Ruxolitinib

What it is used for

OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

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. 1.1 Atopic Dermatitis 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 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

1.2 Nonsegmental Vitiligo OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

The most important thing to know

OPZELURA may cause serious side effects, including: Serious Infections. OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections.

Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while using OPZELURA.

Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay.

You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Before starting OPZELURA, tell your healthcare provider if you: are being treated for an infection have had an infection that does not go away or that keeps coming back have diabetes, chronic lung disease, HIV, or a weak immune system have TB or have been in close contact with someone with TB have had shingles (herpes zoster) have or have had hepatitis B or C live in an area, or have lived in an area, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections.

These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. think you have an infection or have symptoms of an infection such as: fever, sweating, or chills muscle aches cough or shortness of breath blood in your phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than usual feeling very tired After starting OPZELURA, call your healthcare provider right away if you have any symptoms of an infection.

OPZELURA can make you more likely to get infections or make worse any infections that you have. If you get a serious infection, your healthcare provider may stop your treatment with OPZELURA until your infection is controlled. Increased risk of death due to any reason ( all causes). Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.

Cancer and immune system problems. OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker.

Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Tell your healthcare provider if you have ever had any type of cancer.

Increased risk of major cardiovascular events. Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers.

Get emergency help right away if you hav

Side effects, and when to stop

” for more information about side effects. What is OPZELURA? OPZELURA is a prescription medicine used on the skin (topical) for: short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non‑immunocompromised adults and children 2 years of age and older whose disease: is not well controlled with topical prescription therapies or when those therapies are not recommended.

the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older. The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 2 years of age with atopic dermatitis or in children less than 12 years of age with nonsegmental vitiligo.

Before using OPZELURA, tell your healthcare provider about all of your medical conditions, including if you: have an infection are a current or past smoker have had a heart attack, other heart problems, or a stroke have or have had low white or red blood cell counts have high levels of fat in your blood (high cholesterol or triglycerides) are pregnant or plan to become pregnant.

It is not known if OPZELURA will harm your unborn baby. Pregnancy Exposure Registry. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463 or by visiting www.opzelura.pregnancy.incyte.com.

are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use OPZELURA? OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. Use OPZELURA exactly as your healthcare provider tells you. Apply a thin layer of OPZELURA 2 times a day to affected areas.

If you are using OPZELURA for atopic dermatitis: Do not use OPZELURA with tight bandages that cover and seal the skin (occlusive dressings). Adults and children 12 years of age and older: Do not use more than one 60 gram tube each week or more than one 100 gram tube every 2 weeks. Children ages 2 to 11 years of age: Do not use more than one 60 gram tube every 2 weeks.

Ask your healthcare provider if you have questions about applying OPZELURA. Stop using OPZELURA when your signs and symptoms of atopic dermatitis, such as itching, rash, and redness go away, or as directed by your healthcare provider. Tell your healthcare provider if your symptoms do not improve within 8 weeks of treatment.

If you are using OPZELURA for nonsegmental vitiligo: Do not use more than one 60 gram tube each week or more than one 100 gram tube every 2 weeks. Tell your healthcare provider if your treated skin does not improve within 24 weeks of treatment. Wash your hands after applying OPZELURA, unless hands are being treated. If someone else applies OPZELURA, they should wash their hands after applying OPZELURA.

What are the possible side effects of OPZELURA? OPZELURA may cause serious side effects, including: Low blood cell counts. OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood t

Storing it

Store OPZELURA at room temperature between 68°F to 77°F (20°C to 25°C). Keep OPZELURA and all medicines out of the reach of children.