Ruxolitinib INN
Composition: Each gram cream contains Ruxolitinib 15mg Ruxolitinib Phosphate INN.
Indication: Ruxolitinib is a Janus kinase (JAK) inhibitor, which
is indicated for atopic dermatitis and vitiligo.
•Atopic Dermatitis: Ruxolitinib is used in the topical short-term and
non-continuous chronic treatment of mild to moderate atopic dermatitis in
non-immunocompromised adult and pediatric patients 12 years of age and older
whose disease is not adequately controlled with topical prescription therapies
or when those therapies are not advisable.
•Vitiligo: Ruxolitinib is used in the topical treatment of
nonsegmental vitiligo in adult and pediatric patients 12 years of age and
older.
Dosage and Administration:
Administration Instruction: Ruxolitinib cream should not use more than 60 gram
per week or 100 gram per 2 weeks. It is for topical use only. It is not for
intraocular, oral, or intravaginal use.
Recommended Dosage for Atopic
Dermatitis: Patients should apply a
thin layer of Ruxolitinib twice daily to affected areas of up to 20% body
surface area. When signs and symptoms (e.g., itch, rash, and redness) of atopic
dermatitis resolve it should be stopped. If signs and symptoms do not improve
within 8 weeks, patients should be re-examined by registered doctor. Recommended Dosage for Nonsegmental
Vitiligo: Patients should apply a thin layer of Ruxolitinib twice daily to
affected areas of up to 10% body surface area. Satisfactory patient response
may require treatment with Ruxolitinib
for more than 24 weeks. If the patient does not find the repigmentation
meaningful by 24 weeks, the patient should be re-evaluated by registered
doctor.
Use in Pregnancy and Lactation: Because of the serious adverse findings in adults,
including risks of serious infections, thrombocytopenia, anemia, and
neutropenia, women should not breastfeed during treatment with Ruxolitinib and
for approximately four weeks after the last dose.
Packing: Each tube contains 15 gm cream.
