Dasatinib Stada

Leaflet accompanying the packaging: information for the user

Dasatinib Stada, 20 mg, film-coated tablets

Dasatinib Stada, 50 mg, film-coated tablets

Dasatinib Stada, 70 mg, film-coated tablets

Dasatinib Stada, 80 mg, film-coated tablets

Dasatinib Stada, 100 mg, film-coated tablets

Dasatinib Stada, 140 mg, film-coated tablets

Dasatinib

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

• Keep this leaflet, 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Dasatinib Stada 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 infections. In people with CML, white blood cells called granulocytes grow out of control. Dasatinib Stada inhibits the growth of these cancer cells.

Dasatinib Stada is also used to treat acute lymphoblastic leukemia (ALL) with a positive Philadelphia chromosome (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 Stada inhibits the growth of these cancer cells.

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

2. Important information before taking Dasatinib Stada

When not to take Dasatinib Stada

• if you are allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you suspect an allergy.

Warnings and precautions

Before starting to take Dasatinib Stada, discuss it with your doctor or pharmacist.

• if you are taking blood thinners or medicines that prevent blood clots (see "Dasatinib Stada and other medicines");
• if you have had liver or heart problems in the past or currently;
• if you experience difficulty breathing, chest pain, or cough while taking dasatinib: 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 changes in the blood vessels that supply blood to the lungs;
• if you have ever had a hepatitis B virus infection or suspect you have one now, as dasatinib may cause the hepatitis B virus to become active again, which can be life-threatening. Before starting treatment, your doctor will check if you have this infection.
• if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Stada, contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will monitor your health during treatment to assess whether dasatinib is having the desired effect. You will also have regular blood tests while taking Dasatinib Stada.

Children and adolescents

Do not give this medicine to children under 1 year of age. There is limited data on the use of dasatinib in this age group. In children taking Dasatinib Stada, bone growth and development should be closely monitored.

Dasatinib Stada and other medicines

Tell your doctorabout all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

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

Do not take the following medicines with dasatinib:

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

Do not takemedicines that neutralize stomach acid (such as aluminum hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking dasatinib. Tell your doctorif you are taking blood thinners or medicines that prevent blood clots.

Taking Dasatinib Stada with food and drink

Do not take dasatinib with grapefruit or grapefruit juice.

Pregnancy and breastfeeding If you are pregnant or think you may be pregnant, you should

tell your doctor immediately. Dasatinib should not be taken during pregnancy, unless it is absolutely necessary. Your doctor will discuss the possible risks of taking dasatinib during pregnancy with you. Both men and women taking dasatinib are advised to use effective contraception. Tell your doctor if you are breastfeeding. You should not breastfeed while taking dasatinib.

Driving and using machines

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

Dasatinib Stada contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

Dasatinib Stada contains sodium

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

3. How to take Dasatinib Stada

Dasatinib Stada can only be prescribed by a doctor experienced in treating leukemia. This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. Dasatinib Stada is prescribed for adults, adolescents, and children aged 1 year and older.

The recommended initial dose of Dasatinib Stada for adult patients with chronic phase CML is

100 mg once daily.

The recommended initial dose of Dasatinib Stada for adult patients with accelerated phase or blast crisis CML or Ph+ ALL is 140 mg once daily.

Dosing in children with CML in chronic phase or Ph+ ALL is based on body surface area.

Dasatinib is given orally once daily in the form of tablets or powder for oral suspension. It is not recommended to use Dasatinib Stada 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 switching from one formulation to another (i.e., tablets and powder for oral suspension), a dose adjustment may be necessary, so do not switch 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 Stada 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
Dasatinib Stada tablets should not be used in patients with a body weight of less than 10 kg; in these patients, the powder for oral suspension should be used.
There are no recommendations for the dose of Dasatinib Stada in children under 1 year of age.
Based on the response to treatment, the doctor may decide to increase or decrease the dose, or even interrupt treatment temporarily. To administer large or small doses, it may be necessary to use multiple tablets of different strengths.

How to take Dasatinib Stada

Tablets should be taken every day at the same time. Tablets should be swallowed whole. Do notcrush, cut, or chew them. Do not take crushed, cut, chewed, or broken tablets. If tablets are crushed, cut, chewed, or broken, it is uncertain whether the patient received the correct dose. Dasatinib Stada can be taken with or without food.

Special precautions for handling Dasatinib Stada

It is unlikely that Dasatinib Stada tablets will be damaged. However, if this happens, people other than the patient who come into contact with the medicine should wear protective gloves.

How long to take Dasatinib Stada

Dasatinib Stada should be taken every day, until your doctor decides to stop taking the medicine. Make sure Dasatinib Stada is taken for as long as your doctor has prescribed.

Taking more Dasatinib Stada than prescribed

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

Missing a dose of Dasatinib Stada

Do not take a double dose to make up for a missed tablet. Take the next scheduled dose at the usual time.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

All the following symptoms may indicate serious side effects:

• if you experience chest pain, difficulty breathing, cough, and fainting;
• if you experience unexpected bleeding or bruising without previous injury;
• if you vomit blood, have black stools, or blood in your urine;
• if you experience symptoms of infection such as fever, severe chills;
• if you experience fever, mouth pain, or throat pain, blistering, or peeling of the skin and (or) mucous membranes. Tell your doctor immediatelyif you experience any of the above symptoms.

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

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

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

• Infections: pneumonia, herpes virus infection (including cytomegalovirus infection), upper respiratory tract infections, severe blood or tissue infections (including rare cases that were fatal)
• Heart and lung disorders: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 disturbances, bloated or enlarged 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), dry eye, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling
• Pain:joint pain, muscle weakness, chest pain, pain in arms and legs, chills, muscle stiffness and joint stiffness, muscle cramps
• Additional tests may show:fluid around the heart, fluid in the lungs, heart rhythm disturbances, low white blood cell count (neutropenia) with fever, gastrointestinal bleeding, high uric acid levels in the blood

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

• Heart and lung disorders:heart attack (including fatal cases), inflammation of the heart sac, irregular heartbeat, 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
• Gastrointestinal disorders: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 disorders:allergic reactions, including hypersensitivity to pressure, red nodules on the skin (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremors, eye inflammation, which can cause redness or pain, skin condition characterized by sensitivity to pressure, redness, and the appearance of distinct red patches on the skin with sudden onset of fever and increased white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, vision disturbances (including blurred vision), dry eye, bruising, depression, insomnia, flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling, 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 characterized by decreased blood flow to the bone, which can cause bone tissue loss and death), joint inflammation, skin swelling anywhere on the body
• Pain:inflammation of the veins, which can cause redness, pain, and swelling, tendon inflammation
• Brain:memory loss
• Additional tests may show:tumor lysis syndrome (a condition caused by the breakdown of cancer cells, which can lead to kidney damage), low albumin levels in the blood, low lymphocyte count in the blood, high cholesterol levels in the blood, swollen lymph nodes, bleeding in the brain, abnormal heart rhythm, enlarged heart, liver inflammation, protein in the urine, increased creatine phosphokinase activity (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin activity (an enzyme found mainly in the heart and skeletal muscles), increased gamma-glutamyltransferase activity (an enzyme found mainly in the liver), milky fluid around the lungs (chylous effusion)

Rare side effects (may affect up to 1 in 1,000 people)

• Heart and lung disorders:enlargement of the right heart chamber, heart muscle inflammation, coronary artery syndrome (a condition caused by blockage of blood flow to the heart), cardiac arrest (when the heart stops pumping blood), 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 body does not absorb certain nutrients), intestinal obstruction, anal fistula (an abnormal connection between the anus and the skin), kidney disease, diabetes
• Skin, hair, eyes, general disorders:seizures, optic nerve inflammation, which can cause total or partial loss of vision, purple spots on the skin, overactive thyroid, thyroid inflammation, ataxia (a condition characterized by 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, growth retardation

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

• Pneumonia
• Bleeding in the stomach or intestines, which can be fatal
• Reactivation of hepatitis B virus infection (liver infection) in patients who have had the disease in the past
• Reaction with fever, blisters, and ulcers of the mucous membranes
• Kidney disease with symptoms including swelling and abnormal laboratory test results, such as protein in the urine and low albumin levels in the blood
• Blood vessel damage 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 these side effects.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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 Stada

Keep the medicine out of the sight and reach of children.

Do not take this medicine after the expiry date stated on the label, blister, or carton after "EXP". The expiry date refers to the last day of the month stated.

The abbreviation "Lot" on the label, blister, or carton means "Batch number". There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. 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 Stada 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.
• The other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate (see section 2 "Important information before taking Dasatinib Stada"); sodium carboxymethylcellulose, hydroxypropylcellulose, magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E 171), talc, glycerol monostearate, sodium lauryl sulfate.

What Dasatinib Stada looks like and contents of the pack

Dasatinib Stada 20 mg: the film-coated tablet is white or almost white, biconvex, round, with "20" engraved on one side and smooth on the other, with a diameter of 6.1 mm.

Dasatinib Stada 50 mg: the film-coated tablet is white or almost white, biconvex, oval, with "50" engraved on one side and smooth on the other, with dimensions of 10.9 mm x 5.8 mm.

Dasatinib Stada 70 mg: the film-coated tablet is white or almost white, biconvex, round, with "70" engraved on one side and smooth on the other, with a diameter of 8.9 mm.

Dasatinib Stada 80 mg: the film-coated tablet is white or almost white, biconvex, triangular, with "80" engraved on one side and smooth on the other, with dimensions of 10.3 mm x 10.0 mm.

Dasatinib Stada 100 mg: the film-coated tablet is white or almost white, biconvex, oval, with "100" engraved on one side and smooth on the other, with dimensions of 14.8 mm x 7.2 mm.

Dasatinib Stada 140 mg: the film-coated tablet is white or almost white, biconvex, round, with "140" engraved on one side and smooth on the other, with a diameter of 11.8 mm.

Dasatinib Stada, 20 mg, 50 mg, 70 mg, film-coated tablets

Aluminum/OPA/Aluminum/PVC (perforated blisters divisible into single doses).

Aluminum/OPA/Aluminum/PVC blisters.

High-density polyethylene (HDPE) bottles with child-resistant polypropylene caps and a plastic container (HDPE) containing a desiccant (silica gel).

Cartons containing 60 x 1 or 100 x 1 film-coated tablets in perforated blisters divisible into single doses.

Cartons containing 60 or 100 film-coated tablets in blisters.

Cartons containing a bottle of 60 film-coated tablets.

Dasatinib Stada, 80 mg, 100 mg, 140 mg, film-coated tablets

Aluminum/OPA/Aluminum/PVC (perforated blisters divisible into single doses).

Aluminum/OPA/Aluminum/PVC blisters.

High-density polyethylene (HDPE) bottles with child-resistant polypropylene caps and a plastic container (HDPE) containing a desiccant (silica gel).

Cartons containing 30 x 1, 60 x 1, or 100 x 1 film-coated tablets in perforated blisters divisible into single doses.

Cartons containing 30, 60, or 100 film-coated tablets in blisters.

Cartons containing a bottle of 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer/Importer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:

Stada Pharm Sp. z o.o.

ul. Krakowiaków 44

02-255 Warsaw

Tel. +48 22 737 79 20

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium

Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Germany

Dasatinib AL 20mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Denmark

Dasatinib STADA

Finland

Dasatinib STADA 20, 50, 70, 80, 100, 140 mg film-coated tablets

Italy

Dasatinib EG

Luxembourg

Dasatinib EG 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Netherlands

Dasatinib CF 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg, film-coated tablets

Poland

Dasatinib Stada

Sweden

Dasatinib STADA 20, 50, 70, 80, 100, 140 mg film-coated tablets

Date of last revision of the leaflet: 02/2025