Duvyzat 8.86 mg/mL Oral suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Duchenne muscular dystrophy is caused by genetic changes that result in an abnormality in a muscle protein called dystrophin which is needed for muscles to work properly. This abnormality leads to muscle degradation. Givinostat prevents such muscle degradation.

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

Talk to your doctor, pharmacist or nurse before taking Duvyzat.

Duvyzat may be associated with decreased blood cell counts. The dose of Duvyzat may be reduced in case of persistent decrease in platelet count (thrombocytopenia) and your doctor may discontinue your treatment with givinostat if abnormalities persist.

Duvyzat may be associated with increased levels of fats (such as triglycerides) in your blood. The dose of givinostat may be reduced in case of persistent increase in levels of fats in your blood. Your doctor may discontinue treatment if abnormalities persist.

You may experience diarrhoea and vomiting while taking Duvyzat. Your doctor may adjust the dose of Duvyzat based on severity of diarrhoea or discontinue treatment if abnormalities persist.

High doses of Duvyzat (5 times higher than the recommended dose) may cause an irregular heartbeat. Your doctor will evaluate the use of Duvyzat when there is an increased risk for abnormal heartbeat such as narrow coronary arteries, abnormal mineral levels in 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.

Contact your doctor, who may stop your therapy with Duvyzat, if any of the above conditions appear.

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

In particular tell your doctor, pharmacist or nurse if you are taking any of the following medicines:

• medicines used to minimise the sensation of pain (anaesthetics, e.g. sevoflurane, propofol),
• medicines used to treat irregular heartbeat (e.g. amiodarone, sotalol),
• medicines used to treat nausea and vomiting (ondansetron),
• medicines used to treat some bacterial infections (fluconazole, azithromycin, clarithromycin, ciprofloxacin),
• medicines used to treat severe mental health problems (aripiprazole, risperidone),
• medicines used to treat allergies (e.g. famotidine).

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 as it is advisable not to take Duvyzat while you are pregnant or breast-feeding.

If you feel dizzy do not drive or use machines.

Sorbitol:

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’.

Duvyzat is for oral use.

The oral suspension must be shaken by hand 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 the graduated oral syringe.

Important information about dosing Duvyzat:

Ask your doctor, pharmacist or nurse 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 with food to avoid the bitter taste of givinostat;
• Always take Duvyzat using the oral syringe (5 mL) provided with Duvyzat.

First time use of bottle only: Remove Duvyzat bottle and the 5 mL oral syringe from the carton (see Figure A).

Step 1. Make sure the bottle is closed properly and shake the bottle 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.

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.

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).

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).

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.

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.

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.

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).

Step 10. Wash the oral syringe in water and allow to dry.

Store the oral syringe in a clean, dry place.

Contact your doctor or a hospital if you take more than the prescribed dose of Duvyzat.

If you forget a dose, take the next dose when needed. Do not take a double dose. It is important to take the correct dose.

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

Do not stop taking Duvyzat without talking to your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes 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 affects you can help provide more information on the safety of this medicine.

The active substance is givinostat.

Each mL of oral suspension contains 8.86 mg givinostat (as givinostat hydrochloride monohydrate).

The other ingredients 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, propylene glycol E1520), saccharin sodium (E954), liquid sorbitol (E420), tartaric acid (E334), sodium hydroxide (E524), purified water.

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.

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