Givinostat
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Givinostat is a {{{drugClass}}} that is FDA approved for the treatment of DUVYZAT is a histone deacetylase inhibitor that is FDA approved for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.. Common adverse reactions include *Most common adverse reactions (≥10% in DUVYZAT-treated patients) are,
- diarrhea,
- abdominal pain,
- thrombocytopenia,
- nausea/vomiting,
- hypertriglyceridemia, and
- pyrexia..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
- 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 10^9/L.
- The dosage of DUVYZAT is based on patient’s body weight.
- Administer orally twice daily with food.
- Dosage modifications may be needed for decreased platelet counts, diarrhea, increased triglycerides, or QTc prolongation.
- Oral suspension: 8.86 mg/mL givinostat.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Givinostat in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Givinostat in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Givinostat FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Givinostat in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Givinostat in pediatric patients.
Contraindications
None.
Warnings
- Hematological Changes: DUVYZAT can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia. Monitor platelets; dosage adjustment or discontinuation may be needed.
- Increased Triglycerides: An increase in triglycerides can occur; dosage modification may be needed. Discontinuation may be needed.
- Gastrointestinal Disturbances: Adjust dosage if moderate or severe diarrhea occurs. Antiemetics or antidiarrheal medications may be considered during treatment with DUVYZAT. Discontinue DUVYZAT if the symptoms persist.
- QTc Prolongation: Avoid use of DUVYZAT in patients who are at an increased risk for ventricular arrhythmias.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Givinostat Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Givinostat Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Givinostat Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Givinostat in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Givinostat in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Givinostat during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Givinostat in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Givinostat in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Givinostat in geriatric settings.
Gender
There is no FDA guidance on the use of Givinostat with respect to specific gender populations.
Race
There is no FDA guidance on the use of Givinostat with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Givinostat in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Givinostat in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Givinostat in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Givinostat in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Givinostat Administration in the drug label.
Monitoring
There is limited information regarding Givinostat Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Givinostat and IV administrations.
Overdosage
There is limited information regarding Givinostat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Givinostat Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Givinostat Mechanism of Action in the drug label.
Structure
There is limited information regarding Givinostat Structure in the drug label.
Pharmacodynamics
There is limited information regarding Givinostat Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Givinostat Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Givinostat Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Givinostat Clinical Studies in the drug label.
How Supplied
There is limited information regarding Givinostat How Supplied in the drug label.
Storage
There is limited information regarding Givinostat Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Givinostat Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Givinostat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Givinostat Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Givinostat Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.