DUVYZAT – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine DUVYZAT, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Duvyzat is and what it is used for
Duvyzat contains the active substance givinostat.
It is used to treat Duchenne muscular dystrophy (DMD) in patients aged 6 years and older, who are able to walk and are under steroid treatment.
DMD is caused by mutations in the DMD gene. These changes in the gene compromise muscle cells function and lead to muscle progressive degradation.
By blocking the activity of HDAC enzymes in the muscle cells, Duvyzat prevents muscle degradation.
⚠️ 2. What you need to know before you take Duvyzat
Do not take Duvyzat
- If you (or your child) are allergic to givinostat or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Duvyzat.
Duvyzat lowers the number of blood cells in your blood, most notably the number of blood platelets responsible for clotting of the blood (a condition known as thrombocytopenia).
Your doctor will check your blood for levels of platelets before treatment and regularly during the entire course of treatment with Duvyzat.
Your doctor may reduce your dose to increase your platelet count or stop treatment with Duvyzat if thrombocytopenia continues. Inform your doctor if you notice any unexpected bleeding.
27 Duvyzat may be associated with increased levels of fats (triglycerides) in your blood.
Your doctor will do blood tests before you start Duvyzat and regularly during treatment to check your triglyceride levels .
The dose of givinostat may be reduced in case of persistent increase in levels of fats (triglycerides) in your blood.
Your doctor may stop treatment if the levels of fats in your blood (triglycerides) do not decrease despite dietary measures and dose reductions .
You may experience diarrhoea and vomiting while taking Duvyzat.
Your doctor may adjust the dose of Duvyzat based on severity of diarrhoea or stop treatment if diarrhoea and vomiting do not improve .
Your doctor might consider the use of medicines to treat vomiting, diarrhoea and to avoid excessive loss of fluids.
High doses of Duvyzat (5 times higher than the recommended dose) may cause an irregular heartbeat.
Your doctor will consider if you can use Duvyzat when there is an increased risk for abnormal heartbeat, abnormal mineral levels in your body or concomitant use of other medicines.
Your doctor may check your heart function when starting Duvyzat if you have an underlying heart problem or if you use medicines that can cause irregular heartbeat.
Your doctor may consider to stop treatment with Duvyzat if your heartbeat is found irregular .
Contact your doctor, who may stop your therapy with Duvyzat, if any of the above conditions appear.
Other medicines and Duvyzat
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Duvyzat may increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood. Some of these medicines include:
- carbamazepine, phenytoin (a medicine used to treat epilepsy) ,
- amitriptyline (a medicine used to treat low mood and depression) ,
- digoxin (a medicine used to treat heart failure and abnormal heart rhythms) ,
- metformin (a medicine to control type II diabetes) ,
- amiloride (a medicine used to treat high blood pressure) ,
- histamine type 2 receptor antagonists (a medicine used to treat duodenal and gastric ulcers and common heartburn) .
Caution is advised when Duvyzat is administered with medicinal products known to cause abnormal heartbeat.
Pregnancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. If you become pregnant while taking Duvyzat, consult your doctor immediately. Use of Duvyzat should be avoided while you are pregnant or breast – feeding.
Driving and using machines
This medicine may cause dizziness or tiredness . If you feel dizzy or tired, do not drive or use machines.
Duvyzat contains sorbitol, sodium benzoate and sodium
Sorbitol:
28 This medicine contains 400 mg sorbitol in each ml.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Sodium benzoate:
This medicine contains 4.4 mg sodium benzoate in each ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new born babies (up to 4 weeks old).
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium -free’.
💊 3. How to take Duvyzat
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Duvyzat should be taken by mouth, using a syringe. It should be taken two times per day. The recommended dose of Duvyzat depends on your body weight, as shown in the Table 1.
Table 1 – Recommended Dose Weight (kg) Duvyzat oral suspension volume to be taken twice daily ≥ 15 and < 20 2.5 ml ≥ 20 and < 40 3.5 ml ≥ 40 and < 60 5.0 ml ≥ 60 6.0 ml If your prescribed dose is more than 5 ml per dose , you can use the same oral syringe more than on ce.
Your dose may need to be lowered (see Table 2) by your doctor if certain symptoms appear (see Warnings and precautions) :
- decreased platelet count;
- moderate or severe diarrhoea (more than 4 stools per day);
- increased levels of fats in your blood.
Table 2 – First d ose r eduction Weight (kg) Duvyzat oral suspension volume to be taken twice daily ≥ 15 and < 20 2.0 ml ≥ 20 and < 40 2.5 ml ≥ 40 and < 60 3.5 ml ≥ 60 4.5 ml If the above abnormalities do not improve , your doctor may further reduce your dose (see Table 3).
29 Table 3 – Second d ose reduction Weight (kg) Duvyzat oral suspension volume to be taken twice daily ≥ 15 and < 20 1.5 ml ≥ 20 and < 40 2.0 ml ≥ 40 and < 60 3.0 ml ≥ 60 4.0 ml If these abnormalities still persist or if you experience irregular heartbeat, your doctor may consider stopping treatment with Duvyzat.
Method of administration Duvyzat is for oral use.
The oral suspension must be shaken by hand approximately 40 times for at least 30 seconds by continuously turning the bottle up and down until the oral suspension is mixed well and looks the same throughout.
The suspension is dosed by using the graduated oral syringe.
Important information about dosing Duvyzat: Ask your doctor or pharmacist to show you how to measure your prescribed dose.
- Take Duvyzat as prescribed by your doctor (see Tables 1, 2, 3);
- The recommended dose of Duvyzat is taken by mouth 2 times per day;
- Take Duvyzat as it is (not to be diluted in/with water or other liquids);
- Take Duvyzat with food to reduce the bitter taste of givinostat;
- Always take Duvyzat using the oral syringe (5 ml) provided with the medicine .
First time use of bottle only: Remove Duvyzat bottle and the 5 ml oral syringe from the carton (see Figure A).
Figure A Step 1 . Make sure the bottle is closed properly and shake the bottle approximately 40 times for at least 30 seconds by continuously turning the bottle up and down (see Figure B). Stop when the Duvyzat oral suspension is mixed well and looks the same throughout.
Figure B 30 Step 2 . Open the bottle by pressing down on the bottle cap and turning it to the left (counter -clockwise) (see Figure C). Do not throw away the bottle cap.
Figure C Step 3.
For first time use only: Take the provided oral syringe to be used and firmly insert the tip of the oral syringe into the bottle adapter opening (see Figure D).
For all other uses: Take the provided oral syringe to be used, push the plunger all the way down (to remove the air) and firmly insert the tip of the oral syringe into the bottle adapter opening (see Figure D).
Figure D Step 4. While holding the oral syringe in place, turn the bottle upside down.
Slowly pull the plunger down to pull back a small amount of the suspension.
Then push the plunger all the way up to remove any air bubbles (see Figure E).
Figure E Step 5. Slowly pull the plunger down until the bottom of the plunger is even with the markings on the oral syringe for the prescribed dose of Duvyzat (see Figure F).
If your prescribed dose is more than 5 ml, you will need to use the same oral syringe more than one time.
Figure F 31 Step 6. While keeping the plunger in the same position, turn the bottle upright, and place it carefully on a flat surface. Remove the oral syringe by gently twisting or pulling it out from the bottle adapter opening. Do not hold the oral syringe by the plunger because the plunger may come out (see Figure G).
Take or give Duvyzat right away after it is drawn up into the oral syringe. Do not store the filled oral syringe.
Figure G Step 7. Check that the prescribed volume (ml) of Duvyzat has been drawn up into the oral syringe (see Figure H).
Figure H shows an example of a 5 ml dose. Your dose may be a different volume.
Figure H Step 8. The child or adult should sit upright to take a dose of Duvyzat. Place the tip of the oral syringe against the inside of the cheek. Slowly push the plunger all the way down until there is no more medicine left in the oral syringe.
If your prescribed dose is more than 5 ml, repeat Step 3 through Step 8 to give the remaining part of the dose.
Step 9. After use, replace the bottle cap and turn the bottle cap to the right (clockwise) to close the bottle (see Figure I).
Figure I Step 10. Wash the oral syringe in water and allow to dry.
Store the oral syringe in a clean, dry place.
32 If you take more Duvyzat than you should Contact your doctor or a hospital if you take more than the prescribed dose of Duvyzat.
Your doctor will decide what care should be provided. This may include checking your heart function.
If you forget to take Duvyzat
It is important to take the correct dose .
If you forget a dose, take the next dose when needed. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop taking Duvyzat
Do not stop taking Duvyzat without talking to your doctor. 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.
You may have one or more of the following side effects after taking Duvyzat:
Very common side effects (may affect more than 1 in 10 people)
- belly ( abdominal) pain
- decrease in blood platelet count (thrombocytopenia)
- diarrhoea
- elevated levels of blood fats (hyper triglycerid aemia)
- fever (pyrexia)
- vomiting
Common side effects (may affect up to 1 in 10 people)
- anxiety
- constipation
- decreased appetite
- dizziness
- skin redness ( erythema )
- tiredness ( fatigue )
- diarrhoea and vomiting ( gastroenteritis )
- collection of blood under the skin ( haematoma )
- increased thyroid stimulating hormone (TSH) levels in blood
- joint pain (arthralgia)
- muscle pain (myalgia)
- muscular weakness
- rash
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 national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Duvyzat
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 carton and bottle after “EXP”. The expiry date refers to the last day of that month.
33 Once opened, use within 60 days.
Discard any unused Duvyzat oral suspension remaining after 60 days of first opening of the container.
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 Duvyzat contains
The active substance is givinostat.
Each ml of oral suspension contains 8.86 mg givinostat (as hydrochloride monohydrate).
The other ingredient s are: polysorbate 20 (E432), glycerol (E422), tragacanth gum (E413), sodium benzoate (E211), peach flavour (natural flavouring substances, flavouring substances, propylene glycol E1520), cream flavour (natural flavouring substances, flavouring substances, propyl ene glycol E1520), saccharin sodium (E954), liquid sorbitol (E420), tartaric acid (E334), sodium hydroxide (E524), purified water.
What Duvyzat looks like and contents of the pack
Duvyzat is a white to off -white or faintly pink oral suspension.
Pack of one bottle of 140 ml.
The bottle is packed with one 5 ml graduated oral syringe. The oral syringe is graduated from 1 to 5 ml by increments of 0.5 ml.
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale F. Testi, 330 20126 Milano Italy
Manufacturer
Italfarmaco S.A.
San Rafael, 3 28108 Alcobendas (Madrid) Spain or Italfarmaco S.p.A Viale F. Testi, 330 20126 Milano Italy Scan the code with a mobile device to get the package leaflet in different languages.
Or visit the URL https://www.duvyzat.eu
This leaflet was last revised in MM/YYYY
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information DUVYZAT (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1930).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.