Givinostat

DUVYZAT

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Pronunciation: giv-IN-oe-stat (DOO-vi-zat)

Givinostat ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Givinostat ballicule

What it isHistone deacetylase inhibitor; Duchenne muscular dystrophy.

Why this oneTargets fibrosis and inflammation downstream of dystrophin loss, so eligibility does not depend on the mutation.

What limits itThrombocytopenia, triglyceride elevation, and diarrhea limit treatment; monitor platelets and lipids, and review QT interactions.

Givinostat molecular structure (skeletal formula) — Molecular structure: Givinostat

FDA-approved for

Duchenne muscular dystrophy (2024)

Principal riskThrombocytopenia

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger1 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades1 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

FDA dosing	Population	Start	Target	Max
Duchenne muscular dystrophy	Patients ≥6 yr	Weight-based: 22.2 mg BID (10–<20 kg) up to 53.2 mg BID (≥60 kg)		53.2 mg BID

Renal Undefined

Hepatic Undefined

Instructions

Administer orally twice daily with food
Obtain baseline platelet count and triglycerides; do not start if platelets <150 x10^9/L
Modify dose for thrombocytopenia, diarrhea, hypertriglyceridemia, or QTc prolongation

Available strengths

susp 8.86 mg/mL

Cautions

Hematological changes: thrombocytopenia, anemia, neutropenia
Increased triglycerides
GI disturbances (diarrhea)
QTc prolongation — avoid in patients at risk for ventricular arrhythmia

Adverse reactions

Diarrhea
Abdominal pain
Thrombocytopenia
Nausea/vomiting
Hypertriglyceridemia
Pyrexia

Pregnancy No human data; animal studies show fetal harm (decreased fetal weight, variations, embryofetal/offspring mortality).

Lactation No human or animal data.

Cost

Givinostat (DUVYZAT)

Strength		#/mo	generic $/unit	CostPlus
8.86 mg/mL	susp	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Givinostat is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2038 est.

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Self-check

Does givinostat eligibility depend on the dystrophin mutation?
No.
Which blood-cell count needs monitoring with givinostat?
Platelets.