Dasatinib Krka

Package Leaflet: 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

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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) 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 cancerous cells.

Dasatinib Krka is also used to treat acute lymphoblastic leukemia (ALL) 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 cancerous cells.

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

Warnings and precautions

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

• you are taking blood-thinning medicines or medicines that prevent blood clots (see "Dasatinib Krka and other medicines")
• you have liver or heart problems, or have had them in the past
• you experience difficulty breathing, chest pain, or cough while taking Dasatinib Krka: this may be a sign of fluid buildup in the lungs or chest (which may occur more frequently in patients aged 65 and older), or be caused by changes in blood vessels that supply blood to the lungs
• you have ever had or may currently have a 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 symptoms of this infection.
• you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Krka, consult your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will regularly monitor your condition to assess whether Dasatinib Krka is having the desired effect. While taking Dasatinib Krka, regular blood tests will also be performed.

Children and adolescents

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

Dasatinib Krka and other medicines

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.

Do not take the following medicines 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)

Do 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. Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib Krka with food and drink

Do not take Dasatinib Krka with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, inform your doctor immediately. Dasatinib Krka should not be taken during pregnancy unless 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.

Tell your doctor if you are breastfeeding. While taking Dasatinib Krka, do not breastfeed.

Driving and using machines

If you experience side effects such as dizziness and blurred vision, 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, inform your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Dasatinib Krka

Dasatinib Krka will be prescribed only by a doctor experienced in treating leukemia.

Take this medicine exactly as your doctor has told you. If you are unsure, consult 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.

Dosing for children with chronic phase CML and Ph+ ALL is 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 body weight of less than 10 kg and in patients who are unable to swallow tablets, the powder for oral suspension should be used. When changing the formulation (i.e., from tablets to powder for oral suspension), the dose may need to be adjusted; in such cases, do not change 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.

Based on the patient's response to treatment, the doctor may decide to increase or decrease the dose, or even temporarily stop treatment. To take higher or lower doses, it may be necessary to use a combination of tablets of different strengths.

How to take Dasatinib Krka

Take the tablets at the same time every day. Swallow the tablets whole. Do not crush, cut, or chew them. Do not take crushed, cut, chewed, or broken tablets. If the tablets are crushed, cut, chewed, or broken, it is uncertain whether 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

Take Dasatinib Krka every day until your doctor decides to stop it. Make sure you take Dasatinib Krka for as long as your doctor has prescribed.

Taking more Dasatinib Krka than prescribed

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

Missing a dose of Dasatinib Krka

Do not take a double dose to make up for a missed tablet. Take the next dose at the usual time.

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dasatinib Krka can cause side effects, although not everybody gets them.

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, stool, or urine, or black stools
• infection symptoms, such as fever, chills
• fever, mouth pain, or throat pain, with blistering or peeling of the skin and mucous membranes. If you experience any of these symptoms, 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 buildup 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 sores, weight gain, weight loss, stomach inflammation
• 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 buildup around the heart, fluid buildup 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 rare cases that were fatal), pericarditis, irregular heart rhythm, chest pain due to lack of blood flow to the heart (angina), low blood pressure, narrowing of the airways, which can cause difficulty breathing, asthma, increased blood pressure in the pulmonary arteries
• Digestive system: pancreatitis, stomach ulcers, esophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastroesophageal reflux disease (a condition in which stomach 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 the presence of 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 tearing, 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 death (a condition in which there is decreased blood flow to the bone, leading to bone loss and death), joint inflammation, 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: abnormal blood test results and possible kidney function disorders caused by tumor breakdown products (tumor lysis syndrome), 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 mainly found in the heart, brain, and skeletal muscles), increased troponin levels (an enzyme mainly found in the heart and skeletal muscles), increased gamma-glutamyltransferase activity (an enzyme mainly found 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: enlargement of the right heart chamber, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (stoppage of heart function), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
• Digestive system: loss of essential nutrients from the digestive tract, such as proteins, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the skin surrounding it), kidney function disorders, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic nerve inflammation, which can cause total or partial loss of vision, blue-purple spots on the skin, abnormal increased thyroid function, thyroid gland inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• 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

Side effects with unknown frequency(cannot be estimated from available data)

• Pneumonia
• 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 laboratory test results, such as protein in the urine and low protein levels in the blood
• Damage to blood vessels known as thrombotic microangiopathy (TMA), 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 package leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C, 02-222 Warszawa

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.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Dasatinib Krka

Keep this medicine out of the 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Dasatinib Krka contains

• The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, or 140 mg of dasatinib.
• Other ingredients are: Tablet core: lactose monohydrate (200), microcrystalline cellulose (type 101 and 102), croscarmellose sodium, 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 package

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, contact the local representative of the marketing authorization holder:

Krka Polska Sp. z o.o.

ul. Równoległa 5

02-235 Warszawa

phone: +48 22 573 75 00

Date of last revision of the package leaflet:15.09.2022