OPZELURA

OPZELURA is an FDA-registered drug product whose active ingredient is RUXOLITINIB. It is labelled by Incyte Corporation taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 50881-007, application NDA215309, label effective 20260630. It is one of 2 FDA drug label records sharing the active ingredient RUXOLITINIB. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing RUXOLITINIB are most often described in connection with: pediatric patients, years age, atopic dermatitis, nonsegmental vitiligo, janus kinase, topical short-term, non-continuous chronic, treatment mild. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. ( 1.3 ) 1.1 Atopic Dermatitis OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 1.2 Nonsegmental Vitiligo OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

2 DOSAGE AND ADMINISTRATION Atopic Dermatitis Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 20% body surface area. ( 2.1 ) Do not use OPZELURA with occlusive dressings. ( 2.1 ) Adult and Pediatric Patients 12 Years of Age and Older Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. ( 2.1 ) Pediatric Patients 2 to 11 Years of Age Do not use more than one 60 gram tube of OPZELURA per 2 weeks. ( 2.1 ) Nonsegmental Vitiligo Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area. ( 2.2 ) Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. ( 2.2 ) 2.1 Recommended Dosage and Administration for Atopic Dermatitis OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use. Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area. Do not use OPZELURA with occlusive dressings. Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their healthcare provider [see Clinical Studies ( 14.1 )] . Adult and Pediatric Patients 12 Years of Age and Older Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. Pediatric Patients 2 to 11 Years of Age Do not use more than one 60 gram tube of OPZELURA per 2 weeks. 2.2 Recommended Dosage and Administration for Nonsegmental Vitiligo OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use. Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 10% body surface area. Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. Satisfactory patient response may require treatment with OPZELURA for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re‑evaluated by the healthcare provider [see Clinical Studies ( 14.2 )] .

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reactions, pyrexia, and white blood cell decreased. ( 6 ) In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Incyte Corporation at 1-855-463-3463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult and Pediatric Subjects 2 Years of Age and Older with Atopic Dermatitis Adult and Pediatric Subjects 12 Years of Age and Older In two double-blind, vehicle-controlled clinical trials (TRuE-AD1 and TRuE-AD2), 499 adult and pediatric subjects 12 years of age and older with atopic dermatitis were treated topically with OPZELURA twice daily for 8 weeks [see Clinical Studies ( 14.1 )] . The adverse reactions reported by ≥ 1% of OPZELURA treated subjects and at a greater incidence than in the vehicle arm are listed in Table 1. Table 1: Adverse Reactions Occurring in ≥ 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD1 and TRuE-AD2 Adverse Reaction OPZELURA (N = 499) n (%) Vehicle (N = 250) n (%) Nasopharyngitis 13 (3) 2 (1) Bronchitis 4 (1) 0 (0) Ear infection 4 (1) 0 (0) Eosinophil count increased 4 (1) 0 (0) Urticaria 4 (1) 0 (0) Diarrhea 3 (1) 1 (< 1) Folliculitis 3 (1) 0 (0) Tonsillitis 3 (1) 0 (0) Rhinorrhea 3 (1) 1 (< 1) Adverse reactions that occurred in TRuE-AD1 and TRuE-AD2 in < 1% of subjects in the OPZELURA group and none in the vehicle group were: neutropenia, allergic conjunctivitis, pyrexia, seasonal allergy, herpes zoster, otitis externa, Staphylococcal infection, and acneiform dermatitis. No clinically meaningful differences in safety or effectiveness were observed between adult and pediatric subjects 12 to 17 years of age. Pediatric Subjects 2 to 11 Years of Age In a double-blind, vehicle-controlled clinical trial (TRuE-AD3), 130 pediatric subjects 2 to 11 years of age with mild to moderate atopic dermatitis were treated topically with OPZELURA twice daily for 8 weeks [see Clinical Studies ( 14.1 )] . The adverse reactions reported by ≥ 1% of subjects treated with OPZELURA and at a greater incidence than in the vehicle arm are listed in Table 2. Table 2: Adverse Reactions Occurring in ≥ 1% Pediatric Subjects 2 to 11 Years of Age Treated with OPZELURA for Atopic Dermatitis through Week 8 in TRuE-AD3 Adverse Reaction OPZELURA (N = 130) n (%) Vehicle (N = 65) n (%) Upper respiratory tract infection Upper respiratory tract infection includes upper respiratory tract infection, nasopharyngitis, rhinorrhea, oropharyngeal pain, respiratory tract congestion, viral upper respiratory tract infection 20 (15) 7 (11) COVID-19 6 (5) 2 (3) Application site reaction Application site reaction includes application site pain, application site irritation, application site discomfort, application site pruritus 6 (5) 1 (2) Pyrexia 3 (2) 0 (0) White blood cell decreased White blood cell decreased includes white blood cell decreased, leukopenia 2 (2) 0 (0) Subjects with cytopenias (defined as hemoglobin < 10 g/dL, absolute neutrophil count (ANC) < 1000/μL, and platelet count < 100,000/μL) at screening were excluded from the trial. The impact of OPZELURA on blood cell counts in this population has not been studied. Adverse Reactions in Adult and Pediatric Subjects 12 Years of Age and Older with Nonsegmental Vitiligo In two double-blind, vehicle-controlled clinical trials (TRuE-V1 and TRuE-V2), 449 adult and pediatric subjects 12 years of age and older with nonsegmental vitiligo were treated topically with OPZELURA twice daily for 24 weeks [see Clinical Studies ( 14.2 )] . The adverse reactions reported by OPZELURA treated subjects with an incidence of ≥ 1% and at least 1% greater incidence than in the vehicle arm in the 24-week double-blind period are listed in Table 3. Table 3: Adverse Reactions Occurring in ≥ 1% of Adult and Pediatric Subjects 12 Years of Age and Older Treated with OPZELURA for Nonsegmental Vitiligo through Week 24 in TRuE-V1 and TRuE-V2 Adverse Reaction OPZELURA (N = 449) n (%) Vehicle (N = 224) n (%) Application site acne 26 (6) 2 (1) Application site pruritus 23 (5) 6 (3) Nasopharyngitis 19 (4) 5 (2) Headache 17 (4) 6 (3) Urinary tract infection 7 (2) 1 (< 1) Application site erythema 7 (2) 1 (< 1) Pyrexia 6 (1) 0 Adverse reactions that occurred in TRuE-V1 and TRuE-V2 in ≥ 0.5% to < 1% of subjects in the OPZELURA group and none in the vehicle group were: application site dermatitis, hypertension, anxiety, application site discoloration, application site folliculitis, dermatitis contact, diarrhea, ear infection, gastritis, gastroenteritis, hordeolum, influenza-like illness, insomnia, nasal congestion, and vomiting. No clinically meaningful differences in safety or effectiveness were observed between adults and pediatric subjects.

FDA lists 2 drug label records with RUXOLITINIB as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is OPZELURA used for?
1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the …

Who makes OPZELURA?
Incyte Corporation is the labeler of record for OPZELURA. 2 FDA label records share the active ingredient RUXOLITINIB, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does OPZELURA come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is OPZELURA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing RUXOLITINIB?
Yes. 2 FDA drug label records list RUXOLITINIB as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has OPZELURA been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.