LITFULO 50 mg HARD CAPSULES

2. What you need to know before you take Litfulo

Do not take Litfulo

• if you are allergic to ritlecitinib or any of the other ingredients of this medicine (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

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 your phlegm, weight loss, diarrhea, stomach pain, burning when urinating, urinating more frequently than usual, feeling very tired). Litfulo may reduce your body's ability to fight infections and therefore worsen an existing infection or make it more likely to get a new infection;
• you have diabetes or are over 65 years of age, as you may have a higher risk of getting infections.
• you have had tuberculosis or have been in close contact with someone with tuberculosis, or if you live in or travel to areas where tuberculosis is very common. Your doctor will do a tuberculosis test before starting Litfulo and may do it again during treatment;
• you have ever had a herpes infection (such as chickenpox or shingles), because Litfulo may cause it to come back. Tell 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 C. Your doctor will do a hepatitis test before starting Litfulo and may do it again during treatment;
• you have had cancer or have cancer; although it is not clear if Litfulo increases the risk of cancer, your doctor will discuss with you whether treatment with this medicine is suitable and whether you will need checks, including regular skin checks, during treatment;
• you have had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism). Tell your doctor if you have a painful and swollen leg, chest pain, or difficulty breathing, as these may be signs of blood clots;
• you have had blood clots in an artery of the eye (retinal occlusion) or of the heart (heart attack). Tell your doctor if you experience sudden changes in vision (blurred vision, partial or total loss of vision), chest pain, or difficulty breathing, as these may be signs of blood clots in the arteries;
• you have been vaccinated recently or plan to be vaccinated (immunization); this is because certain vaccines (live vaccines) are not recommended while taking Litfulo. Check with your doctor that your vaccines are up to date and if you need additional vaccines, including the herpes vaccine, before treatment with Litfulo;
• you have symptoms without an apparent cause caused by a problem with the nervous system while taking Litfulo. Your doctor will discuss with you whether to stop treatment.

Additional blood tests

Your doctor will do blood tests to check if you have a low white blood cell count or a low platelet count before and about 4 weeks after starting treatment with Litfulo, 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 demonstrated in this age group.

Other medicines and Litfulo

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

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

• anxiety or sleep disorders (e.g. midazolam),
• heart rhythm problems (e.g. quinidine),
• gout (e.g. colchicine),
• organ transplant rejection (e.g. cyclosporin, everolimus, tacrolimus, and sirolimus),

• migraine (e.g. dihydroergotamine and ergotamine),
• schizophrenia and chronic psychosis (e.g. pimozide),
• asthma (e.g. theophylline),
• muscle spasms (e.g. tizanidine),
• idiopathic pulmonary fibrosis (e.g. pirfenidone).

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

If you are in any of the above situations or if you are not sure, talk to your doctor or pharmacist before taking Litfulo.

Pregnancy, contraception, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Contraception in women

If you are a woman of childbearing age, you should use an effective method of contraception 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 take Litfulo if you are pregnant, think you may be pregnant, or are planning to have a baby. This medicine may harm your unborn baby. Tell your doctor immediately if you become pregnant or think you may have become pregnant during treatment.

Breastfeeding

Do not take Litfulo while breastfeeding, as it is not known whether this medicine passes into breast milk or affects breastfed babies. You and your doctor will decide whether to breastfeed or take this medicine.

Fertility

It is not known whether Litfulo reduces fertility in women or men of childbearing age.

Driving and using machines

Litfulo has a limited or no effect on your ability to drive or use machines.

Litfulo contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Litfulo

Always take this medicine exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

The recommended dose is 50 mg once a day by mouth.

Swallow the capsule whole with water. Do not open, crush, or chew the capsule before swallowing, as this may change the amount of medicine 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 side effects listed 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 it is less than 8 hours until your next dose, simply miss the forgotten dose and take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten capsule.

If you stop taking Litfulo

Do not stop taking Litfulo without talking to your doctor.

If you need to stop treatment with Litfulo for a short time (no more than 6 weeks), the risk of losing hair on the scalp is low.

If you have any further questions on 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

See a doctor immediately and seek medical help if you notice any signs of:

• Herpes (herpes zoster), a painful skin rash with blisters with or without fever
• Hives (urticaria), a skin rash with itching

Other side effects

Common(may affect up to 1 in 10 people)

• Nose, throat, or trachea infections
• Diarrhea
• Dizziness
• Acne
• Rash (apart from urticaria and herpes zoster)
• Inflammation (swelling) of the hair follicles that can cause itching or pain (folliculitis)
• Increased levels of an enzyme called creatine phosphokinase, which appears in blood tests (elevated creatine phosphokinase in blood)

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)
• Increased liver enzymes in the blood (ALT and AST elevated)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed 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 which is stated on the carton, bottle, or blister after “EXP”. The expiry date refers to the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are:

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

Hard capsule shell: 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 pack contents

Litfulo 50 mg hard capsules are yellow and blue, 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 a polypropylene cap, 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.

Not all pack sizes may be marketed.

Marketing authorisation holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

You can get more information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

02/2025.

Other sources of information

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