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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 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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.

OPZELURA healthcare professionals atopic dermatitis homepage

Mild to Moderate Atopic Dermatitis

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PATIENT SELECTION

SEE HOW OPZELURA MAY BE ABLE TO HELP YOUR PATIENTS

Real-World Results
Patient Profiles

Consider OPZELURA for all your appropriate patients with itchy, MILD TO MODERATE AD1

A patient for whom OPZELURA may be appropriate1:

  • Has itchy, mild to moderate atopic dermatitis
  • Is 12 years of age or older
  • Has an affected BSA of up to 20%
  • Has tried topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI), unless the use of such alternatives is not advisable

In particular, OPZELURA may be an appropriate choice for patients for whom other topicals haven’t worked, but who do not want to move onto an injectable or systemic treatment.

Routine bloodwork when using OPZELURA is not required. However, blood tests may be called for to evaluate potential side effects or for patients with a history of hematologic malignancies.1

Visualizing real-world results with Opzelura2

The following images depict actual patients treated with OPZELURA. Not clinical trial participants. Scoring was designated by the treating physician. Because the following patients are real-world patients, there may be other factors influencing their treatment results, and individual results may vary.

 

Actual patient treated with OPZELURA. Not a clinical trial participant.        
Scoring was designated by the treating physician. Because this is a real-world (RW) patient, there may be other factors influencing treatment results, and individual results may vary.

Photos by Dr. Jason Smith, MD (Dermatologist - Rome, GA).

BSA, body surface area; IGA, Investigator's Global Assessment.

Designed to help address a range of patient needs

I really want something that will help stop the itching.

Isabelle, 23

Needs meaningful relief from mild to moderate AD itch

Her Ad Story

  • Works in a fast-paced environment as a professional chef but is constantly slowed down by chronic itch

Her treatment needs

  • Has tried multiple TCSs over the years
  • Experiences temporary relief between flare-ups
  • Lesions have increased from 5% to 8% BSA

See Itch Results

Hands and forearms

  • Marked by erythema, excoriation, and lichenification
  • Service gloves exacerbate her pruritus and make the area difficult to scratch

Ankles

  • Afflicted by persistent pruritus
  • Constant scratching occasionally results in bleeding, leading to sanitary concerns at work

Patient portrayal.

*For short-term and non-continuous chronic treatment only. For topical use only. Not for ophthalmic, oral, or intravaginal use.1

AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; TCI, topical calcineurin inhibitor; TCS, topical corticosteroid.

It's difficult to find relief where I need it.

Sarah-Beth, 59

Wants a treatment for her mild to moderate AD in sensitive skin areas*

Her Ad Story

  • Proud shop owner who has eczema on face and upper chest
  • Self-conscious about the ointment she uses, which has a greasy appearance and causes stinging

Her treatment needs

  • Dissatisfaction with tacrolimus has left her doubtful of other options
  • Needs a targeted therapy that can relieve mild to moderate AD in sensitive skin areas*

See Skin Clearence Results

Periorbital area

  • Pruritus and inflammation in periorbital areas*

Upper chest

  • Afflicted by erythematous, bumpy rash easily exacerbated by certain clothing
  • Clothing often gets stained by tacrolimus ointment, causing discomfort and appearance concerns

Patient portrayal.

*For short-term and non-continuous chronic treatment only. For topical use only. Not for ophthalmic, oral, or intravaginal use.1

AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; TCI, topical calcineurin inhibitor; TCS, topical corticosteroid.

I wish I had a different option to control my AD Symptoms.

Faith, 40

Wants a non-steroidal option that is appropriate for use on areas affecting her every day*

Her Ad Story

  • Has suffered from mild to moderate AD for more than 2 years and is prescribed a TCS
  • Works as a registered nurse, which requires constant hand and forearm washing that exacerbates her AD
  • Worried that her open lesions are unhygienic

Her treatment needs

  • Wants to avoid mild atrophic patches in affected areas caused by long-term TCS use
  • Needs a non-steroidal option that is appropriate for use on affected areas (up to 20% BSA)1*

See Skin Clearance Results

Hands and wrists

  • Marked by mild atrophic patches and striae along the affected areas from long-term TCS use

Forearms

  • Afflicted by patchy erythema that feels hot to the touch
  • Often feels that patients are staring at her lesions

Patient portrayal.

*For short-term and non-continuous chronic treatment only. For topical use only. Not for ophthalmic, oral, or intravaginal use.1

AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; TCI, topical calcineurin inhibitor; TCS, topical corticosteroid.

My AD feels all-consuming, but I don't feel comfortable taking that next step.

Henry, 32

Looking for a proven topical treatment option

His Ad Story

  • Works as a landscape architect with exposure to extreme temperatures that exacerbate his AD (18% BSA)
  • Experiences flare-ups of moderate AD

His treatment needs

  • Has failed on TCIs but is hesitant toward systemics
  • His physician has recommended dupilumab, but he is concerned about injectable administration

See EASI Results

Neck

  • Flare-ups have started to spread and are marked by hypopigmentation from long-term TCS use
  • Purple and grey patches exacerbated by perspiration during warm weather and dryness in the winter
Purple and grey patches on elbow folds

Elbow folds

  • Most significant source of pruritus
  • Persistent nighttime itch causes difficulty falling asleep

Patient portrayal.

*For short-term and non-continuous chronic treatment only. For topical use only. Not for ophthalmic, oral, or intravaginal use.1

AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; TCI, topical calcineurin inhibitor; TCS, topical corticosteroid.

I'm tired of feeling like I'm different from other kids.

Alex, 13

Needs a treatment that fits into a teenage lifestyle

His Ad Story

  • Loves baseball, but itching during games has frustrated him
  • Has started seeing the school counselor due to concerns about the appearance of his lesions

His treatment needs

  • His mother recognizes the impact mild to moderate AD is having, but is concerned about continuing to cycle on and off TCS
  • Needs a non-greasy treatment he can fit into his daily routine to help control his itch and inflammation

See Safety Profile

Elbow

  • Marked by patchy, scaly areas of erythema
  • Wears long sleeves even in warm weather to cover the redness

Hands and wrists

  • Most significant source of pruritus
  • Often itches under his baseball glove, causing him to remove it during innings

Patient portrayal.

*For short-term and non-continuous chronic treatment only. For topical use only. Not for ophthalmic, oral, or intravaginal use.1

AD, atopic dermatitis; BSA, body surface area; EASI, Eczema Area and Severity Index; TCI, topical calcineurin inhibitor; TCS, topical corticosteroid.

VIEW ITCH RESULTS
PRIOR AUTHORIZATION INFO
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Important Safety Information and indication

 

INDICATION

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 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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.

IMPORTANT SAFETY 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. 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. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA.

Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.

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 higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

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.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

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.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

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.
Thrombocytopenia, Anemia, and Neutropenia

Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid Elevations

Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions

In atopic dermatitis, the most common adverse reactions (≥1%) are nasopharyngitis (3%), diarrhea (1%), bronchitis (1%), ear infection (1%), eosinophil count increased (1%), urticaria (1%), folliculitis (1%), tonsillitis (1%), and rhinorrhea (1%).

Pregnancy Registry

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 or visiting www.opzelura.pregnancy.incyte.com.

Lactation

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Please see Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.
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Indication

OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic

Important Safety Information

Important Safety Information and indication

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. Reported infections include:

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

REFERENCES: 1. OPZELURA [Prescribing information]. Wilmington, DE: Incyte Corporation; 2023. 2. Data on File. Incyte Corporation. 2023.