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

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, 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 the lymphoblastic phase of 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, ask 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). Consult your doctor if you think you may be allergic.

Warnings and precautions

Before starting treatment with Dasatinib Viatris, discuss it with your doctor or pharmacist.

• if you are taking blood thinners or medicines that prevent blood clots (see "Dasatinib Viatris 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 Viatris: this may be a sign of fluid buildup in the lungs or chest (which can occur more frequently in patients aged 65 and older) or changes in blood vessels that supply blood to the lungs
• if you have had or may have a hepatitis B virus infection; this is because Dasatinib Viatris may cause the hepatitis B virus to become active again, which can be life-threatening 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, 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

Do not use this medicine 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

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.

Do not take the following medicines 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 - a herbal medicine available without a 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 Viatris.
Tell your doctor if you are taking medicines that thin the blood or prevent blood clots.

Taking Dasatinib Viatris with food and drink

Do 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. The 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.
Tell your doctor if you are breastfeeding. Do not breastfeed while taking Dasatinib Viatris.

Driving and using machines

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

Dasatinib Viatris contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, tell your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Dasatinib Viatris

Dasatinib Viatris will only be prescribed by a doctor experienced in treating leukemia. Always take this medicine exactly as your doctor has told you. If you are unsure, 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 phase of CML, or with acute lymphoblastic leukemia with Philadelphia chromosome, is 140 mg taken orally once daily.
Dosing in children with CML in the chronic phase and Ph+ ALL is based on body weight. Dasatinib is given 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 switching from one form to another (i.e., tablets and powder for oral suspension), the dose may need to be adjusted; in such cases, do not switch from one form to another. Based on the patient's body weight, side effects, and response to treatment, the doctor will determine the appropriate form and dose of the medicine. The initial dose of Dasatinib Viatris 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
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 temporarily stop treatment. To administer large or small doses, it may be necessary to use a combination of tablets of different strengths.

How to take Dasatinib Viatris

Take the tablets at the same time every day. Swallow the tablets whole. Do not crush, cut, or chew them. Do not take crushed or broken tablets. If the tablets are crushed, cut, chewed, or broken, it is uncertain whether the patient has received 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, people handling the medicine should wear protective gloves.

How long to take Dasatinib Viatris

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

Taking more Dasatinib Viatris 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 Viatris

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 doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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, chills
• if you experience fever, mouth pain, or throat pain, blisters, 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 lungs: shortness of breath
• Digestive disorders: diarrhea, nausea or vomiting
• Skin, hair, eyes, general symptoms: 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
• 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, coughing
• Digestive disorders: loss of appetite, taste disturbances, bloated or enlarged abdomen, colitis, constipation, heartburn, mouth sores, 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, 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 heartbeat, 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: heart attack (including fatal cases), pericarditis, irregular heartbeat, chest pain due to lack of blood flow to the heart (angina), low blood pressure, bronchospasm, increased blood pressure in the pulmonary arteries
• Digestive disorders: pancreatitis, stomach ulcers, esophagitis, intestinal obstruction, rectal fistula, kidney dysfunction, diabetes
• Skin, hair, eyes, general symptoms: seizures, optic neuritis (which can cause total or partial loss of vision), purple spots on the skin, hyperthyroidism, thyroiditis, ataxia, walking difficulties, miscarriage, vasculitis, scleroderma
• Brain: memory loss
• Lab tests may show: abnormal blood test results and possible kidney dysfunction due to dying tumor cells (tumor lysis syndrome), 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 mucous membrane ulcers
• Kidney disease symptoms, including swelling and abnormal lab test results, such as protein in the urine and low protein levels in the blood
• Damaged 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 for the above side effects.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Dasatinib Viatris

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label, blister, and carton after: EXP. The expiry date refers to the last day of the month stated. The batch number is stated on the bottle label, blister, and carton: Lot.
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 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.
• 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 cartons containing 56 or 60 film-coated tablets in blisters and in cartons 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 cartons 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
For more information, contact your local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
phone: 22 546 64 00
Date of last revision of the leaflet:01/2024