Opzelura (ruxolitinib)

$1,244.38

Opzelura (ruxolitinib) is a prescription cream used on the skin (topical) for:

  • (short-term) treatment of chronic mild to moderate eczema (atopic dermatitis) in patients 12 years or older who aren’t suitable for or have failed other topical prescription drugs (approved by the FDA on Sept 21, 2021);
  • Treatment of non-segmental vitiligo in adults and children over 12 years of age (approved by the EMA on April, 2023).

Opzelura is a registered trademark by Incyte Corporation.

SKU: N/A Categories: ,

What is Opzelura (ruxolitinib) for?

Opzelura (ruxolitinib) is a Janus kinase (JAK) inhibitor.

It’s indicated for the short-term and non-continuous treatment of:

  • Mild to moderate eczema (atopic dermatitis) in non-immunocompromised (without weakened immune systems) people over the age of 12. Opzelura (ruxolitinib) is intended for patients who don’t qualify for or benefit from topical prescription therapies.[1]

Opzelura is also approved for treating:

  • Non-segmental vitiligo in patients aged 12 and up. [1]

How does Opzelura (ruxolitinib) work?

Opzelura (ruxolitinib) is a kinase inhibitor. Ruxolitinib blocks the Janus Kinase (JAK), specifically the JAK 1 and JAK 2. These enzymes mediate different signaling numbers of cytokines, the interferon-gamma (IFN-gamma) is one of them. The IFN-gamma might interfere with the activity of the cells of the immune system that attacks the melanocytes, permitting them to produce pigment[.8]

In vitiligo, Opzelura (ruxolitinib) can help with the repigmentation of the patient’s skin.[4]

The JAK enzymes are also involved in the development of skin inflammation, itching, and skin barrier function.[2 ]By blocking a signaling pathway of the JAK enzymes, Opzelura can reduce and/or lessen the signs and symptoms of eczema by reducing itch, rash, and skin redness.[2]

Where has Opzelura (ruxolitinib) been approved?

Opzelura (ruxolitinib) currently has the following approvals:

For the treatment of moderate to severe eczema in patients aged 12 and up

  • Approved by The Good and Drug Administration (FDA), USA on Sept 21, 2021. [5]

For the treatment of non-segmental vitiligo

  • Approved by The Food and Drug Administration (FDA), USA on July 18, 2022. [5]
  • Approved by The European Medicines Agency (EMA) on Apr 19, 2023. [6]

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Opzelura (ruxolitinib) taken?

The standard dosage is:[1]

  • A thin layer of cream applied twice a day to affected areas of the skin

For eczema patients: Use Opzelura on up to 20% of your body. Do not use more than one 60 g tube per week.[1]

Stop using Opzelura once your eczema signs and symptoms (e.g., itch, rash, and redness) have resolved. If it does not improve within 8 weeks, you should talk to your treating doctor.[1]

For vitiligo patients: Use Opzelura on the depigmented skin twice a day, up to 10% of the body at the same time. [1]

Reaching satisfactory results may take more than 24 weeks. If you have not experienced meaningful repigmentation within this period, please consult your doctor. [1]

Do not use Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine.[1]

Complete information about Opzelura (ruxolitinib) dosage and administration can be found in the official prescribing information listed in our references section.[1]

Note: Please consult with your treating doctor for personalized dosing.

Are there any known adverse reactions or side effects of Opzelura (ruxolitinib)?

Common adverse reactions

The most common side effects (≥1% of patients) listed in the prescribing information include:[1]

In eczema patients

  • Swelling of nasal passages
  • Diarrhea
  • Bronchitis
  • Ear infection
  • Increased eosinophil counts
  • Urticaria
  • Folliculitis
  • Tonsillitis
  • Runny nose.

In vitiligo patients

  • Acne on the treated skin area
  • Skin irritation and itchiness
  • Swelling of nasal passages
  • Headaches
  • Urinary tract infections
  • Redness of the skin
  • Fever.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:[1]

  • Serious infections
  • Major adverse cardiovascular events
  • Clotting (thrombosis)
  • Cancer and immune system problems
  • All-cause mortality for patients taking JAK inhibitors orally (by mouth).

Use in a specific population

Before using Opzelura (ruxolitinib), tell your treating doctor about all of your medical conditions, including if you:

  • Have an infection
  • Have or had tuberculosis (TB), or have been in close contact with someone who has TB
  • Have had shingles (herpes zoster)
  • Have or had hepatitis B or C
  • Have had skin cancer in the past
  • You are a current or past smoker
  • Have or have had low white or red blood cell counts
  • Have high levels of fat in your blood (high cholesterol or triglycerides)
  • You are pregnant or planning to become pregnant. It is not known if this medicine will harm your unborn baby.

Please refer to the official prescribing information for a comprehensive list of side effects and adverse reactions.[1]

Opzelura is a registered trademark by Incyte Corporation.

Tube with cream

(EU) 1 tube of 100 g x 15 mg of ruxolitinib / g cream