Ruxolitinib cream

Pronunciation: RUX-oh-LI-ti-nib
Generic name: ruxolitinib topical
Brand name: Opzelura
Dosage form: topical cream (1.5%)

Medically reviewed by Carmen Pope, BPharm. Last updated on May 25, 2025.

What is ruxolitinib cream?

Topical ruxolitinib is used for atopic dermatitis (eczema) and nonsegmental vitiligo. The brand name is Opzelura, and it is a cream that is applied thinly twice a day. Do not exceed the maximum dose of (1 x 60-gram tube/week or 1 x 100-gram tube/week).

Ruxolitinib works by blocking specific proteins called JAK1 and JAK2 that send "grow and multiply" signals to blood cells and immune cells. By stopping these signals, ruxolitinib cream decreases harmful inflammation in skin conditions such as atopic dermatitis and nonsegmental vitiligo by suppressing inflammatory cytokines. It belongs to the drug class called kinase inhibitors.

Ruxolitinib first gained FDA approval on November 16, 2011, as the oral tablet formulation, under the brand name Jakafi. Topical ruxolitinib was FDA approved on September 21, 2021, under the brand name Opzelura. There is no generic ruxolitinib.

FDA approvals and uses

Topical ruxolitinib is FDA-approved for:

• Mild to moderate atopic dermatitis in non-immunocompromised adults and children 12 years of age and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended (short-term and non-continuous chronic treatment only)
• Nonsegmental vitiligo in adults and children 12 years of age and older.

The use of ruxolitinib cream along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

It is not known if this medicine is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo.

Important: Ruxolitinib cream is for use on the skin only. Do not use in your eyes, mouth, or vagina.

Side effects

The most common side effects of ruxolitinib cream for atopic dermatitis are:

• common cold (nasopharyngitis)
• diarrhea
• bronchitis
• ear infection
• increase in a type of white blood cell
• (eosinophil) count
• hives
• inflamed hair pores (folliculitis)
• swelling of the tonsils (tonsillitis)
• runny nose (rhinorrhea).

The most common side effects of ruxolitinib cream for non-segmental vitiligo are:

• acne at the application site
• itching at the application site
• common cold (nasopharyngitis)
• headache
• urinary tract infection
• redness at the application site
• fever.

Serious side effects and warnings

Ruxolitinib (either oral or topical) can cause the following serious side effects:

• Low blood cell counts. Ruxolitinib may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If you develop bleeding, stop ruxolitinib and call your healthcare provider. Your healthcare provider will do a blood test to check your blood cell counts before you start ruxolitinib and regularly during your treatment with ruxolitinib. Tell your healthcare provider right away if you develop or have worsening of any of these symptoms:
  • unusual bleeding
  • bruising
  • tiredness
  • shortness of breath
  • fever.
• Serious infections. 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 oral JAK inhibitors, 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 ruxolitinib cream. You may be at risk for developing a serious infection during treatment with ruxolitinib. Tell your healthcare provider if you develop any of the following symptoms of infection:
  • chills
  • aches
  • fever
  • nausea
  • vomiting
  • weakness
  • painful skin rash or blisters.
• Cancer. Some people have had certain types of non-melanoma skin cancers during treatment with ruxolitinib. Your healthcare provider will regularly check your skin during your treatment with ruxolitinib. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with ruxolitinib.
• Cholesterol increases. You may have changes in your blood cholesterol levels during treatment with ruxolitinib. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking ruxolitinib, and as needed.
• Increased risk of major cardiovascular events. Increased risk of major cardiovascular events such as heart attack, stroke, or death has occurred in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking oral JAK inhibitors, especially in current or past smokers. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking ruxolitinib, including:
  • discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
  • pain or discomfort in your arms, back, neck, jaw, or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded
  • weakness in one part or on one side of your body
  • slurred speech.
• Increased risk of blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening. Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with ruxolitinib, including:
  • swelling, pain, or tenderness in one or both legs
  • sudden, unexplained chest or upper back pain
  • shortness of breath or difficulty breathing.
• Increased risk of death due to any reason (all causes). Increased risk of death has occurred in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking an oral JAK inhibitor, such as ruxolitinib.
• Possible increased risk of new (secondary) cancers. People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

These are not all the possible side effects of ruxolitinib. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

Before applying

Before applying topical ruxolitinib, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• have or have had low white or red blood cell counts
• have or had tuberculosis (TB), or have been in close contact with someone who has TB
• have had shingles (herpes zoster)
• have or had hepatitis B
• have or have had liver problems
• have or have had kidney problems or are on dialysis. If you are on dialysis, ruxolitinib should be taken after your dialysis.
• have a high level of fat in your blood (high blood cholesterol or triglycerides)
• have had cancer in the past
• are a current or past smoker
• have had a blood clot, heart attack, other heart problems, or stroke
• are pregnant or plan to become pregnant. It is not known if ruxolitinib will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ruxolitinib passes into your breast milk. Do not breastfeed during treatment with ruxolitinib and for 2 weeks after the final dose.

How should I apply ruxolitinib cream?

Ruxolitinib cream is for use on the skin only. Do not use ruxolitinib cream in your eyes, mouth, or vagina. Use it exactly as your healthcare provider tells you. Ask your healthcare provider if you have questions about applying ruxolitinib cream.

• Apply a thin layer of ruxolitinib cream 2 times a day to affected areas.
• Do not use more than one 60-gram tube each week or more than one 100-gram tube every 2 weeks.

If you are using ruxolitinib cream for atopic dermatitis, stop using ruxolitinib cream 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 ruxolitinib cream for non-segmental vitiligo, tell your healthcare provider if your treated skin does not improve within 24 weeks of treatment.

Wash your hands after applying ruxolitinib cream, unless your hands are being treated. If someone else applies ruxolitinib cream, they should wash their hands after applying it.

Dosing information

Dose of ruxolitinib cream for atopic dermatitis

• Apply a thin layer 2 times a day to affected areas of up to 20% body surface area.

Dose of ruxolitinib cream for nonsegmental vitiligo

• Apply a thin layer 2 times a day to affected areas of up to 10% body surface area.

What happens if I miss a dose?

If you miss a dose of ruxolitinib, apply your next dose at your regular time. Do not apply 2 doses at the same time.

What happens if I apply too much?

If you apply too much ruxolitinib, call your healthcare provider or go to the nearest hospital emergency room right away.

What other drugs will affect ruxolitinib cream?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ruxolitinib with certain other medicines may affect how ruxolitinib works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Storage

Store ruxolitinib cream at room temperature, 68°F to 77°F (20°C to 25°C).

Keep out of the reach of children.

Ingredients

Active ingredient: ruxolitinib phosphate 1.5%

Inactive ingredients (Opzelura): cetyl alcohol, dimethicone 350, edetate disodium, glyceryl stearate SE, light mineral oil, medium chain triglycerides, methylparaben, phenoxyethanol, phosphoric acid, polyethylene glycol 200, polysorbate 20, propylene glycol, propylparaben, stearyl alcohol, purified water, white petrolatum, and xanthan gum.

Available in 60-gram and 120-gram tubes.

Who makes ruxolitinib cream?

Topical ruxolitinib is made by Incyte Corporation under the brand Opzelura. Incyte is located in Wilmington, DE 19803.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer