Dosing
A TOPICAL, NON-STEROIDAL MONOTHERAPY1
PATIENT DOSING DETAILS
WHERE AND HOW
OPZELURA is applied in a thin layer, twice daily to affected areas of up to 10% body surface area.1
OPZELURA is designed for topical application across the body, including on sensitive skin areas like1:
- around the eyes and mouth
- on the external genitals
OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use.1
Patients should not use more than one 60 gram tube per week.1
GETTING PATIENTS STARTED BEGINS WITH YOU
Repigmentation begins with a partnership: hearing how to start OPZELURA from you may help patients feel more comfortable about the process. Watch our short video to prepare to help your patients with OPZELURA.
(TITLE SLIDE) GETTING STARTED WITH OPZELURA
(ON-SCREEN TEXT)
INDICATIONS
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.
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 woman smiles at us from a comfortable chair as upbeat music lowers.
(SPEECH) ANDREA NGUYEN: I'm Andrea Nguyen, a dermatology physician assistant.
(ON-SCREEN TEXT) Opzelura® (ruxolitinib) cream 1.5%
For uncontrolled mild to moderate atopic dermatitis in non-immunocompromised patients 12 and older1
For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older1
(DISCLAIMER) This video is sponsored by Incyte Corporation. Andrea Nguyen, PA has been compensated for her time.
(SPEECH) ANDREA NGUYEN: Let's talk about how you can instruct your patients on getting started with OPZELURA. Whether they're using it for nonsegmental vitiligo or mild to moderate atopic dermatitis, these are a few things your patients should keep in mind.
(ON-SCREEN TEXT) TWICE DAILY1
(SPEECH)
OPZELURA is a non-steroidal, twice-daily topical treatment. So patients should try making it part of their morning and evening routines.
(DISCLAIMER) For topical use only. Not for ophthalmic, oral, or intravaginal use.1 Actor portrayal of atopic dermatitis. Real person with vitiligo. Not OPZELURA patients.
(SPEECH) ANDREA NGUYEN: OPZELURA should be applied to affected areas in a thin layer.
(ON-SCREEN TEXT) A THIN LAYER1 SENSITIVE AREAS
(DESCRIPTION) We see two patients apply a thin layer of OPZELURA to the area around their eyes, their elbow, and their knee.
(SPEECH) ANDREA NGUYEN: OPZELURA can even be applied to sensitive areas, like around the eyes and mouth, or on the external genitals. OPZELURA is for topical use only, not for ophthalmic, oral, or intravaginal use.
(DISCLAIMER) Do not use more than one 60 gram tube per week.1
(ON-SCREEN TEXT) ATOPIC DERMATITIS
(DESCRIPTION) We see patient scratch at a flare-up on her inner elbow, before applying a thin layer of OPZELURA.
(SPEECH) ANDREA NGUYEN: Atopic dermatitis patients can apply OPZELURA on up to 20% body surface area, whenever they are experiencing symptoms such as itchiness and erythema.
(ON-SCREEN TEXT) Up to 20% BSA1
(DISCLAIMER) Do not use more than one 60 gram tube per week.1
(SPEECH) ANDREA NGUYEN: They should use it twice daily as needed.
(ON-SCREEN TEXT) USE TWICE DAILY AS NEEDED
(SPEECH) ANDREA NGUYEN: Once their signs and symptoms resolve, patients should stop using OPZELURA.
(ON-SCREEN TEXT) ONCE SYMPTOMS RESOLVE
(SPEECH) ANDREA NGUYEN: If they're not seeing improvement within eight weeks, they should be re-examined.
(ON-SCREEN TEXT) VITILIGO
(DESCRIPTION) We see a sequence of a vitiligo patient examining his depigmented areas on his face and neck, then applying a thin layer to his knee and cheek.
(SPEECH) ANDREA NGUYEN: Patients with vitiligo can apply OPZELURA on vitiligo areas, covering up to 10% body surface area.
(ON-SCREEN TEXT) Up to 10% BSA1
(DISCLAIMER) Do not use more than one 60 gram tube per week.1
(SPEECH)
ANDREA NGUYEN: These patients will need to remember that repigmentation takes time, and adherence is important. Work with your patients to identify areas to prioritize. And remind them to be consistent with twice-daily treatments.
(ON-SCREEN TEXT) ADHERENCE IS KEY1 AREAS TO PRIORITIZE
(DESCRIPTION) A patch of skin appears, showing freckles of repigmentation around hair follicles.
(ON-SCREEN TEXT) Perifollicular
(SPEECH) ANDREA NGUYEN: Remember, areas of higher densities of hair follicles are most likely to repigment. Keep in touch to check their progress along the way.
(DESCRIPTION) We see the vitiligo patient taking photos of the areas he’s treating.
(SPEECH) ANDREA NGUYEN: To track progress with vitiligo repigmentation or atopic dermatitis clearance, patients should take photos before and during their treatment.
(ON-SCREEN TEXT) PROGRESS PHOTOS Same background3 Direct lighting3 Consistent angle3
(SPEECH) ANDREA NGUYEN: At future appointments, they'll want these photos to highlight any progress they've made. So remind patients to capture them consistently. And one more thing, encourage your patients to talk to their pharmacy about reminders that can help them stay on track with refills.
(ON-SCREEN TEXT) REFILLS HELP THEM STAY ON TRACK
(SPEECH) ANDREA NGUYEN: If your patients follow your instructions and remember these tips, it can help them get the most out of OPZELURA.
(ON-SCREEN TEXT) ALL SET Please keep watching to view the full Important Safety Information next.
(SPEECH)
NARRATOR: Indications. 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.
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 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%).
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 Corporation. MAT-OPZ-02008 02/24
