Ritlecitinib (rit-le-SYE-ti-nib)

Treats severe alopecia areata (patchy hair loss).

Brand Name(s):

Litfulo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule whole. Do not chew, crush, or split it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is less than 8 hours before your next dose, skip the missed dose and take your next regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some food and medicines can affect how ritlecitinib works. Tell your doctor if you are using midazolam, rifampin, or products that contain caffeine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have liver disease (including hepatitis B or C), diabetes, lung disease, weak immune system, or a history of tuberculosis. Tell your doctor if you have a current infection or an infection that keeps coming back, or if you are a current or past smoker.
• Do not breastfeed during treatment and for at least 14 hours after the last dose with this medicine.
• This medicine may cause the following problems:
  • Increased risk of serious infections (bacterial, fungal, viral), including herpes infection or shingles
  • Increased risk of cancer (including lymphoma, lung cancer, skin cancer)
  • Increased risk of serious heart or blood vessel disease (including heart attack, stroke)
  • Increased risk of blood clots (including arterial thrombosis, deep vein thrombosis, pulmonary embolism)
• You will need to have a skin test for tuberculosis (TB) before you start this medicine. Tell your doctor if you or anyone in your home has ever had a positive TB skin test or been exposed to TB.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning, itching, and pain in hairy areas, pus at root of the hair
• Chest pain that may spread, trouble breathing, coughing up blood, nausea, unusual sweating, fainting
• Fever, chills, cough, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Skin or mole changes, sores that do not heal
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Headache
• Sores or white patches on your lips, mouth, or throat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088