HELPING YOUR PATIENTS MANAGE FLARES WITH OPZELURA
Hear board-certified dermatologist, Dr. Michael Cameron, share tips on getting the most out of OPZELURA treatment for mild to moderate atopic dermatitis. Dr. Michael Cameron was compensated for his participation.
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HELPING YOUR PATIENTS MANAGE FLARES WITH OPZELURA
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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 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 starts speaking from a comfortable chair as upbeat music lowers.
(SPEECH)DR. MICHAEL CAMERON: I'm Dr. Cameron, a dermatologist, and these are a few tips that you can pass along to your patients who are managing flares with OPZELURA for mild to moderate atopic dermatitis.
(ON-SCREEN TEXT)Opzelura® (ruxolitinib) cream 1.5%
For uncontrolled mild to moderate atopic dermatitis in non-immunocompromised patients 12 and older1
(ON-SCREEN TEXT)DR. MICHAEL CAMERON
DERMATOLOGIST
(DISCLAIMER)This video is sponsored by Incyte Corporation. Dr. Cameron has been compensated for his time.
(DESCRIPTION)Video cuts to a full-screen super.
(ON-SCREEN TEXT)ONE SINGLE CREAM1
(SPEECH)DR. MICHAEL CAMERON: OPZELURA is a therapy studied for use on its own,...
(DESCRIPTION)Video cuts to a further shot of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: …not in combination with other prescription products for atopic dermatitis,…
(ON-SCREEN TEXT)Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.1
(DESCRIPTION)Video cuts to the patient bathroom set, where the patient tucks her hair to prepare to apply OPZELURA.
(SPEECH)DR. MICHAEL CAMERON: …to help non-immunocompromised patients 12 years of age and older.
(ON-SCREEN TEXT)Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.1 Actor portrayal; not an OPZELURA patient.
(DESCRIPTION)Video cuts to a full-screen super.
(ON-SCREEN TEXT)WHEN TO START
(DESCRIPTION)Video cuts to a further shot of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: Patients can apply OPZELURA…
(ON-SCREEN TEXT)For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(SPEECH)DR. MICHAEL CAMERON: …at the first sign of atopic dermatitis symptoms such as itchiness and erythema.
(ON-SCREEN TEXT)At Week 8, 53.8% and 51.3% of patients using OPZELURA achieved clear or almost clear results vs. 15.1% and 7.6% for vehicle in TRuE-AD1 and TRuE-AD2 respectively.1
(DESCRIPTION)Video cuts to bathroom where patient is picking up OPZELURA tube.
(SPEECH)DR. MICHAEL CAMERON: Instruct patients to apply…
(ON-SCREEN TEXT)For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)The patient shows us a thin layer before applying. Copy animates in.
(SPEECH)DR. MICHAEL CAMERON: …a thin layer of OPZELURA…
(ON-SCREEN TEXT)A THIN LAYER1
For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Cut to close-up of the patient applying a thin layer.
(SPEECH)DR. MICHAEL CAMERON: …twice daily to affected areas of skin.
(ON-SCREEN TEXT)For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to the patient’s bedroom set, where she applies a thin layer to her knee.
(SPEECH)DR. MICHAEL CAMERON: Patients can apply that thin layer…
(ON-SCREEN TEXT)For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to bedroom close up where the patient is applying OPZELURA with an on-screen super.
(SPEECH)DR. MICHAEL CAMERON: …on up to 20% of their body surface area.
(ON-SCREEN TEXT)UP TO 20% BSA1
For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to a mid-shot of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: For reference, you can tell them that one of their handprints is about 1% BSA.
(ON-SCREEN TEXT)Handprint = 1% BSA
(palm and 5 digits, with fingers tucked together and
thumb tucked to the side)2
For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to a close up of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: So, 20% of a patient’s BSA is about the size of 20 of their handprints combined.
(ON-SCREEN TEXT)Handprint = 1% BSA
(palm and 5 digits, with fingers tucked together and
thumb tucked to the side)2
For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to the patient bathroom set, where the patient’s hand reaches from off-screen to grab the OPZELURA tube and apply the cream..
(SPEECH)DR. MICHAEL CAMERON: OPZELURA is for topical use only. Not for ophthalmic, oral, or intravaginal use.
(ON-SCREEN TEXT)For topical use only. Not for ophthalmic, oral, or intravaginal use.1
(DESCRIPTION)Video cuts to a full-screen super.
(ON-SCREEN TEXT)WHEN SYMPTOMS RESOLVE1
(SPEECH)DR. MICHAEL CAMERON: Once their signs and symptoms resolve, patients should stop using OPZELURA.
(DESCRIPTION)Cut to a mid-shot of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: If they aren’t seeing improvement within 8 weeks, patients should be re-examined.
(ON-SCREEN TEXT)Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve.1
(DESCRIPTION)A split-screen comes on screen, showing Dr. Cameron and the patient grabbing the OPZELURA tube from offscreen.
(SPEECH)DR. MICHAEL CAMERON: Just be sure they keep it on hand,...
(DESCRIPTION)Cut to patient itching.
(SPEECH)DR. MICHAEL CAMERON: …since they’ll need to start treating as soon as they notice new flares.
(ON-SCREEN TEXT)At Week 8, 53.8% and 51.3% of patients using OPZELURA achieved clear or almost clear results vs. 15.1% and 7.6% for vehicle in TRuE-AD1 and TRuE-AD2 respectively.1
(DESCRIPTION)Video cuts to Dr. Cameron with an on screen super.
(SPEECH)DR. MICHAEL CAMERON: And remind them to take photos each week to share with you during their next appointment.
(ON-SCREEN TEXT)TAKING PHOTOS3
(DESCRIPTION)Video cuts to a full screen super.
(ON-SCREEN TEXT)BE PROACTIVE
(DESCRIPTION)A patient swipes in, creating a split screen. The patient is taking a picture of her OPZELURA box.
(SPEECH)DR. MICHAEL CAMERON: Remind patients to pay attention to how much is left in their tube.
(ON-SCREEN TEXT)Do not use more than one 60 gram tube per week.1
(DESCRIPTION)Video cuts to a close up of Dr. Cameron with an on screen super animating in.
(SPEECH)DR. MICHAEL CAMERON: That way they can refill their prescription to have on hand when they need it.
(ON-SCREEN TEXT)REFILLS
Do not use more than one 60 gram tube per week.1
(DESCRIPTION)Cut to full screen super. Copy animates in as the droplet animates around the copy.
(ON-SCREEN TEXT)ALL SET
(DESCRIPTION)Cut to a close up of Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: As healthcare providers, we get to watch our patients…
(ON-SCREEN TEXT)At Week 8, 53.8% and 51.3% of patients using OPZELURA achieved clear or almost clear results vs. 15.1% and 7.6% for vehicle in TRuE-AD1 and TRuE-AD2 respectively.1
(DESCRIPTION)Video cuts to the patient bathroom set, where the patient’s hand reaches from off-screen to grab the OPZELURA tube.
(SPEECH)DR. MICHAEL CAMERON: …experience OPZELURA—first-hand.
(ON-SCREEN TEXT)At Week 8, 53.8% and 51.3% of patients using OPZELURA achieved clear or almost clear results vs. 15.1% and 7.6% for vehicle in TRuE-AD1 and TRuE-AD2 respectively.1
(DESCRIPTION)Video cuts back to Dr. Cameron.
(SPEECH)DR. MICHAEL CAMERON: Please continue watching for Important Safety Information.
(ON-SCREEN TEXT)Please keep watching to view the full Important Safety Information next.
(SPEECH)NARRATOR: 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, 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 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 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 (greater than or equal to 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. 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-02006 06/24
