This site is intended for US healthcare professionals.

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

Change condition>

ADVERSE EVENTS PROFILE

ADVERSE REACTIONS REPORTED IN TRIALS OF OPZELURA

AEs through Week 8
AEs through 52 Weeks
Safety Considerations
Additional Safety

ADVERSE REACTIONS REPORTED IN PHASE 3 TRIALS OF OPZELURA

ADVERSE REACTIONS OCCURRING IN ≥1% OF SUBJECTS TREATED WITH OPZELURA FOR ATOPIC DERMATITIS THROUGH WEEK 81

Adverse  
Reaction		OPZELURA  
(n = 499) n (%)		Vehicle  
(n = 250) n (%)
Subjects with any TEAE132 (27)83 (33)
Nasopharyngitis13 (3)2 (1)
Bronchitis4 (1)0 (0)
Ear infection4 (1)0 (0)
Eosinophil count increased4 (1)0 (0)
Urticaria4 (1)0 (0)
Diarrhea3 (1)1 (<1)
Folliculitis3 (1)0 (0)
Tonsillitis3 (1)0 (0)
Rhinorrhea3 (1)1 (<1)
 

Low rate of treatment-related application site reactions such as burning (0.8% with OPZELURA vs. 4.4% with vehicle) and pruritus (0% with OPZELURA vs. 2.4% with vehicle)2

Low rate of discontinuation due to TEAEs: 0.8% with OPZELURA vs. 3.2% with vehicle2

Adverse reactions occurring in <1% for OPZELURA vs. 0% for vehicle were neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, staphylococcal infection, and acneiform dermatitis1

TEAE, treatment-emergent adverse event.

 

TEAEs THROUGH 52-WEEK STUDY PERIOD

COMMON TEAEs OCCURRING IN ≥2% OF PATIENTS RECEIVING OPZELURA IN THE 52-WEEK STUDY PERIOD3

TEAE, n (%)OPZELURA
(n = 598)*
Upper respiratory tract infection60 (10.0)
Nasopharyngitis58 (9.7)
Headache24 (4.0)
Bronchitis20 (3.3)
Influenza18 (3.0)
Rhinitis12 (2.0)
Atopic dermatitis12 (2.0)
Asthma12 (2.0)
 

OPZELURA is for short-term and non-continuous use only1

Adverse events through 52 weeks inclusive of 8-week vehicle control and long-term extension periods3

  • Safety data from the 44-week extension study are not included in the Prescribing Information for OPZELURA
  • No conclusions of safety should be made based on these results
  • Adverse reaction rates observed in clinical trials and long-term extension studies may not predict the rates observed in a broader patient population in clinical practice

*Includes patients who received ≥1 dose of OPZELURA in the vehicle-controlled and/or extension periods.3

TEAE, treatment-emergent adverse event.

 

SAFETY CONSIDERATIONS1,4

Exposure-adjusted incidence rates of select TEAEs from baseline to Week 521,4*

 OPZELURA
E/100 PY (n = 598) PY = 466.00		Vehicle
E/100 PY (n = 250) PY = 34.99
Serious infections0.20.0
Opportunistic infections0.00.0
Tuberculosis0.00.0
Herpes zoster1.10.0
Mortality0.00.0
Malignancies and lymphoproliferative disorders 
Lymphomas0.00.0
NMSC0.40.0
Other malignancies (excluding lymphomas and NMSC)0.02.9
Major adverse cardiovascular events (MACE) 
Cardiovascular death0.00.0
Myocardial infarction0.00.0
Cerebrovascular accident (nonfatal stroke)0.20.0
Venous thromboembolic events 
Pulmonary embolism0.20.0
Deep venous thrombosis0.20.0
 

Adverse reaction rates observed in clinical trials and LTE studies may not predict the rates observed in a broader patient population in clinical practice.

TEAEs observed (per 100 patient years [PY]) in patients who applied ruxolitinib cream 0.75% in the phase 3 program include: serious infections (0.9), herpes zoster (0.7), NMSC (0.7), other malignancies (excluding lymphomas and NMSC) (0.2), cerebrovascular accident (0.2), myocardial infarction (0.2), and pulmonary embolism (0.2).4

*Not inclusive of adverse event information collected in earlier phase trials or trials involving other disease states.

E/100 PY, exposure-adjusted incidence rate (the number of patients with the event per 100 patient years of exposure); LTE, long-term extension; NMSC, non-melanoma skin cancer; PY, patient years of exposure (defined as the duration from first cream application to last application); TEAE, treatment-emergent adverse event.

ADDITIONAL PHASE 3

SAFETY INFORMATION (8 WEEKS)1,4

 OPZELURA  
(n = 499) %		Vehicle  
(n = 250) %
Atrophy0%0%
Striae0%0%
Nausea0.2%0%
Vomiting0%0%
Learn about dosing and administration
VIEW DISEASE CONTROL DATA
Back To Top

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.
See More  

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. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863-872. doi:10.1016/j.jaad.2021.04.085 3. 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. 4. Data on File. Incyte Corporation.