Opzelura (ruxolitinib cream)

Q: What is Opzelura used for?

It is a cream used for mild to moderate atopic dermatitis in people 2 years of age and older (short-term and non-continuous chronic treatment) and for nonsegmental vitiligo in people 12 years of age and older.

Q: How do I apply Opzelura?

Apply a thin layer twice daily to affected areas. For atopic dermatitis, treat areas of up to 20% body surface area; for vitiligo, up to 10%. Do not use occlusive dressings. It is for the skin only, not the eyes, mouth or vagina.

Q: How much cream can I use?

People 12 years and older should not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Children 2 to 11 years old with atopic dermatitis should not use more than one 60 gram tube per 2 weeks.

Q: What should I do if I miss a dose?

Apply it as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not apply extra to make up for it.

Q: What are the serious risks?

The boxed warning lists serious infections, higher death rates, cancers, major cardiovascular events and blood clots seen with JAK inhibitors. Stop Opzelura and get help if symptoms of a heart attack, stroke or blood clot occur.

Q: Can I use Opzelura while pregnant or breastfeeding?

Pregnancy data are not enough to judge risk. The label advises not to breastfeed during treatment and for approximately four weeks after the last dose. Tell your doctor if you are pregnant or plan to become pregnant.

Q: Should I stop using it when my skin clears?

For atopic dermatitis, the label says to stop using it when signs and symptoms such as itch, rash and redness resolve, and to see a healthcare provider again if there is no improvement within 8 weeks. For vitiligo, a good response may require more than 24 weeks.

Generic name: ruxolitinib · Brand names: Opzelura

Quick facts

Drug class

Section

HIGHLIGHTS, INDICATIONS AND USAGE

Source

Opzelura label; MedlinePlus says 'Ruxolitinib is in a class of medications called Janus kinase (JAK) inhibitors.'

Source text (exact source wording)

OPZELURA is a Janus kinase (JAK) inhibitor indicated for:

Rx or otc

Value

Prescription (label has a Medication Guide; MedlinePlus: 'You will be given the Medication Guide when you begin treatment... each time you refill your prescription.' The label text captured does not print the words 'Rx only'.)

Source

Opzelura label; MedlinePlus

Forms and strengths

Value

Cream: 15 mg of ruxolitinib per gram (1.5%) of white to off-white cream supplied in 60 g and 100 g tubes

Source

Opzelura label, section 3 DOSAGE FORMS AND STRENGTHS

Generic available

Value

No generic label found. DailyMed list search for drug_name=opzelura returned one entry (Incyte). Other names not searched.

Source

https://dailymed.nlm.nih.gov/dailymed/services/v2/spls.json?drug_name=opzelura

Common use one line

Topical treatment of mild to moderate atopic dermatitis (ages 2 years and older) and nonsegmental vitiligo (ages 12 years and older), per label section 1.

What it is used for

Opzelura is a cream for the skin. It is used for short-term and non-continuous long-term treatment of mild to moderate atopic dermatitis in people 2 years of age and older who are not immunocompromised and whose disease is not controlled well by other prescription skin treatments, or when those are not advisable. It is also used for nonsegmental vitiligo in people 12 years of age and older. Using it with biologics, other JAK inhibitors, or strong immune-suppressing drugs such as azathioprine or cyclosporine is not recommended.

Section

1 INDICATIONS AND USAGE

Source

Opzelura label

Source text (exact source wording)

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.

How it works

Ruxolitinib is a JAK inhibitor. It blocks JAK1 and JAK2, which carry signals for cytokines and growth factors important for blood cell formation and immune function. The label says it is not currently known how blocking specific JAK enzymes relates to how well the drug works.

Section

12.1 Mechanism of Action

Source

Opzelura label

Source text (exact source wording)

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. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

Dosage: adults

For atopic dermatitis, apply a thin layer twice daily to affected areas of up to 20% body surface area. Do not use occlusive dressings. Stop when signs such as itch, rash and redness resolve. If there is no improvement within 8 weeks, see a healthcare provider again. For people 12 years and older, do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. For nonsegmental vitiligo, apply a thin layer twice daily to affected areas of up to 10% body surface area, with the same tube limits. Vitiligo response may take more than 24 weeks, and patients should be re-evaluated if repigmentation is not meaningful by 24 weeks. It is for use on the skin only, not for the eyes, mouth or vagina.

Section

2.1 and 2.2 DOSAGE AND ADMINISTRATION

Source

Opzelura label

Source text (exact source wording)

2.1 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. 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. 2.2 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.

Dosage: children

For children 2 to 11 years old with atopic dermatitis, do not use more than one 60 gram tube per 2 weeks. Safety and effectiveness have not been established in children younger than 2 years for atopic dermatitis, or younger than 12 years for nonsegmental vitiligo.

Section

2.1 DOSAGE AND ADMINISTRATION; 8.4 Pediatric Use

Source

Opzelura label

Source text (exact source wording)

Pediatric Patients 2 to 11 Years of Age (Atopic Dermatitis): Do not use more than one 60 gram tube of OPZELURA per 2 weeks. 8.4 Pediatric Use: The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 2 years of age with atopic dermatitis. The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 12 years of age with nonsegmental vitiligo.

Dosage adjustments

Drug interaction caps

Avoid using Opzelura with strong CYP3A4 inhibitors, because they could raise the amount of ruxolitinib in the body and could increase the risk of side effects.

Section

7 DRUG INTERACTIONS

Source

Opzelura label

Source text (exact source wording)

Strong Inhibitors of CYP3A4: Avoid concomitant use of OPZELURA with strong inhibitors of CYP3A4 as there is a potential to increase the systemic exposure of ruxolitinib and could increase the risk of OPZELURA adverse reactions.

Elderly

In atopic dermatitis trials, no clinically meaningful differences in safety or effectiveness were seen between people younger than 65 and people 65 and older. The vitiligo trials did not include enough people 65 and older to tell whether they respond differently.

Section

8.5 Geriatric Use

Source

Opzelura label

Source text (exact source wording)

Of the 1249 total subjects with atopic dermatitis in clinical trials with OPZELURA, 115 (9%) were 65 years of age and older. No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older. Of the 831 total subjects enrolled with nonsegmental vitiligo in clinical trials with OPZELURA, 65 (8%) were 65 years of age and older. Clinical trials of OPZELURA in subjects with nonsegmental vitiligo did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

Missed dose

Apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not apply extra to make up for it.

Section

What should I do if I forget a dose?

Source

MedlinePlus https://medlineplus.gov/druginfo/meds/a621053.html (label has no missed-dose section)

Source text (exact source wording)

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra ruxolitinib topical to make up for a missed one.

Overdose

The label has no overdose section. MedlinePlus says in case of overdose to call poison control at 1-800-222-1222, and to call 911 if the person has collapsed, had a seizure, has trouble breathing, or can't be awakened.

Section

In case of emergency/overdose (MedlinePlus)

Source

MedlinePlus https://medlineplus.gov/druginfo/meds/a621053.html

Storage

Store at 20ºC to 25ºC (68ºF to 77ºF); short excursions from 15ºC to 30ºC (59ºF to 86ºF) are permitted.

Section

16 HOW SUPPLIED/STORAGE AND HANDLING

Source

Opzelura label (60 g tube: NDC 50881-007-05; 100 g tube: NDC 50881-007-07)

Source text (exact source wording)

Store OPZELURA at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Boxed warning

The boxed warning covers serious infections, higher death rates, cancers, major cardiovascular events (heart attack, stroke, cardiovascular death) and blood clots. Most of the mortality, cancer, cardiovascular and clot findings come from a study of an oral JAK inhibitor in rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular risk factor. Avoid Opzelura in patients with an active, serious infection. Discontinue it after a heart attack or stroke, or if symptoms of thrombosis occur. Current or past smokers are at additional increased risk.

Section

WARNING (boxed warning, full prescribing information)

Source

Opzelura label

Source text (exact source wording)

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)]. MORTALITY: In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions (5.2)]. MALIGNANCIES: Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions (5.3)]. MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke [see Warnings and Precautions (5.4)]. THROMBOSIS: Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately [see Warnings and Precautions (5.5)].

Contraindications

The label lists no contraindications.

Section

4 CONTRAINDICATIONS

Source

Opzelura label

Source text (exact source wording)

None.

Warnings and precautions

Serious and sometimes fatal infections have been reported with oral JAK inhibitors, and serious lower respiratory tract infections were reported with topical ruxolitinib. Avoid use with an active, serious infection. Watch for signs of infection during and after treatment, interrupt Opzelura for a serious infection, and do not resume until it is controlled. Starting Opzelura is not recommended with active hepatitis B or hepatitis C.

Heading

5.1 Serious Infections

Section

5.1

Source

Opzelura label

Source text (exact source wording)

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. 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. Do not resume OPZELURA until the infection is controlled. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.

A higher rate of death from any cause, including sudden cardiovascular death, was seen with an oral JAK inhibitor than with TNF blockers in a large study of RA patients 50 years and older with a cardiovascular risk factor. Benefits and risks should be considered for each patient.

Heading

5.2 Mortality

Section

5.2

Source

Opzelura label

Source text (exact source wording)

In a large, randomized, postmarketing safety study of an oral JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in patients treated with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

Cancers including lymphomas have occurred with JAK inhibitors. Basal cell and squamous cell skin cancers have occurred with Opzelura. Periodic skin exams are advised during and after treatment, and sunlight and UV exposure should be limited with protective clothing and broad-spectrum sunscreen.

Heading

5.3 Malignancy and Lymphoproliferative Disorders / Non-melanoma Skin Cancers

Section

5.3

Source

Opzelura label

Source text (exact source wording)

Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions. Non-melanoma skin cancers including basal cell and squamous cell carcinoma have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

Consider benefits and risks, especially for current or past smokers and people with other cardiovascular risk factors. Patients should know the symptoms of serious cardiovascular events. Stop Opzelura after a myocardial infarction or stroke.

Heading

5.4 Major Adverse Cardiovascular Events (MACE)

Section

5.4

Source

Opzelura label

Source text (exact source wording)

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

Blood clots (DVT, PE, arterial thrombosis) have been reported with JAK inhibitors and thromboembolic events were seen in Opzelura trials. Avoid in patients who may be at increased risk, and stop Opzelura if symptoms of thrombosis occur.

Heading

5.5 Thrombosis

Section

5.5

Source

Opzelura label

Source text (exact source wording)

Thromboembolic events were observed in clinical trials with OPZELURA. Thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Avoid OPZELURA in patients who may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue OPZELURA and evaluate and treat patients appropriately.

Low platelet, red cell and white cell counts were reported in trials. Consider benefits and risks if there is a known history of these, do blood counts (CBC) as clinically indicated, and stop Opzelura if signs of clinically significant decreases occur.

Heading

5.6 Cytopenias

Section

5.6

Source

Opzelura label

Source text (exact source wording)

Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. Discontinue OPZELURA if signs and/or symptoms associated with clinically significant decreases in laboratory values occur.

Oral JAK inhibitors have been associated with increases in total cholesterol, LDL cholesterol and triglycerides, and with low blood sugar (hypoglycemia) in patients with diabetes.

Heading

5.7 Potential Risks Related to JAK Inhibition

Section

5.7

Source

Opzelura label

Source text (exact source wording)

Treatment with oral JAK inhibitors has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides. Treatment with oral JAK inhibitors has been associated with hypoglycemia in patients with diabetes.

Pregnancy and breastfeeding

Data from pregnancies in trials are not enough to judge the risk of birth defects, miscarriage or other outcomes. In animal studies, oral ruxolitinib caused adverse developmental outcomes at doses that were also toxic to the mother. A pregnancy registry exists: 1-855-463-3463. There are no data on ruxolitinib in human milk. The label advises not to breastfeed during treatment and for approximately four weeks after the last dose; MedlinePlus says the same (4 weeks after your final dose).

Section

8.1 Pregnancy; 8.2 Lactation

Source

Opzelura label

Medlineplus text

tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using ruxolitinib topical, call your doctor. tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with ruxolitinib topical and for 4 weeks after your final dose.

Source text (exact source wording)

8.1 Pregnancy: 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. 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. 8.2 Lactation: There are no data on the presence of ruxolitinib in human milk, the effects on the breastfed child, or the effects on milk production. Ruxolitinib was present in the milk of lactating rats. Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5‑6 elimination half-lives).

Side effects

Common

In atopic dermatitis trials, reactions in 1% or more of people included nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, hives (urticaria), folliculitis, tonsillitis, runny nose, upper respiratory tract infection, COVID-19, application site reactions, fever (pyrexia) and decreased white blood cells. In vitiligo trials, they included application site acne, application site itching, nasopharyngitis, headache, urinary tract infection, application site redness and fever.

Threshold

incidence ≥ 1% (label's own threshold, Highlights section 6)

Section

HIGHLIGHTS, ADVERSE REACTIONS; 6.1 Clinical Trials Experience (Tables 1 to 3)

Source

Opzelura label

Table detail

Table 1 (AD, 12 years and older, 8 weeks; OPZELURA N=499 vs vehicle N=250): Nasopharyngitis 13 (3) vs 2 (1); Bronchitis 4 (1) vs 0 (0); Ear infection 4 (1) vs 0 (0); Eosinophil count increased 4 (1) vs 0 (0); Urticaria 4 (1) vs 0 (0); Diarrhea 3 (1) vs 1 (<1); Folliculitis 3 (1) vs 0 (0); Tonsillitis 3 (1) vs 0 (0); Rhinorrhea 3 (1) vs 1 (<1). Table 2 (AD, 2 to 11 years, 8 weeks; OPZELURA N=130 vs vehicle N=65): Upper respiratory tract infection 20 (15) vs 7 (11); COVID-19 6 (5) vs 2 (3); Application site reaction 6 (5) vs 1 (2); Pyrexia 3 (2) vs 0 (0); White blood cell decreased 2 (2) vs 0 (0). Table 3 (vitiligo, 12 years and older, 24 weeks; OPZELURA N=449 vs vehicle N=224): Application site acne 26 (6) vs 2 (1); Application site pruritus 23 (5) vs 6 (3); Nasopharyngitis 19 (4) vs 5 (2); Headache 17 (4) vs 6 (3); Urinary tract infection 7 (2) vs 1 (<1); Application site erythema 7 (2) vs 1 (<1); Pyrexia 6 (1) vs 0.

Source text (exact source wording)

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. 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.

Less common

Below 1% in atopic dermatitis trials: neutropenia, allergic conjunctivitis, fever, seasonal allergy, herpes zoster, otitis externa, Staphylococcal infection and acneiform dermatitis. In vitiligo trials, at 0.5% to under 1%: application site dermatitis, hypertension, anxiety, application site discoloration, application site folliculitis, contact dermatitis, diarrhea, ear infection, gastritis, gastroenteritis, hordeolum, influenza-like illness, insomnia, nasal congestion and vomiting.

Section

6.1 Clinical Trials Experience

Source

Opzelura label

Source text (exact source wording)

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. 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.

Serious

Label: serious infections, higher mortality, cancers, major cardiovascular events, blood clots and low blood counts (see warnings). MedlinePlus: stop using it and call your doctor right away for unusual bleeding or bruising, or for the symptoms in its Important Warning (for example fever, chills, cough, shortness of breath, crushing chest pain, or leg pain, warmth, redness or swelling).

Section

WARNING; 5.1-5.6

Source

Opzelura label

Medlineplus text

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using topical ruxolitinib and call your doctor immediately: unusual bleeding or bruising

Medlineplus source

https://medlineplus.gov/druginfo/meds/a621053.html

Source text (exact source wording)

Serious infections, mortality, malignancy (including non-melanoma skin cancers), major adverse cardiovascular events, thrombosis and cytopenias (thrombocytopenia, anemia, neutropenia, lymphopenia, leukopenia): see the boxed warning and sections 5.1 to 5.6 above. No postmarketing section is present in this label.

Interactions

Drugs

Avoid using Opzelura with strong CYP3A4 inhibitors. CYP3A4 inhibitors may raise and CYP3A4 inducers may lower ruxolitinib levels in the body. Drug interaction studies with Opzelura have not been conducted.

Name

Strong CYP3A4 inhibitors

Section

7 DRUG INTERACTIONS; 12.3

Source text (exact source wording)

Ruxolitinib is known to be a substrate for cytochrome P450 3A4 (CYP3A4). Inhibitors of CYP3A4 may increase ruxolitinib systemic concentrations whereas inducers of CYP3A4 may decrease ruxolitinib systemic concentrations. Avoid concomitant use of OPZELURA with strong inhibitors of CYP3A4 as there is a potential to increase the systemic exposure of ruxolitinib and could increase the risk of OPZELURA adverse reactions. Drug interaction studies with OPZELURA have not been conducted.

Use with biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

Name

Biologics, other JAK inhibitors, potent immunosuppressants (azathioprine, cyclosporine)

Section

1.3 Limitations of Use

Source text (exact source wording)

Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

Food and alcohol

Continue your normal diet unless your doctor says otherwise. The label has no food or alcohol interaction statement.

Name

Diet

Section

What special dietary instructions should I follow? (MedlinePlus)

Source text (exact source wording)

Unless your doctor tells you otherwise, continue your normal diet.

Other

Do not cover treated skin with occlusive dressings.

Name

Occlusive dressings

Section

2.1

Source text (exact source wording)

Do not use OPZELURA with occlusive dressings.

Patient tips

Label patient information

Section

MEDICATION GUIDE (partially captured); 17 PATIENT COUNSELING INFORMATION

Source

Opzelura label

Source text (exact source wording)

Important: OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. Before starting OPZELURA, tell your healthcare provider if you: are being treated for an infection (Medication Guide, remaining text beyond 50,000 characters not captured)

Medlineplus

Apply a thin layer to all affected areas twice a day at around the same times each day. Keep it out of the eyes, mouth and genital area. Wash your hands afterward unless your hands are being treated. Do not cover treated areas with occlusive dressings. Keep all doctor and lab appointments.

Section

How should this medicine be used?

Source

MedlinePlus https://medlineplus.gov/druginfo/meds/a621053.html

Source text (exact source wording)

Ruxolitinib topical comes as a cream to apply to the skin. Apply twice a day to the affected area(s). Apply it at around the same times every day. Ruxolitinib topical is for use on the skin only. Be careful not to get ruxolitinib in your eyes, mouth, or genital area. Apply a thin layer of ruxolitinib topical to all affected areas of your skin. Wash your hands with soap and water to remove any leftover ruxolitinib. Do not wash your hands if you are treating them with topical ruxolitinib. Do not put occlusive dressings (air and water tight dressing) over treated areas. Keep all appointments with your doctor and the laboratory.

Alternatives

Pharmacologic class from label

Janus kinase (JAK) inhibitor (Opzelura label, Indications)

Openfda pharm class epc

not checked

Note

No recommendation made.

Frequently asked questions

Question

What is Opzelura used for?

Answer

It is a cream used for mild to moderate atopic dermatitis in people 2 years of age and older (short-term and non-continuous chronic treatment) and for nonsegmental vitiligo in people 12 years of age and older.

Source section

1 INDICATIONS AND USAGE

Source

Opzelura label

Question

How do I apply Opzelura?

Answer

Apply a thin layer twice daily to affected areas. For atopic dermatitis, treat areas of up to 20% body surface area; for vitiligo, up to 10%. Do not use occlusive dressings. It is for the skin only, not the eyes, mouth or vagina.

Source section

2.1 and 2.2

Source

Opzelura label

Question

How much cream can I use?

Answer

People 12 years and older should not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks. Children 2 to 11 years old with atopic dermatitis should not use more than one 60 gram tube per 2 weeks.

Source section

2.1

Source

Opzelura label

Question

What should I do if I miss a dose?

Answer

Apply it as soon as you remember. If it is almost time for the next dose, skip the missed one. Do not apply extra to make up for it.

Source section

What should I do if I forget a dose?

Source

MedlinePlus

Question

What are the common side effects?

Answer

In atopic dermatitis trials, reactions in 1% or more of people included nasopharyngitis, diarrhea, bronchitis, ear infection, hives, folliculitis and application site reactions, among others. In vitiligo trials they included application site acne, application site itching, nasopharyngitis, headache and urinary tract infection, among others.

Source section

HIGHLIGHTS, ADVERSE REACTIONS; 6.1

Source

Opzelura label

Question

What are the serious risks?

Answer

The boxed warning lists serious infections, higher death rates, cancers, major cardiovascular events and blood clots seen with JAK inhibitors. Stop Opzelura and get help if symptoms of a heart attack, stroke or blood clot occur.

Source section

WARNING; 5.1-5.5

Source

Opzelura label

Question

Can I use Opzelura while pregnant or breastfeeding?

Answer

Pregnancy data are not enough to judge risk. The label advises not to breastfeed during treatment and for approximately four weeks after the last dose. Tell your doctor if you are pregnant or plan to become pregnant.

Source section

8.1, 8.2

Source

Opzelura label; MedlinePlus

Question

Should I stop using it when my skin clears?

Answer

For atopic dermatitis, the label says to stop using it when signs and symptoms such as itch, rash and redness resolve, and to see a healthcare provider again if there is no improvement within 8 weeks. For vitiligo, a good response may require more than 24 weeks.

Source section

2.1 and 2.2

Source

Opzelura label

Sources

DailyMed OPZELURA (ruxolitinib) cream, Incyte Corporation
Set id: 24da5509-6631-4795-9d42-273faecd08e7 · Label effective or revised date: Revised: 6/2026 · Dailymed version date: Jul 15, 2026 (published_date in DailyMed list) · Fetched at: 2026-11-03 · Sections used: Highlights, boxed warning, 1-8, 11-12, 14, 16, 17; Medication Guide partly (first 50,000 of 63,765 characters read)
MedlinePlus Ruxolitinib Topical
Set id: n/a · Label effective or revised date: Last Revised - 08/15/2026 · Fetched at: 2026-11-03 · Sections used: patient wording, missed dose, precautions, side effects, overdose, brand names
DailyMed list API (opzelura)
Fetched at: 2026-11-03 · Sections used: set ID and publish date

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug