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Uses

What is Opzelura used for?

Opzelura (ruxolitinib) is commonly used for atopic dermatitis, also called eczema. It 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 healthcare 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)?

Opzelura is available as a 1.5% topical cream that is applied to the skin.

How should I store Opzelura?

Opzelura should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 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. Tell your healthcare 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, or itching 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)

There may be other side effects of Opzelura that are not listed here. Contact your healthcare 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. 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
  • 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 that can spread around the body. You may also be at a higher risk for shingles (herpes zoster). Call your healthcare 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 healthcare 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 healthcare 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 healthcare 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 healthcare 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

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 healthcare 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 healthcare provider if your symptoms have not gotten better after using Opzelura for eight weeks.

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

People who are 50 years or older can be at greater risk for some side effects from Opzelura. Talk to your healthcare 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.

What should I tell my healthcare provider before using Opzelura?

Tell your healthcare 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 determine 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 healthcare 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)

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

  • Heart problems or have had a stroke or heart attack
  • Diabetes, HIV, or lung problems
  • A weak immune system
  • Blood clots in your legs or lungs 
  • 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 healthcare 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 an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use Opzelura while you are pregnant or trying to get pregnant. If you become pregnant while using Opzelura, you or your healthcare provider can register with the manufacturer by calling 855-463-3463. 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 four weeks after stopping treatment. Tell your healthcare 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 manufacturer’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 healthcare 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 healthcare 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 healthcare 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. 

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