Deuruxolitinib

Brand Name(s): Leqselvi®

Why is this medicine prescribed?

Deuruxolitinib is used for treatment of alopecia areata (a disease that causes sudden hair loss). Deuruxolitinib is in a class of medications called kinase inhibitors. It works by decreasing the activity of the immune system. How it work to help stop hair loss in individuals with alopecia areata is not well understood.

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?

Deuruxolitinib comes as a tablet to take by mouth. It is usually taken with or without food twice a day. Take deuruxolitinib at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deuruxolitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may need to temporarily or permanently stop treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment and keep all appointments with the lab.

What special precautions should I follow?

Before taking deuruxolitinib,

  • tell your doctor and pharmacist if you are allergic to deuruxolitinib, any other medications, or any of the ingredients in deuruxolitinib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • some medications should not be taken with deuruxolitinib. Other medications may cause dosing changes or extra monitoring when taken with deuruxolitinib. Make sure you have discussed any medications you are currently taking or plan to take before starting deuruxolitinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking deuruxolitinib, please get the advice of your doctor or pharmacist.
  • tell your doctor if you have stomach pain that has not been diagnosed or if you have or have ever had ulcers in your stomach or intestines, diverticulitis (inflammation of small pouches that can form in the lining of the bowels), a low number of white blood cells, anemia (a lower than normal number of red blood cells), liver disease, or kidney disease.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking deuruxolitinib. If you become pregnant while taking deuruxolitinib, call your doctor. Deuruxolitinib may harm the fetus.
  • tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking deuruxolitinib and for 1 day after your final dose.
  • tell your doctor if you have recently received or are scheduled to receive any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.

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?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose 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?

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

  • acne
  • weight gain
  • headache
  • runny nose, sneezing, sore throat, or congestion

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • stomach pain, especially if it comes along with fever, chills, nausea or vomiting
  • shortness of breath, tiredness, weakness, or pale skin

Deuruxolitinib 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 ( http://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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

What other information should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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