Opzelura Cream: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Opzelura Cream (ruxolitinib) is a prescription topical Janus kinase (JAK) inhibitor used to treat mild-to-moderate eczema (atopic dermatitis) in adults and children 2 years and older, and nonsegmental vitiligo in adults and children 12 years and older. It works by calming an overactive immune signaling pathway in the skin to reduce inflammation or support skin color return. Opzelura carries a boxed warning for serious risks including infections, cancer, major heart-related events, and blood clots, based on data from oral JAK inhibitors.

What is Opzelura Cream

Opzelura is a prescription cream applied to the skin. It contains ruxolitinib and is used to calm an overactive immune response in certain skin conditions.

Opzelura Cream uses

• Mild-to-moderate eczema (atopic dermatitis) in adults and children 2 years and older whose condition is not well controlled with topical prescription treatments, or when those treatments are not recommended
• Nonsegmental vitiligo in adults and children 12 years and older

Benefits of Opzelura Cream

• May reduce inflammation, rashes, and redness in eczema
• May help skin regain color in vitiligo

How Opzelura Cream works

Opzelura blocks two enzymes called JAK1 and JAK2 that are part of a signaling pathway your immune system uses. In eczema and vitiligo, this pathway can become overactive and cause inflammation or skin color loss. By calming these signals where the cream is applied, the medicine helps reduce inflammation in eczema or may help skin color return in vitiligo.

Opzelura Cream dosage

Apply a thin layer to the affected areas of skin twice a day. This medicine is for use on the skin only — do not use in the eyes, mouth, or vagina. Do not cover the treated area with tight bandages or dressings that seal the skin. Wash your hands after applying, unless the hands are the area being treated. If someone else applies it for you, they should wash their hands afterward.

For eczema, stop using once itching, rash, and redness have gone away, or as your health care provider directs; tell your provider if symptoms have not improved after 8 weeks of use. For vitiligo, talk to your health care provider if you do not see changes in skin color after 6 months (or report if treated skin does not improve within 24 weeks).

If you miss a dose, apply it as soon as you remember; if it is almost time for your next dose, skip the missed one and continue with your regular schedule — do not use double or extra amounts. Children 2 to 11 years old may be more likely to have certain side effects than older children and adults.

Available forms and strengths

• 1.5% topical cream

Side effects of Opzelura Cream

Common

• Infections of 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 a type of white blood cell (eosinophil)
• Itching, skin rash, or hives
• Kidney or bladder infections
• Inflamed hair pores (folliculitis)
• Swelling in the tonsils (tonsillitis)
• Common cold (nasopharyngitis)
• Bronchitis
• Ear infection
• Runny nose (rhinorrhea)
• Upper respiratory tract infection
• COVID-19
• Urinary tract infection

Serious

• Severe allergic reactions (breathing problems, swelling of face/lips/mouth/tongue/throat, hives)
• Serious infections, including tuberculosis and infections caused by bacteria, fungi, or viruses; higher risk of shingles
• Blood disorders such as anemia, thrombocytopenia, and low white blood cell counts
• Certain cancers, including skin cancers and (with oral JAK inhibitors) lymphoma or lung cancer
• Heart attack and stroke
• Blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• Increased cholesterol or triglyceride levels
• Low blood sugar in people with diabetes

Warnings and precautions

• Opzelura carries a boxed warning for serious infections, increased risk of death, cancer, major heart-related events, and blood clots, based on findings with JAK inhibitors taken by mouth.
• Do not use Opzelura if you have an active, serious infection, including localized infections, unless your health care provider says it is okay.
• Using Opzelura with other biologic medicines, other JAK inhibitors, or strong immune-suppressing drugs like azathioprine or cyclosporine is not recommended.
• People 50 years or older with a heart disease risk factor, or those who smoke or have smoked, may have a higher risk of death, heart attack, stroke, or blood clots, based on data from oral JAK inhibitors.
• Opzelura is for use on the skin only — never use it in the eyes, mouth, or vagina, and do not cover treated skin with tight, sealing bandages.
• Children 2 to 11 years old may have a greater risk of certain side effects compared with older children and adults, including discomfort, irritation, itching at the application site, fever, or low white blood cell counts.
• It is not known if Opzelura could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or planning to become pregnant.
• It is not known if Opzelura passes into breast milk. Do not breastfeed while using it and for about 4 weeks after stopping.
• No routine kidney-specific dose adjustment is established for topical use. No routine liver-specific dose adjustment is established. It is unknown if drinking alcohol will affect Opzelura. Opzelura is not expected to impair driving.

Storage

• Store at room temperature, between 68°F and 77°F (20°C and 25°C)
• Can be exposed to temperatures between 59°F and 86°F (15°C and 30°C) for shorter periods, such as when transporting it
• Store in a cool, dry place
• Keep out of the reach of children

When to see a doctor

• Stop using Opzelura and get help right away if you have signs of a serious allergic reaction, such as trouble breathing, swelling of the face/lips/mouth/tongue/throat, or widespread hives.
• Call your health care provider right away if you have signs of an infection, such as burning when you urinate, cough, fever, sweats, chills, or shortness of breath.
• Stop using Opzelura and get help right away if you notice signs of a blood disorder, such as fever, shortness of breath, pale or yellowish skin, easy bruising or bleeding, or unusual weakness.
• Get help right away for signs of a heart attack or stroke, such as chest pain or pressure, sudden weakness on one side of the body, or slurred speech.
• Tell your health care provider right away if you notice swelling, redness, or pain in your leg, or chest pain and shortness of breath, which could signal a blood clot.
• If you or someone else uses too much Opzelura, get medical help right away or contact a poison control center.

Alternatives

• Tacrolimus ointment
• Pimecrolimus cream
• Crisaborole cream
• Topical corticosteroids