Opzelura Cream (Ruxolitinib)
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Fact Table
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| Formula | C17H21N6O4P (ruxolitinib phosphate salt); free base formula C17H18N6 |
| License | Prescription only (Rx-only, topical JAK inhibitor) |
| Bioavailability | Low systemic absorption; quantifiable plasma levels, but no evidence of accumulation after 28 days |
| Legal status | Rx-only (US, EU, Canada, etc.) |
| Chemical Name | (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate |
| Elimination half-life | ~116?hours (after topical application) |
| Dosage (Strength) | Cream 1.5% (15?mg ruxolitinib per gram; equivalent to 19.8?mg phosphate salt); apply thin layer twice daily |
| Pregnancy | Use only if clearly needed—consult healthcare provider (not well established) |
| Brands | Opzelura |
| Protein binding | Approximately 97% (systemic) |
| PubChem CID | 25126798 (free base); 25127112 (phosphate) |
| MedlinePlus | a612006 |
| ChEBI | Not assigned |
| ATC code | L01EJ (ruxolitinib), topical-specific not assigned |
| DrugBank | DB08877 |
| KEGG | D09959 (free base); D09960 (phosphate salt) |
| Routes of administration | Topical (cream) |
Opzelura Cream is a topical formulation containing ruxolitinib, a Janus kinase (JAK) inhibitor. It is indicated for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, and for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years and older. By inhibiting JAK1 and JAK2, Opzelura modulates cytokine signaling involved in inflammatory and immune responses, contributing to its clinical efficacy in these dermatologic conditions.
Directions
Apply a thin layer of Opzelura Cream to the affected areas twice daily, ensuring the skin is clean and dry before application. Avoid use on more than 10% of body surface area and do not apply to broken or infected skin. Hands should be washed after application unless the treated area includes the hands. Use only as directed by a healthcare provider, and do not cover the treated area with occlusive dressings unless advised by a physician.
Ingredients
Each gram of Opzelura Cream contains 15 mg of ruxolitinib (1.5%) as the active ingredient. Inactive ingredients include but are not limited to isopropyl myristate, medium chain triglycerides, propylene glycol, cetyl alcohol, stearyl alcohol, purified water, and other excipients designed to ensure appropriate skin absorption and stability of the formulation.
Cautions
Patients should be monitored for signs of infection during treatment with Opzelura, as JAK inhibition may impair immune function. Use with caution in patients with a history of chronic or recurrent infections, and those receiving immunosuppressive therapy. Avoid use in patients with untreated tuberculosis, active hepatitis, or other serious systemic infections. The safety and efficacy of long-term use beyond the recommended treatment duration have not been established. Opzelura is not indicated for use in pediatric patients under 12 years of age.
Contraindications
Opzelura is contraindicated in individuals with known hypersensitivity to ruxolitinib or any component of the formulation. It should not be used in patients with active serious infections, including tuberculosis, or by individuals who are immunocompromised, unless under direct supervision of a healthcare provider.
Side Effects
Common side effects reported with the use of Opzelura Cream include:
- Application site acne
- Application site itching or irritation
- Nasopharyngitis
- Headache
- Fever
- Increased creatine phosphokinase
Rare but serious side effects may include:
- Serious infections
- Thrombosis
- Cytopenias
- Elevations in liver enzymes and lipid parameters
- Patients experiencing any unusual or severe symptoms should seek medical advice promptly.
Frequently Asked Questions about Opzelura Cream (Ruxolitinib)
What is Opzelura Cream used for?
Opzelura Cream is a prescription topical medication used to treat nonsegmental vitiligo in patients 12 years and older and mild to moderate atopic dermatitis in patients 12 years and older who are not adequately controlled with other therapies or for whom those therapies are not recommended.
How does Opzelura work?
Opzelura contains ruxolitinib, a Janus kinase (JAK) inhibitor. It works by targeting specific enzymes involved in the body’s inflammatory and immune response, helping to reduce inflammation, itching, and skin depigmentation seen in conditions like atopic dermatitis and vitiligo.
How should Opzelura Cream be applied?
Apply a thin layer of Opzelura to the affected areas of the skin twice daily. It is for topical use only and should not be used on more than 10% of the body surface area. Avoid application on the face unless directed by a healthcare provider.
What are the common side effects of Opzelura?
The most commonly reported side effects include acne at the application site, redness or itching, headache, and nasopharyngitis. Some users may also experience application site pain or swelling.
Can Opzelura Cream cause serious side effects?
Yes, although rare, serious side effects can include infections, low blood cell counts, increased cholesterol levels, and potential risk of blood clots. Patients should be monitored for signs of infection and other systemic effects, especially with long-term use.
Is Opzelura a steroid or immunosuppressant?
Opzelura is not a steroid, but it does have immunosuppressive effects due to its action on the JAK-STAT pathway. This means it can affect the body’s immune response, so its use should be monitored, especially in individuals with weakened immune systems.
Can children use Opzelura Cream?
Opzelura is approved for use in children 12 years and older for both vitiligo and atopic dermatitis. Its safety and effectiveness have not been established in children under 12 years of age.
Are there any precautions when using Opzelura with other medications?
Yes, Opzelura may interact with other immunosuppressive drugs or strong CYP3A4 inhibitors. It’s important to inform your healthcare provider about all medications, supplements, and topical products being used to avoid potential interactions.
Can Opzelura be used long-term?
The safety of long-term use is still being evaluated. Regular follow-up with a healthcare provider is recommended, especially for users applying the cream for extended periods or over large body areas.
Should Opzelura Cream be used during pregnancy or breastfeeding?
The effects of Opzelura during pregnancy or breastfeeding are not fully known. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and under the guidance of a healthcare provider.
