Prospect: information for the patient

Litfulo 50 mg hard capsules

ritlecitinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You may contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospect. See section 4.

In addition to this prospect, your doctor will give you a patient card that contains important safety information that you should be aware of. Keep this patient card with you.

Litfulo contains the active ingredient 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, resulting in inflammation that leads to hair and facial hair loss on other parts of the body.

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

Do not take Litfulo

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

Warnings and precautions

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

• you have an infection (possible signs may be fever, sweating, chills, muscle aches, cough, difficulty breathing, blood in sputum, weight loss, diarrhea, stomach pain, burning sensation while urinating, urinating more frequently than usual, feeling extremely tired). Litfulo may reduce your body's ability to fight infections and, therefore, worsen an existing infection or make it more likely that you will contract a new infection;
• you have diabetes or are over 65 years old, as you may be at a higher risk of contracting infections.
• you have or have had tuberculosis or have been in close contact with someone with tuberculosis, or if you reside or travel to regions where tuberculosis is very common. Your doctor will perform a tuberculosis test before starting Litfulo and may repeat the 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 have a painful skin rash with blisters, as this may be a sign of herpes;
• you have ever had hepatitis B or hepatitis C. Your doctor will perform a hepatitis test before starting Litfulo and may repeat the test during treatment;
• you have cancer or have had cancer; although it is not clear if Litfulo increases the risk of cancer, your doctor will discuss with you whether treatment with this medication is appropriate and if regular checks, including skin checks, will be necessary during treatment;
• you have had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism). Inform your doctor if you have a painful and swollen leg, chest pain or difficulty breathing, as these may be signs of blood clots in the veins;
• you have had blood clots in an artery of the eye (retinal occlusion) or in the heart (myocardial infarction). Inform your doctor if you experience sudden changes in vision (blurred vision, partial or complete loss of vision), 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 (vaccines made with live microorganisms) are not recommended while taking Litfulo. Check with your doctor that your vaccinations are up to date and if you need additional vaccinations, including the herpes vaccine, before starting treatment with Litfulo;
• you have symptoms without apparent cause originating from a problem with the nervous system while taking Litfulo. Your doctor will discuss with you whether treatment should be discontinued.

Additional laboratory tests

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

Children

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

Other medications and Litfulo

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

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

• anxiety or sleep disorders (e.g. midazolam),
• heart rhythm problems (e.g. quinidina),
• gout (e.g. colchicina),
• organ transplant rejection (e.g. ciclosporina, everólimus, tacrólimus and sirólimus),

• migraine (e.g. dihidroergotamina and ergotamina),
• schizophrenia and chronic psychosis (e.g., pimozida),
• asthma (e.g., teofilina),
• muscle spasms (e.g., tizanidina),
• idiopathic pulmonary fibrosis (e.g., pirfenidona).

Litfulo may increase the amount of these medications in your blood.

If you are in any of the above 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Contraception in women

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

Pregnancy

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

Breastfeeding

Do not use Litfulo during breastfeeding, as it is unknown whether this medication passes into breast milk or if breastfed babies are affected. You and your doctor should decide whether to breastfeed or use this medication.

Fertility

It is unknown whether Litfulo reduces fertility in fertile women or men.

Driving and operating machinery

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

Litfulo contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is 50 mg once a day taken orally.

Swallow the capsule whole with water. Do not open, crush, or chew the capsule before swallowing it, as this may change the amount of medication that enters your body.

You can take the capsule with or without food.

If you take more Litfulo than you should

If you take more Litfulo than you should, 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 there are less than 8 hours until your next dose, simply omit the missed dose and take the next dose as scheduled.
• Do not take a double dose to make up for the missed capsule.

If you interrupt treatment with Litfulo

You should not stop taking Litfulo without consulting your doctor.

If you must interrupt treatment with Litfulo for a short time (not more than 6 weeks), the risk of hair loss on the scalp is low.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Adverse Effects

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

• Herpes (shingles), a painful skin eruption with blisters with or without fever
• Hives (urticaria), a skin eruption with itching

Other Adverse Effects

Frequent(may affect up to 1 in 10 people)

• Nasal, throat, or tracheal infections
• Diarrhea
• Dizziness
• Acne
• Eruption (apart from urticaria and shingles)
• Folliculitis, an inflammation (swelling) of hair follicles that may cause itching or pain
• Increased levels of an enzyme called creatine phosphokinase, which appears in blood tests (elevated creatine phosphokinase in blood)

Rare(may affect up to 1 in 100 people)

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

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box, bottle, or blister pack after “EXP”. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Litfulo

• The active ingredient is ritlecitinib.

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

• The other components are:

Hard capsule content: microcrystalline cellulose, lactose monohydrate, crospovidone, dibehenate of glycerol (see section 2 “Litfulo contains lactose monohydrate”).

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

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

Appearance of Litfulo and contents of the package

The hard capsules of Litfulo 50 mg have a yellow body and a blue cap of approximately 16 mm in length and 6 mm in width, with the body printed with “RCB 50” and the cap printed with “Pfizer” in black.

The 50 mg hard capsules are presented 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 that is used to keep the capsules dry. Do not ingest the silica gel desiccant.

Only some package sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

02/2025.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu.