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.
Nonsegmental Vitiligo
Staying on Track with OPZELURA
Dr. Hougeir, dermatologist, connects with us to discuss how patients can stay on track with OPZELURA, as well as some helpful tips and reminders. Dr. Hougeir was compensated for his participation.
(TITLE SLIDE) HELPING PATIENTS STAY ON TRACK WITH OPZELURA
(ON-SCREEN TEXT)
INDICATION
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.
IMPORTANT SAFETY INFORMATION
Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving Janus kinase inhibitors for inflammatory conditions. Regularly monitor patients for infection and manage it promptly.
Higher rate of all-cause mortality, including sudden cardiovascular death has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.
Lymphoma and other malignancies have been observed in patients treated with Janus kinase inhibitors for inflammatory conditions. Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate.
Higher rate of MACE (including cardiovascular death, myocardial infarction, and stroke) has been observed in patients treated with Janus kinase inhibitors for inflammatory conditions.
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with Janus kinase inhibitors for inflammatory conditions.
Important Safety Information will be discussed in more detail, later in this video.
(DESCRIPTION) A man in a suit sits in a comfortable chair, smiling at us.
(SPEECH) FIRAS HOUGEIR: How can you make sure your patients are staying on track with their OPZELURA treatment for nonsegmental vitiligo? I'm Dr. Hougeir, a dermatologist.
(ON-SCREEN TEXT) Opzelura® (ruxolitinib) cream 1.5% For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older1
DR. FIRAS HOUGEIR DERMATOLOGIST
(DISCLAIMER) This video is sponsored by Incyte Corporation. Dr. Firas Hougeir has been compensated for his time.
(SPEECH) FIRAS HOUGEIR: and these are a few tips for what to expect from OPZELURA. OPZELURA is the first and only FDA-approved prescription treatment for vitiligo repigmentation for patients 12 years of age and older.
(ON-SCREEN TEXT) SETTING EXPECTATIONS: DIFFERENT SKIN, DIFFERENT RATES1,2
(SPEECH) FIRAS HOUGEIR: Different people and different parts of the body may repigment at different rates and by different amounts. Work together to build a treatment plan that addresses their unique goals and helps them stay on track. OPZELURA has been shown to help repigmentation, but it is a gradual process. OPZELURA was studied as monotherapy for the duration of the two identical, phase III randomized studies. At 24 weeks, the primary endpoint was assessed, followed by a 28-week open-label treatment extension period.
(ON-SCREEN TEXT) REPIGMENTATION IS GRADUAL2
(DISCLAIMER) Across two 24-week studies, 29.9% of those using OPZELURA saw 75% facial vitiligo repigmentation compared with 7.5% and 12.9% of those using vehicle.1 Results may vary.
(SPEECH) FIRAS HOUGEIR: Here's some more information about those clinical studies at 24 weeks, 52 weeks, and 104 weeks.
(DISCLAIMER) For all 24-week, 52-week*, and 104-week* study results go to: OPZELURAHCP.COM *No conclusions of safety or efficacy should be made.
(SPEECH) FIRAS HOUGEIR: Adherence is key.
(ON-SCREEN TEXT) TWICE DAILY ADHERENCE IS KEY1
(SPEECH) FIRAS HOUGEIR: OPZELURA is indicated for twice-daily use.
(ON-SCREEN TEXT) Where to apply
(DESCRIPTION) We watch a patient apply a thin layer of OPZELURA to a depigmented area on his elbow.
(SPEECH) FIRAS HOUGEIR: Applied as thin layer on the affected areas of their skin. OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.
(ON-SCREEN TEXT) OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.
(SPEECH) FIRAS HOUGEIR: OPZELURA can be applied on up to 10% body surface area.
(ON-SCREEN TEXT) Up to 10% body surface area1 Handprint = 1% BSA (palm and 5 digits, with fingers tucked together and thumb tucked to the side)3
(DESCRIPTION) Dr. Hougeir holds his hand up, displaying 1% body surface area, with his fingers together and thumb tucked.
(SPEECH) FIRAS HOUGEIR: For perspective, you can let them know that this is about the size of 10 of their handprints.
(ON-SCREEN TEXT) TRACKING PROGRESS4
(DISCLAIMER) Do not use more than one 60 gram tube per week.1
(SPEECH) FIRAS HOUGEIR: As your patients are applying OPZELURA, encourage them to watch for the signs of repigmentation.
(DISCLAIMER) Do not use more than one 60 gram tube per week.1
(DESCRIPTION) Two patches of skin appear, one with freckles of pigment and the other with pigment appearing at the edges of a depigmented area.
(SPEECH) FIRAS HOUGEIR: Look for new pigment around the edges of depigmented areas, or as freckles around the hair of their depigmented skin.
(ON-SCREEN TEXT) Marginal2,6 Perifollicular2,7
(SPEECH) FIRAS HOUGEIR: To help your patients keep a record of their progress with OPZELURA, suggest they take photos of the areas they're treating.
(ON-SCREEN TEXT) TAKE PICS4
(SPEECH) FIRAS HOUGEIR: As your patients achieve results with OPZELURA, this would be a good time to start a conversation about long-term maintenance.
(ON-SCREEN TEXT) For all long-term maintenance study results go to: OPZELURAHCP.COM
(DISCLAIMER) Extension data are as observed. No conclusions of safety or efficacy should be made.
(SPEECH) FIRAS HOUGEIR: Encourage them to talk to their pharmacy about reminders that can help them stay on track with refills.
(ON-SCREEN TEXT) ALL SET
(SPEECH) FIRAS HOUGEIR: By prescribing OPZELURA and encouraging patients to stay consistent, we can guide our patient along in their pursuit for repigmentation. Please continue watching for important safety information.
(DISCLAIMER) Please keep watching to view the full Important Safety Information next.
(SPEECH) NARRATOR: Indication. 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.
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, for example, 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, post-marketing 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 than 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 nonsegmental vitiligo, the most common adverse reactions (incidence greater than or equal to 1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).
Pregnancy. 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.
Lactation. Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose, approximately 5 to 6 elimination half-lives.
Please see Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.
OPZELURA, the OPZELURA logo, Incyte, and the Incyte logo are registered trademarks of Incyte.
© 2023-2024, Incyte. MAT-OPZ-02007 06/24
Dr. Hougeir talked about our study results: to learn more, get started with our F-VASI data.
VISIBLE RESULTS
See facial and body repigmentation photos of OPZELURA clinical trial participants.
VIEW PATIENT PHOTOS
RESOURCES FOR YOU AND YOUR PATIENTS
Here are some educational resources and trackers to help you both work toward the goal of repigmentation.
VIEW RESOURCESOPZELURA 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.
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.
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 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.
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.
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.
Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).
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.
Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).
OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients
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:
