Dasatinib Viatris

Leaflet accompanying the packaging: information for the user

Dasatinib Viatris, 20 mg, film-coated tablets

Dasatinib Viatris, 50 mg, film-coated tablets

Dasatinib Viatris, 70 mg, film-coated tablets

Dasatinib Viatris, 80 mg, film-coated tablets

Dasatinib Viatris, 100 mg, film-coated tablets

Dasatinib Viatris, 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 doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What is Dasatinib Viatris and what is it used for
Important information before taking Dasatinib Viatris
How to take Dasatinib Viatris
Possible side effects
How to store Dasatinib Viatris
Contents of the packaging and other information

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

Dasatinib Viatris contains the active substance dasatinib. This medicine is used to treat acute
lymphoblastic leukemia (ALL) with Philadelphia chromosome (Ph+) 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 acute lymphoblastic leukemia, white blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Viatris inhibits the growth of these leukemia cells.
Dasatinib Viatris is also used to treat chronic myeloid leukemia (CML) 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 CML, white blood cells called granulocytes multiply in an uncontrolled manner. Dasatinib Viatris inhibits the growth of these leukemia cells.
If you have any questions about how Dasatinib Viatris works or why it has been prescribed for you, you should consult your doctor.

2. Important information before taking Dasatinib Viatris

When not to take Dasatinib Viatris

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

Warnings and precautions

Before starting to take Dasatinib Viatris, you should discuss this with your doctor or pharmacist.

• if you are taking blood-thinning medicines or medicines that prevent blood clots (see section "Dasatinib Viatris and other medicines")
• if you have had or currently have liver or heart problems
• if you experience difficulty breathing, chest pain, or cough while taking Dasatinib Viatris: 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 or may currently have a hepatitis B virus infection; this is because Dasatinib Viatris may cause the hepatitis B virus to become active again, which can be fatal in some cases; patients will be closely monitored by their doctor for signs of this infection before starting treatment
• if you experience bruising, bleeding, fever, fatigue, and confusion while taking Dasatinib Viatris, you should contact your doctor. This may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will perform regular checks during treatment to assess whether Dasatinib Viatris is having the desired effect. While taking Dasatinib Viatris, regular blood tests will also be performed.

Children and adolescents

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

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

The following medicines should not be taken with Dasatinib Viatris:

• 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 to treat epilepsy
• rifampicin - this is a medicine used to treat tuberculosis
• famotidine, omeprazole - these are medicines that block stomach acid production
• St. John's Wort - herbal medicines available without a 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 Viatris.
You should tell your doctor about any medicines that thin the blood or prevent blood clots.

Taking Dasatinib Viatris with food and drink

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

Pregnancy and breastfeeding

Women who are pregnant or think they may be pregnant should inform their doctor. Dasatinib Viatris should not be given to pregnant women unless it is absolutely necessary. Your doctor will discuss the risks that may occur during treatment with Dasatinib Viatris during pregnancy. It is recommended that both men and women use effective contraception during treatment with Dasatinib Viatris.
You should inform your doctor if you are breastfeeding. You should not breastfeed while taking Dasatinib Viatris.

Driving and using machines

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

Dasatinib Viatris contains lactose and sodium

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

3. How to take Dasatinib Viatris

Dasatinib Viatris 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 consult your doctor or pharmacist. Dasatinib Viatris is intended for adults and children aged 1 year and older.
The recommended initial dose of Dasatinib Viatris for adult patients in the chronic phase of CML is 100 mg taken orally once daily.
The recommended initial dose of Dasatinib Viatris for adult patients in the accelerated phase or blast crisis phase of CML, or with Philadelphia chromosome-positive acute lymphoblastic leukemia, is 140 mg taken orally once daily.
Dosing in children with CML in the chronic phase and Ph+ ALL is based on body surface area. Dasatinib is administered orally once daily in the form of either tablets or powder for oral suspension. It is not recommended to use dasatinib in tablet form 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 from one formulation to another (i.e., from tablets to powder for oral suspension), the dose may need to be adjusted; in such cases, the dose should not be changed 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 of Dasatinib Viatris. The initial dose of Dasatinib Viatris in children is calculated based on body surface area, as shown below:

Body surface area (m2) Daily dose (mg)

0.45 to less than 0.6 m2
40 mg
0.6 to less than 0.8 m2
60 mg
0.8 to less than 1.0 m2
70 mg
1.0 to less than 1.2 m2
80 mg
1.2 to less than 1.5 m2
100 mg
1.5 m2 or greater
140 mg
It is not recommended to use tablets 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 Viatris 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 a combination of tablets of different strengths.

How to take Dasatinib Viatris

Tablets should be taken at the same time every day. Tablets should be swallowed whole. They should not be crushed, cut, or chewed. Crushed, cut, chewed, or broken tablets should not be taken. If tablets are crushed, cut, chewed, or broken, it is uncertain whether the patient will receive the correct dose. Dasatinib Viatris tablets can be taken with or without food.

Special precautions for handling Dasatinib Viatris

It is unlikely that Dasatinib Viatris tablets will be damaged. However, if this happens, individuals who come into contact with the medicine should wear protective gloves.

How long to take Dasatinib Viatris

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

Taking more than the recommended dose of Dasatinib Viatris

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 Viatris

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 doubts about taking this medicine, you should consult 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.

• if you experience chest pain, difficulty breathing, coughing, 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, blisters, or peeling of the skin and mucous membranes

You should immediately inform your doctorif 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 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 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, weakened heart muscle, high blood pressure, increased blood pressure in the lungs, coughing
• Digestive system: loss of appetite, taste disturbances, bloating or swelling of the abdomen, 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 eye, 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 pain, muscle cramps
• Lab tests may show: fluid around the heart, fluid in the lungs, irregular heart rhythm, 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 lungs: enlarged right heart chamber, heart muscle inflammation, blockage of blood flow to the heart (acute coronary syndrome), cardiac arrest (stop 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
• Digestive system: malabsorption (reduced absorption of nutrients from the gut), intestinal obstruction, anal fistula (abnormal channel between the anus and the skin around the anus), kidney dysfunction, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic nerve inflammation (which can cause total or partial loss of vision), purple spots on the skin, overactive thyroid, thyroid inflammation, lack of coordination, difficulty walking, miscarriage, skin blood vessel inflammation, skin scarring
• Brain: memory loss
• Lab tests may show: tumor lysis syndrome (a condition caused by the breakdown of cancer cells), low albumin levels in the blood, low lymphocyte count in the blood, high cholesterol levels in the blood, swollen lymph nodes, brain bleeding, abnormal heart rhythm, enlarged heart, 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), milky fluid around the lungs (chylous effusion)

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

• Pneumonitis
• Gastrointestinal bleeding, which can be fatal
• Reactivation (recurrence) 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 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), including reduced red blood cell count, reduced platelet count, and blood clot formation

During treatment, your doctor will check for the above side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicines Monitoring, 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 Viatris

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, 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 packaging and other information

What Dasatinib Viatris 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:lactose monohydrate, microcrystalline cellulose (type 101), microcrystalline cellulose (type 102), sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate Tablet coating: lactose monohydrate, hypromellose (15 mPas), titanium dioxide (E171), triacetin (see section 2 "Dasatinib Viatris contains lactose and sodium")

What Dasatinib Viatris looks like and contents of the pack

Dasatinib Viatris, 20 mg: the film-coated tablet is white or almost white, biconvex, round with a diameter of about 5.6 mm, with "D7SB" engraved on one side and "20" on the other side.
Dasatinib Viatris, 50 mg: the film-coated tablet is white or almost white, biconvex, oval with a length of about 11.0 mm and a width of about 6.0 mm, with "D7SB" engraved on one side and "50" on the other side.
Dasatinib Viatris, 70 mg: the film-coated tablet is white or almost white, biconvex, round with a diameter of about 9.1 mm, with "D7SB" engraved on one side and "70" on the other side.
Dasatinib Viatris, 80 mg: the film-coated tablet is white or almost white, biconvex, triangular with a length of about 10.4 mm and a width of about 10.6 mm, with "D7SB" engraved on one side and "80" on the other side.
Dasatinib Viatris, 100 mg: the film-coated tablet is white or almost white, biconvex, oval with a length of about 15.1 mm and a width of about 7.1 mm, with "D7SB" engraved on one side and "100" on the other side.
Dasatinib Viatris, 140 mg: the film-coated tablet is white or almost white, biconvex, round with a diameter of about 11.7 mm, with "D7SB" engraved on one side and "140" on the other side.
Dasatinib Viatris, 20 mg, 50 mg, or 70 mg film-coated tablets are available in cardboard boxes containing 56 or 60 film-coated tablets in blisters, and in cardboard boxes containing 56 x 1 or 60 x 1 film-coated tablets in single-dose blisters. They are also available in containers containing 60 film-coated tablets.
Dasatinib Viatris, 80 mg, 100 mg, or 140 mg film-coated tablets are available in cardboard boxes containing 30 film-coated tablets in blisters, and 30 x 1 film-coated tablets in single-dose blisters. They are also available in containers containing 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

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
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
tel. 22 546 64 00
Date of last revision of the leaflet:01/2024