinorrhea. Vitiligo: application site reactions (eg, acne, pruritus, erythema), nasopharyngitis, headache, UTI, pyrexia. Both: non-melanoma skin cancers, increased lipid parameters (total cholesterol, LDL, triglycerides).
Generic Drug Availability:
NO
How Supplied:
Crm—60g, 100g
Miscellaneous dermatological conditions:
Pigmentation disorders:
Indications for: OPZELURA
Nonsegmental vitiligo.
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 10% body surface area. Max: 60g per week or 100g per 2 weeks. May require treatment for >24 weeks. Reevaluate if repigmentation is not meaningful by 24 weeks.
Boxed Warning:
Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.
OPZELURA Warnings/Precautions:
Not for intraocular, 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. Screen for viral hepatitis before starting therapy. In rheumatoid arthritis patients age ≥50yrs with ≥1 CV risk factor treated with an oral JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), malignancies (esp. lymphomas, lung cancers), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). 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).
OPZELURA Classification:
Janus kinase (JAK) inhibitor.
OPZELURA Interactions:
May be potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); avoid.
Adverse Reactions:
Atopic dermatitis: nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, urticaria, folliculitis, tonsillitis, rhinorrhea. Vitiligo: application site reactions (eg, acne, pruritus, erythema), nasopharyngitis, headache, UTI, pyrexia. Both: non-melanoma skin cancers, increased lipid parameters (total cholesterol, LDL, triglycerides).
Generic Drug Availability:
NO
How Supplied:
Crm—60g, 100g
