What Is Opzelura™ (​​ruxolitinib)?

Opzelura™ (ruxolitinib) is a topical JAK inhibitor drug approved to treat mild to moderate atopic dermatitis (the most common form of eczema) in people 12 years or older who are not immunocompromised and whose atopic dermatitis is not well controlled with other topical drugs, or when other topical drugs cannot be used.^1-3

The approval made Opzelura the first topical Janus kinase (JAK) inhibitor approved in the United States. Several oral JAK inhibitors are approved to treat other conditions, such as rheumatoid arthritis.^1,2

The FDA originally granted priority review to Opzelura. The FDA can give priority review when a new drug seems promising and may greatly help a disease. Priority review means the FDA will decide whether to approve new drugs in 6 months. It is only for drugs that seem to work better or are safer than current treatments.^1,2

What are the ingredients in Opzelura?

The active ingredient in Opzelura is ruxolitinib phosphate.^1-3

How does Opzelura work?

Opzelura is a JAK inhibitor. JAK proteins aid in making immune cells that cause atopic dermatitis symptoms, such as redness, itching, and inflammation. JAK inhibitor drugs block JAK proteins, making inflammatory reactions less likely.^1,2

What are the possible side effects?

The most common side effects of Opzelura include:²

• Common cold/runny nose
• Bronchitis
• Ear infection
• Hives
• Inflammation of the tonsils
• Diarrhea
• Hair follicle inflammation
• Increased white blood cell count

Opzelura has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because JAK inhibitors for inflammatory conditions can cause serious problems, including:³

• Serious, life-threatening infections, including tuberculosis
• A higher rate of death, including from heart attack
• Lymphoma and other cancers
• Major heart effects including heart attack, stroke, and death
• Clotting events, including clots in the lungs and legs, that can cause death

These are not all the possible side effects of Opzelura. Talk to your doctor about what to expect when using Opzelura. You also should call your doctor if you have any changes that concern you when using Opzelura.

Things to know about Opzelura

Opzelura cream is for use on the skin only. Do not use it in your eyes, mouth, or vagina. If symptoms do not improve after 8 weeks with Opzelura, you should be reevaluated by your healthcare provider.³

Opzelura should not be used in combination with certain drugs, including:³

• Biologics
• Other JAK inhibitors
• Immunosuppressants such as azathioprine or cyclosporine

Before taking Opzelura, tell your doctor if you:³

• Have an infection
• Have or had tuberculosis (TB) or have been in close contact with someone who has TB
• Have had shingles
• Have or had hepatitis B or C
• Had skin cancer
• Are a current or past smoker
• Have or had low white or red blood cell counts
• Have high cholesterol or triglycerides

There is not enough data to know if Opzelura is safe to take when pregnant or while breastfeeding. There is a pregnancy registry for people who use Opzelura during pregnancy. The registry will collect information about the health of people who take Opzelura during pregnancy and the health of their babies. Before taking Opzelura, talk to your doctor if you are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.³

JAK inhibitors like Opzelura affect your immune system. Your doctor will monitor you for signs of infection during and after treatment with Opzelura. Report symptoms of infection or seek medical treatment right away. Symptoms include fever, sweating, chills, muscle pain, cough, shortness of breath, and pain while urinating.³

There is an increased risk of heart attack, stroke, or death in people with risk factors who smoke or used to smoke while using JAK inhibitors. Seek medical help right away if you have chest pain or tightness, pain in the chest/throat/neck/jaw, shortness of breath, cold sweats, nausea, vomiting, weakness on one side of the body, or slurred speech.³

Opzelura can cause blood clots in the veins of the legs. This is called deep vein thrombosis (DVT). These clots can travel to the lungs. This is called pulmonary embolism (PE). DVT or PE can be life-threatening. Get medical help right away if you have pain, swelling, or tenderness in the leg(s), sudden pain in the chest or upper back, or shortness of breath.³

Opzelura can cause low blood cell counts. Your doctor will monitor your lab tests during treatment with Opzelura. Tell your doctor if you have unusual bruising or bleeding, shortness of breath, fever, or tiredness.³

Before beginning treatment for atopic dermatitis, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Opzelura.