Ritlecitinib

pronounced as (rit″ le sye′ ti nib)

Brand Name(s): Litfulo®

Why is this medicine prescribed?

Ritlecitinib is used for treatment of alopecia areata (a disease that causes sudden hair loss) in adults and children 12 years of age and older. Ritlecitinib is in a class of medications called kinase inhibitors. 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?

Ritlecitinib comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take ritlecitinib at around the same time 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 ritlecitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

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 ritlecitinib,

  • tell your doctor and pharmacist if you are allergic to ritlecitinib, any other medications, or any of the ingredients in ritlecitinib capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • some medications should not be taken with ritlecitinib. Other medications may cause dosing changes or extra monitoring when taken with ritlecitinib. Make sure you have discussed any medications you are currently taking or plan to take before starting ritlecitinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ritlecitinib, please get the advice of your doctor or pharmacist.
  • tell your doctor if you have or have ever had liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ritlecitinib, call your doctor.
  • do not have any vaccinations without talking to your doctor. Your doctor may recommend you receive some vaccines before starting ritlecitinib.

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?

Take the missed dose as soon as you remember it. However, if it is less than 8 hours before the next 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?

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

  • headache
  • diarrhea
  • acne
  • itchiness
  • fever
  • dizziness

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 {or get emergency medical treatment}:

  • hives, rash, trouble breathing, swelling of lips, tongue or throat

Ritlecitinib 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 all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ritlecitinib.

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

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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