Ruxolitinib Topical

pronounced as (rux'' oh li' ti nib)

Brand Name(s): Opzelura®

Why is this medicine prescribed?

Ruxolitinib topical is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) and vitiligo (condition that causes skin to lose color). Ruxolitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

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.

Use ruxolitinib topicalexactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

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.

What special precautions should I follow?

Before using ruxolitinib topical,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • you should know that some medications should not be taken while using ruxolitinib topical. Other medications may cause dosing changes or extra monitoring when taken while using ruxolitinib topical. Make sure you have discussed any medications you are currently taking or plan to take before starting ruxolitinib topical with your doctor and pharmacist. Before starting, stopping, or changing any medications while using ruxolotinib topical, please get the advice of your doctor or pharmacist.
  • tell your doctor if you have or have ever had high cholesterol or triglycerides (fatty substances in the blood), anemia, a low number of red or low white blood cells, diabetes, or heart problems.
  • you should know that in patients with diabetes, use of ruxolitinib topical may cause hypoglycemia (low blood sugar).
  • 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.

What special dietary instructions should I follow?

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

What should I do if I forget to take a dose?

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.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Ruxolitinib topical may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nose or throat pain
  • stuffy or runny nose
  • ear pain, discharge, and other signs of infection
  • diarrhea
  • hives
  • red skin or pimple

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

Ruxolitinib topical may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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