JAYPIRCA 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: 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 allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Jaypirca and what is it used for

Jaypirca is a cancer medicine that contains the active substance pirtobrutinib. It belongs to a class of medicines 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 (fast-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 medicine is used when the cancer has come back (relapsed) or the treatment has not worked (refractory).

How Jaypirca works

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

2. What you need to know before you take Jaypirca

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

Talk to your doctor, pharmacist, or nurse before taking Jaypirca:

• If you have an infection or are at a higher risk of developing an opportunistic infection (infections seen 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 unusual bruising or bleeding or are taking any medicines or supplements that may increase your risk of bleeding. See section “Other medicines and Jaypirca” below.
• If you have recently had low red blood cell counts (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 going to have surgery. Your doctor may ask you to stop taking Jaypirca for a short period (3 to 5 days) before and after surgery.
• If you have or have ever had irregular heartbeats or other heart problems and/or blood vessel problems, such as high blood pressure, history of heart attack, or heart valve damage.

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

Talk to your doctor if you develop a new lesion 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 skin checks.

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

During treatment, your doctor will monitor you for signs and symptoms of bleeding (see section 4) and monitor your blood cell counts.

Your doctor may monitor your heart rate during treatment for any irregularities.

Children and adolescents

Do not give 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

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

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

• acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen,
• anticoagulants such as 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 apply to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before taking Jaypirca.

Tell your doctor or pharmacist if you are taking any of the following medicines, as Jaypirca may affect how well they work:

• repaglinide, rosiglitazone, or pioglitazone (used to treat diabetes)
• dasabuvir (used to treat hepatitis C infection)
• selexipag (used to treat a type of high blood pressure in the lungs called pulmonary arterial hypertension)
• rosuvastatin (a statin, a type of medicine used 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)
• mephenytoin, phenytoin, and carbamazepine (a type of medicine used to treat seizures)
• midazolam (a sedative)
• alfentanil (a medicine used for anesthesia)
• tacrolimus (used to prevent organ rejection and skin disorders)
• rifampicin (an antibiotic)
• methotrexate (a medicine used to treat other types of cancer or immune system disorders)
• mitoxantrone (a medicine used to treat other types of cancer)

Pregnancy, 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.

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

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

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

It is not known if Jaypirca will have an effect on fertility. Talk to your doctor or pharmacist for advice if you are planning to have a baby.

Driving and using machines

Jaypirca has a minor effect on your ability to drive and use machines. You may feel tired, dizzy, or weak after taking Jaypirca, and this may affect your ability to drive or use machines.

Jaypirca contains lactose

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

Jaypirca contains sodium

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

3. How to take Jaypirca

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

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

Take Jaypirca at about 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 break the tablets before swallowing to make sure you get the correct dose.

If you take more Jaypirca than you should

If you have taken more Jaypirca than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you. You may need medical treatment.

If you forget to take Jaypirca

• If it has been less than 12 hours since the usual time for taking a dose, take the missed dose as soon as possible. Take the next dose the following day at the usual scheduled time.
• If it has been more than 12 hours since the usual time for taking a dose, skip the missed dose. Take the next dose the following day at the usual scheduled time.
• Do not take a double dose of Jaypirca to make up for a missed dose. Take the next dose at the usual scheduled time.
• Do not take a double dose of Jaypirca if you vomit. Take the next dose at the usual scheduled time.

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

4. Possible side effects

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

Stop taking Jaypirca and tell a doctor straight away if you get any of the following side effects:

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

Tell your doctor straight away if you get any of the following side effects:

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

Tell your doctor, pharmacist, or nurse if you get any of the following side effects:

Very common(may affect more than 1 in 10 people)

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

Common(may affect up to 1 in 10 people)

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 Jaypirca

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 and blister after “EXP”. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

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. Container contents and additional information

Composition of Jaypirca

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

The other ingredients are:

• Core of the tablet: acetate succinate 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; carmine indigo (E132).

Appearance of the product and container contents

Jaypirca 50 mg is supplied as blue, curved triangular film-coated tablets (tablets) marked with "Lilly 50" on one side 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 tablets marked with "Lilly 100" on one side 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 authorisation holder

Eli Lilly Nederland B.V.,

Papendorpseweg 83,

3528BJ Utrecht,

Netherlands.

Manufacturer

Lilly S.A.,

Avda. de la Industria 30,

28108 Alcobendas,

Madrid, Spain.

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

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

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

Other sources of information

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