JAYPIRCA 50 mg Tabletki Powlekane

Treść ulotki

1. Jaypirca 50 mg film-coated tablets, 100 mg film-coated tablets
   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. How to store Jaypirca
   6. Contents of the pack and other information

Jaypirca 50 mg film-coated tablets, 100 mg film-coated tablets

pirtobrutinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects experienced during the use of this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 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

1. What is Jaypirca and what is it used for

Jaypirca is an anti-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) for the treatment of the following blood cancers in adult patients
previously treated with another BTK inhibitor:

• Mantle cell lymphoma (MCL). MCL is an aggressive (fast-growing) cancer of a type of white blood cells called B cells. B cells are part of the immune system (the body's natural defenses). This medicine is used when the cancer has returned (relapsed) or the treatment has not worked (refractory).
• Chronic lymphocytic leukemia (CLL): a type of cancer that affects white blood cells called lymphocytes. This medicine is used when the cancer has returned (relapsed) or the treatment has not worked (refractory).

How Jaypirca works
Jaypirca works by blocking BTK, a protein in the body that allows MCL and CLL cells to
grow and survive. By blocking BTK, Jaypirca helps to kill these cells and can reduce
their number, slowing 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 more likely to develop an opportunistic infection (infections observed in patients with a weakened immune system). Your doctor may prescribe medicines to treat or prevent infections.
• if you have or have had unusual bruising or bleeding, or are taking medicines or supplements that may increase the risk of bleeding. See the section “Other medicines and Jaypirca” below.
• if you have recently had a low number of red blood cells (anaemia), neutrophils (a type of white blood cells that fight infections) or platelets (components that help blood to clot).
• if you have recently had surgery or are about 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 had an irregular heartbeat or other heart and/or blood vessel problems, such as high blood pressure, a history of heart attack or damage to the heart valves.

During treatment with Jaypirca you may get infections. Talk to your doctor if you have fever,
chills, weakness, confusion, muscle aches, cough, cold or flu-like symptoms, if you feel
tired, if you have shortness of breath, if you have pain or a burning sensation when you urinate. These
could be signs of an infection.
Talk to your doctor if you develop a new skin lesion or any change in the appearance of an area of
skin as treatment with Jaypirca may increase the risk of developing skin cancer. Use
sun protection and have regular skin checks.
Rarely, unusual levels of chemicals in the blood have been reported during treatment with Jaypirca
caused by the rapid breakdown of cancer cells, known as tumour lysis syndrome (TLS). This can lead to
changes in kidney function, abnormal heartbeat or seizures. Your doctor or another healthcare
professional may perform blood tests to check for TLS.
Your doctor will check you for signs and symptoms of bleeding (see section 4) and
check your blood cell count as needed during treatment.
Your doctor may monitor your heart rhythm for any irregularities during treatment.

Children and adolescents
Do not give Jaypirca to children and adolescents under 18 years of age, 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 it easier to bleed. This means you must tell your doctor if
you take other medicines that increase the risk of bleeding. This includes 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 for treating or preventing blood clots,
• supplements that may increase the 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 are taking any of the following medicines as Jaypirca may
affect the effectiveness of these medicines:

• 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 for treating 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)
• mefenitoin, phenytoin and carbamazepine (a type of medicines for treating seizures)
• midazolam (sedative)
• alfentanil (medicine used in anaesthesia)
• tacrolimus (used to prevent organ rejection and skin disorders)
• rifampicin (antibiotic)
• methotrexate (medicine used to treat other cancers or immune system disorders)
• mitoxantrone (medicine used to treat other cancers)

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Jaypirca during pregnancy. If you are a woman of childbearing potential, you must use
effective contraception during treatment and for 5 weeks after the last dose of Jaypirca. Tell your
doctor immediately if you become pregnant.
If you are a man, you must use effective contraception during treatment and for 3 months after
the last dose of Jaypirca.
Do not breastfeed while taking Jaypirca and for one week after the last dose of Jaypirca.
It is not known whether Jaypirca passes into breast milk.
It is not known whether Jaypirca will affect fertility. Ask your doctor or pharmacist for
advice if you are planning to have a baby.

Driving and using machines
Jaypirca has a minor effect on the ability to drive and operate machines. After taking
Jaypirca you may feel tired, dizzy or weak and this may affect your
ability to drive or operate machines.

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

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

3. How to take Jaypirca

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose of Jaypirca is 200 mg once a day.
If you experience any undesirable effects while taking Jaypirca, your doctor may
temporarily interrupt the treatment or decrease the dose.
Jaypirca should be taken at approximately the same time each day. You can take the tablets with or
without food. Swallow the tablet whole with a glass of water. Do not chew, crush, or split
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 to hospital immediately for
medical treatment.

If you forget to take Jaypirca

• If less than 12 hours have passed from the usual time for taking a dose: take the forgotten dose immediately. Take the next dose at the usual scheduled time the next day.
• If more than 12 hours have passed from the usual time for taking a dose: skip the forgotten dose. Take the next dose at the usual scheduled time the next day.
• Do not take a double dose of Jaypirca to make up for the missed dose. Take the next dose at the usual scheduled time.
• Do not take a double dose of Jaypirca in case of vomiting. Take the next dose at the usual scheduled time.

If you have any questions about 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 your doctor immediately if you notice any of the
following side effects:

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

Contact your doctor immediately if you experience any of the following side effects:

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

Tell your doctor, pharmacist or nurse if you notice any of the following other side
effects:
Very common(may affect more than 1 in 10 people)

• tiredness
• low levels of neutrophils (a type of white blood cells that fight infections; neutropenia)
• frequent or loose stools (diarrhoea)
• bruising
• contusions
• feeling sick (nausea)
• low number of red blood cells (anaemia), which can cause tiredness and pale skin
• joint pain (arthralgia)
• low number of platelets in the blood (cells that help the blood to clot; thrombocytopenia)
• rash
• stomach pain (abdominal)
• swelling of the 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 cells, 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 side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system listed
in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 pack after “Scad.” and on the
blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Jaypirca contains
The active ingredient is pirtobrutinib. Each film-coated tablet contains 50 or 100 mg of
pirtobrutinib.
The other ingredients are:

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

Description of the appearance of Jaypirca and contents of the pack
Jaypirca 50 mg is provided in the form of a blue, triangle-shaped film-coated tablet (tablet) with rounded edges, imprinted with “Lilly 50” on one side and “6902” on the other. It is available in
blister packs of 28, 30 or 84 film-coated tablets.
Jaypirca 100 mg is provided in the form of a blue, round tablet imprinted with “Lilly 100” on one side and
“7026” on the other. It is available in blister packs of 28, 30, 56, 60, 84 or 168 film-coated
tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Eli Lilly Nederland B.V.,
Papendorpseweg 83,
3528BJ Utrecht,
Netherlands

Manufacturer
Lilly S.A.,
Avda. de la Industria 30,
28108 Alcobendas,
Madrid, Spain
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
ТП "Ели Лили Недерланд" Б.В. - България
тел. + 359 2 491 41 40

België/Belgique/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Nederland
Eli Lilly Nederland B.V.
Tel: + 31-(0) 30 60 25 800

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Ísland
Icepharma hf.
Sími + 354 540 8000

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000
An authorisation has been granted for this medicinal product under “exceptional circumstances”.
This means that further data on this medicinal product are required.
The European Medicines Agency will review the new information at least annually on this

Other sources of information
Detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .