Opzelura

The active ingredient in Opzelura is ruxolitinib phosphate, which is a Janus kinase (JAK) inhibitor. It works by inhibiting the JAK1 and JAK2 enzymes (proteins) that block the activation of other immune system proteins. This reduces inflammation in the skin (redness, swelling, and pain) to treat eczema. This also avoids the loss of certain skin cells responsible for skin color (pigmentation) when treating nonsegmental vitiligo.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Opzelura. However, the following is a synopsis of the general guidelines for the use of $Drugname:

• Opzelura is solely for use on the skin. Opzelura should not be used in the mouth, eyes, or vagina. Follow the instructions provided by your healthcare practitioner. If you have any questions regarding how to use Opzelura, consult your healthcare professional.
• Apply a thin layer of Opzelura to the afflicted areas twice a day.
• Use no more than one 60-gram tube every week, or one 100-gram tube every two weeks.
• If you are taking Opzelura for atopic dermatitis, discontinue use when your atopic dermatitis symptoms, such as itching, rash, and redness, resolve, or as recommended by your healthcare professional.
• Wash your hands after applying Opzelura, unless you are being treated. If someone else uses Opzelura, they should wash their hands afterward.

The most common side effects of Opzelura seen in clinical trials as compared to placebo include:

• Common cold symptoms such as a runny nose (rhinorrhea) or sore throat.
• Bronchitis.
• Ear infections.
• Diarrhea.
• Fever.
• Acne on the application site.
• Increased cholesterol levels.
• Increase in white blood cells (eosinophils).
• Inflamed hair pores (folliculitis)
• Swelling of your tonsils (tonsillitis).

Some individuals may experience serious side effects while using Opzelura. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Stroke symptoms such as abrupt weakness in your body, difficulty speaking, confusion, and dizziness.
• A blood clot in your heart, which has symptoms that include chest pain, shortness of breath, pain in the jaw, neck, or back, and feelings of weakness or lightheadedness.
• Cough, chest pain, difficulty breathing, and a racing heart are symptoms of a pulmonary embolism (a blood clot in the lungs).
• A blood clot in the leg, which causes leg cramping, swelling, pain, and muscle tightness.
• Serious bleeds include bleeding or bruising easily, bleeding that is difficult to stop, stomach pain, spitting up blood, and blood in your stool or urine.
• Serious infections and symptoms such as fever, trouble breathing, weakness, diarrhea, cough, stomach discomfort, chills, sweating, and frequent or painful urination.
• Some people have developed skin cancer while using Opzelura. Throughout your Opzelura treatment, your healthcare professional will perform regular skin checks. Limit how much time you spend in the sun. When you're out in the sun, wear protective gear and apply broad-spectrum sunscreen.
• Increased risk of lymphomas.

These are not all of the possible side effects of Opzelura. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Opzelura, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether any of the following apply:

• A serious infection.
• You a current or former smoker.
• Had a heart attack, another heart condition, or a stroke.
• Recently had hepatitis B.
• You have low red blood cell counts (thrombocytopenia) or anemia.
• High blood fat levels (high cholesterol or triglycerides).
• Invasive fungal infections, including cryptococcosis and pneumocystosis.

Boxed Warning

Oral JAK inhibitors used for inflammatory conditions carry serious risks, including life-threatening infections (including tuberculosis (TB), fungal infections, and herpes zoster), increased mortality (especially from cardiovascular causes), higher rates of malignancy, major adverse cardiovascular events (MACE), and thrombosis, necessitating careful patient selection and ongoing monitoring.

There are no contraindications with Opzelura.

In trials on how effectively Opzelura works for atopic dermatitis, 54% of participants had clear or almost clear skin, and 52% had substantially reduced itching after using the medication for two months, compared to 15% who got similar results with a placebo. In studies looking at how effectively Opzelura works for nonsegmental vitiligo in the face, roughly 30% of participants showed at least a 75% improvement in their skin pigmentation (color) after about 5 months of treatment.

When Opzelura is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• The use of Opzelura along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.

Opzelura is a topical treatment that comes in a cream that contains 0.15% ruxolitinib.

Eczema: Apply a thin layer to the affected areas twice a day. Do not apply to more than 20% of your body's surface area. Typically, your dermatologist would advise you to continue medication until the eczema symptoms improve. However, if your skin does not improve after two months, they will consult with you about future steps.

Vitiligo: Apply a small coating to the affected areas twice a day. Do not apply to more than 10% of your body's surface area. If your skin does not improve within 6 months, your dermatologist will consult with you about the next steps.

Use no more than one 60-gram tube of Opzelura each week or one 100-gram tube every two weeks.

Store at room temperature and keep out of reach of children.

Incyte Corporation is a pharmaceutical company that manufactures Opzelura.

There are no lower-cost generics available for this medication.

Opzelura is a twice-daily therapy. Because it is a topical, steroid-free cream, you can discontinue use after symptoms have resolved without having to taper off.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is advised that women should not breastfeed during treatment with this medication and for approximately four weeks after the last dose. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend the best way for you to feed your infant.