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Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Opzelura Cream (Ruxolitinib)
Prescription Required
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Product Details
Description
Opzelura (ruxolitinib) is a prescription cream used to treat certain skin conditions. It treats mild to moderate atopic dermatitis (eczema) in people whose symptoms are not well controlled with other topical prescription treatments. It is also approved for nonsegmental vitiligo in people 12 years of age and older. Opzelura is a topical JAK (Janus kinase) inhibitor. It works by reducing overactive immune activity in the skin that can lead to itching, inflammation, and loss of skin color.
Fact Table
Formula
C17H18N6 (ruxolitinib); C17H21N6O4P (ruxolitinib phosphate)
License
US FDA, NDA 215309
Bioavailability
Approximately 6.22% systemic bioavailability following topical application in patients with atopic dermatitis
Legal status
Rx-only (US)
Chemical Name
(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate
Elimination half-life
Approximately 116 hours following topical application
Dosage (Strength)
1.5% cream (15 mg ruxolitinib per gram); apply a thin layer twice daily, subject to indication-specific body-surface-area and weekly quantity limits
Pregnancy
Available human data are insufficient to evaluate drug-associated risk; use only after medical assessment and enroll exposed patients in the pregnancy registry
Brands
Opzelura
Protein binding
Approximately 97%, primarily to albumin
PubChem CID
25126798 (ruxolitinib); 25127112 (ruxolitinib phosphate)
MedlinePlus
a621053
ChEBI
66919 (ruxolitinib); 66917 (ruxolitinib phosphate)
ATC code
D11AH09
DrugBank
DB08877
KEGG
D09959 (ruxolitinib); D09960 (ruxolitinib phosphate)
Routes of administration
Topical cutaneous use only
Directions
Use Opzelura exactly as directed by a healthcare provider. Apply a thin layer to the affected areas twice daily.
For eczema, do not apply Opzelura to more than 20% of the body surface area. Stop using the cream once symptoms such as itching, rash, and redness have cleared. If symptoms do not improve within 8 weeks, contact your healthcare provider.
For vitiligo, do not apply Opzelura to more than 10% of the body surface area. It may take more than 24 weeks of treatment to see a meaningful return of skin color.
Do not use more than one 60-gram tube per week or one 100-gram tube every 2 weeks. For children 2 to 11 years of age with eczema, do not use more than one 60-gram tube every 2 weeks.
Opzelura is for use on the skin only. Do not apply it in the eyes, mouth, or vagina, and do not cover treated areas with airtight bandages or dressings.
Ingredients
The active ingredient in Opzelura is ruxolitinib. Inactive ingredients may include cetyl alcohol, dimethicone, edetate disodium, glyceryl stearate, light mineral oil, medium chain triglycerides, methylparaben, phenoxyethanol, phosphoric acid, polyethylene glycol, polysorbate 20, propylene glycol, propylparaben, stearyl alcohol, purified water, white petrolatum, and xanthan gum.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Opzelura carries a boxed warning for serious infections, an increased risk of death, cancers such as lymphoma and skin cancers, major cardiovascular events such as heart attack and stroke, and blood clots.
Do not start Opzelura during an active, serious infection. Tell a healthcare provider about any signs of infection and any history of tuberculosis, hepatitis B or C, or shingles before starting treatment.
Opzelura is not recommended for use in combination with biologic medications, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine.
People who smoke or have had a heart attack, stroke, blood clot, or cancer should discuss these risks with a healthcare provider before using Opzelura.
A healthcare provider may check blood counts and cholesterol levels during treatment because JAK inhibitors can lower blood cell counts and increase cholesterol levels.
Do not breastfeed while using Opzelura and for approximately 4 weeks after the last dose. Discuss the use of Opzelura during pregnancy with a healthcare provider.
Contraindications
There are no contraindications for Opzelura listed in the drug label.
Side Effects
Common side effects of Opzelura may include:
- Acne or itching where the cream is applied
- Redness at the application site
- Common cold symptoms
- Headache
- Urinary tract infection
- Fever
Serious side effects are possible. Get medical help immediately if there are signs of a serious infection, heart attack, stroke, or blood clot.
Unusual bleeding or bruising, ongoing tiredness, new skin growths, or changing moles should also be reported to a healthcare provider.
References
- Opzelura Highlights of Prescribing Information. Wilmington, DE: Incyte Corporation; 2026.
- Opzelura Drug Label Information. Wilmington, DE: Incyte Corporation; 2025.
Frequently Asked Questions about Opzelura Cream
What is Opzelura Cream?
Opzelura is a prescription topical medicine containing ruxolitinib 1.5%. It is a Janus kinase inhibitor that reduces immune-system signals involved in skin inflammation and loss of pigmentation.
What is Opzelura used for?
Opzelura is used for short-term and non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children aged 2 years and older when other topical prescription treatments are inadequate or unsuitable. It is also used for nonsegmental vitiligo in adults and children aged 12 years and older.
How is Opzelura applied?
Apply a thin layer to the affected skin twice daily, following the prescribed limits for the treatment area. Wash your hands afterward unless the hands are being treated.
How much skin can be treated with Opzelura?
For atopic dermatitis, it should generally be applied to no more than 20% of the body surface area. For vitiligo, treatment is generally limited to no more than 10% of the body surface area.
How long does Opzelura take to work?
Itching from atopic dermatitis may begin improving within days, while visible skin improvement can take several weeks. Repigmentation in vitiligo develops gradually and may require continuous treatment for several months.
What are the common side effects of Opzelura?
Possible side effects include application-site acne, redness, itching, irritation, headache, fever, cold-like symptoms, and inflammation of the hair follicles. Side effects may differ depending on the condition being treated.
Does Opzelura have serious safety warnings?
Yes. Opzelura carries warnings associated with the JAK-inhibitor drug class, including serious infections, cancer, blood clots, major cardiovascular events, and increased risk of death. Systemic exposure is generally lower with topical use, but warning symptoms should be reported promptly.
Who should use Opzelura cautiously?
Caution is appropriate for people with weakened immune systems, recurring infections, tuberculosis exposure, cancer, blood disorders, cardiovascular risk factors, or a history of blood clots. Tell the prescriber about all medical conditions before treatment.
Can Opzelura be used with other immune-suppressing medicines?
Using Opzelura with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. All prescription medicines, nonprescription products, and supplements should be discussed with the prescriber.
Where should Opzelura not be applied?
Opzelura is for skin use only. Do not put it in the eyes, mouth, or vagina, and do not use it under airtight dressings unless specifically instructed. It should not be applied more often, over a larger area, or for longer than prescribed.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 15212
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