Medical Information FAQs
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Frequently Asked Questions
What monitoring needs to be done before starting givinostat?
Before initiating givinostat, obtain and evaluate baseline platelet counts and triglycerides; do not initiate treatment in patients with a platelet count <150 × 109/L. Monitor blood counts every 2 weeks for the first 2 months of treatment, then monthly for the first 3 months, and every 3 months thereafter. Monitor triglycerides at 1 month, 3 months, 6 months, and then every 6 months thereafter.1
In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with givinostat, during concomitant use, and as clinically indicated.1
Reference
- Duvyzat. Prescribing information. ITF Therapeutics LLC.
What should be done in case of a missed dose of givinostat?
If a dose of givinostat is missed, patients should not take double or extra doses.1 Take the next dose of givinostat as scheduled.2
References
- Duvyzat. Prescribing information. ITF Therapeutics LLC.
- Duvyzat. Medication Guide. ITF Therapeutics LLC.
How do you adjust the dosage of givinostat if the patient has a decrease in platelets, experiences diarrhea, or has an increase in fasting triglycerides?
Givinostat may cause adverse reactions that may necessitate a dosage modification; these include platelet count <150 × 109/L verified in 2 assessments 1 week apart, moderate or severe diarrhea, or fasting triglycerides >300 mg/dL verified by 2 assessments 1 week apart. Based on the severity of these adverse reactions, treatment interruption prior to dosage modification should be considered.1
For patients weighing 10 kg to less than 20 kg, the first dosage modification is 17.7 mg in a suspension volume of 2 mL twice daily; the second dosage modification is 13.3 mg in a suspension volume of 1.5 mL twice daily.1
For patients 20 kg to less than 40 kg, the first dosage modification is 22.2 mg in a suspension volume of 2.5 mL twice daily; the second dosage modification is 17.7 mg, in a suspension volume of 2 mL twice daily.1
For patients weighing 40 kg to less than 60 kg, the first dosage modification is 31 mg in a suspension volume of 3.5 mL twice daily; the second dosage modification is 26.6 mg in a suspension volume of 3 mL twice daily.1
For patients weighing 60 kg or more, the first dosage modification is 39.9 mg in a suspension volume of 4.5 mL twice daily; the second dosage modification is 35.4 mg in a volume of 4 mL twice daily.1
If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification. If the adverse reaction(s) persist after the second dosage modification, givinostat should be discontinued.1
Dose Modifications Table:
Dosage Modifications for Adverse Reactions in Patients 6 Years of Age and Older
for the Treatment of DMD1
| First dosage modification† | Second dosage modification‡ | |||
| Weight* | Dosage | Oral suspension volume | Dosage | Oral suspension volume |
| 10 kg to less than 20 kg | 17.7 mg twice daily | 2 mL twice daily | 13.3 mg twice daily | 1.5 mL twice daily |
| 20 kg to less than 40 kg | 22.2 mg twice daily | 2.5 mL twice daily | 17.7 mg twice daily | 2 mL twice daily |
| 40 kg to less than 60 kg | 31 mg twice daily | 3.5 mL twice daily | 26.6 mg twice daily | 3 mL twice daily |
| 60 kg or more | 39.9 mg twice daily | 4.5 mL twice daily | 35.4 mg twice daily | 4 mL twice daily |
*Based on actual body weight. †If the adverse reaction(s) persist after the first dosage modification, proceed to the second dosage modification. ‡If the adverse reaction(s) persist after the second dosage modification, givinostat should be discontinued.
Reference
- Duvyzat. Prescribing information. ITF Therapeutics LLC.
How should givinostat be stored?
Store givinostat at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. Store upright. Discard any unused givinostat remaining after 60 days of first opening of the bottle.1
Reference
- Duvyzat. Prescribing Information. ITF Therapeutics, LLC.
If givinostat has been stored at temperatures outside of what is stated in the recommended storage conditions, is it still ok to use?
Please contact ITF Therapeutics Medical Information
What are the ingredients of Duvyzat?
Duvyzat contains givinostat 8.86 mg/mL (equivalent to givinostat hydrochloride monohydrate 10 mg/mL) and the following inactive ingredients: cream flavor, glycerin, non-crystallizing sorbitol solution, peach flavor, polysorbate 20, purified water, saccharin sodium, sodium benzoate, soidum hydroxide, tartaric acid, and tragacanth.
Reference
Duvyzat. Prescribing Information. ITF Therapeutics, LLC.