Jaypirca 50 mg film-coated tablets

• 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.

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

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

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

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

• If you have an infection or are at an increased 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 ever had unusual bruising or bleeding or are on any medicines or supplements that could increase your risk of bleeding. See section “Other medicines and Jaypirca” below.
• If you recently had low counts of red blood cells (anaemia), neutrophils (a type of white blood cell that fights infections) or platelets (components that help the blood to clot).
• If you have recently had any surgery or are planning to have surgery. Your doctor may ask you to stop taking Jaypirca for a short time (3 to 5 days) before and after your surgery.
• If you have or ever had an irregular heartbeat or have other heart and/or blood vessel problems, such as high blood pressure, history of a heart attack or have heart valve damage.
• If you have liver problems.

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

Talk to your doctor if you develop a new lesion or any change in the appearance of an area on the skin, as treatment with Jaypirca may increase your risk of developing skin cancer. Use sun protection and make regular skin examinations.

Unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells, known as tumour lysis syndrome (TLS), have been reported rarely during treatment with Jaypirca. This may lead to changes in kidney function, abnormal heartbeat, or seizures. Your doctor or another healthcare professional may do blood tests to check for TLS.

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

Your doctor may monitor your heart rhythm for any irregularities throughout treatment.

Liver problems can happen in people treated with Jaypirca. Your healthcare provider will do blood tests to check your liver before and during treatment with Jaypirca. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.

Do not give Jaypirca to children and adolescents aged less than 18 years. This is because it has not been studied in this age group.

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. This includes medicines such as:

• acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatories (NSAIDs) such as ibuprofen and naproxen,
• anticoagulants such as warfarin, heparin and other medicines for treating or preventing 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 you are not sure), talk to your doctor, pharmacist or nurse before taking Jaypirca.

Tell your doctor or pharmacist if you take any of the following medicines as Jaypirca may affect how well these medicines work:

• Repaglinide, rosiglitazone, or pioglitazone (used to treat diabetes)
• Dasabuvir (used for 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 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 (sedative),
• Alfentanil (medicine used for anesthesia)
• Tacrolimus (used to prevent organ rejection and skin conditions)
• Rifampicin (antibiotic)
• Methotrexate (medicine used to treat other cancers or immune system disorders)
• Mitoxantrone (medicine used to treat other cancers)

If you are pregnant or breast-feeding, 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 use Jaypirca during pregnancy. If you are a woman of childbearing age, you must use an effective method of contraception 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 method of contraception during treatment and for 3 months after your last dose of Jaypirca.

Do not breast-feed while taking Jaypirca and for one week after your last dose of Jaypirca. It is unknown whether Jaypirca passes into breast milk.

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

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.

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

This medicine contains less than 1 mmol sodium (23 mg) per 200 mg daily dose, that is to say essentially ‘sodium-free’.

If you have taken more Jaypirca than you should, contact a doctor or go to a hospital immediately for advice. Take the tablets and this leaflet with you. Medical treatment may be necessary.

• If less than 12 hours have passed after your usual time for taking a dose: Take the missed dose right away. Take the next dose at your usual scheduled time the next day.
• If more than 12 hours have passed after your usual time for taking a dose: Skip the missed dose. Take the next dose at your usual scheduled time the next day.
• Do not take a double dose of Jaypirca to make up for a forgotten dose. Take the next dose at your usual scheduled time.
• Do not take a double dose of Jaypirca if you experience vomiting. Take the next dose at your scheduled usual time.

• itchy bumpy rash, difficulty breathing, swelling of your face, lips, tongue or throat – you may be having an allergic reaction to the medicine.

• fever, chills, feeling weak or confused, cough, cold or flu symptoms, shortness of breath, pain or burning feeling when passing urine; these could be signs of an infection. These could include the very common side effects (may affect more than 1 in 10 people) of infection of the lung (pneumonia), nose, sinus or throat (upper respiratory tract infection) or infection of the urinary tract (may affect up to 1 in 10 people).
• bleeding, which may affect more than 1 in 10 people. Signs could include the common side effects (may affect up to 1 in 10 people) of nosebleeds, collection of blood under tissue (haematoma) and bleeding in the tissue lining the eye. Other signs of bleeding may include pink or brown urine, black stools or stools with blood, bleeding gums, vomiting or coughing up blood.
• irregular heartbeats, weak or uneven pulse, light headedness, shortness of breath, chest discomfort as these are symptoms of heart rhythm problems (may affect up to 1 in 10 people).

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

• tiredness (fatigue)
• low levels of neutrophils (a type of white blood cell that fights infection; neutropenia)
• frequent or loose stools (diarrhoea)
• bruising
• contusion
• feeling sick (nausea)
• low red blood cell counts (anaemia), which can cause tiredness and pale skin
• joint pain (arthralgia)
• low blood platelet counts (cells that help blood to clot; thrombocytopenia)
• rash
• belly (abdominal) pain
• swollen hands, ankles or feet
• headache

Common (may affect up to 1 in 10 people)

• lymphocytosis (a higher-than-normal amount of lymphocytes, a type of white blood cell, in the blood)
• tiny blood spots under the skin (petechiae)

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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

The other ingredients are:

• Tablet core: hypromellose acetate succinate; cellulose, microcrystalline; lactose monohydrate (see section 2 “Jaypirca contains lactose”); croscarmellose sodium (see section 2 “Jaypirca contains sodium”); magnesium stearate; silica, colloidal hydrated.
• Tablet film-coat: hypromellose; titanium dioxide; triacetin; indigo carmine (E132).

Jaypirca 50 mg is supplied as a blue, arc-triangle shaped film-coated tablet (tablet) debossed with “Lilly 50” on one side and “6902” on the other side. It is available in blister packs of 28, 30 or 84 film-coated tablets.

Jaypirca 100 mg is supplied as a blue, round tablet debossed with “Lilly 100” on one side and “7026” on the other side. It is available in blister packs of 28, 30, 56, 60, 84 or 168 film-coated tablets.

Not all the pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: