Opzelura

(Ruxolitinib)

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Dosage & Administration

Atopic Dermatitis

* Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 20% body surface area.
* Do not use OPZELURA with occlusive dressings.

Adult and Pediatric Patients 12 Years of Age and Older

* Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.

Pediatric Patients 2 to 11 Years of Age

* Do not use more than one 60 gram tube of OPZELURA per 2 weeks.

Nonsegmental Vitiligo

* Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area. (

2.1 Recommended Dosage and
Administration for Atopic Dermatitis

OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.

Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area.

Do not use OPZELURA with occlusive dressings.

Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their healthcare provider

[see Clinical Studies (

14.1

)]

Adult and Pediatric Patients 12 Years of Age and Older

Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.

Pediatric Patients 2 to 11 Years of Age

Do not use more than one 60 gram tube of OPZELURA per 2 weeks.

)

* Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. (

2.1 Recommended Dosage and
Administration for Atopic Dermatitis

OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.

Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area.

Do not use OPZELURA with occlusive dressings.

[see Clinical Studies (

14.1

)]

Adult and Pediatric Patients 12 Years of Age and Older

Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.

Pediatric Patients 2 to 11 Years of Age

Do not use more than one 60 gram tube of OPZELURA per 2 weeks.

)

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Opzelura Prescribing Information

SERIOUS INFECTIONS

Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death

[see Warnings and Precautions and Adverse Reactions ]

Reported infections include:

Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
Invasive fungal infections, including
cryptococcosis,
and pneumocystosis.
Bacterial, viral,
including herpes zoster,
and other infections due to opportunistic pathogens.

Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled.

The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA

[see Warnings and Precautions ]

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a h

igher rate of all-cause mortality, including sudden cardiovascular death, was observed

with the JAK inhibitor

[see Warnings and Precautions ]

MALIGNANCIES

Malignancies were reported in patients treated with OPZELURA.

Lymphoma and other malignancies have been observed in patients

receiving JAK inhibitors used to treat inflammatory conditions. In RA patients

treated with

an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk

[see Warnings and Precautions ]

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (

MACE) (

defined as

cardiovascular death, myocardial infarction, and stroke)

, was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke

[see Warnings and Precautions ]

THROMBOSIS

Thromboembolic events were observed in trials with OPZELURA.

Thrombosis, including

pulmonary embolism (PE),

deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients

receiving JAK

inhibitors

used to treat

inflammatory conditions. Many of these adverse reactions were serious and some resulted in death.

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If

symptoms of thrombosis

occur, discontinue OPZELURA and treat appropriately

[see Warnings and Precautions ]

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 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.
)
the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. (
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.
)

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 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.

)

Atopic Dermatitis

Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 20% body surface area.
Do not use OPZELURA with occlusive dressings.

Adult and Pediatric Patients 12 Years of Age and Older

Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.

Pediatric Patients 2 to 11 Years of Age

Do not use more than one 60 gram tube of OPZELURA per 2 weeks.

Nonsegmental Vitiligo

Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area. (
2.1 Recommended Dosage and
Administration for Atopic Dermatitis
OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.
Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area.
Do not use OPZELURA with occlusive dressings.
Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their healthcare provider
[see Clinical Studies (
14.1
)]
.
Adult and Pediatric Patients 12 Years of Age and Older
Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.
Pediatric Patients 2 to 11 Years of Age
Do not use more than one 60 gram tube of OPZELURA per 2 weeks.
)

Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. (
2.1 Recommended Dosage and
Administration for Atopic Dermatitis
OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.
Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area.
Do not use OPZELURA with occlusive dressings.
Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their healthcare provider
[see Clinical Studies (
14.1
)]
.
Adult and Pediatric Patients 12 Years of Age and Older
Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.
Pediatric Patients 2 to 11 Years of Age
Do not use more than one 60 gram tube of OPZELURA per 2 weeks.
)

Lactation
: Advise not to breastfeed. (
8.2 Lactation
Risk Summary
There are no data on the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production. Ruxolitinib was present in the milk of lactating rats
(see Data
)
. When a drug is present in animal milk, it is likely that the drug will be present in human milk. 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).
Data
Lactating rats were administered a single dose of [14C]-labeled ruxolitinib (30 mg/kg) on postnatal Day 10, after which plasma and milk samples were collected for up to 24 hours. The AUC for total radioactivity in milk was approximately 13 times the maternal plasma AUC. Additional analysis showed the presence of ruxolitinib and several of its metabolites in milk, all at levels higher than those in maternal plasma.
)

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