Ritlecitinib - Oral

Ritlecitinib is used to treat severe alopecia areata (an autoimmune disease that causes hair loss on the scalp, face, and sometimes on other areas of the body).

Take Ritlecitinib exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

You may take this medicine with or without food. Try to take it at the same time each day.

Swallow the capsule whole with a glass of water. Do not crush, split, or chew the capsule.

Your doctor will advise you on the treatment timeframe depending on your condition and your response to the medication.

Ritlecitinib must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

If you miss a dose and it is 8 hours or more before the next dose is due, take the missed dose and return to your normal dosing schedule.

If it is less than 8 hours before the next dose is due, skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Alert your doctor if you have the following conditions:

• active serious infections e.g. TB (lung infection known as tuberculosis)
• severe liver disease

as Ritlecitinib may not be suitable for you.

Do not take this medicine if you are pregnant. If you become pregnant while on Ritlecitinib therapy, alert your doctor immediately. This medicine may cause harm to your unborn child.

It is important that you do not get pregnant while taking this medicine. You must use proven birth control methods during Ritlecitinib therapy and for 1 month after stopping the treatment. You may wish to discuss reliable methods of birth control with your doctor.

Do not breastfeed while you are being treated with this medicine.

Inform your doctor if you have the following conditions:

• long-term or recurring infection
• exposure to TB
• history of serious infection
• diabetes
• heart problems
• hepatitis B (contagious liver infection caused by a virus that is spread through contact with infected blood or other body fluids)
• hepatitis C (contagious liver infection caused by a virus that is spread through exposure to infected blood [blood-to-blood contact])
• history of blockage of blood vessel due to blood clot
• cancer

Be sure to check with your doctor or pharmacist before giving Ritlecitinib to a child or the elderly. Children and elderly people may be more sensitive to the side effects.

Notify your doctor if you are a current or past smoker.

Inform your doctor if you have resided in or travelled to areas with endemic cases of TB or fungal infections.

If you have been recently vaccinated, inform your doctor. Do not receive any vaccinations without first asking your doctor.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Screening for the presence of TB and viral hepatitis must be done before treatment to know if this medicine is suited for you to take.
• Routine tests (e.g. liver function, blood tests, skin examination) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs or symptoms of infection may also be needed.

Ritlecitinib may cause any of the following side effects: headache, dizziness, diarrhoea, and pimples.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• unusual bleeding or bruising
• frequent sore throat, mouth sores, fever, chills or sweating
• signs and symptoms of allergic reaction e.g. rashes, breathlessness, swelling of the face, eyes or mouth
• skin lump or growth
• signs and symptoms of blood clots in a lung artery e.g. shortness of breath, chest pain, cough which may contain blood
• signs and symptoms of heart attack e.g. chest pain, tightness or pressure, pain that may spread to the arms, jaw, neck, shoulder or back, shortness of breath, lightheadedness
• weakness or numbness on one side of the body, trouble speaking, vision problems, changes in balance or coordination

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor and pharmacist if you are taking any of these medicines:

• medicines used in organ transplants or certain immune disorders e.g. ciclosporin, tacrolimus, sirolimus
• medicines for migraine (severe throbbing pain or pulsating sensation usually affecting one side of the head) e.g. sumatriptan, ergotamine, dihydroergotamine
• rifampicin (medicine for TB)
• itraconazole (medicine to treat fungal infection)

This list does not include all medicines that may interact with Ritlecitinib.

Avoid vaccinations with live vaccines while you are being treated with Ritlecitinib. Inform your doctor if you have been recently vaccinated or if you are planning to get vaccinated.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.