Dasatinib Sandoz 50 mg film-coated tablets – patient leaflet, side effects, dosage

What Dasatinib is and what it is used for

Dasatinib 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 cancer of white blood cells. These white cells usually help the body to fight infection. In people with CML, white cells called granulocytes start growing out of control. Dasatinib inhibits the growth of these leukaemic cells.

Dasatinib 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

CML in adults who are not benefiting from prior therapies. In people with ALL, white cells called lymphocytes multiply too quickly and live too long. Dasatinib inhibits the growth of these leukaemic cells.

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

If you are breast-feeding, tell your doctor. You should stop breast-feeding while you are taking dasatinib.

Driving and using machines

Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.

Dasatinib contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

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How to take Dasatinib

Dasatinib will only be prescribed to you

by a doctor with experience in treating leukaemia. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Dasatinib is prescribed for adults and children at least 1 year of age.

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What you need to know before you take Dasatinib

The starting dose recommended for adult patients with chronic phase CML is

100 mg once a day.

Do not take Dasatinib

•

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

If you could be allergic, ask your doctor for advice.

Warnings and precautions

Talk to your doctor or pharmacist before using Dasatinib

•

if you are taking

medicines to thin the blood

or prevent clots (see “Other medicines and Dasatinib”)

•

if you have a liver or heart problem, or used to have one

•

if you start

having difficulty breathing, chest

pain, or a cough

when taking dasatinib: this may

be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65

years and older), or due to changes in the blood vessels supplying the lungs

•

if you have ever had or might now have a

hepatitis B infection. This is because dasatinib could cause hepatitis B to become active again, which can be fatal in some cases. Patients will

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

Dosing for children with chronic phase CML or Ph+ ALL is on the basis of body weight.

Dasatinib is administered orally once daily. Dasatinib tablets are not recommended for patients weighing less than 10 kg. A powder for oral suspension may be available for patients weighing less than 10 kg and patients who cannot swallow tablets. A change in dose may occur when switching between formulations (i.e., tablets and powder for oral suspension), so you should not switch from one to the other.

Your doctor will decide the right formulation and dose based on your weight, any side effects and response to treatment. The starting dose of Dasatinib for children is calculated by body weight as shown below:

•

of this infection before treatment is started.

if you experience bruising, bleeding, fever, fatigue and confusion when taking Dasatinib, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).

Your doctor will regularly monitor your condition to check whether dasatinib is having the desired effect. You will also have blood tests regularly while you are taking Dasatinib.

Children and adolescents

Do not give this medicine to children younger than

one year of age. There is limited experience with

the use of dasatinib in this age group.

Bone growth and development will be closely monitored in children taking dasatinib.

Other medicines and Dasatinib

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

Dasatinib is mainly handled by the liver. Certain medicines may interfere with the effect of dasatinib when taken together.

These medicines are not to be used with Dasatinib:

•

ketoconazole, itraconazole - these are

antifungal medicines

•

erythromycin, clarithromycin, telithromycin - these are

antibiotics

•

ritonavir - this is an

antiviral medicine

•

phenytoin, carbamazepine, phenobarbital -

these are treatments for

epilepsy

•

rifampicin - this is a treatment for

tuberculosis

•

famotidine, omeprazole - these are medicines that

block stomach acids

•

St. John’s wort - a herbal preparation obtained

without a prescription, used to treat

depression and other conditions

(also known as

Hypericum perforatum)

Do not take medicines that neutralise stomach acids (antacids such as aluminium hydroxide or magnesium hydroxide) in the 2 hours before or 2 hours after taking dasatinib.

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

^a The tablet is not recommended for patients weighing less than 10 kg ; a powder for oral suspension may be available for these patients.

There is no dose recommendation for Dasatinib with children under 1 year of age.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly. For higher or lower doses, you may need to take combinations of the different tablet strengths.

The tablets may come in packs with calendar blisters. These are blisters showing the days of the week. There are arrows to show the next tablet to be taken according to your treatment schedule.

How to take Dasatinib

Take your tablets at the same time every day.

Swallow the tablets whole. Do not crush, cut or chew them. Do not take dispersed tablets. You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets. Dasatinib can be taken with or without a meal.

Special handling instructions for Dasatinib

It is unlikely that the Dasatinib tablets will get broken. But if they do, persons other than the patient should use gloves when handling Dasatinib.

How long to take Dasatinib

Take Dasatinib daily until your doctor tells you to stop. Make sure you take Dasatinib tablets for as long as it is prescribed.

If you take more Dasatinib than you should

If you have accidentally taken too many tablets, talk to your doctor immediately.

You may require medical attention.

If you forget to take Dasatinib

Do not take a double dose to make up for a forgotten tablet. Take the next scheduled dose at the regular time.

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

Dasatinib with food and drink

Do not take dasatinib with grapefruit or grapefruit juice.

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Possible side effects

Pregnancy and breast-feeding

If you are pregnant or think you may be pregnant, tell your doctor immediately. Dasatinib is not

to be used during pregnancy unless clearly necessary. Your doctor will discuss with you the

potential risk of taking dasatinib during pregnancy. Both men and women taking dasatinib will be advised to use effective contraception during treatment.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following can all be signs of serious side effects:

•

if you have chest pain, difficulty breathing, coughing and fainting

•

if you experience

unexpected bleeding

or bruising

without having an injury

•

if you find blood in your vomit, stools or urine, or have black stools

•

if you get

signs of infections such as

fever, severe chills

•

if you get fever, sore mouth or throat, blistering or

peeling of your skin and/or mucous membranes

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

Very common side effects (may affect more than 1 in 10 people)

•

Infections (including bacterial, viral and fungal)

•

Heart and lungs: shortness of breath

•

Digestive problems: diarrhoea, feeling

or being sick (nausea, vomiting)

•

Skin, hair, eye, general: skin rash, fever,

swelling around the face, hands and feet, headache, feeling tired or weak, bleeding

•

Pain: pain in the muscles (during or after

discontinuing treatment), tummy (abdominal) pain

•

Tests may show: low blood platelet count,

low white blood cells count (neutropaenia), anaemia, fluid around the lungs

Common side effects (may affect up to

1 in 10 people)

•

Infections: pneumonia, herpes virus infection

(including cytomegalovirus-CMV), upper respiratory tract infection, serious infection of the blood or tissues (including uncommon cases with fatal outcomes)

•

Heart and lungs: palpitations, irregular

heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough

•

Digestive problems: appetite disturbances,

taste disturbance, bloated or distended tummy

(abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis

•

Skin, hair, eye, general: skin tingling, itching, dry

skin, acne, inflammation of the skin, persistent

noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, bruise, depression, insomnia, flushing, dizziness, contusion (bruising), anorexia, somnolence, generalised oedema

•

Pain: pain in joints, muscular weakness, chest

pain, pain around hands and feet, chills, stiffness in muscles and joints, muscle spasm

•

Tests may show: fluid around the heart, fluid

in the lungs, arrhythmia, febrile neutropaenia, 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

outcome), inflammation of the lining (fibrous sack) surrounding the heart, irregular heartbeat, chest pain due to lack of blood supply to the

heart (angina), low blood pressure, narrowing of airway that may cause breathing difficulties, asthma, increased blood pressure in the arteries (blood vessels) of the lungs

•

Digestive problems: inflammation of the

pancreas, peptic ulcer, inflammation of the food pipe, swollen tummy (abdomen), tear in the skin of the anal canal, difficulty in swallowing, inflammation of the gallbladder, blockage of bile

ducts, gastro-oesophageal reflux (a condition where acid and other stomach contents come back up into the throat)

•

Skin, hair, eye, general: allergic reaction

including tender, red lumps on the skin (erythema

nodosum), anxiety, confusion, mood swings, lower sexual drive, fainting, tremor, inflammation of the eye which causes redness or pain, a skin disease characterized by tender, red, well-defined

blotches with the sudden onset of fever and raised white blood cell count (neutrophilic dermatosis), loss of hearing, sensitivity to light,

visual impairment, increased eye tearing, disturbance in skin colour, inflammation of fatty tissue under the skin, skin ulcer, blistering of the

skin, nail disorder, hair disorder, hand-foot

disorder, renal failure, urinary frequency, breast

enlargement in men, menstrual disorder, general weakness and discomfort, low thyroid function, losing balance while walking, osteonecrosis (a

disease of reduced blood flow to the bones, which can cause bone loss and bone death), arthritis, skin swelling anywhere in the body

•

Pain: inflammation of vein which can cause

redness, tenderness and swelling, inflammation of the tendon

•

Brain: loss of memory

•

Tests may show: abnormal blood test results

and possibly impaired kidney function caused by the waste products of the dying tumour (tumour lysis syndrome), low levels of albumin in the blood, low levels of lymphocytes (a type of white blood cell) in the blood, high level of cholesterol in the blood, swollen lymph nodes, bleeding in the brain, irregularity of the electrical activity of the heart, enlarged heart, inflammation of the liver, protein in the urine, raised creatine phosphokinase (an enzyme mainly found in the

heart, brain and skeletal muscles), raised troponin (an enzyme mainly found in the heart and skeletal muscles), raised

gamma-glutamyltransferase (an enzyme mainly found in the liver)

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

•

Heart and lungs: enlargement of the right

ventricle in the heart, inflammation of the heart muscle, collection of conditions resulting from blockage of blood supply to the heart muscle (acute coronary syndrome), cardiac arrest (stopping of blood flow from the heart), coronary (heart) artery disease, inflammation of the tissue covering the heart and lungs, blood clots, blood clots in the lungs

•

Digestive problems: loss of vital nutrients

such as protein from your digestive tract,

bowel obstruction, anal fistula (an abnormal opening from the anus to the skin around the anus), impairment of kidney function, diabetes

•

Skin, hair, eye, general: convulsion,

inflammation of the optic nerve that may cause a complete or partial loss of vision, blue-purple mottling of the skin, abnormally high thyroid function, inflammation of the thyroid gland, ataxia (a condition associated with lack of muscular coordination), difficulty walking, miscarriage, inflammation of the skin blood vessels, skin fibrosis

•

Brain: stroke, temporary episode of

neurologic dysfunction caused by loss of

blood flow, facial nerve paralysis, dementia

•

Immune system: severe allergic reaction

•

Musculoskeletal and connective tissue:

delayed fusion of the rounded ends that form

joints (epiphyses); slower or delayed growth

Other side effects that have been reported (with frequency not known - cannot be estimated from the available data):

•

Inflammation of the lungs

•

Bleeding in the stomach or bowels that can cause death

•

Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection)

•

A reaction with fever, blisters on the skin, and ulceration of the mucous membranes

•

Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood

•

Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots

Your doctor will check for some of these effects during your treatment.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Dasatinib

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

Do not use this medicine after the expiry date which is stated on the bottle label, blister or carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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Contents of the pack and other information

What Dasatinib contains

•

The active substance is dasatinib.

Each film-coated tablet contains 20 mg of dasatanib.

Each film-coated tablet contains 50 mg of dasatanib.

Each film-coated tablet contains 70 mg of dasatanib.

Each film-coated tablet contains 80 mg of dasatanib.

Each film-coated tablet contains 100 mg of dasatanib.

Each film-coated tablet contains 140 mg of dasatanib.

•

The other ingredients are:

Tablet core: cellulose, microcrystalline (E 460),

lactose monohydrate (see section 2 “What you need to know before you take Dasatinib”); croscarmellose sodium, hydroxypropylcellulose (E 463), magnesium stearate (E 470b)

Film-coating: poly(Vinyl Alcohol) (E 1203),

titanium dioxide (E 171), talc (E 553b), glyceryl monostearate (E 471), sodium laurilsulfate.

What Dasatinib looks like and contents of the pack

Dasatinib 20 mg film-coated tablets

White to off-white, biconvex, round film-coated tablet with “20” debossed on one side and plain on the other, with a diameter of 6.1 mm.

Dasatinib 50 mg film-coated tablets

White to off-white, biconvex, oval film-coated tablet with “50” debossed on one side and plain on the other, with dimensions 10.9 mm x 5.8 mm.

Dasatinib 70 mg film-coated tablets

White to off-white, biconvex, round film-coated tablet with “70” debossed on one side and plain on the other, with a diameter of 8.9 mm.

Dasatinib 80 mg film-coated tablets

White to off-white, biconvex, triangular film-coated tablet with “80” debossed on one side and plain on the other, with dimensions 10.3 mm x 10.0 mm.

Dasatinib 100 mg film-coated tablets

White to off-white, biconvex, oval film-coated tablet with “100” debossed on one side and plain on the other, with dimensions 14.8 mm x 7.2 mm.

Dasatinib 140 mg film-coated tablets

White to off-white, biconvex, round film-coated tablet with “140” debossed on one side and plain on the other, with a diameter of 11.8 mm.

The film-coated tablets are packed in aluminium-OPA/aluminium/PVC blisters (calendar blisters or perforated unit dose blisters) or are packed in a HDPE bottle with a polypropylene child-resistant closure and a plastic (HDPE) canister containing silica gel and inserted in a carton.

Pack sizes:

Dasatinib 20 mg, 50 mg, 70 mg film-coated tablets

Carton containing 12 film-coated tablets in 1 calendar blister.

Carton containing 56 film-coated tablets in 4 calendar blisters of 14 film-coated tablets each.

Carton containing 12 x 1 and 60 x 1 film-coated tablets in perforated unit dose blisters.

Carton containing one bottle with 60 film-coated tablets.

Dasatinib 80 mg, 100 mg, 140 mg film-coated tablets

Carton containing 10 film-coated tablets in 1 calendar blister.

Carton containing 10 x 1 and 30 x 1 film-coated tablets in perforated unit dose blisters.

Carton containing one bottle with 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer

Remedica Ltd, Aharnon Street, Limassol Industrial

Estate, 3056 Limassol, Cyprus or Lek Pharmaceuticals d.d. Verovskova 57, Ljubljana, 1526, Slovenia

This leaflet was last revised in 06/2022.

SZ00000LT000

N002: Minor changes to PIL and CNs

Legend:

27/06/2022

Cutting:

157 x 500 mm

44084112, 44084111, 44084120, 44084110, 44084099

AQWA#:

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Production site:

Technical num:

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Old Comp num:

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