← Search & browse all drugs
MUSCULO-SKELETAL SYSTEM › OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM › OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM › Other drugs for disorders of the musculo-skeletal system
givinostat
M09AX14
Forms & Strengths
- Oral suspension: 48.6 mg/mL
Adult Dosing
- Not evaluated or indicated for adult Duchenne muscular dystrophy in this clinical context
Pediatric Dosing
- Pediatric patients 6 years of age and older with Duchenne muscular dystrophy
- Weight-based dosing administered orally twice daily with food
- 30 kg to < 35 kg: 72.9 mg (1.5 mL) twice daily
- 35 kg to < 50 kg: 87.5 mg (1.8 mL) twice daily
- 50 kg to < 60 kg: 106.9 mg (2.2 mL) twice daily
- 60 kg or greater: 121.5 mg (2.5 mL) twice daily
Indications
- Treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older
Mechanism of Action
- Histone deacetylase (HDAC) inhibitor
- Promotes muscle regeneration, reduces fibrosis and inflammation, and counteracts muscle atrophy associated with DMD
Contraindications
- Severe hepatic impairment
- Known hypersensitivity to givinostat or any of its excipients
Adverse Reactions
- Diarrhea
- Abdominal pain
- Thrombocytopenia
- Hypertriglyceridemia
- Nausea
- Vomiting
- QTc interval prolongation
- Decreased platelet count
Drug Interactions
- Strong CYP3A4 inhibitors may increase givinostat exposure and toxicity
- Strong CYP3A4 inducers may decrease givinostat efficacy
- Drugs known to prolong the QTc interval may increase the risk of cardiac arrhythmias
Curated Content: Needs Vetting Before Put to Clinical Use