Opzelura (Ruxolitinib) – Topical

What Is Opzelura?

Opzelura (ruxolitinib) is a prescription-only topical cream approved by the Food and Drug Administration (FDA) to treat mild to moderate atopic dermatitis and nonsegmental vitiligo. 

Atopic dermatitis is the most common form of eczema and affects approximately 30% of the U.S. population. 

Opzelura is in a class of medications known as Janus kinase (JAK) inhibitors. JAK enzymes cause and promote types of inflammation in the body. Opzelura works by interfering with these enzymes, preventing inflammation that would otherwise lead to redness and itching of the skin. This same inflammation can cause vitiligo in some people.

Opzelura carries a boxed warning on its label due to the increased risk of serious infections, lymphoma or other cancers, sudden heart attack or stroke, and blood clots. A boxed warning (or black box warning) is the FDA's highest safety-related warning for a medication. Your healthcare provider should discuss any potential risks before using this medication.

Opzelura is a topical treatment, meaning it is applied to the skin. It is available as a cream.

Drug Facts

Generic Name: Ruxolitinib

Brand Name(s): Opzelura

Drug Availability: Prescription

Administration Route: Topical

Therapeutic Classification: Dermatological agent

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Ruxolitinib

Dosage Form(s): Cream

What Is Opzelura Used For?

The FDA approved Opzelura to treat:

  • Mild to moderate atopic dermatitis (AD) in adults and children over the age of 12 who have no problems with their immune system and whose symptoms are not controlled by other topical therapies or if other treatments are not advisable
  • Nonsegmental vitiligo in adults and children over 12

AD is a skin disorder that causes red, itchy, inflamed skin that can weep clear fluid when scratched.  Nonsegmental vitiligo is the most common type of vitiligo. It is characterized by a symmetrical loss of pigmentation on the skin. This pigment loss is more readily visible on darker skin tones, as the loss of pigment and smooth, whitish patches stand out more.

How to Use Opzelura

How you use Opzelura will depend on whether you are treating AD or vitiligo.

Atopic Dermatitis

When using Opzelura for AD, apply a thin layer to affected areas twice a day. It should cover no more than 20% of your body's surface area. Stop using Opzelura when the itch, redness, and rash resolve. If there is no improvement within eight weeks, contact your healthcare provider.

Vitiligo

When using Opzelura for vitiligo, apply a thin layer to the affected areas twice a day. This area should cover no more than 10% of your body. It may take up to 24 weeks of treatment or longer to see a meaningful response. If there is no improvement after 24 weeks of treatment, contact your healthcare provider.

Regardless of why you are using Opzelura, washing your hands before and after applying the cream is important unless your hands are affected by the condition. If your healthcare provider also recommends a moisturizer, you should use it after applying Opzelura.

Storage

Store Opzelura cream at room temperature (68–77 degrees Fahrenheit) away from moisture and light. Keep it out of the reach of children and pets.

How Long Does Opzelura Take to Work?

If you are using Opzelura to treat AD, you should notice improvement within eight weeks. You may experience relief of itching within the first 12 hours.  If you are using it for vitiligo, it may take up to six months to show marked symptom improvement.

What Are the Side Effects of Opzelura?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects associated with Opzelura include:

  • Pain or swelling in your nose or throat
  • Hives
  • Ear infection
  • Diarrhea
  • Runny nose
  • Swelling of the tonsils

Severe Side Effects

Call your healthcare provider immediately if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects can include the following:

  • Serious cardiovascular event risk, such as stroke, heart attack, or a blood clot in lungs, arteries, or veins
  • Low blood cell counts, such as anemia (low red blood cells), neutropenia (low white blood cells), and thrombocytopenia (low platelets)
  • Lung infections
  • Increased risk of certain cancers

Opzelura has a boxed warning, the FDA's highest safety warning for medications, attached to its label. The boxed warning notes an increased risk of the following with the use of JAK inhibitors for inflammatory conditions:

  • Severe infections (e.g., tuberculosis) that may lead to hospitalization or death
  • Sudden heart attack or stroke
  • Lymphoma and other types of cancers
  • Blood clots in the lungs, arteries, or veins

Long-Term Side Effects

There have not yet been studies to determine the long-term effects of Opzelura. However, at least temporarily, low blood cell counts can persist after stopping treatment. The overall increased risk of developing cancer after ending treatment is unknown.

Report Side Effects

Opzelura may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Opzelura Should I Use?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (cream):

For mild to moderate atopic dermatitis:

  • Adults and children 12 years of age and older—Apply to the affected area of the skin 2 times a day. Do not use more than 1 tube (60 grams) of this medicine per week.
  • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Modifications

Stop using Opzelura temporarily if you develop an infection while using the medication. Notify your healthcare provider immediately if you believe you have an infection, even if it is unrelated to your AD. 

If you experience low blood cell counts, heart attack, or blood clots, stop using Opzelura. Before beginning treatment with Opzelura, tell your healthcare provider if you have a history of any of these conditions.

Missed Dose

If you miss one of your scheduled doses of Opzelura, apply it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not apply extra cream to try to compensate for the missed dose. Missing doses of Opzelura will not cause harm, but it may delay the progress and success of your treatment.

Overdose: What Happens If I Use Too Much Opzelura?

There have been no reports of Opzelura cream overdoses, but this medication can be harmful if swallowed. If this occurs, it may result in low blood cell counts, which can be a serious condition. Contact the Poison Control Center immediately if you or someone else ingests Opzelura.

What Happens If I Overdose on Opzelura?

If you think you or someone else may have overdosed on Opzelura, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after using Opzelura, call 911 immediately.

Precautions

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It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects. 

This medicine should not be used together with azathioprine or cyclosporine. 

If your condition does not improve within 8 weeks, or if it become worse, check with your doctor. 

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections (eg, herpes, tuberculosis, hepatitis B or C, fungal infection) more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. 

This medicine may increase your risk of cancer (eg, lymphoma, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin. 

This medicine may increase your risk of serious heart or blood vessel problems, including heart attack or stroke. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting. 

Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing. These may be symptoms of serious blood clots (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis). 

This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns. 

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Use Opzelura?

Do not use Opzelura if you:

  • Currently have an infection
  • Have ever had a heart attack, stroke, or a blood clot
  • Are under the age of 12

There is no information available about Opzelura's safety in pregnancy or while breastfeeding. If you are pregnant or breastfeeding, it is best to speak with your healthcare provider to determine if Opzelura would be a safe treatment option.

What Other Medications Interact With Opzelura?

Since it is a topically applied cream, Opzelura has few drug interactions.

Opzelura may interact with Vonjo (pacritinib), which is an oral capsule used to treat myelofibrosis (a disease that causes scarring of the bone marrow, leading to abnormal blood cell counts and other serious complications). Like Opzelura, Vonjo is a JAK inhibitor. Using these drugs together can increase the chance of experiencing severe side effects.  

It is not recommended to use Opzelura with other JAK inhibitors, such as Jakafi (ruxolitinib), which contains the same active ingredient as Opzelura; potent immunosuppressants, such as Azasan (azathioprine) or Gengraf (cyclosporine); or certain biologics, such as Enbrel (etanercept) or Humira (adalimumab).

If your healthcare provider recommends using a moisturizer with Opzelura, it is best to apply Opzelura first before applying the moisturizer.

What Medications Are Similar?

Opzelura belongs to a family of drugs known as JAK inhibitors. It is the first topical drug in its class, but there are oral forms of JAK inhibitors, such as:

  • Jakafi (ruxolitinib), which has same active ingredient as Opzelura, but Jakafi is a capsule dosage form and treats different conditions
  • Xeljanz (tofacitinib), which treats various forms of arthritis
  • Olumiant (baricitinib), which treats rheumatoid arthritis
  • Rinvoq (upadacitinib), which treats AD and rheumatoid arthritis

This is a list of drugs in the same family of drugs as Opzelura. It is not a list of drugs recommended to take with Opzelura. In fact, you should not take these drugs together. Discuss any questions with your pharmacist or a healthcare provider.

Frequently Asked Questions

  • Is Opzelura a steroid cream?

    No, Opzelura is not a steroid cream. It has different properties and works in different ways than steroid creams. Unlike many steroid creams, Opzelura can be used on the face, as long as you avoid contact with the eyes and mouth. Opzelura does not have the same side effects as steroids, but it does have a different set of side effects that can be just as serious.

  • How is Opzelura supplied?

    Opzelura is supplied in 60-gram tubes. You should not use more than one tube per week if using the maximum dosage. This is the only size and packaging in which Opzelura is currently sold.

  • How much does Opzelura cost?

    One 60-gram tube of Opzelura retails at a list price of $1,950.00. However, this price may not reflect what you will pay. Insurance can significantly decrease this amount. If Opzelura is unaffordable, the manufacturer, Incyte Dermatology, may have a patient assistance program that offers the medication at a deep discount.

  • Since ruxolitinib is the active ingredient in both Opzelura and Jakafi, can I use Jakafi instead if I would rather take a pill?

    No. Although both Opzelura and Jakafi are the same drug, they are used to treat very different diseases. While Opzelura treats skin conditions such as atopic dermatitis and vitiligo, Jakafi treats conditions such as myelofibrosis (a rare bone marrow disease), polycythemia vera (a disease in which your body produces too many blood cells, which increases the risk of blood clots in the body), and graft-versus-host disease (a condition in which the body attacks donor tissue after a transplant). Opzelura and Jakafi cannot be used interchangeably to treat any disease.

How Can I Stay Healthy While Taking Opzelura?

It is important to ensure that all of your questions and concerns are addressed with your healthcare provider before and during treatment with Opzelura. If at any time you feel that something is not right or you believe you are developing an infection, contact your healthcare provider immediately. 

Washing your hands before and after applying Opzelura can help ensure the medication only affects the desired areas (unless your hands are also affected by your disease). Use the medication regularly to get the most out of your treatment.

While using Opzelura, check with your healthcare provider or pharmacist about drug-to-drug or supplement-to-drug interactions before starting any new medications, vitamins, or herbal supplements.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

The author would like to recognize and thank Jonathan Toellner for contributing to this article.

5 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
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  2. National Institute of Allergy and Infectious Diseases. Eczema (atopic dermatitis).

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  4. Papp K, Szepietowski JC, Kircik L, et al. Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. J Am Acad Dermatol. 2021;85(4):863-872. doi: 10.1016/j.jaad.2021.04.085.

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