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Duvyzat Dosage

Generic name: GIVINOSTAT 8.86mg in 1mL
Dosage form: oral suspension
Drug class: Histone deacetylase inhibitors

Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.

Recommended Evaluation and Testing Before Initiation of DUVYZAT

Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of DUVYZAT. Do not initiate DUVYZAT in patients with a platelet count less than 150 x 109/L. Monitor platelet counts and triglycerides as recommended during treatment to determine if dosage modifications are needed.

In addition, in patients with underlying cardiac disease or taking concomitant medications that cause QT prolongation, obtain ECGs when initiating treatment with DUVYZAT, during concomitant use, and as clinically indicated.

Recommended Dosage

The recommended dosage of DUVYZAT is based on body weight and administered orally twice daily with food (see Table 1).

Table 1: Recommended Dosage in Patients 6 Years of Age and Older for the Treatment of DMD
Weight* Dosage Oral Suspension Volume
*
Based on actual body weight
10 kg to less than 20 kg 22.2 mg twice daily 2.5 mL twice daily
20 kg to less than 40 kg 31 mg twice daily 3.5 mL twice daily
40 kg to less than 60 kg 44.3 mg twice daily 5 mL twice daily
60 kg or more 53.2 mg twice daily 6 mL twice daily

Dosage Modifications for Adverse Reactions

Decrease in Platelets, Diarrhea, Increase in Triglycerides

DUVYZAT may cause adverse reactions, which may necessitate a dosage modification (see Table 2) if the following occur:

  • Platelet count <150 x 109/L verified in two assessments one week apart
    or
  • Moderate or severe diarrhea
    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 in Patients 6 Years of Age and Older for the Treatment of DMD
First Dosage Modification* Second Dosage Modification
*
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, DUVYZAT should be discontinued.
Based on actual body weight
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

QTc Interval Prolongation

Withhold DUVYZAT if the QTc interval is > 500 ms or the change from baseline is > 60 ms.

Preparation and Administration Instructions

See the Instructions for Use for further details.

  • Before use, shake the DUVYZAT suspension for at least 30 seconds by inverting the bottle by 180°.
  • Visually verify the homogeneity of the suspension.
  • Using a graduated oral syringe, measure the appropriate volume of suspension corresponding to the prescribed dose of DUVYZAT.
  • Administer orally with the provided graduated oral syringe.

Missed Dose

If a dose is missed, patients should not take double or extra doses.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.