DASATINIB VIATRIS 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dasatinib Viatris 20mg film-coated tablets EFG

Dasatinib Viatris 50mg film-coated tablets EFG

Dasatinib Viatris 70mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dasatinib Viatris and what is it used for
2. What you need to know before you take Dasatinib Viatris
3. How to take Dasatinib Viatris
4. Possible side effects
5. Storage of Dasatinib Viatris
6. Contents of the pack and other information

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

This medicinal product contains the active substance dasatinib. This medicinal product is used to treat chronic myeloid leukaemia (CML) in adults, adolescents and children from 1 year of age. Leukaemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infection. In patients with CML, a type of white blood cell called granulocytes start to multiply out of control. This medicinal product inhibits the growth of these leukaemic cells.

This medicinal product is also used to treat Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) in adults, adolescents and children from 1 year of age and lymphoid blast crisis CML in adults who have not benefited from previous treatments. Leukaemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infection. In patients with ALL, a type of white blood cell called lymphocytes multiply too quickly and live too long. This medicinal product inhibits the growth of these leukaemic cells.

If you have any questions about how this medicinal product works or why this medicinal product has been prescribed for you, ask your doctor.

2. What you need to know before you take Dasatinib Viatris

Do not take Dasatinib Viatris

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

If you think you may be allergic, ask your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicinal product

• If you are taking medicines to make your blood thinner or prevent blood clots (see “Other medicines and Dasatinib Viatris”).
• If you have or have had any liver or heart problems.
• If you start to have difficulty breathing, chest pain or cough while taking this medicinal product: this may be a sign of fluid build-up in the lungs or chest (which may be more frequent in patients 65 years or older) or due to 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 this medicinal product could cause hepatitis B to become active again, which can be fatal in some cases. Your doctor will carefully check for signs of this infection before starting treatment.
• If you experience bruising, bleeding, fever, fatigue and confusion while taking this medicinal product, contact your doctor. This may be a sign of blood vessel damage known as thrombotic microangiopathy (TMA).

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

Children and adolescents

Do not give this medicinal product to children under 1 year of age. Experience with the use of this medicinal product in this age group is limited. In children taking this medicinal product, growth and bone development should be closely monitored.

Other medicines and Dasatinib Viatris

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This medicinal product is mainly broken down by the liver. Some medicines may interfere with the effect of this medicinal product when taken together.

The following medicines must not be used during treatment with dasatinib:

• Ketoconazole, itraconazole – medicines for fungi.
• Erythromycin, clarithromycin, telithromycin – antibiotics.
• Ritonavir – an antiviral medicine.
• Phenytoin, carbamazepine, phenobarbital – treatments for epilepsy.
• Rifampicin – a treatment for tuberculosis.
• Famotidine, omeprazole – medicines that block stomach acid secretion.
• St John’s Wort – a herbal medicine that can be bought without a prescription for the treatment of depression and other illnesses (also known as Hypericum perforatum).

Do not take medicines that neutralise stomach acid (antacids such as aluminium hydroxide/magnesium hydroxide) in the 2 hours before or 2 hours after taking this medicinal product.

Tell your doctor if you are taking medicines to make your blood thinner or prevent blood clots.

Taking Dasatinib Viatris with food and drinks

Do not take this medicinal product with grapefruit or grapefruit juice.

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, tell your doctor immediately. This medicinal product must not be used during pregnancy unless clearly necessary. Your doctor will inform you of the potential risk of taking this medicinal product during pregnancy.

Both men and women are advised to use effective contraceptive methods during treatment with dasatinib.

If you are breast-feeding, tell your doctor. You must stop breast-feeding while taking this medicinal product.

Driving and using machines

Be careful while driving or using machines if you experience side effects such as dizziness or blurred vision.

Dasatinib Viatris contains lactose and sodium

This medicinal product contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicinal product.

This medicinal product contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Dasatinib Viatris

This medicinal product will only be prescribed by a doctor with experience in the treatment of leukaemia. Follow exactly the instructions of your doctor. If you are unsure, ask your doctor or pharmacist. This medicinal product is prescribed for adults and children from 1 year of age.

The recommended initial dose for adult patients with CML in the chronic phase is 100 mg once a day.

The recommended initial dose for adult patients with CML in the accelerated phase or blast crisis or Ph+ ALL is 140 mg once a day.

Dosing regimen in children with CML in the chronic phase or Ph+ ALL based on body weight. Dasatinib is administered orally once a day, either as tablets or as powder for oral suspension. Dasatinib tablets are not recommended in patients weighing less than 10 kg. The powder for oral suspension should be used in patients weighing less than 10 kg and in patients who cannot swallow tablets. A change in dose may be required when changing between formulations (i.e. tablets and powder for oral suspension), so do not change between formulations. Your doctor will decide on the correct formulation and dose based on your weight, side effects and response to treatment. In children, the starting dose of this medicinal product is calculated based on body weight as shown below:

a Dasatinib tablets are not recommended in patients weighing less than 10 kg, the powder for oral suspension should be used in these patients.

There is no recommendation for the use of this medicinal product in children under 1 year of age.

Depending on how you respond to treatment, your doctor may prescribe a higher or lower dose, or even interrupt treatment briefly. To take higher or lower doses you may need to take combinations of tablets of different strengths.

How to take Dasatinib Viatris

Take the tablets at the same time each day. Swallow the tablets whole. Do not crush, cut or chew them. Do not take the tablets dissolved. It cannot be guaranteed that you will receive the correct dose if the tablets are crushed, cut, chewed or dispersed. The tablets of this medicinal product can be taken with or without food.

Special handling instructions for dasatinib

It is unlikely that dasatinib tablets will break, but if they do break, people other than the patient should wear gloves when handling this medicinal product.

How long to take this medicinal product

Take this medicinal product every day until your doctor tells you to stop. Make sure to take this medicinal product for the duration it has been prescribed for.

If you take more Dasatinib Viatris than you should

If you accidentally take too many tablets, contact your doctor immediately. You may need medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicinal product and the amount ingested.

If you forget to take Dasatinib Viatris

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

If you have any other questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following may be signs of serious adverse effects:

• If you have chest pain, difficulty breathing, coughing, and fainting.
• If you have unexpected bleeding or bruising without injury.
• If you notice blood in your vomit, stools, or urine, or have black stools.
• If you develop symptoms of infection, such as fever, severe chills.
• If you have fever, mouth or throat pain, itching, or skin and/or mucous membrane peeling.

Contact your doctor immediatelyif you experience any of the above.

Adverse effects very frequently(may affect more than 1 in 10 people)

• Infections (caused by bacteria, viruses, and fungi).
• Heart and lungs: difficulty breathing.
• Digestive problems: diarrhea, feeling unwell (nausea, vomiting).
• Skin, hair, eyes, general: skin rash, fever, swelling in the face, hands, and feet, headache, fatigue or weakness, bleeding.
• Pain: muscle pain (during or after stopping treatment), abdominal pain.
• Laboratory tests: low platelet count, low white blood cell count (neutropenia), anemia, fluid around the lungs.

Adverse effects frequently(may affect up to 1 in 10 people)

• Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infection, severe blood or tissue infection (including rare cases with fatal outcomes).
• Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, high blood pressure in the lungs, coughing.
• Digestive problems: changes in appetite, changes in taste, abdominal distension or swelling, colon inflammation, constipation, gastroesophageal reflux, mouth ulcers, weight loss, weight gain, gastritis.
• Skin, hair, eyes, general: tingling sensation on the skin, itching, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, visual disturbances (including blurred vision and distorted vision), dry eyes, bruising, depression, insomnia, hot flashes, dizziness, bruising, anorexia, somnolence, generalized edema.
• Pain: joint pain, muscle weakness, chest pain, pain in the hands and feet, chills, muscle and joint stiffness, muscle spasms.
• Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, gastrointestinal bleeding, high levels of uric acid in the blood.

Adverse effects infrequently(may affect up to 1 in 100 people)

• Heart and lungs: heart attack (including fatal outcome), inflammation of the membrane surrounding the heart (pericarditis), irregular heartbeat, chest pain due to lack of blood supply to the heart (angina), low blood pressure, narrowing of the airways that could cause breathing difficulties, asthma, high blood pressure in the arteries (blood vessels) that go to the lungs.
• Digestive problems: pancreas inflammation, peptic ulcer, digestive tract inflammation, abdominal swelling, anal canal skin tear, difficulty swallowing, gallbladder inflammation, bile duct blockage, gastroesophageal reflux (acid and other stomach contents returning to the throat).

• Skin, hair, eyes, general: allergic reactions including sensitivity, red lumps on the skin (erythema nodosum), anxiety, confusion, mood swings, low sex drive, fainting, tremors, eye inflammation that can cause redness or pain, skin disease characterized by sensitivity, redness, well-defined spots with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, sensitivity to light, visual disturbance, increased eye tearing, changes in skin pigmentation, inflammation of the fatty tissue under the skin, skin ulcers, blisters on the skin, changes in nails, changes in hair, changes in hands and feet, kidney failure, frequent urination, breast enlargement in men, changes in menstruation, general weakness and malaise, low thyroid function, loss of balance while walking, osteonecrosis (a disease where blood supply to the bones is reduced, which can cause bone loss and death), arthritis, skin swelling anywhere on the body.
• Pain: inflammation of the veins that can cause redness, sensitivity, and swelling, tendon inflammation.
• Brain: memory loss.
• Laboratory tests: abnormal blood test results and possible kidney failure caused by tumor waste products during healing (tumor lysis syndrome), low albumin levels in blood, low lymphocyte levels (a type of white blood cell) in blood, high cholesterol levels in blood, swelling of lymph nodes, cerebral hemorrhage, irregular heart electrical activity, enlarged heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), elevated troponin (an enzyme found mainly in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme found mainly in the liver), milky fluid around the lungs (chylothorax).

Adverse effects rarely(may affect up to 1 in 1,000 people)

• Heart and lungs: right ventricular dilation, heart muscle inflammation, set of symptoms produced by blockage of blood supply to the heart muscle (acute coronary syndrome), heart attack (interruption of blood supply to the heart), coronary artery disease (of the heart), inflammation of the tissue that covers the heart and lungs, blood clots, blood clots in the lungs.
• Digestive problems: loss of vital nutrients such as proteins from the digestive system, intestinal obstruction, anal fistula (abnormal opening of the anus to the surrounding skin), kidney failure, diabetes.
• Skin, hair, eyes, general: convulsions, optic nerve inflammation that can cause complete or partial vision loss, bluish-purple spots on the skin, abnormally high thyroid function, thyroid gland inflammation, ataxia (associated with loss of muscle coordination), difficulty walking, spontaneous abortion, skin vessel inflammation, cutaneous fibrosis.
• Brain: stroke, temporary episode of neurological failure caused by loss of blood flow, facial nerve paralysis, dementia.
• Immune system: severe allergic reactions.
• Connective tissue and musculoskeletal system: delayed fusion of the rounded ends that form joints (epiphysis); slow or delayed growth.

Other adverse effects that have been reported with unknown frequency(cannot be estimated from available data)

• Lung inflammation.
• Bleeding in the stomach or intestine that can cause death.
• Recurrence (reactivation) of hepatitis B virus infection if you have had hepatitis B in the past (a liver infection).
• Reaction with fever, blisters on the skin, and mucous membrane ulcers.
• Kidney disorders with symptoms such as edema and abnormal laboratory test results such as protein in the urine and low protein levels in the blood.
• Damage to blood vessels known as thrombotic microangiopathy (TMA), which includes decreased red blood cell count, decreased platelet count, and blood clot formation.

Your doctor will check if you have any of these effects during your treatment.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dasatinib Viatris

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

Do not use this medicine after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be thrown away in drains or trash. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dasatinib Viatris

• The active ingredient is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, or 70 mg of dasatinib.
• The other ingredients are:

Tablet core: lactose monohydrate (200); microcrystalline cellulose (101 and 102); sodium croscarmellose; hydroxypropylcellulose (MW 80,000); magnesium stearate.

Film coating: lactose monohydrate; hypromellose (15 mPas); titanium dioxide (E171); triacetin.

(see section 2 "Dasatinib Viatris contains lactose and sodium")

Appearance and Package Contents

Dasatinib Viatris 20 mg: the film-coated tablets are white to off-white, biconvex, round, with a diameter of approximately 5.6 mm, with "D7SB" engraved on one side and "20" on the other.

Dasatinib Viatris 50 mg: the film-coated tablets are white to off-white, biconvex, oval, with a length of approximately 11.0 mm and a width of approximately 6.0 mm, with "D7SB" engraved on one side and "50" on the other.

Dasatinib Viatris 70 mg: the film-coated tablets are white to off-white, biconvex, round, with a diameter of approximately 9.1 mm, with "D7SB" engraved on one side and "70" on the other.

Dasatinib Viatris 20 mg, 50 mg, and 70 mg film-coated tablets are available in packages containing 56 or 60 film-coated tablets in blisters or containing 56 x 1 or 60 x 1 film-coated tablets in unit-dose blisters. They are also available in packages containing 60 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Synthon Hispania S.L.

Castelló, 1 - Polígono Las Salinas

08830 - Sant Boi de Llobregat

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Date of the last revision of this leaflet:July 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/