pharmacopeia
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Boxed warning

SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Invasive fungal infections, including cryptococcosis, and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions ( 5.1 )] .

Mechanism of action

Sourced from openFDA

Ruxolitinib, a Janus kinase (JAK) inhibitor, inhibits JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.

Janus Kinase

Indications

Sourced from openFDA
  • 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.ICD-10: L20.9

Contraindications

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  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

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Serious Infections: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Regularly monitor patients for infection and manage it promptly. ( 5.1 ) Non-melanoma Skin Cancers . Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate. ( 5.3 ) Thrombosis. Thromboembolic events have occurred. ( 5.5 ) Cytopenias: Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia have occurred. Perform CBC monitoring as clinically indicated. ( 5.6 ) 5.1 Serious Infections Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving oral JAK inhibitors. Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating OPZELURA in patients: with chronic or recurrent infection with a history of a serious or an opportunistic infection who have been exposed to tuberculosis who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA. Interrupt OPZELURA if a patient develops a serious infection, an opportunistic infection, or sepsis.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463 or visiting www.opzelura.pregnancy.incyte.com. Risk Summary Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity (see Data) . The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The background risk in the U.S. general population of major birth defects and miscarriage is 2-4% and 15-20%, respectively. Data Animal Data Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30, or 60 mg/kg/day in rats and 10, 30, or 60 mg/kg/day in rabbits. There were no treatment-related malformations at any dose.

Pharmacokinetics

Sourced from openFDA
Metabolism
In Trial INCB18424-103, the pharmacokinetics of ruxolitinib were evaluated in 20 adult subjects and 21 pediatric subjects 13 years of age and older with atopic dermatitis with a mean ± SD BSA involvement of 37.5 ± 16.1% (range 25% to 90%). Subjects applied approximately 1.5 mg/cm 2 of OPZELURA (dose range was approximately 1.2 grams to 37.6 grams per application) twice daily for 28 days.

Approval history

Sourced from openFDA
  • Nov 16, 2011NDANDA202192Incyte Corp
  • Sep 21, 2021NDANDA215309Incyte Corp
  • May 1, 2026NDANDA217180Incyte Corp

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
69,262 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use13,94820%
  2. 2Death6,2889.1%
  3. 3Fatigue5,9738.6%
  4. 4Anaemia3,0324.4%
  5. 5Haemoglobin Decreased2,9334.2%
  6. 6Platelet Count Decreased2,6683.9%
  7. 7Diarrhoea2,6243.8%
  8. 8Product Dose Omission Issue2,4913.6%
  9. 9Asthenia2,4853.6%
  10. 10Dizziness2,4583.5%
  11. 11Headache2,3713.4%
  12. 12Product Availability Issue2,2763.3%
  13. 13Pneumonia2,1133.1%
  14. 14Nausea2,0863.0%
  15. 15Drug Ineffective2,0793.0%

Clinical trials

View JSON

The 10 most recently updated of 475 ClinicalTrials.gov registrations naming Ruxolitinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ruxolitinib work?
Ruxolitinib, a Janus kinase (JAK) inhibitor, inhibits JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression.
What is Ruxolitinib used for?
According to FDA labeling, Ruxolitinib carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ruxolitinib?
Ruxolitinib is classified as Agents for dermatitis, excluding corticosteroids, Janus-associated kinase (JAK) inhibitors, Janus Kinase Inhibitor, Kinase Inhibitor, Janus Kinase Inhibitors, Cellular Proliferation Alteration, Decreased Hematopoiesis.
What are the brand names for Ruxolitinib?
Ruxolitinib is marketed under brand names including Jakafi, Opzelura.
What are the contraindications for Ruxolitinib?
Ruxolitinib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for ruxolitinib is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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