ruxolitinib

FDA Drug Profile — OPZELURA, JAKAFI

Drug Details

Generic Name
ruxolitinib
Brand Names
OPZELURA, JAKAFI
Application Number
NDA215309
Sponsor
Catalent Pharma Solutions, LLC
NDC Codes
11
Dosage Forms
TABLET, CREAM
Routes
TOPICAL, ORAL
Active Ingredients
RUXOLITINIB, RUXOLITINIB PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. ( 1.3 ) 1.1 Atopic Dermatitis OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 1.2 Nonsegmental Vitiligo OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.