®()

Opzelura®(Ruxolitinib)

Prescription Only

Opzelura is for mild to moderate eczema and nonsegmental vitiligo. It is intended for short-term and non-continuous use in people aged 12 and above who are not immunocompromised...

Dosage & Administration

Administration

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Topical. Learn more.

Dosing

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Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Not for ophthalmic, oral, or intravaginal use. Atopic Dermatitis: Apply a thin layer twice daily to affected areas of up to 20% body surface area. . Learn more.

Latin Shorthand

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Apply a thin layer BID to affected areas up to 20% body surface area.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

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$0. Learn more.

Annual Cap

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$1,755 per tube, $10,000 per calendar year. Learn more.

Assistance Expiration

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12/31/2023. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.. Learn more.

Mechanism of Actions (MoA)

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Protein kinase inhibitors. Learn more.

Special Populations

Is there a pregnancy exposure registry for OPZELURA?

Yes, there is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

What is the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with OPZELURA?

Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes.

What is the recommended duration of not breastfeeding during treatment with OPZELURA?

Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

What is the safety and effectiveness of OPZELURA in pediatric patients?

The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established. The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established. Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures.

Is there a difference in safety and effectiveness of OPZELURA between geriatric and younger patients?

No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

®()	Opzelura®(Ruxolitinib)

Prescription Only	Prescription Only Opzelura is for mild to moderate eczema and nonsegmental vitiligo. It is intended for short-term and non-continuous use in people aged 12 and above who are not immunocompromised...
Dosage & Administration	Dosage & Administration comparison data
Administration
Learn more.	Topical. Learn more.
Dosing
Learn more.	Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Not for ophthalmic, oral, or intravaginal use. Atopic Dermatitis: Apply a thin layer twice daily to affected areas of up to 20% body surface area. . Learn more.
Latin Shorthand
Learn more.	Apply a thin layer BID to affected areas up to 20% body surface area.. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
Learn more.	$0. Learn more.
Annual Cap
Learn more.	$1,755 per tube, $10,000 per calendar year. Learn more.
Assistance Expiration
Learn more.	12/31/2023. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
Learn more.	In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, and rhinorrhea. In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.. Learn more.
Mechanism of Actions (MoA)
Learn more.	Protein kinase inhibitors. Learn more.
Special Populations
	Is there a pregnancy exposure registry for OPZELURA? Yes, there is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463. What is the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with OPZELURA? Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. What is the recommended duration of not breastfeeding during treatment with OPZELURA? Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives). What is the safety and effectiveness of OPZELURA in pediatric patients? The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established. The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established. Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures. Is there a difference in safety and effectiveness of OPZELURA between geriatric and younger patients? No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.

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