Opzelura is a prescription medication used to treat atopic dermatitis and vitiligo. It’s a cream that’s applied to the skin twice daily. Although it’s an effective treatment option, Opzelura can increase the risk of serious side effects, such as severe infections, heart problems, certain types of cancers, and blood clots.
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Opzelura
Ruxolitinib
Mild to moderate atopic dermatitis that isn’t managed with other treatments
Nonsegmental vitiligo
Janus kinase inhibitor
Topical cream
Applied to the skin twice daily
Opzelura is approved by the Food and Drug Administration (FDA) to treat mild to moderate atopic dermatitis (eczema) and vitiligo that is present on both sides of the body (nonsegmental vitiligo). It can be used to treat adults and children 12 years of age and older.
Opzelura is a topical cream that belongs to a group of medications called janus kinase (JAK) inhibitors. It works by blocking certain proteins in the immune system to decrease skin inflammation.
Oral janus kinase (JAK) inhibitors have caused serious side effects, such as severe infections, increased risk of death in certain adults, and serious heart problems. Although Opzelura is a topical medication, it still puts you at risk of these serious side effects.
Because of these risks, Opzelura should not be taken with certain biologic medications, other JAK inhibitors, or any medications that strongly weaken the immune system. Examples include Imuran (azathioprine) and cyclosporine.
Topical cream
1.5%
Atopic dermatitis
Apply a thin layer twice per day to the affected area. Do not apply it to more than 20% of your body surface area.
Nonsegmental vitiligo
Apply a thin layer twice per day to the affected area. Do not apply it to more than 10% of your body surface area.
Maximum dosage
One 60-gram tube every week or one 100-gram tube every 2 weeks
Opzelura
5gm of 1.5% tube
Opzelura
60gm of 1.5% tube of cream
Apply a thin layer to the affected area of the skin twice per day.
Contact your healthcare provider. They can help advise you whether to apply the missed dose or skip it.
None
Serious infections: Opzelura can make it harder for your immune system to fight infections. Because of this, it increases the risk of serious and life-threatening bacterial, viral, and fungal infections, including tuberculosis, lung infections, and herpes zoster. Opzelura shouldn’t be used if you have an active, serious infection. If you have a history of chronic (long-term) or recurrent infections, let your healthcare provider know. During Opzelura treatment, report any signs or symptoms of infections to your healthcare provider right away. These may include fever, sweating, chills, muscle aches, cough, breathing problems, diarrhea, burning while you urinate, and warm, red, or painful sores on your body.
Increased risk of death: Opzelura may increase the risk of death in adults ages 50 years and older who have at least one heart-related risk factor. Examples include high blood pressure, high cholesterol, diabetes, or obesity.
Certain cancers: Opzelura can increase the risk of certain cancers. These include lymphoma, skin cancer, and lung cancer. The risk of lung cancer is higher if you are a current or past smoker. Due to this risk, your healthcare provider will regularly check for signs and symptoms of cancer during Opzelura treatment. You should also limit your exposure to sunlight and wear protective clothing and sunscreen while out in the sun.
Serious heart problems: Opzelura can increase the risk of major heart problems, such as heart attack, stroke, and death. The risk is higher if you are 50 years of age or older and have at least one heart-related risk factor or if you are a current or past smoker. If you experience any symptoms of a heart problem, such as chest tightness or pain, shortness of breath, breaking out in a cold sweat, lightheadedness, slurred speech, or weakness in one side of your body, get emergency medical help right away. Blood clots: Opzelura can increase the risk of blood clots in the legs or lungs. This can be life-threatening. Report any signs or symptoms of blood clots to a healthcare professional right away. Examples include swelling, redness, or pain in one or both legs, sudden chest pain, and shortness of breath.
Abnormal blood cell levels: Opzelura can cause thrombocytopenia (low platelet levels), anemia (low red blood cell levels), and neutropenia (low neutrophil levels). Your healthcare provider may monitor your blood cell levels during Opzelura treatment.
High cholesterol: Opzelura may increase your cholesterol levels. Due to this risk, your healthcare provider may monitor your cholesterol during Opzelura treatment.
Certain drugs may affect the levels of Opzelura in the body. This can increase the risk of serious side effects or make the medication less effective. Examples of these drugs include ketoconazole, Cardizem (diltiazem), and clarithromycin. However, there may be several other drugs that interact with Opzelura. Before starting any new medications, discuss your current medication list with your healthcare provider or pharmacist.
Opzelura can cause side effects that range from mild to severe in severity.
Serious side effects that require emergency medical help:
Allergic reaction: itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
Heart problem: chest tightness or pain, shortness of breath, breaking out in a cold sweat, lightheadedness, slurred speech, or weakness in one side of your body
Blood clot: swelling, redness, or pain in one or both legs, sudden chest pain, and shortness of breathSerious side effects that should be reported to a healthcare provider right away:
Infection: fever, sweating, chills, muscle aches, cough, breathing problems, diarrhea, burning while you urinate, and warm, red, or painful sores on your body
Low blood cell counts: abnormal bleeding or bruising, fever, shortness of breath, tiredness
Less serious side effects:
Diarrhea
Ear infection
Common cold
Hives
Runny nose
Bronchitis
Acne, itching, or redness where the medication is applied
Headache
Urinary tract infection
Know your risk for heart disease, Centers for Disease Control and Prevention (2023)
Opzelura–ruxolitinib cream prescribing information, Food and Drug Administration (2023)
Ruxolitinib topical, MedlinePlus, National Institutes of Health (2021)
Ashley Wong, Pharm.D., has worked for healthcare companies where she translated complex drug information into easy-to-understand language for patients. She also served as a Senior Medical Information Specialist at a medical communications company, where she delivered clinically accurate drug information to healthcare providers and patients and compiled adverse event reports in accordance with the FDA's reporting guidelines.
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