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 leukaemia (CML, ang. Chronic Myeloid Leukaemia) in adults, adolescents and children aged 1 year and above. Leukaemia is a cancer of white blood cells. White blood cells normally help the body to fight infection. In people with CML, white blood cells called granulocytes grow out of control. Dasatinib Krka works by blocking the growth of these leukaemic cells.
Dasatinib Krka is also used to treat acute lymphoblastic leukaemia (ALL, ang. acute lymphoblastic leukaemia) with Philadelphia chromosome positive (Ph+ ) in adults, adolescents and children aged 1 year and above, as well as lymphoblastic blast crisis CML in adults who have not responded to previous treatment. In people with acute lymphoblastic leukaemia, white blood cells called lymphocytes multiply too quickly and live too long.
Dasatinib Krka works by blocking the growth of these leukaemic 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

Warnings and precautions

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

• you are taking medicines that thin your blood or prevent blood clots (see section "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 cavity (which may occur more frequently in patients aged 65 and over), or be caused by changes in the blood vessels supplying 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 fatal in some cases. Before starting treatment, your doctor will check whether you have any signs of this infection.
• you experience bruising, bleeding, fever, tiredness and confusion while taking Dasatinib Krka, you should contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA, ang. thrombotic microangiopathy).

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

Children and adolescents

Dasatinib Krka must not be used in children below 1 year of age. There is only limited data available on the use of Dasatinib Krka in this age group. Children taking Dasatinib Krka should be carefully monitored for growth and development.

Dasatinib Krka and other medicines

You should tell your doctor about all the medicines you are taking, or have recently taken, and those you plan to take.
Dasatinib Krka is mainly broken down in the liver. Some medicines may affect the way Dasatinib Krka works if taken at the same time.

The following medicines must 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 aluminium 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 your 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 consult 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 the treatment of leukaemia.
This medicine should always be taken exactly as your doctor has instructed. 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 a day.
The recommended initial dose for adults with accelerated phase or blast crisis CML, or with Philadelphia chromosome positive acute lymphoblastic leukaemia is 140 mg once a day.
Dosing in children with chronic phase CML and Ph+ ALL is based on body surface area. Dasatinib is given orally once a day 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. For patients weighing less than 10 kg and for patients who are unable to swallow tablets, the powder for oral suspension should be used. When changing from one formulation to another (i.e. from tablets to powder for oral suspension), a change in dose may occur; in such cases, the dose should not be changed when switching from one formulation to another. Based on the patient's body surface area, side effects, and response to treatment, the doctor will determine the appropriate formulation and dose. The initial dose of Dasatinib Krka in 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 use 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 or divided tablets. If the tablets are crushed or divided, 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 this happens, 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 unless 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 too much Dasatinib Krka

If you accidentally take more tablets than you were told to, you should immediately inform 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 forgotten 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, Dasatinib Krka can cause side effects, although not everybody gets them.

All of the following may be signs of 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 (melena)
• signs of infection, such as fever, high temperature
• fever, mouth pain or throat pain, blistering or peeling of skin and (or) mucous membranes In case of any of the above 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
• Gastrointestinal disorders: diarrhoea, nausea or vomiting
• Skin, hair, eyes, general disorders: rash, fever, swelling of the face, hands and feet, headache, feeling tired or weak, bleeding
• Pain: muscle pain (during or after treatment), abdominal pain
• Laboratory tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, fluid 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 some cases that were fatal)
• Heart and lungs: rapid heartbeat, irregular heartbeat, heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, cough
• Gastrointestinal disorders: loss of appetite, taste disturbance, bloating or swelling of the abdomen, colitis, constipation, heartburn, mouth ulcers, weight gain, weight loss, gastritis
• Skin, hair, eyes, general disorders: tingling, itching, dry skin, acne, skin inflammation, ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred vision and disturbed vision), dry eyes, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, general swelling
• Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, muscle stiffness and joint stiffness
• Laboratory tests may show: fluid around the heart, fluid in the lungs, irregular heart rhythm, neutropenic fever, 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 some cases that were fatal), inflammation of the sac surrounding the heart, irregular heart rhythm, chest pain due to reduced blood flow to the heart (angina), low blood pressure, narrowing of the airways which can cause difficulty breathing, asthma, increased blood pressure in the arteries (blood vessels) of the lungs
• Gastrointestinal disorders: pancreatitis, stomach ulcers, oesophagitis, abdominal swelling, anal fissure, difficulty swallowing, gallbladder inflammation, bile duct obstruction, gastro-oesophageal reflux disease (a condition in which acid and other stomach contents flow back up into the throat)
• Skin, hair, eyes, general disorders: allergic reactions, including the development of tender red lumps on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremors, eye inflammation which causes redness or pain, skin disease characterized by the presence of tender red lumps and 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, disorders of the nails, hair or 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 reduced blood flow to the bone, resulting in bone loss and bone death), arthritis, skin swelling at any site on the body

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

• Heart and lungs: enlargement of the right side of the heart, heart muscle inflammation, a condition characterized by blockage of blood flow to the heart muscle (acute coronary syndrome), cardiac arrest (heart stoppage), coronary artery disease (heart disease), inflammation of the tissue surrounding the heart and lungs, blood clots, blood clots in the lungs
• Gastrointestinal disorders: malabsorption (a condition in which the gut does not absorb the necessary nutrients, such as proteins), intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the skin surrounding it), kidney problems, diabetes
• Skin, hair, eyes, general disorders: seizures, optic neuritis (inflammation of the nerve that carries visual information from the eye to the brain), which can cause total or partial loss of vision, purple spots on the skin, abnormal overactivity of the thyroid gland, thyroid inflammation, ataxia (a condition related to lack of muscle coordination), difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain: stroke, transient neurological disturbances due to 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 the 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
• Disease of blood vessels known as thrombotic microangiopathy (TMA, ang. thrombotic microangiopathy), including decreased red blood cell count, decreased platelet count and blood clot formation

During treatment, your doctor will check whether any of the above side effects have occurred.

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 for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +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 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 that 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 carboxymethylcellulose, 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.
Równoległa 5 Street
02-235 Warsaw
phone: +48 22 573 75 00
Date of last revision of the leaflet:15.09.2022