Opzelura cream is a locally applied Janus kinase (JAK) inhibitor that selectively inhibits JAK1 and JAK2, regulates cytokine signaling pathways, and reduces inflammation and immune-mediated skin lesions.

1、 Drug name and manufacturer

1. Drug name: Ruxolitinib Cream, English name Ruxolitinib Cream, trade name Opzelura.

2. Manufacturer: Produced by IncyteCorporation.

2、 Indications

1. This product is suitable for short-term and non continuous chronic treatment of mild to moderate atopic dermatitis (eczema) patients aged 12 years and above with non immune dysfunction.

2. Applicable to patients: Topical prescription therapy is insufficient to control the condition, or these therapies are not suitable.

3、 Specifications and characteristics

1. Specification: Each gram of cream contains 15mg of Lucretinib, with a concentration of 1.5%. Each aluminum hose is packaged in 60g.

2. Appearance: This product is a white to off white water in oil emulsion cream.

4、 Main components

Active ingredient: Ruxolitinib, its chemical form is ruxolitinib phosphate.

5、 Usage and dosage

1. Usage: Apply a thin layer on the affected skin twice a day.

2. Usage limit: The total amount used per week should not exceed 60 grams. The application area should not exceed 20% of the body surface area.

3. Discontinuation indication: When the signs and symptoms of atopic dermatitis (such as itching, rash, and redness) disappear, the use should be stopped.

4. Follow up requirements: If the signs and symptoms do not improve after 8 weeks of medication, the patient should seek medical attention again for examination.

6、 Dose adjustment

1. This product is an external preparation and does not require dosage adjustment for regular use.

2. If severe infection, opportunistic infection, or sepsis occurs, treatment should be interrupted until the infection is under control.

3. If a patient develops shingles, treatment may be considered to be interrupted until symptoms improve.

7、 Medication precautions

1. For external use only: This product is for skin use only and should not be used in the eyes, mouth, or vagina.

2. Pre medication evaluation: for patients with chronic or recurrent infection, serious or opportunistic infection history, contact with tuberculosis patients, or living or traveling in tuberculosis or endemic fungal disease endemic areas, the risks and benefits should be carefully evaluated before medication.

3. Infection monitoring: During and after treatment, patients should be closely monitored for signs and symptoms of infection.

4. Hand washing: Wash hands after applying, unless the hands are in the treatment area. If someone helps apply it, the helper should also wash their hands.

8、 Medication for special populations

1. Pregnant women: There is currently insufficient data to assess drug-related risks. When using this product during pregnancy, it is recommended to report exposure to the company via phone 1-855-463-3463 for inclusion in pregnancy registration.

2. Breastfeeding women: It is recommended to stop breastfeeding during the treatment period and within about 4 weeks (approximately 5 half lives) after the last dose.

3. Pediatric patients: Safety and efficacy have been determined in adolescents aged 12 to 17. The safety and efficacy in children under 12 years old have not yet been determined.

4. Elderly: In clinical studies, no clinically significant differences were observed between patients aged 65 and above and younger patients.

9、 Adverse reactions

1. Common adverse reactions (incidence rate ≥ 1%): including nasopharyngitis, bronchitis, ear infections, increased eosinophil count, urticaria, diarrhea, folliculitis, tonsillitis, and rhinorrhea.

2. Other adverse reactions: Adverse reactions with an incidence rate of less than 1% include neutropenia, allergic conjunctivitis, fever, seasonal allergies, herpes zoster, otitis externa, staphylococcal infection, and acne like dermatitis.

10、 Contraindications

This product has no specific contraindications.

11、 Drug interactions

1. Combination with other drugs: It is not recommended to use in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants (such as azathioprine or cyclosporine).

2. CYP3A4 inhibitor: Lucretinib is a substrate of CYP3A4. Strong CYP3A4 inhibitors, such as ketoconazole, may increase systemic exposure to fluconazole.

3. CYP3A4 inducers: CYP3A4 inducers (such as rifampicin) may reduce systemic exposure to Lucretinib.

12、 Storage method

1. Storage conditions: It should be stored at room temperature between 20 ° C and 25 ° C, with short-term fluctuations allowed between 15 ° C and 30 ° C.

2. Safety requirements: Please keep this product and all medications out of reach of children.

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