DUVYZAT Oral suspension Ref.[115472] Active ingredients: Givinostat

Treatment with givinostat should be initiated by a physician experienced in the management of Duchenne muscular dystrophy.

Posology

Baseline platelet counts and triglycerides should be obtained and evaluated prior to initiation of givinostat. Givinostat should not be initiated in patients with a platelet count less than 150 x 109/l. Platelet counts and triglycerides should be monitored as recommended during treatment to determine if dosage modifications are needed (see section 4.4 and dose adjustment instructions below).

In addition, in patients with underlying cardiac disease or taking concomitant medicines that cause QT prolongation, an ECG should be obtained when initiating treatment with givinostat, during concomitant use, and as clinically indicated (see section 4.4).

The recommended dose of givinostat is based on body weight and should be administered orally twice daily (see Table 1).

Table 1. Recommended Dosage:

^a Based on actual body weight

The decision to continue treatment in patients who become non-ambulatory should be taken at the discretion of the physician based on the overall benefit and risk assessment.

Dose adjustment for thrombocytopenia, diarrhoea or hypertriglyceridaemia

A dose reduction (see Table 2) should be applied for patient with:

• Platelet count <150 x 10⁹/l verified by two assessments one week apart,

or

• Moderate or severe diarrhoea (more than 4 stools per day),

or

• Fasting triglycerides >300 mg/dl verified by two assessments one week apart.

Based on the severity of these adverse reactions, treatment interruption prior to dosage modification should be considered.

Table 2. Dosage modifications for adverse reactions:

^a Based on actual body weight
^b If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification.
^c If the adverse reaction(s) persist after the second dosage modification, Duvyzat should be discontinued.

Patients should not take a double or extra dose if a dose is missed.

Paediatric population

The efficacy and safety of Duvyzat in children below 6 years of age has not been established. No data are available.

Method of administration

For oral use.

Before its use, the suspension must be shaken for at least 30 seconds by rotating the bottle by 180° for approximately 40 times, and the homogeneity of the suspension should be visually verified.

Incorrect shaking may lead to over dosing or under dosing.

Duvyzat must be taken as it is (i.e. not to be diluted in/with water or other liquids).

The suspension should be administered using the provided graduated oral syringe to measure the appropriate volume of suspension corresponding to the prescribed dose for the patient.

Duvyzat should be administered with the ingestion of food to mitigate the bitter taste of givinostat.

In the event of a suspected overdose, supportive medical care, including cardiac monitoring should be provided.

3 years.

After first opening: 60 days.

This medicinal product does not require any special temperature storage conditions.

Amber polyethylene terephthalate bottle containing 140 ml oral suspension closed with a high-density polyethylene child-resistant closure with low-density polyethylene syringe adapter.

Each pack contains one bottle and one graduated oral syringe of 5 ml.

The syringe of 5 ml is graduated from 1 to 5 ml by increments of 0.5 ml.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.