Prospect: information for the patient

Jaypirca 50 mg film-coated tablets

Jaypirca 100 mg film-coated tablets

pirtobrutinib

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can 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, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

Jaypirca is a cancer medication that contains the active ingredient pirtobrutinib. It belongs to a class of medications called Bruton's tyrosine kinase (BTK) inhibitors.

It is used alone (monotherapy) to treat mantle cell lymphoma (MCL) in adult patients who have been previously treated with another BTK inhibitor. MCL is an aggressive (rapidly growing) cancer of a type of white blood cell called B lymphocytes. B lymphocytes are part of the immune system (the body's natural defenses). This medication is used when the cancer has relapsed or the treatment has not been effective.

How Jaypirca works

In MCL, Jaypirca acts by blocking BTK, a protein in the body that helps MCL cells grow and survive. By blocking BTK, Jaypirca helps destroy these cells and may reduce their number, which may slow the progression of the cancer.

Do not take Jaypirca

• if you are allergic to pirtobrutinib or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Jaypirca:

• If you have an infection or have a higher risk of developing an opportunistic infection (infections observed in patients with a weakened immune system). Your doctor may give you medicines to treat or prevent infections.
• If you have or have ever had atypical bleeding or bruising or are taking any medicine or supplements that may increase your risk of bleeding. See the section “Other medicines and Jaypirca” below.
• If you have recently had low counts of red blood cells (anemia), neutrophils (a type of white blood cell that fights infections) or platelets (components that help blood clotting).
• If you have recently undergone surgery or are about to undergo a surgical procedure. Your doctor may ask you to stop taking Jaypirca for a short period of time (3 to 5 days) before and after the procedure.
• If you have or have ever had irregular heartbeats or have other heart and/or blood vessel problems, such as high blood pressure, a history of myocardial infarction or damage to the heart valves.

You may develop infections during treatment with Jaypirca. Contact your doctor if you have fever, chills, weakness, confusion, body aches, cough, symptoms of a cold or flu, feel tired, lack of breath, have pain or burning sensation while urinating. These may be signs of an infection.

Consult your doctor if you develop a new injury or any change in the appearance of a skin area, as treatment with Jaypirca may increase your risk of developing skin cancer. Use sun protection and have regular dermatological check-ups.

Rarely, during treatment with Jaypirca, unusual levels of chemicals in the blood have been reported due to the rapid breakdown of cancer cells, known as tumor lysis syndrome (TLS). This may cause changes in kidney function, irregular heartbeats or seizures. Your doctor or other healthcare professional may perform blood tests to detect TLS.

Your doctor will monitor your signs and symptoms of bleeding (see section 4) and check your blood cell counts during treatment.

Your doctor may monitor your heart rhythm during treatment if there are any irregularities.

Children and adolescents

Do not administer Jaypirca to children and adolescents under 18 years of age. This is because it has not been studied in this age group.

Other medicines and Jaypirca

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

Jaypirca may make you bleed more easily. This means you should inform your doctor if you take other medicines that increase your risk of bleeding. This includes medicines such as:

• aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen,
• anticoagulants like warfarin, heparin and other medicines to treat or prevent blood clots,
• supplements that may increase your risk of bleeding, such as fish oil, vitamin E or flaxseed.

If any of the above situations apply to you (or if you are unsure), consult your doctor, pharmacist or nurse before taking Jaypirca.

Inform your doctor or pharmacist if you take any of the following medicines, as Jaypirca may affect the efficacy of these medicines:

• repaglinide, rosiglitazone or pioglitazone (used to treat diabetes)
• dasabuvir (used to treat hepatitis C)
• selexipag (used to treat a type of high blood pressure in the lungs called pulmonary arterial hypertension)
• rosuvastatin (a statin, a type of medicine to treat high cholesterol)
• montelukast (used to treat asthma)
• digoxin (used to treat heart disorders)
• dabigatran etexilate (an anticoagulant, a type of medicine used to prevent blood clots)
• phenobarbital (a barbiturate, a type of medicine used to treat seizures)
• mephobarbital, phenytoin and carbamazepine (a type of medicine used to treat seizures)
• midazolam (sedative)
• alfentanil (medicine used for anesthesia)
• tacrolimus (used to prevent organ rejection and skin diseases)
• rifampicin (antibiotic)
• methotrexate (medicine used to treat other types of cancer or immune system disorders)
• mitoxantrone (medicine used to treat other types of cancer)

Pregnancy, 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.

Do not use Jaypirca during pregnancy. If you are a woman of childbearing age, you should use an effective contraceptive method during treatment and for 5 weeks after your last dose of Jaypirca. Inform your doctor immediately if you become pregnant.

If you are a man, you should use an effective contraceptive method during treatment and for 3 months after your last dose of Jaypirca.

Do not breastfeed your child while taking Jaypirca and for 1 week after your last dose of Jaypirca. It is unknown whether Jaypirca passes into breast milk.

It is unknown whether Jaypirca will affect fertility. Talk to your doctor or pharmacist for advice if you are planning to have a baby.

Driving and operating machinery

Jaypirca has a minor effect on your ability to drive and operate machinery. You may feel tired, dizzy or weak after taking Jaypirca, which may affect your ability to drive or operate machinery.

Jaypirca contains lactose

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

Jaypirca contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per daily dose of 200 mg; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Jaypirca is 200 mg once a day.

If you experience certain adverse effects while taking Jaypirca, your doctor may temporarily suspend treatment or reduce your dose.

Jaypirca should be taken approximately at the same time every day. You can take the tablets with or without food. Swallow the tablet whole with a glass of water. Do not chew, crush, or divide the tablets before swallowing to ensure you receive the correct dose.

If you take more Jaypirca than you should

If you have taken more Jaypirca than you should, contact a doctor or go immediately to a hospital for advice. Bring the tablets and this leaflet with you. You may need medical treatment.

If you forgot to take Jaypirca

• If less than 12 hours have passed since the usual time to take a dose, take the missed dose immediately. Take the next dose the following day at the usual scheduled time.
• If more than 12 hours have passed since the usual time to take a dose, omit the missed dose. Take the next dose the following day at the usual scheduled time.
• Do not take a double dose of Jaypirca to compensate for the missed dose. Take the next dose at the usual scheduled time.
• Do not take a double dose of Jaypirca if you experience vomiting. Take the next dose at the usual scheduled time.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Jaypirca and immediately inform your doctor if you experience any of the following side effects:

• skin rash with bumps and itching, difficulty breathing, swelling of the face, lips, tongue, or throat, as you may be having an allergic reaction to the medicine.

Immediately contact your doctor if you experience any of the following side effects:

• fever, chills, feeling weak or confused, cough, symptoms of a cold or flu, difficulty breathing, pain or burning sensation while urinating; these could be signs of an infection. These may include the frequent side effects (can affect up to 1 in 10 people) of lung infection (pneumonia), nose, sinuses, or throat (upper respiratory tract infection) or urinary tract infection.
• bleeding, which can affect more than 1 in 10 people. The signs may include the frequent side effects (can affect up to 1 in 10 people) of nosebleed and accumulation of blood under the tissue (hematoma). Other signs of bleeding may include pink or brown urine, bleeding under the eye tissue, black or bloody stools, bleeding gums, vomiting or coughing up blood.
• irregular heartbeats, weak or irregular pulse, dizziness, difficulty breathing, chest discomfort, as these are symptoms of heart rhythm disorders (can affect up to 1 in 10 people).

Inform your doctor, pharmacist, or nurse if you experience any of the following side effects:

Very frequent(can affect more than 1 in 10 people)

• fatigue (tiredness)
• low neutrophil count (a type of white blood cell that fights infections; neutropenia)
• soft or frequent stools (diarrhea)
• hematomas
• bruising
• feeling dizzy (nausea)
• low red blood cell count (anemia), which can cause fatigue and pale skin
• joint pain (arthralgia)
• low platelet count in the blood (cells that help blood clotting; thrombocytopenia)
• skin rash
• abdominal pain

Frequent(can affect up to 1 in 10 people)

• headache
• lymphocytosis (an elevated number of lymphocytes, a type of white blood cell, in the blood)
• small blood spots under the skin (petechiae)

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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 and the blister pack after “CAD” and “EXP” respectively. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines 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. In this way, you will help protect the environment.

Composition of Jaypirca

The active ingredient is pirtobrutinib. Each film-coated tablet contains 50 or 100 mg of pirtobrutinib.

The other components are:

• Core tablet: acetate succinate of hypromellose, microcrystalline cellulose, lactose monohydrate (see section 2 "Jaypirca contains lactose"), sodium croscarmellose (see section 2 "Jaypirca contains sodium"), magnesium stearate, hydrated colloidal silica.
• Film coating: hypromellose, titanium dioxide, triacetin; indigo carmine (E132).

Appearance of the product and contents of the pack

Jaypirca 50 mg is supplied as blue, triangular, arched film-coated tablets, marked with "Lilly 50" on one face and "6902" on the other. It is available in blisters of 28, 30 or 84 film-coated tablets.

Jaypirca 100 mg is supplied as blue, round film-coated tablets, marked with "Lilly 100" on one face and "7026" on the other. It is available in blisters of 28, 30, 56, 60, 84 or 168 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83,

3528BJ Utrecht,

Netherlands.

Responsible for manufacturing

Lilly S.A.,

Avda. de la Industria 30,

28108 Alcobendas,

Madrid, Spain.

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

Date of the last revision of this leaflet:

This medicinal product has been authorised with a "conditional approval".

This type of approval means that more information is expected to be obtained about this medicinal product. The European Medicines Agency will review the new information about this medicinal product at least once a year and this leaflet will be updated as necessary.

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).