Litfulo 50 mg hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Litfulo 50 mg hard capsules

ritlecitinib

This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will provide you with a patient card containing important safety information you should be aware of. Keep this patient card with you.

Contents of this leaflet

1. What Litfulo is and what it is used for
2. What you need to know before taking Litfulo
3. How to take Litfulo
4. Possible side effects
5. How to store Litfulo
6. Contents of the pack and other information

1. What Litfulo is and what it is used for

Litfulo contains the active substance ritlecitinib. It is used to treat severe alopecia areata in adults and adolescents aged 12 years and older. Alopecia areata is a disease in which the body's own immune system attacks the hair follicles, causing inflammation that leads to loss of hair and body hair on the face and other parts of the body.

Litfulo works by reducing the activity of enzymes known as JAK3 and TEC kinases, which are involved in inflammation of the hair follicle. This reduction in inflammation leads to hair regrowth in patients with alopecia areata.

2. What you need to know before starting Litfulo

Do not take Litfulo

• if you are allergic to ritlecitinib or to any of the other ingredients of this medicine (listed in section 6);
• if you have a serious ongoing infection, including tuberculosis;
• if you have severe liver problems;
• if you are pregnant or breastfeeding (see section “Pregnancy, contraception, breastfeeding and fertility”).

Warnings and precautions

Talk to your doctor or pharmacist before and during treatment with Litfulo if:

• you have an infection (possible signs may include fever, sweating, chills, muscle aches, cough, difficulty breathing, blood in phlegm, weight loss, diarrhea, stomach pain, burning sensation when urinating, urinating more frequently than usual, or feeling very tired). Litfulo may reduce your body’s ability to fight infections and may therefore worsen an existing infection or make you more likely to get a new infection;
• you have diabetes or are over 65 years of age, as you may have an increased risk of infections;
• you have had tuberculosis or have been in close contact with someone who has tuberculosis, or if you live in or travel to areas where tuberculosis is common. Your doctor will test you for tuberculosis before starting Litfulo and may repeat this test during treatment;
• you have ever had a herpes infection (such as chickenpox or shingles), as Litfulo may cause it to reappear. Inform your doctor if you develop a painful rash with blisters, as this may be a sign of herpes;
• you have ever had hepatitis B or hepatitis C. Your doctor will test you for hepatitis before starting Litfulo and may repeat this test during treatment;
• you have or have had cancer. Although it is unclear whether Litfulo increases the risk of cancer, your doctor will assess whether treatment with this medicine is appropriate and whether monitoring, including regular skin checks, is needed during treatment;
• you have ever had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism). Inform your doctor if you experience a painful and swollen leg, chest pain, or difficulty breathing, as these may be signs of blood clots in the veins;
• you have ever had blood clots in an artery in the eye (retinal vein occlusion) or in the heart (myocardial infarction). Inform your doctor if you experience sudden changes in vision (blurred vision, partial or complete vision loss), chest pain, or difficulty breathing, as these may be signs of blood clots in the arteries;
• you have recently been vaccinated or plan to be vaccinated (immunization); this is because certain vaccines (those made with live microorganisms) are not recommended while taking Litfulo. Check with your doctor that your vaccinations are up to date and whether you need additional vaccines, including the herpes zoster vaccine, before starting Litfulo;
• you experience unexplained symptoms affecting the nervous system while taking Litfulo. Your doctor will evaluate whether treatment should be discontinued.

Additional laboratory tests

Your doctor will perform blood tests to check for low white blood cell count or low platelet count before starting Litfulo and approximately 4 weeks after beginning treatment, and may adjust your treatment if necessary.

Children

This medicine is not approved for use in children under 12 years of age because the safety and benefits of Litfulo have not been established in this age group.

Other medicines and Litfulo

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist before taking Litfulo if you are taking any of the following medicines:

• for anxiety or sleep disorders (e.g., midazolam);
• for heart rhythm problems (e.g., quinidine);
• for gout (e.g., colchicine);
• to prevent organ transplant rejection (e.g., cyclosporine, everolimus, tacrolimus, and sirolimus);
• for migraine (e.g., dihydroergotamine and ergotamine);
• for schizophrenia and chronic psychosis (e.g., pimozide);
• for asthma (e.g., theophylline);
• for muscle spasms (e.g., tizanidine);
• for idiopathic pulmonary fibrosis (e.g., pirfenidone).

Litfulo may increase the levels of these medicines in your blood.

If you are in any of these situations or are unsure, consult your doctor or pharmacist before taking Litfulo.

Pregnancy, contraception, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Contraception in women

If you are a woman of childbearing age, you must use an effective method of contraception during treatment with Litfulo and for at least one month after the last dose. Your doctor can advise you on suitable contraceptive methods.

Pregnancy

Do not use Litfulo if you are pregnant, think you may be pregnant, or plan to become pregnant. This medicine may harm the developing baby. Inform your doctor immediately if you become pregnant or think you may have become pregnant during treatment.

Breastfeeding

Do not use Litfulo while breastfeeding, as it is unknown whether this medicine passes into breast milk or whether it may affect breastfed infants. You and your doctor should decide whether to breastfeed or use this medicine.

Fertility

It is unknown whether Litfulo reduces fertility in women or men of reproductive age.

Driving and using machines

Litfulo has no or negligible effect on your ability to drive or operate machinery.

Litfulo contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Litfulo

Follow exactly the instructions for using this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is 50 mg once daily, taken orally.

You must swallow the capsule whole with water. Do not open, crush, or chew the capsule before swallowing, as this may alter the amount of medicine entering your body.

You may take the capsule with or without food.

If you take more Litfulo than you should

If you take more Litfulo than prescribed, contact your doctor. You may experience some of the adverse effects described in section 4.

If you forget to take Litfulo

• If you forget a dose, take it as soon as you remember, unless your next dose is due in less than 8 hours.
• If less than 8 hours remain before your next dose, simply skip the missed dose and take your next dose at the usual time.
• Do not take a double dose to make up for the missed capsule.

If you stop taking Litfulo

Do not stop taking Litfulo without consulting your doctor.

If you need to interrupt treatment with Litfulo for a short period (no longer than 6 weeks), the risk of losing scalp hair is low.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Contact your doctor and seek immediate medical help if you notice any signs of:

• Shingles (herpes zoster), a painful skin rash with blisters with or without fever
• Hives (urticaria), an itchy skin rash

Other side effects

Common (may affect up to 1 in 10 people)

• Infections of the nose, throat, or trachea
• Diarrhea
• Dizziness
• Acne
• Rash (other than urticaria and herpes zoster)
• Inflammation (swelling) of hair follicles which may cause itching or pain (folliculitis)
• Increase in an enzyme called creatine phosphokinase, seen in blood tests (elevated blood creatine phosphokinase)

Uncommon (may affect up to 1 in 100 people)

• Low platelet count, seen in a blood test (decreased platelet count)
• Low white blood cell count, seen in a blood test (decreased lymphocyte count)
• Increase in liver enzymes in the blood (elevated ALT and AST)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Litfulo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, bottle, or blister pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Litfulo

• The active substance is ritlecitinib.

Each hard capsule contains ritlecitinib tosylate equivalent to 50 mg of ritlecitinib.

• The other components are:

Contents of the hard capsule: microcrystalline cellulose, lactose monohydrate, crospovidone, glyceryl dibehenate (see section 2, "Litfulo contains lactose monohydrate").

Hard capsule shell: hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), brilliant blue FCF (E133).

Printing ink: shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.

Appearance of Litfulo and contents of the pack

Litfulo 50 mg opaque hard capsules have a yellow body and a blue cap, approximately 16 mm long and 6 mm wide, with "RCB 50" printed on the body and "Pfizer" printed on the cap in black.

The 50 mg hard capsules are available in high-density polyethylene (HDPE) bottles with polypropylene closures containing 28 hard capsules, or in OPA/Al/PVC/Al blisters containing 30 or 90 hard capsules. The bottle contains a silica gel desiccant used to keep the capsules dry. Do not ingest the silica gel desiccant.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

02/2025.

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.