Opzelura
Opzelura (ruxolitinib) is a topical Janus kinase (JAK) inhibitor. It's a non-steroid cream used to treat atopic dermatitis (eczema) and nonsegmental vitiligo (a condition where skin loses its color) in adults and children ages 12 years and older. Opzelura (ruxolitinib) is applied directly on the skin twice daily. Even though Opzelura (ruxolitinib) has the same black box warnings as oral JAK inhibitors, it's less likely to cause serious side effects compared to oral medications. Some of the more commonly reported side effects of Opzelura (ruxolitinib) include acne, itching or redness, and symptoms of the common cold.
What is Opzelura (ruxolitinib)?
What is Opzelura (ruxolitinib) used for?
How Opzelura (ruxolitinib) works
Opzelura (ruxolitinib) is a Janus kinase (JAK) inhibitor. It works by blocking an enzyme (protein) called Janus kinase, which prevents the activation of other proteins in your immune system. This lowers inflammation (redness, swelling, pain) in the skin to treat eczema. This also prevents destruction of certain skin cells responsible for skin pigmentation (color) to treat nonsegmental vitiligo.
Drug Facts
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What are the side effects of Opzelura (ruxolitinib)?
Common Side Effects
- Runny nose, sore throat (3%)
- Bronchitis (1%)
- Ear infection (1%)
- Hives (1%)
- Diarrhea (1%)
- Redness and swelling around hair pores (1%)
- Swelling of the tonsils (1%)
- Acne on application site (6%)
- Itching on application site (5%)
- Runny nose, sore throat (4%)
- Headache (4%)
- Urinary tract infection (2%)
- Redness on application site (2%)
Other Side Effects
- Fever
- Blisters, painful rash, and other symptoms of shingles infection
- Watery eyes
- Ear pain, hearing loss, and other symptoms of swimmer's ear
- Stuffy nose
- Trouble sleeping
- Stomach pain
Serious Side Effects
- Stroke: sudden weakness in your body, trouble speaking, confusion, dizziness
- Arterial thrombosis (blood clot in the heart): chest pain, short of breath, pain in the jaw, neck, or back, feeling weak or light-headed
- Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
- Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
- Serious bleeds: bleed or bruise easily, bleeding that's hard to stop, coughing blood, stomach pain, blood in urine or stool
- Serious infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills, burning when you urinate, urinating more often
Source: DailyMed
More on Opzelura (ruxolitinib) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Infection—fever, chills, cough, or sore throat
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Acne
- Diarrhea
- Headache
- Runny or stuffy nose
- Sore throat
Pros and cons of Opzelura (ruxolitinib)
Pros
Applied directly onto the skin
Approved for children ages 12 years and older
Possible option for people who haven't had success with other treatments for eczema and vitiligo
Cons
Applied twice daily
Brand name only; no generic available
Not recommended during breastfeeding
Pharmacist tips for Opzelura (ruxolitinib)
Opzelura (ruxolitinib) is for topical use (on your skin) only. Don't apply the medication in your eyes, mouth, or vagina, or this could lead to side effects.
After using Opzelura (ruxolitinib), make sure to thoroughly wash your hands with soap and water (unless your hands are being treated) so you don't accidentally get the medication anywhere else.
Your dermatologist will ask you to use a maximum or one 60-gram tube of Opzelura (ruxolitinib) every week or one 100-gram tube every 2 weeks. If you think you might need more than this amount to treat your condition, talk with you dermatologist. They'll let you know whether Opzelura (ruxolitinib) is still a good option for you or if you should consider other treatment options.
Store Opzelura (ruxolitinib) at room temperature only. Don't put it in the refrigerator or freezer because this could damage the medication.
Opzelura (ruxolitinib) might interaction with some medications, even though it's a topical cream. Taking it with certain medications, such as ketoconazole or clarithromycin, might raise the level of Opzelura (ruxolitinib) in the body and put you at higher risk for side effects. Make sure to tell your primary care provider (PCP) about all the medications you're taking so they can help you check for interactions.
Let your PCP know if you're taking other medications that can weaken your immune system. While Opzelura (ruxolitinib) isn't likely to weaken your immune system as much as oral JAK inhibitors, there have been rare reports that people who used Opzelura (ruxolitinib) have experienced serious respiratory infections. It's important to protect yourself from infections, especially if you're higher risk of getting sick.
There isn't enough research to know how safe it is to use Opzelura (ruxolitinib) during pregnancy. If you're pregnant or thinking of getting pregnant, talk to your dermatologist or OB/GYN about the risk and benefits of taking Opzelura (ruxolitinib) during pregnancy. If you choose to take Opzelura (ruxolitinib) during pregnancy, you're recommended to enroll in the Opzelura pregnancy registry that monitors the health outcomes of you and your baby by calling 1-855-463-3463.
Opzelura (ruxolitinib) might pass through breast milk. To avoid serious side effects, avoid nursing your baby during treatment and for at least 1 month after the last dose of Opzelura (ruxolitinib). If you're nursing, talk with your healthcare team about safer ways to feed your baby during this time.
Frequently asked questions about Opzelura (ruxolitinib)
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What are the risks and warnings for Opzelura (ruxolitinib)?
Opzelura (ruxolitinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Serious infections
Risk factors: Current infection | Past infections that keep coming back | Other conditions that raise your risk of infection | Living in or traveling to places with high rates of TB infections | Taking medications that weaken your immune system
People who took oral JAK inhibitors have experience life-threatening infections, including fungal and viral infections. It's unclear whether topical JAK inhibitors, like Opzelura (ruxolitinib), carry that same risk. But there people who used Opzelura (ruxolitinib) have reported serious respiratory infections during treatment.
Your dermatologist will routinely monitor you for infections before and during treatment with Opzelura (ruxolitinib). If you notice any signs of infection during treatment like fever, chills, body aches, or cough, let your dermatologist know right away.
Possible higher risk of death
Risk factors: Age 50 years and older | High blood pressure | High cholesterol (fat) | High blood sugar
Use of oral JAK inhibitors for rheumatoid arthritis has been linked to higher risk of death for some people, such as older adults with at least one heart-related risk factor. While topical Opzelura (ruxolitinib) isn't known to have this same risk, please use this medication with caution. Talk to your dermatologist about the risks and benefits of using Opzelura (ruxolitinib) before you start treatment.
Possible risk of cancer
Risk factors: History of cancer | People who smoke
Some people who took oral JAK inhibitors reported they developed cancer during treatment. These cancers included lymphoma and skin cancer. While the same hasn't been reported with Opzelura (ruxolitinib), there's a possibility that it can also raise your risk for cancer. Because of this, your provider will monitor you for your risk of cancer during treatment. Additionally, make sure you schedule yearly screenings for skin cancer and let your dermatologist know if you notice changes to your skin. Wear protective clothing and use sunscreen if you're out in the sun, and avoid UV light (e.g., tanning beds) to lower your risk of skin cancer.
Possible risk of heart attack, stroke, and other blood clots
Risk factors: Age 50 years and older | High blood pressure | High cholesterol (fat) | High blood sugar | People who smoke | Past blood clots
People who took oral JAK inhibitors reported blood clots in various parts of the body, including the heart and brain. While these conditions haven't been linked to Opzelura (ruxolitinib), please use it with caution. Get medical help right away if you experience symptoms of blood clots, such as:
Legs (deep vein thrombosis): leg cramp, swelling, pain, muscle tightness
Lungs (pulmonary embolism): cough, chest pain, trouble breathing, racing heart
Heart (arterial thrombosis): chest pain, short of breath, pain in the jaw, neck, or back, feeling weak or light-headed
Brain (stroke): sudden weakness in your body, trouble speaking, confusion, dizziness
Your dermatologist might have you stop taking Opzelura (ruxolitinib) if you experience any blood clots.
Low blood cell counts
Opzelura (ruxolitinib) can cause low red blood cell (RBC), white blood cell (WBC), and platelet levels. This can raise your risk for bleeds, anemia, and infections. Your prescriber might order blood draws to check your blood cell counts, as needed. Let your prescriber know if you experience possible symptoms of low blood cell counts, such as:
Bleeds (low platelet count): small, flat red spots under your skin, blood in your urine or stool, easy bleeding or bruising
Anemia (low RBC count): feeling tired, headache, pale skin, fast heart rate, trouble breathing
Infections (low WBC count): fever, chills, tiredness, cough, body aches, runny nose
Your prescriber might have you stop taking Opzelura (ruxolitinib) if you experience low blood cell counts.
High cholesterol
Jakafi (ruxolitinib), the oral form of Opzelura (ruxolitinib), has been shown to raise cholesterol. It's not known if Opzelura (ruxolitinib) has the same risk. Let your dermatologist know if you have high cholesterol, or are taking medications for high cholesterol, before starting Opzelura (ruxolitinib). They might need to perform blood work to check your cholesterol levels.
Opzelura (ruxolitinib) dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 60g of 1.5% | 1 tube | $1979.37 | $1979.37 |
Typical dosing for Opzelura (ruxolitinib)
Each gram of cream contains 15 mg of ruxolitinib.
Eczema: Apply a thin layer to the affected area(s) twice daily. Don't apply to more than 20% of your body surface area. Typically, your dermatologist will ask you to continue treatment until eczema symptoms get better. But if your skin doesn't improve within 2 months, they'll talk with you about next-steps.
Vitiligo: Apply a thin layer to the affected area(s) twice daily. Don't apply to more than 10% of your body surface area. If your skin doesn't improve within 6 months, your dermatologist will talk with you about next-steps.
Don't use more than one 60-gram tube of Opzelura (ruxolitinib) every week or one 100-gram tube every 2 weeks.
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References
Best studies we foundAmerican Cancer Society. (n.d.). Lymphoma.
Centers for Disease Control and Prevention. (2024). Heart disease risk factors.
Cichorek, M., et al. (2013). Skin melanocytes: Biology and development. Advances in Dermatology and Allergology.
Incyte Corporation. (2023). Opzelura- ruxolitinib cream [package insert]. DailyMed.
National Eczema Association. (n.d.). FAQ - Opzelura (ruxolitinib) cream.
Papp, K., et al. (2021). Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies. Journal of the American Academy of Dermatology.
Rosmarin, D., et al. (2022). Two phase 3, randomized, controlled trials of ruxolitinib cream for vitiligo. The New England Journal of Medicine.
Samarasinghe, V., et al. (2012). Nonmelanoma skin cancer. Journal of Cutaneous and Aesthetic Surgery.
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