Opzelura: Uses, Side Effects and Dosage

Serious warnings and precautions box

What OPZELURA is used for:

OPZELURA is used on the skin (topical) to treat:

• patients aged 12 years and older with a skin condition known as nonsegmental vitiligo which causes skin to lose its pigment.
• patients aged 2 years and older with mild to moderate atopic dermatitis, also known as eczema. It is used when treatment with other topical prescription medicines have not worked well or have not been tolerated well, or when those medicines should not be used.

How OPZELURA works:

Nonsegmental vitiligo

Vitiligo is an autoimmune disease causing white or pink (depigmented) patches of skin. OPZELURA reduces the body’s attack on pigment-producing cells. This allows the skin to restore pigment and achieve its normal color.

Eczema (atopic dermatitis)

Inflammation causes the signs and symptoms of eczema. OPZELURA works by blocking many of the molecules, called cytokines, that worsen the inflammation and itch. However, the exact way that OPZELURA works to reduce signs and symptoms is not known.

The ingredients in OPZELURA are:

Medicinal ingredient: Ruxolitinib (as ruxolitinib phosphate)

Non-medicinal ingredients: Cetyl alcohol, dimethicone 350, edetate disodium, glyceryl stearate SE, light mineral oil, medium chain triglycerides, methylparaben, phenoxyethanol, phosphoric acid, polyethylene glycol 200, polysorbate 20, propylene glycol, propylparaben, purified water, stearyl alcohol, white

petrolatum, and xanthan gum.

OPZELURA comes in the following dosage forms:

Cream, 1.5%.

Do not use OPZELURA if:

• you or your child are allergic to ruxolitinib or any of the other ingredients in OPZELURA.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OPZELURA. Talk about any health conditions or problems you may have, including if you:

• have serious kidney problems.

• are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. If you are able to get pregnant, use an effective method of birth control to avoid becoming pregnant while taking OPZELURA and for 4 weeks after you stop your treatment.

• are breast-feeding or plan to breast-feed. It is not known if OPZELURA passes into breast milk. You should not breastfeed during your treatment with OPZELURA and for 4 weeks after your last dose. Talk with your healthcare professional about the best way to feed your baby if you use OPZELURA.

Other warnings you should know about

Non-melanoma skin cancer

Non-melanoma skin cancers have been reported in patients treated with topical (skin) ruxolitinib medicines. Your healthcare professional may want to check your skin before you begin taking OPZELURA.

Low blood cell count

Low blood cell counts including thrombocytopenia (low platelets), anemia (low hemoglobin) and low white blood cells (neutropenia) were reported in patients taking OPZELURA. Tell your healthcare professional if you have had any of these problems in the past before starting OPZELURA. Your doctor may order blood tests while taking OPZELURA and may stop your treatment based on the results.

Infections

OPZELURA should not be used if you have an active or a serious infection. Before taking OPZELURA, tell your healthcare professional if you have:

• a chronic infection or an infection that keeps coming back
• a history of serious infections
• tuberculosis, had it in the past, or have been in close contact with someone who had tuberculosis
• lived or travelled to areas where you are more likely to contract tuberculosis or if you have underlying conditions that make you more likely to get tuberculosis
• hepatitis C or B

You will be monitored by your healthcare professional for signs and symptoms of an infection during and after treatment with OPZELURA. You will stop your treatment if you get a serious infection. Do not continue your treatment until your infection is under control.

Cases of shingles (herpes zoster) were reported in patients taking OPZELURA and other drugs that belong in the same class of medicines as OPZELURA, called JAK inhibitors, but are taken by mouth. If you develop shingles while you are taking OPZELURA, your healthcare professional may stop your treatment until your shingles goes away.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take OPZELURA:

• OPZELURA is applied twice a day. Use OPZELURA exactly as your healthcare professional tells you.
• Do not use in your eyes, mouth, or vagina. Topical medicine is for use only on the skin.
• Do not use OPZELURA with other medicines known as “JAK inhibitors,” or medicines for your immune system. If you are not sure, ask your healthcare professional.
• Do not apply OPZELURA to the lips to avoid swallowing it by accident.
• Wash your hands after applying OPZELURA, unless you are treating your hands. If you are applying the cream to someone you are caring for, wash your hands after you apply OPZELURA.

Nonsegmental vitiligo

• Do not use more than one 60 gram tube per week or one 100 gram tube per 2 weeks.
• If you are using OPZELURA for nonsegmental vitiligo, the cream should not be used on more than 10% of your body surface area for each application. 10% of your body surface area is about 10 times the size of your hand (including the palm and fingers).
• Avoid using OPZELURA on your lips to prevent swallowing it.
• If you are using OPZELURA for nonsegmental vitiligo, tell your healthcare professional if your treated skin does not improve within 24 weeks of treatment.

Eczema (atopic dermatitis)

• Adult and Pediatric Patients 12 Years of Age and Older: Do not use more than one 60 gram tube 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 per 2 weeks or one 100 gram tube per 4 weeks.
• If you are using OPZELURA for eczema, the cream should not be used on more than 20% of your body surface area for each application. 20% of your body surface area is about 20 times the size of your hand (including the palm and fingers).
• Avoid using OPZELURA on your lips to prevent swallowing it.
• If you are using OPZELURA for eczema, tell your healthcare professional if your treated skin does not improve within 8 weeks of treatment.

Usual dose:

• Apply a thin layer of OPZELURA twice daily, with at least 8 hours between applications.
• Your healthcare professional will tell you how to use OPZELURA based on you or your child’s medical condition and response to the medicine.

Overdose:

If you have applied too much OPZELURA, wipe off any extra cream.

Missed Dose:

If you or your child forget to use OPZELURA as directed, skip the missed application and continue with the next scheduled application.

Possible side effects from using OPZELURA:

These are not all the possible side effects you may have when using OPZELURA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• common cold
• headache
• influenza
• fever

You may experience the following side effects on the area where you applied OPZELURA:

• acne
• pain, such as burning or stinging sensation
• itching
• redness
• rash
• exfoliation (removal of the dead skin)

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Close cap completely after each use.

Store OPZELURA at room temperature, 15-25°C.

Discard 6 months after opening. Do not use after the expiry date.

Keep out of reach and sight of children.

If you want more information about OPZELURA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.incytebiosciences.ca ), or by calling 1-833-309-2759.

Wilmington, Delaware 19803 USA

Imported and distributed by:

Innomar Strategies Inc., Oakville, ON, L6L 0C4

Date of Authorization: 2026-07-09