Dasatinib eugia: detailed information

Package leaflet: information for the user

Dasatinib Eugia, 20 mg, film-coated tablets
Dasatinib Eugia, 50 mg, film-coated tablets
Dasatinib Eugia, 80 mg, film-coated tablets
Dasatinib Eugia, 100 mg, film-coated tablets
Dasatinib Eugia, 140 mg, film-coated tablets
Dasatinibum
Please read all of this leaflet carefully before 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 personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Dasatinib Eugia is and what it is used for
What you need to know before you take Dasatinib Eugia
How to take Dasatinib Eugia
Possible side effects
How to store Dasatinib Eugia
Contents of the pack and other information

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

Dasatinib Eugia contains the active substance dasatinib. This medicine is used to treat chronic
myeloid leukaemia (CML) in adults, adolescents, and children aged at least 1 year. Leukaemia is
a cancer of the white blood cells. Normally, white blood cells help the body fight infection. In
people with CML, white blood cells called granulocytes grow uncontrollably. Dasatinib Eugia
inhibits the growth of these leukaemic cells.
Dasatinib Eugia is also used to treat Philadelphia chromosome-positive (Ph+) acute lymphoblastic
leukaemia (ALL) in adults, adolescents, and children aged at least 1 year, as well as the lymphoid
blast crisis phase of CML in adults who did not respond to prior therapy. In people with ALL, white
blood cells called lymphocytes multiply too quickly and live too long. Dasatinib Eugia inhibits
the growth of these leukaemic cells.
If you have any questions about how Dasatinib Eugia works or why this medicine has been
prescribed for you, please consult your doctor.

2. Important information before taking Dasatinib Eugia

When not to take Dasatinib Eugia:

if the patient is allergic to dasatinib or any of the other ingredients of this medicine (listed in section 6). Consult a doctor if an allergic reaction is suspected.

Warnings and precautions
Before starting treatment with Dasatinib Eugia, discuss the following with your doctor or pharmacist:

if the patient is taking blood-thinning medicines or medications that prevent blood clots (see section "Dasatinib Eugia with other medicines")
if the patient has or has previously had liver or heart disease
if difficulty breathing, chest pain, or cough occurs while taking Dasatinib Eugia: these may be symptoms of fluid accumulation in or around the lungs (which may occur more frequently in patients aged 65 years and older) or changes in blood vessels supplying blood to the lungs
if the patient has ever had or may currently have hepatitis B virus infection; this is because Dasatinib Eugia may cause reactivation of hepatitis B virus, which in some cases may be fatal; patients will be closely monitored by their doctor for signs of this infection before starting treatment
if bruising, bleeding, fever, fatigue, or confusion occur while taking Dasatinib Eugia, contact a doctor immediately. These may indicate damage to blood vessels known as thrombotic microangiopathy (TMA).

During treatment, the doctor will periodically monitor the patient's health to assess whether Dasatinib Eugia is producing the intended effect. Regular blood tests will also be performed while taking Dasatinib Eugia.

Children and adolescents
Dasatinib Eugia should not be used in children under one year of age. Data on use in this age group are limited. Growth and development should be closely monitored in children receiving Dasatinib Eugia.

Dasatinib Eugia with other medicines
Tell your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

Dasatinib Eugia is mainly metabolized in the liver. Some medicines may affect the action of Dasatinib Eugia when taken at the same time.

Do not take the following medicines with Dasatinib Eugia:

ketoconazole, itraconazole – these are antifungal medicines
erythromycin, clarithromycin, telithromycin – these are antibiotics
ritonavir – this is an antiviral medicine
phenytoin, carbamazepine, phenobarbital – these are medicines used for epilepsy
rifampicin – this is a medicine used for tuberculosis
famotidine, omeprazole – these are medicines that reduce stomach acid secretion
St. John’s wort (Hypericum perforatum) – herbal medicines available without prescription, used in the treatment of depression and other conditions

Do not take medicines that neutralize stomach acid (such as aluminium hydroxide or magnesium hydroxide) within 2 hours before or 2 hours after taking Dasatinib Eugia.

Tell your doctor if the patient is taking blood-thinning medicines or medications that prevent blood clots.

Dasatinib Eugia with food and drink
Do not take Dasatinib Eugia with grapefruit or grapefruit juice.

Pregnancy and breastfeeding
If the patient is pregnant or suspects she may be pregnant, she should immediately inform her doctor. Dasatinib Eugia should not be used during pregnancy, unless absolutely necessary. The doctor will discuss with the patient the potential risks associated with taking Dasatinib Eugia during pregnancy.

It is recommended that both men and women use effective contraception during treatment with Dasatinib Eugia.

Inform your doctor if breastfeeding. Breastfeeding must not be used while taking Dasatinib Eugia.

Driving and using machines
If undesirable effects such as dizziness or visual disturbances occur, exercise particular caution when driving or operating machinery.

Dasatinib Eugia contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should inform the doctor before taking this medicine.

3. How to take Dasatinib Eugia

Dasatinib Eugia must only be prescribed by a physician experienced in the treatment of leukemia. This medicine should always be taken exactly as directed by the physician. If in doubt, consult the physician or pharmacist. Dasatinib Eugia is intended for use in adults and children aged at least 1 year.

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

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

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

Dasatinib is administered orally once daily in the form of film-coated tablets or powder for oral suspension. The use of Dasatinib Eugia tablets is not recommended in patients weighing less than 10 kg. For patients weighing less than 10 kg and for patients who have difficulty swallowing tablets, the powder for oral suspension should be used.

When switching between formulations (i.e., tablets and powder for oral suspension), a change in dose may be required; therefore, do not interchange one formulation with another.

Based on the patient's body weight, adverse reactions, and response to treatment, the physician will determine the appropriate formulation and dose. The initial dose of Dasatinib Eugia in children is calculated according to 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
at least 45 kg 100 mg

The use of tablets is not recommended in patients weighing less than 10 kg; in such patients, the powder for oral suspension should be used.

There are no dosage recommendations for Dasatinib Eugia in children under 1 year of age.

Depending on the response to treatment, the physician may decide to increase or reduce the dose, or even temporarily interrupt treatment. To administer higher or lower doses, it may be necessary to use a combination of tablets with different strengths.

Tablets may be available in packaging containing calendar blister packs. These are blister packs marked with days of the week. Arrows on the blister indicate which tablet should be taken next, according to the patient's prescribed dosing schedule.

How to take Dasatinib Eugia

Tablets should be taken at the same time each day. Tablets must be swallowed whole. Do not crush, split, or chew them. Do not take fragmented tablets. If tablets are crushed, cut, chewed, or fragmented, it cannot be ensured that the patient receives the correct dose. Dasatinib Eugia tablets may be taken with or without food.

Special handling instructions for Dasatinib Eugia

It is unlikely that Dasatinib Eugia tablets will be damaged. However, in such a case, individuals handling Dasatinib Eugia should wear protective gloves.

How long to take Dasatinib Eugia

Dasatinib Eugia should be taken daily until the physician advises to discontinue treatment. Ensure that Dasatinib Eugia is taken for as long as directed by the physician.

Taking more than the recommended dose of Dasatinib Eugia

If the patient accidentally takes more tablets than recommended, immediately inform the physician. The patient may require medical assistance.

Missed dose of Dasatinib Eugia

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 questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The symptoms listed below may indicate serious adverse reactions:

if chest pain, difficulty breathing, cough, or fainting occur
if there is unexpected bleeding or bruising without prior injury
if blood is present in vomit, stool, or urine, or if the stool is black in colour
if signs of infection occur, such as fever, severe chills
if fever, mouth or throat pain, formation of blisters, or peeling of skin and (or) mucous membranes occur

You should contact your doctor immediately if any of the symptoms listed above occur.
Very common adverse reactions (may affect more than 1 in 10 people)

Infections (including bacterial, viral, and fungal infections)
Heart and lungs: shortness of breath
Gastrointestinal disorders: diarrhoea, feeling sick or being sick (nausea, 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 treatment or after discontinuation), abdominal (pelvic) pain
Laboratory tests may show: low platelet count, low white blood cell count (neutropenia), anaemia, presence of fluid around the lungs

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

Infections: pneumonia, herpes virus infection (including cytomegalovirus - CMV), upper respiratory tract infections, severe blood or tissue infection (including uncommon cases resulting in death)
Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weakening of the heart muscle, high blood pressure, increased blood pressure in the lungs, cough
Gastrointestinal disorders: appetite disturbances, taste disturbances, bloating or abdominal distension, inflammation of the large intestine, constipation, heartburn, mouth ulcers, weight gain, weight loss, stomach inflammation
Skin, hair, eyes, general symptoms: tingling, itchy skin, dry skin, acne, skin inflammation, persistent ringing in the ears, hair loss, excessive sweating, vision disturbances (including blurred or impaired vision), dry eyes, bruising, depression, insomnia, sudden flushing, dizziness, injuries (bruises), loss of appetite, drowsiness, generalized swelling
Pain: joint pain, muscle weakness, chest pain, pain in hands and feet, chills, stiffness of muscles and joints, muscle cramps
Laboratory tests may show: fluid around the heart, fluid in the lungs, heart rhythm disturbances, febrile neutropenia, gastrointestinal bleeding, high levels of uric acid in the blood

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

Heart and lungs: heart attack (including fatal cases), inflammation of the sac surrounding the heart (pericarditis), irregular heartbeat, chest pain due to reduced blood flow to the heart (angina), low blood pressure, narrowing of the airways causing breathing difficulties, asthma, increased blood pressure in the pulmonary arteries
Gastrointestinal disorders: pancreatitis, peptic ulcer disease, oesophagitis, abdominal swelling (ascites), anal fissures, difficulty swallowing, gallbladder inflammation, biliary obstruction, gastro-oesophageal reflux (a condition in which acid and other stomach contents flow back into the throat)
Skin, hair, eyes, general symptoms: allergic reactions, including tenderness to touch, red skin nodules (erythema nodosum), anxiety, disorientation, mood changes, decreased libido, fainting, tremor, eye inflammation causing redness or pain, skin disease characterized by tenderness, redness, and appearance of distinct erythematous patches with sudden onset of fever and elevated white blood cell count (neutrophilic dermatosis), hearing loss, light sensitivity, vision disturbances, excessive tearing of the eyes, skin colour changes, inflammation of subcutaneous fat tissue, skin ulceration, blistering of the skin, nail disorders, hair disorders, disorders of hands and feet, kidney failure, frequent urination, breast enlargement in men, menstrual disorders, general weakness and discomfort, reduced thyroid function, loss of balance while walking, bone necrosis (a condition involving reduced blood flow to bones, loss of bone mass, and bone death), joint inflammation, skin swelling anywhere on the body
Pain: vein inflammation (phlebitis), which may cause redness, pain, and swelling; tendon inflammation
Brain: memory loss
Laboratory tests may show: abnormal blood test results and possible kidney function disorders caused by remnants of dying tumour (tumour lysis syndrome), low albumin levels in the blood, low lymphocyte count (a type of white blood cell) in the blood, high cholesterol levels in the blood, swollen lymph nodes, brain haemorrhage, abnormalities in heart electrical activity, heart enlargement, liver inflammation, presence of protein in urine, increased creatine phosphokinase activity (an enzyme mainly present in the heart, brain, and skeletal muscles), increased troponin levels (an enzyme mainly present in the heart and skeletal muscles), increased gamma-glutamyl transferase levels (an enzyme mainly present in the liver), milky fluid around the lungs (chylous effusion)

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

Heart and lungs: enlargement of the right ventricle of the heart, myocarditis (inflammation of the heart muscle), acute coronary syndrome (a set of symptoms resulting from blocked blood flow to the heart muscle), cardiac arrest (cessation of blood pumping from the heart), coronary artery disease (heart), inflammation of the tissue covering the heart and lungs (pericarditis, pleuritis), blood clots, pulmonary embolism
Gastrointestinal disorders: loss of essential nutrients from the gastrointestinal tract such as proteins, intestinal obstruction, anal fistula (abnormal formation of a channel between the anus and the surrounding skin), kidney function disorders, diabetes
Skin, hair, eyes, general symptoms: seizures, optic neuritis (which may cause complete or partial vision loss), bluish-purple skin spots, abnormally high thyroid function, thyroid gland inflammation, ataxia (a condition associated with lack of muscle coordination), difficulty walking, miscarriage, cutaneous vasculitis (inflammation of blood vessels in the skin), skin fibrosis
Brain: stroke, transient neurological deficits due to impaired blood flow, facial nerve paralysis, dementia
Immune system: severe allergic reaction
Musculoskeletal and connective tissue: delayed healing of rounded ends of bones (epiphyses) forming joints; slowed or delayed growth

Other observed adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

Pneumonitis
Bleeding in the stomach or intestines, which may lead to death
Reactivation of hepatitis B virus infection in patients who previously had this disease
Reaction with fever, skin blisters, and mucosal ulceration
Symptoms of kidney disease, including oedema and abnormal laboratory findings such as protein in urine and low blood protein levels
Blood vessel damage known as thrombotic microangiopathy (TMA), including reduced red blood cell count, reduced platelet count, and blood clot formation

During treatment, your doctor will monitor for the occurrence of the adverse reactions listed above.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dasatinib Eugia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or cardboard box after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Package contents and other information

What Dasatinib Eugia contains

The active substance is dasatinib. Each film-coated tablet contains 20 mg, 50 mg, 80 mg, 100 mg, or 140 mg of dasatinib (as dasatinib monohydrate).
Other ingredients are:
- Tablet core: lactose monohydrate (see section 2 “Dasatinib Eugia contains lactose”), microcrystalline cellulose (Type 101), hydroxypropylcellulose, sodium croscarmellose, microcrystalline cellulose (Type 112), magnesium stearate
- Tablet coating: HPMC 2910/Hypromellose, titanium dioxide (E 171), macrogol 400.

What Dasatinib Eugia looks like and contents of the pack
Dasatinib Eugia, 20 mg: white or almost white, biconvex, round film-coated tablet,
with an embossed mark “D” on one side and “20” on the other side.
Dasatinib Eugia, 50 mg: white or almost white, biconvex, oval film-coated tablet,
with an embossed mark “D” on one side and “50” on the other side.
Dasatinib Eugia, 80 mg: white or almost white, biconvex, triangular film-coated tablet,
with an embossed mark “D” on one side and “80” on the other side.
Dasatinib Eugia, 100 mg: white or almost white, biconvex, oval film-coated tablet,
with an embossed mark “D” on one side and “100” on the other side.
Dasatinib Eugia, 140 mg: white or almost white, biconvex, round film-coated tablet,
with an embossed mark “D” on one side and “140” on the other side.
Dasatinib Eugia film-coated tablets, 20 mg, 50 mg, 80 mg, 100 mg, and 140 mg, are available
in blister packs containing 30, 56, 60, or 120 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Eugia Pharma (Malta) Limited
Vault 14, level 2
Valletta Waterfront
Floriana, FRN 1914
Malta
e-mail: [email protected]

Manufacturer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal
Arrow Génériques
26 Avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Dasatinib Arrow 20mg, comprimé pelliculé
Dasatinib Arrow 50mg, comprimé pelliculé
Dasatinib Arrow 70mg, comprimé pelliculé
Dasatinib Arrow 100mg, comprimé pelliculé
Dasatinib Arrow 140mg, comprimé pelliculé
Germany: Dasatinib PUREN 20 mg Filmtabletten
Dasatinib PUREN 50 mg Filmtabletten
Dasatinib PUREN 70 mg Filmtabletten
Dasatinib PUREN 80 mg Filmtabletten
Dasatinib PUREN 100 mg Filmtabletten
Dasatinib PUREN 140 mg Filmtabletten
Italy: Dasatinib Aurobindo
Poland: Dasatinib Eugia
Spain: Dasatinib Eugia 50 mg comprimidos recubiertos con película EFG
Dasatinib Eugia 70 mg comprimidos recubiertos con película EFG
Dasatinib Eugia 100 mg comprimidos recubiertos con película EFG
Dasatinib Eugia 140 mg comprimidos recubiertos con película EFG
Portugal: Dasatinib Eugia