Duvyzat Dosage

Generic name: GIVINOSTAT 8.86mg in 1mL
Dosage form: oral suspension

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 [see Warnings and Precautions (5.1, 5.2)]. 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 [see Dosage and Administration (2.3)].

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 [see Dosage and Administration (2.3), Warnings and Precautions (5.4), and Drug Interactions (7.2)].

Recommended Dosage

The recommended dosage of DUVYZAT is based on body weight and administered orally twice daily with food (see Table 1) [see Dosage and Administration (2.4)].

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 [see Warnings and Precautions (5.1, 5.2, 5.3)], 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 [see Warnings and Precautions (5.4) and Drug Interactions (7.2)].

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.