Ruxolitinib Phosphate
Class: Skin and Mucous Membrane Agents, Miscellaneous
Chemical Name: (3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric acid
Molecular Formula: C17H21N6O4P
CAS Number: 1092939-17-7
Brands: Opzelura
Warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS
See full prescribing information for complete boxed warning.
Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving Janus kinase inhibitors for inflammatory conditions.
Higher rate of all-cause mortality, including sudden cardiovascular death have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.
Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.
Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors for inflammatory conditions.
Introduction
Ruxolitinib phosphate is a topical Janus kinase (JAK) inhibitor.
Uses for Ruxolitinib Phosphate
Ruxolitinib phosphate has the following uses:
Ruxolitinib phosphate 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 patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Ruxolitinib phosphate has the following limitations of use:
Use of ruxolitinib phosphate in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
Ruxolitinib Phosphate Dosage and Administration
General
Ruxolitinib phosphate is available in the following dosage form(s) and strength(s):
Cream: 1.5% (of ruxolitinib)
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
For topical use only.
Not for ophthalmic, oral, or intravaginal use.
Pediatric Patients
Dosage and Administration
Pediatric patients ≥12 years of age: Apply a thin layer twice daily to affected areas of up to 20% body surface area. Do not use more than 60 grams per week.
Adults
Dosage and Administration
Apply a thin layer twice daily to affected areas o...
