Dasatinib Krka

Leaflet accompanying the packaging: information for the user

Dasatinib Krka, 20 mg, film-coated tablets

Dasatinib Krka, 50 mg, film-coated tablets

Dasatinib Krka, 70 mg, film-coated tablets

Dasatinib Krka, 80 mg, film-coated tablets

Dasatinib Krka, 100 mg, film-coated tablets

Dasatinib Krka, 140 mg, film-coated tablets

Dasatinib

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Dasatinib Krka and what is it used for
• 2. Important information before taking Dasatinib Krka
• 3. How to take Dasatinib Krka
• 4. Possible side effects
• 5. How to store Dasatinib Krka
• 6. Contents of the pack and other information

1. What is Dasatinib Krka and what is it used for

Dasatinib Krka contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukemia (CML, English Chronic Myeloid Leukaemia) in adults, adolescents, and children aged 1 year and older. Leukemia is a cancer of white blood cells. White blood cells normally help the body fight infection. In people with CML, white blood cells called granulocytes grow out of control. Dasatinib Krka works by stopping the growth of these leukemia cells.

Dasatinib Krka is also used to treat acute lymphoblastic leukemia (ALL, English acute lymphoblastic leukaemia) with Philadelphia chromosome positive (Ph+) in adults, adolescents, and children aged 1 year and older, as well as lymphoblastic blast crisis CML in adults who have not responded to previous treatment. In people with acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Krka works by stopping the growth of these leukemia cells.

If you have any questions about how Dasatinib Krka works or why it has been prescribed for you, you should ask your doctor.

2. Important information before taking Dasatinib Krka

When not to take Dasatinib Krka

• if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, you should consult your doctor.

Warnings and precautions

Before starting to take Dasatinib Krka, you should discuss it with your doctor or pharmacist if:

• you are taking blood thinning medicines or medicines to prevent blood clots (see "Dasatinib Krka and other medicines")
• you have had liver or heart problems in the past
• you experience difficulty breathing, chest pain, or cough while taking Dasatinib Krka: this may be a sign of fluid build-up in the lungs or chest, or changes in the blood vessels that supply blood to the lungs
• you have ever had or may currently have hepatitis B virus infection. This is because Dasatinib Krka may cause the hepatitis B virus to become active again, which can be life-threatening in some cases. Before starting treatment, your doctor will check if you have any signs of this infection.
• you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Krka, you should contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA, English thrombotic microangiopathy).

Your doctor will regularly check your condition to see if Dasatinib Krka is having the desired effect. While taking Dasatinib Krka, you will also have regular blood tests.

Children and adolescents

Dasatinib Krka should not be used in children under 1 year of age. There is limited data on the use of Dasatinib Krka in this age group. In children taking Dasatinib Krka, bone growth and development should be closely monitored.

Dasatinib Krka and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Dasatinib Krka is mainly broken down in the liver. Some medicines may affect the action of Dasatinib Krka if taken at the same time.

The following medicines should not be taken with Dasatinib Krka:

• ketokonazole, itraconazole - antifungal medicines
• erythromycin, clarithromycin, telithromycin - antibiotics
• ritonavir - antiviral medicine
• phenytoin, carbamazepine, phenobarbital - medicines used to treat epilepsy
• rifampicin - medicine used to treat tuberculosis
• famotidine, omeprazole - medicines that block stomach acid production
• St. John's Wort - herbal preparation available without prescription, used to treat depression and other conditions (also known as Hypericum perforatum)

You should not take medicines that neutralize stomach acid (such as aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Krka. You should tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib Krka with food and drink

You should not take Dasatinib Krka with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, you should tell your doctor immediately. You should not take Dasatinib Krka during pregnancy unless it is absolutely necessary. Your doctor will discuss the possible risks of taking Dasatinib Krka during pregnancy with you. It is recommended that both men and women use effective contraception during treatment with Dasatinib Krka. You should tell your doctor if you are breastfeeding. You should not breastfeed while taking Dasatinib Krka.

Driving and using machines

If you experience side effects such as dizziness and blurred vision, you should be careful when driving or operating machinery.

Dasatinib Krka contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should tell your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that it is essentially "sodium-free".

3. How to take Dasatinib Krka

Dasatinib Krka will only be prescribed by a doctor who is experienced in treating leukemia. You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist. Dasatinib Krka is intended for use in adults and children over 1 year of age.

The recommended initial dose for adults with chronic phase CML is 100 mg once daily. The recommended initial dose for adults with accelerated phase or blast crisis CML, or with Philadelphia chromosome-positive acute lymphoblastic leukemia, is 140 mg once daily. The dosage for children with chronic phase CML and Ph+ ALL is determined based on body weight. Dasatinib is given orally once daily in the form of tablets or powder for oral suspension. It is not recommended to use dasatinib tablets in patients with a body weight of less than 10 kg. In patients with a weight of less than 10 kg and in patients who are unable to swallow tablets, the powder for oral suspension should be used. When switching from one formulation to another (i.e., tablets and powder for oral suspension), the dose may need to be adjusted; in such cases, the dose should not be changed when switching from one formulation to another. Based on the patient's body weight, side effects, and response to treatment, the doctor will determine the appropriate formulation and dose. The initial dose of Dasatinib Krka for children is calculated based on body weight, as shown below:

Body weight (kg)

Daily dose (mg)

10 to less than 20 kg

40 mg

20 to less than 30 kg

60 mg

30 to less than 45 kg

70 mg

45 kg or more

100 mg

There are no recommendations for the dose of Dasatinib Krka in children under 1 year of age. Depending on the patient's response to treatment, the doctor may decide to increase or decrease the dose, or even interrupt treatment for a short time. To take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

How to take Dasatinib Krka

Tablets should be taken at the same time every day. The tablets should be swallowed whole. They should not be crushed, cut, or chewed. You should not take crushed, cut, chewed, or broken tablets. If the tablets are crushed, cut, chewed, or broken, it is not certain that you will receive the correct dose. Dasatinib Krka tablets can be taken with or without food.

Special precautions for handling Dasatinib Krka

It is unlikely that Dasatinib Krka tablets will be damaged. However, if they are, people other than the patient who come into contact with Dasatinib Krka should wear protective gloves.

How long to take Dasatinib Krka

Dasatinib Krka should be taken every day until your doctor decides to stop it. You should make sure that you take Dasatinib Krka for as long as your doctor has prescribed it.

Taking more Dasatinib Krka than prescribed

If you accidentally take more tablets than prescribed, you should immediately tell your doctor, as you may need medical attention.

Missing a dose of Dasatinib Krka

You should not take a double dose to make up for a missed tablet. You should take the next dose at the usual time. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

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

All of the following symptoms may indicate serious side effects:

• chest pain, difficulty breathing, cough, and fainting
• unexpected bleeding or bruising without previous injury
• blood in vomit, stools, or urine, or black stools
• signs of infection, such as fever, chills
• fever, mouth or throat pain, blisters, or peeling of the skin and (or) mucous membranes. If you notice any of these symptoms, you should contact your doctor immediately.

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

• Infections (including bacterial, viral, and fungal infections)
• Heart and lungs: shortness of breath
• Digestive system: diarrhea, nausea, or vomiting
• Skin, hair, eyes, general symptoms: rash, fever, swelling of the face, hands, and feet, headache, feeling tired or weak, bleeding
• Pain: muscle pain (during or after treatment), abdominal pain
• Lab tests may show: low platelet count, low white blood cell count (neutropenia), anemia, fluid build-up around the lungs

Common side effects(may affect up to 1 in 10 people)

• Infections: pneumonia, cytomegalovirus (CMV) infection, upper respiratory tract infections, severe blood or tissue infections (including rare cases that were fatal)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Digestive system: loss of appetite, taste disturbances, bloating or abdominal distension, colitis, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
• Skin, hair, eyes, general symptoms: tingling, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred or disturbed vision), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling
• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness
• Lab tests may show: fluid build-up around the heart, fluid build-up in the lungs, irregular heart rhythm, febrile neutropenia, gastrointestinal bleeding, high uric acid levels in the blood

Uncommon side effects(may affect up to 1 in 100 people)

• Heart and lungs: heart attack (including fatal cases), pericarditis, irregular heart rhythm, angina pectoris, low blood pressure, bronchospasm, increased blood pressure in the pulmonary arteries
• Digestive system: pancreatitis, stomach ulcers, esophagitis, abdominal swelling, anal fissure, gastrointestinal disorders, gastroesophageal reflux disease (a condition in which acid and other stomach contents flow back into the throat)
• Skin, hair, eyes, general symptoms: allergic reactions, including the development of painful, red lumps on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremors, eye inflammation, which can cause redness or pain, a skin condition characterized by painful, red, distinct spots with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances, increased tear production, skin discoloration, skin inflammation, blistering of the skin, nail disorders, hair disorders, disorders of the hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, decreased thyroid function, loss of balance while walking, bone necrosis (a condition in which there is decreased blood flow to the bone, leading to bone loss and bone death), arthritis, skin swelling at any site on the body
• Pain: vein inflammation, which can cause redness, tenderness, and swelling, tendon inflammation
• Brain: memory loss
• Lab tests may show: tumor lysis syndrome (a condition that occurs when a large number of cancer cells die quickly), low albumin levels in the blood, low lymphocyte count in the blood, high cholesterol levels in the blood, lymph node swelling, brain bleeding, irregular heart rhythm, enlarged heart muscle, liver inflammation, protein in the urine, increased creatine phosphokinase activity (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin levels (an enzyme found mainly in the heart and skeletal muscles), increased gamma-glutamyltransferase activity (an enzyme found mainly in the liver), presence of milky fluid around the lungs (pleural effusion)

Rare side effects(may affect up to 1 in 1000 people)

• Heart and lungs: enlarged right heart chamber, heart muscle inflammation, acute coronary syndrome (a condition caused by blockage of blood flow to the heart muscle), cardiac arrest (stoppage of blood flow from the heart), coronary artery disease (heart), inflammation of the tissue surrounding the heart and lungs, blood clots, blood clots in the lungs
• Digestive system: malabsorption (a condition in which the body does not absorb necessary nutrients from the digestive tract), intestinal obstruction, anal fistula (an abnormal channel between the anus and the skin surrounding it), kidney disorders, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic neuritis (inflammation of the optic nerve, which can cause complete or partial loss of vision), purple spots on the skin, hyperthyroidism, thyroid inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin inflammation of blood vessels, skin thickening
• Brain: stroke, transient neurological disturbances caused by lack of blood flow, facial nerve paralysis, dementia
• Immune system: severe allergic reaction
• Musculoskeletal and connective tissue disorders: delayed bone growth or growth retardation

Other observed side effects with unknown frequency(cannot be determined from available data)

• Pneumonitis
• Gastrointestinal bleeding, which can be fatal
• Reactivation (recurrence) of hepatitis B virus infection (liver infection) in patients who have had this infection in the past
• A reaction characterized by fever, blistering of the skin, and mucous membrane ulcers
• Kidney disease with symptoms including swelling and abnormal lab test results, such as protein in the urine and low albumin levels in the blood
• Damaged blood vessels known as thrombotic microangiopathy (TMA, English thrombotic microangiopathy), including decreased red blood cell count, decreased platelet count, and blood clot formation

During treatment, your doctor will check if you have experienced any of the above side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dasatinib Krka

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of the month. There are no special storage instructions for this medicine. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dasatinib Krka contains

• The active substance of Dasatinib Krka is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, or 140 mg of dasatinib.
• The other ingredients are: Tablet core: lactose monohydrate (200), microcrystalline cellulose (type 101 and 102), sodium carmellose, hydroxypropylcellulose (MW 80,000), magnesium stearate. Tablet coating: lactose monohydrate, hypromellose (15 mPas), titanium dioxide (E 171), triacetin. See section 2 "Dasatinib Krka contains lactose and sodium".

What Dasatinib Krka looks like and contents of the pack

Dasatinib Krka, 20 mg: white or almost white, biconvex, round film-coated tablet (tablet) with a diameter of about 5.6 mm, with "D7SB" embossed on one side and "20" on the other side. Dasatinib Krka, 50 mg: white or almost white, biconvex, oval film-coated tablet (tablet) with a length of about 11.0 mm and a width of about 6.0 mm, with "D7SB" embossed on one side and "50" on the other side. Dasatinib Krka, 70 mg: white or almost white, biconvex, round film-coated tablet (tablet) with a diameter of about 9.1 mm, with "D7SB" embossed on one side and "70" on the other side. Dasatinib Krka, 80 mg: white or almost white, biconvex, triangular film-coated tablet (tablet) with a length of about 10.4 mm and a width of about 10.6 mm, with "D7SB" embossed on one side and "80" on the other side. Dasatinib Krka, 100 mg: white or almost white, biconvex, oval film-coated tablet (tablet) with a length of about 15.1 mm and a width of about 7.1 mm, with "D7SB" embossed on one side and "100" on the other side. Dasatinib Krka, 140 mg: white or almost white, biconvex, round film-coated tablet (tablet) with a diameter of about 11.7 mm, with "D7SB" embossed on one side and "140" on the other side. Dasatinib Krka is available in packs containing 30 or 60 film-coated tablets in non-perforated blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

Synthon Hispania, S.L. Calle Castelló 1, Polígono Las Salinas 08830 Sant Boi de Llobregat, Barcelona Spain Synthon BV Microweg 22 6545 CM Nijmegen Netherlands KRKA, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia KRKA-FARMA d.o.o.

• V. Holjevca 20/E 10450 Jastrebarsko Croatia

For more information about this medicine, you should contact the local representative of the marketing authorization holder: Krka Polska Sp. z o.o. ul. Równoległa 5 02-235 Warsaw phone: +48 22 573 75 00 Date of last revision of the leaflet:15.09.2022