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Overview: Opzelura is a cream that is applied to the skin to treat atopic dermatitis or vitiligo. It works by blocking pathways in an overactive immune system. Common side effects may include acne, redness, itching, irritation, or discomfort where the medicine is applied, certain types of infections, headache, diarrhea, and fever. Tell your health care provider right away if you have any infection or symptoms such as burning or stinging when you pee, a cough, sweats, chills, or shortness of breath. Follow the instructions from your health care provider about how to apply Opzelura.

Uses

What is Opzelura used for?

Opzelura (ruxolitinib) is commonly used for atopic dermatitis, also called eczema. This condition causes your skin to be dry, itchy, and inflamed.

Opzelura is also commonly used for vitiligo, a skin condition that causes some areas of your skin to lose its color. 

Learn more about how Opzelura treats eczema.

Learn more about how Opzelura treats vitiligo.

Opzelura may also be used for other conditions as determined by your health care provider.

How does Opzelura work (mechanism of action)?

Opzelura works by blocking pathways in your overactive immune system.  

For people with atopic dermatitis, this reduces inflammation, rashes, and redness in your skin.  

For vitiligo, Opzelura blocks the immune system attack on your skin pigment and may lead to getting the color back in your skin.  

How is Opzelura supplied (dosage forms)?

Brands and other names

  • Opzelura

Dosage forms and strengths

  • 1.5% topical cream

How should I store Opzelura?

Opzelura should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Opzelura?

The most common side effects of Opzelura are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Infections in the ear, nose, throat, or airways, or common cold symptoms
  • Acne, redness, itching, irritation, or discomfort where the medicine is applied
  • Headache
  • Diarrhea
  • Fever
  • Increase in levels of a type of white blood cell (eosinophil)
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Kidney or bladder infections
  • Inflammation in hair pores (folliculitis)
  • Swelling in the tonsils (tonsillitis)
  • Blood disorders (see below)

There may be other side effects of Opzelura that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Opzelura?

While less common, the most serious side effects of Opzelura are described below, along with what to do if they happen.

Severe Allergic Reactions. Opzelura may cause allergic reactions, which can be serious. Stop using Opzelura and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infections. Opzelura can increase the risk of infections, including serious infections. These serious infections may include tuberculosis (TB) or other infections caused by bacteria, fungi, or viruses. You may also be at a higher risk for shingles (herpes zoster). Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Cough or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Warm, red, or painful sores on your body
  • Feeling very tired

Blood Disorders. Opzelura can cause blood disorders, such as low red blood cell levels (anemia), low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia). Stop using Opzelura and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, feeling lightheaded, or fainting 
  • Headache
  • Fast or abnormal heartbeat

Cancer. Opzelura may increase the risk of certain cancers, including skin cancers. Limit the amount of time in the sun or devices that give off similar light, such as sunlamps and tanning beds. Use sunscreen and wear a hat and other protective clothing if you need to be in the sun. Check your skin regularly and talk to your health care provider if you have any new areas or changes to your skin that are not normal for you. People taking medicine by mouth from the same medicine class as Opzelura may also have a higher risk of some other cancers, such as lymphoma or lung cancer, especially if they smoke. Tell your health care provider if you have had cancer in the past or if you have any new symptoms that bother you. 

Heart Attack and Stroke. People taking medicine by mouth from the same medicine class as Opzelura may have a higher risk of a heart attack or stroke that can lead to death. This risk is higher in people who already have heart disease. Tell your health care provider if you have ever had a heart attack or stroke. Get help right away if you have any of the following symptoms of a heart attack or stroke.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech

Blood Clots. Opzelura may cause blood clots. Blood clots may happen in the legs (deep vein thrombosis) or lungs (pulmonary embolism) and may be life-threatening. This risk may be higher in people who are 50 years of age or older and who have any risks for heart disease. Tell your health care provider right away if you have any of the following symptoms of a blood clot.  

  • Swelling, redness, pain or tenderness in your leg
  • Chest or back pain that is worse with deep breaths
  • Shortness of breath or trouble breathing

Increased Cholesterol Levels. People taking medicine by mouth from the same medicine class as Opzelura have had increased levels of cholesterol or triglycerides. Keep all appointments with your health care provider, including for blood work. Talk with your health care provider about how to maintain healthy cholesterol levels. 

Warnings & Precautions

Who should not use Opzelura?

Allergies to Ingredients. People who are allergic to any of the following should not use Opzelura.

  • Opzelura 
  • Ruxolitinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Opzelura.

What should I know about Opzelura before using it?

Do not use Opzelura unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Opzelura with other people, even if they have the same condition as you. It may harm them.

Keep Opzelura out of the reach of children.

Only use Opzelura on the skin. Do not use it in your eyes, mouth, or vagina. 

Wash your hands after you use Opzelura, unless you are treating an area on your hands. 

If you are using Opzelura for atopic dermatitis (eczema), stop using it after the rash and itching have stopped. Tell your health care provider if your symptoms have not gotten better after using Opzelura for 8 weeks. Do not cover the area where you apply Opzelura with any bandages or dressings.

If you are using Opzelura for vitiligo, talk to your health care provider if you do not see any changes in the color of your skin after 6 months. 

People who are 50 years or older can be at greater risk for some side effects from Opzelura. Talk to your health care provider about your risks if you are age 50 years or older, have any risk factors for heart disease, or have smoked or currently smoke.

People who are 2 to 11 years old can be at greater risk of some side effects from Opzelura compared to older children and adults. These side effects may include discomfort, irritation, or itching where the medicine is applied, fever, or low white blood cell levels. Talk to your health care provider about your risks if you are in this age group.

Some people with diabetes who take medicine by mouth from the same medicine class as Opzelura have had low blood sugar. If you have diabetes, talk with your health care provider about how to maintain healthy blood sugar levels and how often to check your blood sugar while using Opzelura.

What should I tell my health care provider before using Opzelura?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Opzelura is right for you.

In particular, make sure that you discuss any of the following.

Infections. Opzelura may increase your risk for certain infections. Tell your health care provider if you have any of the following, which may increase your chance of having an infection.

  • Are being treated for any infection or think you may have an infection
  • Had an infection that keeps coming back
  • Have been around someone that has tuberculosis
  • Live in an area that has a higher risk of specific fungal infections (like the Ohio or Mississippi River valleys and the Southwest)

Other Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems or have had a stroke or heart attack
  • Diabetes
  • HIV
  • Lung problems
  • A weak immune system
  • A blood clot 
  • Any type of cancer
  • Shingles (herpes zoster)
  • Hepatitis B or C
  • Smoker
  • High cholesterol or triglycerides

Other Medicines and Supplements. Opzelura is not recommended if you are taking certain medicines that may weaken your immune system, such as azathioprine, cyclosporine, biologic medicines, or other medicines in the same class as Opzelura (known as Janus kinase inhibitors). Opzelura may also interact with other medicines and supplements. Before using Opzelura, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. It is not known if or how Opzelura could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Opzelura while you are pregnant or trying to get pregnant. If you become pregnant while using Opzelura, you or your health care provider can register with the drugmaker by calling 855-463-3463 or by going to  www.opzelura.pregnancy.incyte.com. This registry collects safety information about the use of Opzelura during pregnancy.

Breastfeeding. It is not known if Opzelura passes into breast milk. Do not breastfeed if you are using Opzelura and for around 4 weeks after stopping treatment. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Opzelura?

For more information about Opzelura, you can visit the drugmaker’s website at www.opzelura.com or call them at 855-463-3463.

Interactions

Does Opzelura interact with foods or drinks?

There are no known interactions between Opzelura and foods or drinks.

It is unknown if drinking alcohol will affect Opzelura.

Does Opzelura interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  

Some other medicines may alter the blood levels of Opzelura. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Opzelura. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Opzelura?

If you or someone else has used too much Opzelura, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Opzelura?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.