Patient Leaflet Updated 30-May-2022 | Zentiva
Dasatinib 20mg 50mg 80mg 100mg 140mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dasatinib Zentiva 20 mg film-coated tablets
Dasatinib Zentiva 50 mg film-coated tablets
Dasatinib Zentiva 80 mg film-coated tablets
Dasatinib Zentiva 100 mg film-coated tablets
Dasatinib Zentiva 140 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Dasatinib is and what it is used for
2. What you need to know before you take Dasatinib
3. How to take Dasatinib
4. Possible side effects
5. How to store Dasatinib
6. Contents of the pack and other information
1 What Dasatinib is and what it is used for
The name of your medicine is Dasatinib Zentiva (called Dasatinib throughout this leaflet). It contains the active substance dasatinib. This medicine is used to treat Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) 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 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.
Dasatinib which is contained in this medicine may also be authorised to treat other conditions which are not mentioned in this leaflet. Ask your doctor or pharmacist if you have further questions.
2 What you need to know before you take Dasatinib
Do not take Dasatinib
If you could be allergic, ask your doctor for advice.
Warnings and precautions
Talk to your doctor or pharmacist before using Dasatinib if you:
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 less than 1 year old. 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:
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.
Dasatinib with food and drink
Do not take Dasatinib with grapefruit or grapefruit juice.
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.
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.
Important information about some of the ingredients of Dasatinib
Dasatinib contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3 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.
The starting dose recommended for adult patients with Ph+ ALL is 140 mg once a day.
Dosing for children with Ph+ ALL is on the basis of body weight.
Dasatinib is administered orally once daily in the form of either dasatinib tablets or dasatinib powder for oral suspension.
Dasatinib tablets are not recommended for patients weighing less than 10 kg. The powder for oral suspension should be used 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:
Body Weight (kg)a 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
a The tablet is not recommended for patients weighing less than 10 kg; the powder for oral suspension should be used 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.
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 tablets 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 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.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following can all be signs of serious side effects:
Contact your doctor immediately if you notice any of the above.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Other side effects that have been reported with frequency not known (cannot be estimated from the available data):
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the 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.
6 Contents of the pack and other information
What Dasatinib contains
What Dasatinib looks like and contents of the pack
20 mg: the film-coated tablet is white to off-white, biconvex, round with a diameter of approximately 5.6 mm, with “D7SB” debossed on one side and “20” on the other side.
50 mg: the film-coated tablet is white to off-white, biconvex, oval with a length of approximately 11.0 mm and a width of approximately 6.0 mm, with “D7SB” debossed on one side and “50” on the other side.
80 mg: the film-coated tablet is white to off-white, biconvex, triangular with a length of approximately 10.4 mm and a width of approximately 10.6 mm, with “D7SB” debossed on one side and “80” on the other side.
100 mg: the film-coated tablet is white to off-white, biconvex, oval with a length of approximately 15.1 mm and a width of approximately 7.1 mm, with “D7SB” debossed on one side and “100” on the other side.
140 mg: the film-coated tablet is white to off-white, biconvex, round with a diameter of approximately 11.7 mm, with “D7SB” debossed on one side and “140” on the other side.
The 20 mg and 50 mg film-coated tablets are available in boxes containing 60 film-coated tablets in blisters.
The 80 mg, 100 mg and 140 mg film-coated tablets are available in boxes containing 30 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in May 2022