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
Please read this leaflet carefully before 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 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Dasatinib Krka is and what it is used for
2. What you need to know 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 Dasatinib Krka is and what it is used for

Dasatinib Krka contains the active substance dasatinib. This medicine is used to treat chronic
myeloid leukaemia (CML) in adults, adolescents and children aged at least 1 year. Leukaemia is a
cancer of the white blood cells. Normally, white blood cells help the body fight infection. In people
with CML, white blood cells called granulocytes grow uncontrollably. Dasatinib Krka helps to
inhibit the growth of these leukaemia cells.
Dasatinib Krka is also used to treat Philadelphia chromosome-positive acute lymphoblastic
leukaemia (Ph+ ALL) in adults, adolescents and children aged at least 1 year, as well as the
lymphoblastic blast crisis phase of CML in adults who have not responded to prior therapy. In people
with acute lymphoblastic leukaemia, white blood cells called lymphocytes multiply too quickly and
live too long. Dasatinib Krka helps to inhibit the growth of these leukaemia cells.
If you have any questions about how Dasatinib Krka works or why it has been prescribed, please
consult your doctor.

2. Important information before using Dasatinib Krka

When not to use Dasatinib Krka

• if the patient is allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). If the patient suspects they may have an allergic reaction, they should consult their doctor.

Warnings and precautions
Before starting treatment with Dasatinib Krka, discuss with your doctor or pharmacist if:

• the patient is taking medicines that thin the blood or prevent blood clots (see section "Dasatinib Krka and other medicines")
• the patient has or has had liver or heart problems in the past
• the patient experiences difficulty breathing, chest pain, or coughing while taking Dasatinib Krka: these may be symptoms of fluid accumulation in the lungs or chest cavity (which may occur more frequently in patients aged 65 years and older), or may be caused by changes in blood vessels supplying blood to the lungs
• the patient has ever had or may currently have hepatitis B virus infection. This is because Dasatinib Krka may cause reactivation of hepatitis B virus, which in some cases may lead to death. Before starting treatment, the doctor will carefully check whether the patient shows signs of this infection.
• the patient experiences bruising, bleeding, fever, fatigue, or confusion while taking Dasatinib Krka, they should contact their doctor immediately. These symptoms may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

The doctor will regularly monitor the patient's clinical condition to assess whether Dasatinib Krka is producing the desired effect. Regular blood tests will also be performed during treatment with Dasatinib Krka.
Children and adolescents
This medicine should not be used in children under one year of age. Data on the use of Dasatinib Krka in this age group are limited. In children receiving Dasatinib Krka, bone growth and development should be closely monitored.
Dasatinib Krka and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Dasatinib Krka is mainly metabolized in the liver. Some medicines may affect the action of Dasatinib Krka when used concomitantly.
Do not use the following medicines together with Dasatinib Krka:

• ketoconazole, itraconazole – antifungal medicines
• erythromycin, clarithromycin, telithromycin – antibiotics
• ritonavir – antiviral medicine
• phenytoin, carbamazepine, phenobarbital – medicines used in the treatment of epilepsy
• rifampicin – medicine used to treat tuberculosis
• famotidine, omeprazole – medicines that block gastric acid secretion
• St. John's wort – herbal preparation available without prescription, used in the treatment of depression and other conditions (also known as Hypericum perforatum)

Do not take medicines that neutralize stomach acid (such as aluminium hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Krka.
Inform your doctor if the patient is taking medicines that thin the blood or prevent clot formation.
Taking Dasatinib Krka with food and drink
Do not take Dasatinib Krka with grapefruit or grapefruit juice.
Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, she should inform her doctor immediately. Dasatinib Krka should not be used during pregnancy unless absolutely necessary. The doctor will discuss with the patient the potential risks associated with taking Dasatinib Krka during pregnancy.
It is recommended that both men and women use effective contraception during treatment with Dasatinib Krka.
Inform your doctor if you are breastfeeding. Breastfeeding must not be undertaken during treatment with Dasatinib Krka.
Driving and operating machinery
If the patient experiences adverse effects such as dizziness or blurred vision, they should exercise particular caution when driving or operating machinery.
Dasatinib Krka contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should inform their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Dasatinib Krka

Dasatinib Krka will be prescribed only by a physician experienced in the treatment of leukemia.
This medicine should always be taken exactly as recommended by the doctor. In case of doubt, 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 adult patients in the chronic phase of CML is 100 mg once
daily.
The recommended initial dose for adult patients in the accelerated phase or blast phase
of CML, or with acute lymphoblastic leukemia with the Philadelphia chromosome, is
140 mg once daily.
Dosing in children with chronic phase CML and Ph+ ALL is based on body weight. Dasatinib is administered orally once daily in the form of tablets or powder for oral suspension. The use of dasatinib tablets is not recommended in patients with body weight less than 10 kg. In patients weighing less than 10 kg and in patients unable to swallow tablets, the powder for oral suspension should be used. When switching between formulations (i.e. tablets and powder for oral suspension), a dose adjustment may be necessary; therefore, do not interchange between the two formulations without medical advice. Based on the patient's body weight, adverse reactions, and response to treatment, the doctor will determine the appropriate formulation and dose. The initial dose of Dasatinib Krka in children is calculated according to 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
at least 45 kg 100 mg
There are no dosage recommendations for 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 temporarily interrupt treatment. To achieve 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 each day. Tablets must be swallowed whole.
Do not crush, cut, or chew them. Do not take crushed, broken, chewed, or powdered tablets. If tablets are crushed, cut, chewed, or otherwise damaged, there is no guarantee that the patient will receive the correct dose. Dasatinib Krka tablets may be taken with or without food.
Special handling instructions for Dasatinib Krka
It is unlikely that Dasatinib Krka tablets will be damaged. However, if this occurs, individuals 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 daily until the doctor decides that treatment should be discontinued. Ensure that Dasatinib Krka is taken for as long as recommended by the doctor.
Taking more than the recommended dose of Dasatinib Krka
If a patient accidentally takes more tablets than recommended, contact the doctor immediately, as medical assistance may be required.
Missed 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
All of the symptoms listed below may indicate serious adverse reactions:

• chest pain, difficulty breathing, cough, and fainting
• unexpected bleeding or bruising without prior injury
• blood in vomit, stools, or urine, or black stools (tarry stools)
• signs of infection, such as fever, severe chills
• fever, mouth or throat pain, formation of blisters or peeling of the skin and (or) mucous membranes

If any of the above symptoms occur, contact your doctor immediately.

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

• Infections (including bacterial, viral, and fungal infections)
• Heart and lungs: shortness of breath
• Gastrointestinal disorders: diarrhoea, 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 treatment or after discontinuation), abdominal pain
• Laboratory tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid around the lungs

Common adverse reactions (may affect up to 1 in 10 people)

• Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infections, severe blood or tissue infection (including uncommon cases resulting in death)
• Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Gastrointestinal disorders: loss of appetite, taste disturbances, bloating or abdominal distension, inflammation of the large intestine, constipation, heartburn, mouth ulcers, weight gain, weight loss, inflammation of the stomach lining
• Skin, hair, eyes, general symptoms: tingling, skin itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred or disturbed vision), dry eyes, bruising, depression, insomnia, sudden skin redness, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling
• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle and joint stiffness, muscle cramps
• Laboratory tests may show: fluid around the heart, fluid in the lungs, heart rhythm disturbances, neutropenic fever, gastrointestinal bleeding, high levels of uric acid in the blood

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Heart and lungs: heart attack (including cases resulting in death), inflammation of the lining (fibrous sac) around the heart, irregular heart function, chest pain due to lack of blood flow to the heart (angina), low blood pressure, narrowing of the airways causing breathing difficulties, asthma, increased blood pressure in the pulmonary arteries
• Gastrointestinal disorders: pancreatitis, peptic ulcer disease, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux (a condition in which acid and other stomach contents flow back into the throat)
• Skin, hair, eyes, general symptoms: allergic reactions, including tender red nodules on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremor, eye inflammation causing redness or pain, skin disease characterized by tender red distinct lesions with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, vision disturbances, excessive tearing of the eyes, skin pigmentation disorders, inflammation of subcutaneous fat tissue, skin ulcers, blistering of the skin, nail disorders, hair disorders, hand and foot disorders, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, reduced thyroid function, loss of balance while walking, bone necrosis (a condition with reduced blood flow to the bone, leading to loss of bone mass and bone death), joint inflammation, skin swelling anywhere on the body
• Pain: vein inflammation causing redness, tenderness, and swelling, tendon inflammation
• Brain: memory loss
• Laboratory tests may show: abnormal blood test results and possible kidney dysfunction due to tumour breakdown products (tumour lysis syndrome), low blood albumin levels, low lymphocyte count (a type of white blood cell), high blood cholesterol levels, swollen lymph nodes, brain haemorrhage, irregular electrical heart activity, heart muscle enlargement, liver inflammation, protein in urine, increased creatine phosphokinase activity (an enzyme mainly present in the heart, brain, and skeletal muscles), increased troponin levels (an enzyme mainly present in the heart and skeletal muscles), increased gamma-glutamyl transferase activity (an enzyme mainly present in the liver), milky fluid around the lungs (chylous pleural effusion)

Rare adverse reactions (may affect up to 1 in 1,000 people)

• Heart and lungs: enlargement of the right ventricle of the heart, myocarditis (inflammation of the heart muscle), syndrome of symptoms caused by blocked blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (cessation of blood flow from the heart), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs
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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 pack and carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Dasatinib Krka contains

• The active substance is dasatinib. Each 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 croscarmellose, 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 coated tablet (tablet) with a diameter of approximately 5.6 mm, engraved with "D7SB" on one side and "20" on the other side.
Dasatinib Krka, 50 mg: white or almost white, biconvex, oval coated tablet (tablet) with a length of approximately 11.0 mm and width of approximately 6.0 mm, engraved with "D7SB" on one side and "50" on the other side.
Dasatinib Krka, 70 mg: white or almost white, biconvex, round coated tablet (tablet) with a diameter of approximately 9.1 mm, engraved with "D7SB" on one side and "70" on the other side.
Dasatinib Krka, 80 mg: white or almost white, biconvex, triangular coated tablet (tablet) with a length of approximately 10.4 mm and width of approximately 10.6 mm, engraved with "D7SB" on one side and "80" on the other side.
Dasatinib Krka, 100 mg: white or almost white, biconvex, oval coated tablet (tablet) with a length of approximately 15.1 mm and width of approximately 7.1 mm, engraved with "D7SB" on one side and "100" on the other side.
Dasatinib Krka, 140 mg: white or almost white, biconvex, round coated tablet (tablet) with a diameter of approximately 11.7 mm, engraved with "D7SB" on one side and "140" on the other side.

Dasatinib Krka is available in all strengths in packs containing:

• 30 or 60 coated tablets in non-perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorisation 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
The 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: +48 22 573 75 00