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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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A TOPICAL, STEROID-FREE MONOTHERAPY1

 

FOR SHORT-TERM, TWICE DAILY USE AND LONG-TERM MANAGEMENT OF AD FLARE-UPS1,2

OPZELURA is appropriate for adult and pediatric patients 12 and older with mild to moderate AD, especially those who suffer with persistent AD, uncontrolled itch, including sensitive skin areas, and those reluctant toward systemics. OPZELURA is not an injectable or systemic—it’s an elegant, non-greasy, steroid-free cream that targets the source of itch and inflammation through JAK inhibition.1

AD, atopic dermatitis; JAK, Janus kinase.

HOW TO USE OPZELURA

  • Patients should apply a thin layer 2x a day directly to affected skin areas —up to 20% BSA1
  • Patients should not use more than one 60 gram tube per week1
  • Patients should use OPZELURA until signs and symptoms resolve1

For topical use only. Not for ophthalmic, oral, or intravaginal use.1

If signs and symptoms do not improve within 8 weeks, patients should be re-examined.1

Patients can start using OPZELURA again at first sign of recurrence.2

BSA, body surface area.

BSA DIAGRAM

OPZELURA CAN BE USED ON AFFECTED AREAS UP TO 20% BSA IN AD1

1 Handprint = 1% BSA3,4

(palm and 5 digits, with fingers tucked together and thumb tucked to the side)3,4

Figure illustrating how body surface area is quantified across body parts via the Palmar Method.

This figure illustrates how BSA is quantified across body parts via the Palmar Method. Exact affected areas and sizes will differ by patients.5,6

20% BSA in AD - approximately 20 handprints

Patients should stop using when signs and symptoms of AD resolve.

If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their HCP.1

SEE REAL-WORLD RESULTS FROM OPZELURA

For topical use only. Not for ophthalmic, oral, or intravaginal use.1

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

AD, atopic dermatitis; BSA, body surface area.

Photo of female applying OPZELURA to atopic dermatitis on the inside of her right elbow.
Photo of female applying OPZELURA to atopic dermatitis on the inside of her right elbow.

ADDITIONAL TIPS FOR PATIENTS

Whether they are just starting OPZELURA or resuming use for a new flare-up, encourage your patients to:

  • track their applications
  • jot down notes or take photos of their lesions to share with you7
  • use OPZELURA exactly as directed1
  • stop when signs and symptoms of mild to moderate AD resolve1

For subsequent recurrences, advise patients that they can restart OPZELURA twice daily.1,2

Your patients can get additional tips and resources on the OPZELURA patient website.

“EASE-OF-USE"

An online quantitative survey* was conducted on behalf of Incyte from March 19 to May 10, 2024 including 95 current OPZELURA users with AD.8

According to the 95 AD patients,

100% OF PATIENTS AGREED THAT OPZELURA IS EASY TO USE8

SEE MORE SURVEY RESULTS

Data were self-reported and outcomes may vary. No conclusions of safety or efficacy should be made based on these results.

Limitations: This survey relied on self-reported data, was not confirmed by a medical professional, and can be affected by bias from selection, recall, response styles, and other sources. Opinions may not be representative of the general population.

 

*Participants with AD reported they: had received an AD diagnosis; had been using OPZELURA for ≥2 weeks; were current or former users of topical corticosteroids and/or non-steroidal creams.8

The survey covered condition and treatment background, AD disease state, OPZELURA experience, and overall OPZELURA satisfaction.8

AD, atopic dermatitis.

View Itch Results
VIEW PATIENT PHOTOS
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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. 2. Papp K, Szepietowski JC, Kircik L, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. Presented at the Revolutionizing Atopic Dermatitis Virtual Conference; June 13, 2021. 3. Rosmarin D, Pandya AG, Lebwohl M, et al. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020;396(suppl):110-120. doi:10.1016/S0140-6736(20)30609-7 4. Berke R, Singh A, Guralnick M. Atopic dermatitis: an overview. Am Fam Physician. 2012;86(1):35-42. 5. Bibeau K, Butler K, Sun K, Skaltsa K, Hamzavi IH. Assessment of measurement properties of the facial and total vitiligo area scoring index instruments in the topical ruxolitinib evaluation in vitiligo (TRuE-V) phase 3 studies. Presented at the Maui Derm for Dermatologists; January 24–28, 2022; Maui, HI. 6. Moore RA, Waheed A, Burns B. Rule of Nines. Treasure Island, FL: StatPearls Publishing; 2021. https://www.ncbi.nlm.nih.gov/books/NBK513287/?report=reader. Accessed February 25, 2021 7. Marin-Gomez FX, Vidal-Alaball J, Poch PR, Sariola CJ, Ferrer RT, Peña JM. Diagnosis of skin lesions using photographs taken with a mobile phone: an online survey of primary care physicians. J Prim Care Community Health. 2020;11:2150132720937831. doi:10.1177/2150132720937831 8. Data on File. Incyte Corporation.