Dasatinib Viatris 70 mg film-coated tablets EFG

Package leaflet: Information for the user

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 the entire 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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

This medicine contains the active substance dasatinib. This medicine is used to treat chronic myeloid leukaemia (CML) in adults, adolescents, and children at least 1 year of age. Leukaemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infections. In patients with CML, a type of white blood cell called granulocytes begins to multiply uncontrollably. This medicine inhibits the growth of these leukaemic cells.

This medicine is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) in adults, adolescents, and children at least 1 year of age, and lymphoid blast chronic myeloid leukaemia in adults who have not benefited from prior treatments. Leukaemia is a type of cancer of the white blood cells. These white blood cells normally help the body fight infections. In patients with ALL, a type of white blood cell called lymphocytes multiplies too quickly and lives too long. This medicine inhibits the growth of these leukaemic cells.

If you have any questions about how this medicine works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Dasatinib Viatris

Do not take Dasatinib Viatris

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine

• If you are taking medicines to thin the blood or prevent blood clots (see “Other medicines and Dasatinib Viatris”).
• If you have or have had any liver or heart problems.
• If you start having difficulty breathing, chest pain, or cough while taking this medicine: this may be a sign of fluid retention in the lungs or chest (which may be more common in patients aged 65 years or older) or due to changes in the blood vessels supplying blood to the lungs.
• If you have ever had or may currently have an infection with hepatitis B virus. This is because this medicine 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 medicine, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will monitor your condition regularly to check whether this medicine is having the desired effect. You will also have periodic blood tests while receiving this medicine.

Children and adolescents

Do not give this medicine to children under one year of age. Experience with the use of this medicine in this age group is limited. In children taking this medicine, 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 need to take any other medicines.

This medicine is mainly metabolized by the liver. Some medicines may interfere with the effect of this medicine when taken together.

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

• Ketoconazole, itraconazole – antifungal medicines.
• Erythromycin, clarithromycin, telithromycin – antibiotics.
• Ritonavir – an antiviral medicine.
• Phenytoin, carbamazepine, phenobarbital – treatments for epilepsy.
• Rifampicin – a treatment for tuberculosis.
• Famotidine, omeprazole – medicines that block acidic stomach secretions.
• St. John’s wort – a herbal medicine available without prescription used for the treatment of depression and other conditions (also known as Hypericum perforatum).

Do not take medicines that neutralize stomach acid (antacids such as aluminium hydroxide/magnesium hydroxide) within 2 hours before or 2 hours after taking this medicine.

Inform your doctor if you are taking medicines to thin the blood or prevent blood clots.

Taking Dasatinib Viatris with food and drink

Do not take this medicine with grapefruit or grapefruit juice.

Pregnancy and breastfeeding

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

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

If you are breastfeeding, inform your doctor. You must stop breastfeeding while taking this medicine.

Driving and using machines

Exercise particular caution when driving or operating machinery if you experience adverse effects such as dizziness or blurred vision.

Dasatinib Viatris contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Dasatinib Viatris

This medicine will only be prescribed by a doctor experienced in the treatment of leukemia. Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist. This medicine is prescribed for adults and children aged at least 1 year.

The recommended initial dose for adult patients with chronic phase CML is 100 mg once daily.

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

Dosing schedule for children with chronic phase CML or Ph+ ALL based on body weight. Dasatinib is administered orally once daily, either as tablets or as oral suspension powder. Dasatinib tablets are not recommended for patients weighing less than 10 kg. The oral suspension powder should be used in patients weighing less than 10 kg and in patients who cannot swallow tablets. A dose adjustment is required when switching between formulations (i.e., tablets and oral suspension powder); therefore, do not switch from one formulation to the other without medical advice. Your doctor will determine the appropriate formulation and dose based on your body weight, side effects, and response to treatment. In children, the starting dose of this medicine is calculated according to body weight as shown below:

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

There is no dosage recommendation for this medicine 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 temporarily interrupt treatment. 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 dissolved tablets. If you crush, cut, chew, or disperse the tablets, you cannot be sure of receiving the correct dose. The tablets of this medicine may be taken with or without food.

Special handling instructions for dasatinib

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

How long to take this medicine

Take this medicine daily until your doctor instructs you to stop treatment. Make sure you take this medicine for the prescribed duration.

If you take more Dasatinib Viatris than you should

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

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

If you forget to take Dasatinib Viatris

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

If you have any further questions about 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 everyone will experience them.

The following may be signs of serious adverse effects:

• If you have chest pain, difficulty breathing, cough, or 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 signs of infection, such as fever or severe chills.
• If you have fever, mouth or throat pain, burning sensation, or skin and/or mucous membrane peeling.

Contact your doctor immediately if you experience any of the above.

Very common adverse effects (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: rash, fever, swelling of the face, hands, and feet, headache, tiredness 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.

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

• Infections: pneumonia, herpes virus infection (including cytomegalovirus – CMV), upper respiratory tract infection, severe infection of the blood or tissues (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, cough.
• Digestive problems: changes in appetite, changes in taste, abdominal distension or bloating, inflammation of the colon, constipation, esophageal reflux, mouth ulcers, weight loss, weight gain, gastritis.
• Skin, hair, eyes, general: tingling of 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 flushes, dizziness, contusions (bruises), anorexia, somnolence, generalized edema.
• Pain: joint pain, muscle weakness, chest pain, pain in the feet and hands, chills, muscle and joint stiffness, muscle spasm.
• Laboratory tests: fluid around the heart, fluid in the lungs, heart arrhythmias, febrile neutropenia, gastrointestinal bleeding, elevated levels of uric acid in the blood.

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

• Heart and lungs: heart attack (including fatal outcome), inflammation of the membrane surrounding the heart (fibrous sac), irregular heartbeat, chest pain due to reduced 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) going to the lungs.
• Digestive problems: inflammation of the pancreas, peptic ulcer, inflammation of the digestive tract, abdominal swelling, anal skin tear, difficulty swallowing, inflammation of the gallbladder, blockage of bile ducts, gastroesophageal reflux (stomach acid and other contents flowing back into 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, tremor, eye inflammation that may 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, light sensitivity, visual disturbance, increased eye tearing, changes in skin color, inflammation of the fatty tissue under the skin, skin ulcer, blisters on the skin, nail changes, hair changes, changes in hands and feet, kidney failure, frequent urination, enlarged breasts in men, menstrual disorders, general weakness and malaise, low thyroid function, loss of balance while walking, osteonecrosis (a condition where blood supply to the bones is reduced, which may lead to bone loss and death), arthritis, skin swelling anywhere on the body.
  • Pain: inflammation of veins that may cause redness, tenderness, and swelling, tendon inflammation.
  • Brain: memory loss.
  • Laboratory tests: abnormal blood test results and possibly kidney failure caused by tumor breakdown products during treatment (tumor lysis syndrome), low blood albumin levels, low lymphocyte count (a type of white blood cell) in the blood, elevated blood cholesterol levels, swollen lymph nodes, brain hemorrhage, irregularity in the heart's electrical activity, enlarged heart, liver inflammation, protein in urine, elevated creatine phosphokinase (an enzyme found mainly in the heart, brain, and skeletal muscles), increased troponin (an enzyme found mainly in the heart and skeletal muscle), elevated gamma-glutamyl transferase (an enzyme found mainly in the liver), milky-looking fluid around the lungs (chylothorax).

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

• Heart and lungs: dilation of the right ventricle of the heart, inflammation of the heart muscle, a set of symptoms caused 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 covering the heart and lungs, blood clots, blood clots in the lungs.
• Digestive problems: loss of vital nutrients such as proteins from your digestive system, intestinal obstruction, anal fistula (abnormal opening from the anus to the surrounding skin), impaired kidney function, diabetes.
• Skin, hair, eyes, general: seizure, inflammation of the optic nerve that may cause complete or partial vision loss, bluish to purplish spots on the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (associated with loss of muscle coordination), difficulty walking, miscarriage, inflammation of the skin's blood vessels, cutaneous fibrosis.
• Brain: stroke, transient episode of neurological deficiency caused by loss of blood flow, facial nerve paralysis, dementia.
• Immune system: severe allergic reactions.
• Connective tissue and musculoskeletal: delayed fusion of the rounded ends forming joints (epiphyses); slow or delayed growth.

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

• Inflammation of the lungs.
• Bleeding in the stomach or intestine, which may be fatal.
• 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 mucosal ulceration.
• 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 reduced red blood cell count, reduced platelets, and blood clot formation.

Your doctor will monitor you for any of these effects during your treatment.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after CAD/EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dasatinib Viatris

• The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg or 70 mg of dasatinib.
• The other components 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 of the product and contents of the pack

Dasatinib Viatris 20 mg: the film-coated tablets (tablets) are white to off-white, biconvex, round, with an approximate diameter of 5.6 mm, engraved with “D7SB” on one side and “20” on the other.

Dasatinib Viatris 50 mg: the film-coated tablets (tablets) are white to off-white, biconvex, oval, with an approximate length of 11.0 mm and an approximate width of 6.0 mm, engraved with “D7SB” on one side and “50” on the other.

Dasatinib Viatris 70 mg: the film-coated tablets (tablets) are white to off-white, biconvex, round, with an approximate diameter of 9.1 mm, engraved with “D7SB” on one side and “70” on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

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

Date of the most recent review of this leaflet: July 2023.

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