Opzelura: FDA Expands Use of Steroid-Free Skin Cream for Young Children With Eczema

Opzelura (ruxolitinib) is a prescription cream that helps reduce skin inflammation. It works by blocking certain proteins in the body called Janus kinases (JAKs) that help regulate the immune system and can cause skin inflammation when overactive.

The FDA has now approved this cream for children as young as 2 years old with mild-to-moderate atopic dermatitis (also known as eczema) in whom other prescription creams don’t work well or aren’t suitable for certain reasons.

This matters because Opzelura is a first-of-its-kind steroid-free skin cream approved in the U.S. for young children with eczema, a long-term skin condition caused by an overactive immune system. Affecting about 2 million to 3 million children in the U.S., eczema causes itchy, irritated skin with red oozing patches that can crust over. Opzelura offers a short-term treatment providing temporary relief and improving daily comfort.

Why Was It Approved?

Opzelura was approved for children based on a clinical trial involving over 300 kids with eczema that showed that the cream is safe and effective for treating eczema in young children.

In the study, more children who used Opzelura twice a day had clear or nearly clear skin after eight weeks compared with those who used a placebo cream. By the end of the study period, significantly more children experienced a 75% or greater improvement in their eczema symptoms with Opzelura compared to those who were treated with the placebo cream. Overall, the safety of Opzelura in this group was similar to that seen in earlier studies.

The most common side effect is an upper respiratory tract infection, which can include a runny nose or sore throat and fever. Low white blood cell counts and skin reactions where the cream is applied can also occur. During the eight-week study, there were no reports of serious infections, heart problems, cancer, or blood clots.

What Do I Need to Know?

Opzelura is a cream that you apply directly on the affected areas of your child’s skin, twice a day. However, it should not be used on more than 20% of the body at a time. For children aged 2 to 11, you also shouldn’t use more than one 60-gram tube every two weeks. Do not apply Opzelura in your child’s mouth, eyes, or groin area.

During treatment with Opzelura, your doctor will check your child’s skin regularly. Be sure that your child avoids too much sun exposure, wears protective clothing, and uses a broad-spectrum sunscreen when outdoors.

This cream should not be used with other immune-suppressing treatments. Be sure to tell your health care provider about all medicines your child takes, including over-the-counter products, herbal treatments, or supplements, to avoid possible reactions.

Opzelura affects the immune system and may raise the risk for serious infections, skin cancer, blood clots, low blood counts, and heart-related issues — especially in people who are 50 or older and have other underlying health problems.

Do not use Opzelura if your child has an active infection. Let your health care provider know if your child has had infections like tuberculosis, shingles, or hepatitis; has a weak immune system; or lives in areas where certain fungal infections are common. Also inform them if your child keeps getting infections that don’t go away or keep coming back before starting Opzelura.

Contact your health care provider right away if your child shows symptoms of infection such as fever, sweating, or chills; muscle aches; cough; warm, red, or painful skin or sores; diarrhea or stomach pain; unusual tiredness; bruising; or breathing problems during the treatment.

It is not known if Opzelura affects a fetus or passes into breast milk. Patients who are pregnant or planning pregnancy should inform their health care provider. Avoid breastfeeding during treatment and for about four weeks after the last dose.

Opzelura is not a cure for eczema, but it may help manage symptoms.