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Givinostat is available as a 8.86 mg/mL oral suspension.

Givinostat is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Givinostat is a histone deacetylase inhibitor, which means it blocks a protein called histone deacetylase from working. People with DMD are thought to have higher histone deacetylase activity in their weakening muscles. By blocking these proteins, Givinostat helps muscles rebuild and reduces inflammation.

The dose of Givinostat is based on the patient ‘s body weight and is given by mouth twice daily with food. Dose adjustments may be needed for decreased platelet counts, diarrhea, increased triglycerides, or QTc prolongation.

Givinostat is a safe and effective treatment when used for FDA approved indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Givinostat: Diarrhea Stomach pain Low platelet counts in blood Nausea/vomiting Increase levels of fat in your blood Fever Muscle Pain Joint pain

Serious side effects are rare with Givinostat. Contact your healthcare provider immediately if you experience any of the following: Serious Bleeding: nosebleeds, excessive bleeding, unusual bleeding, blood in stool, tiredness Abnormal heart rhythm: heart pounding, dizziness, light headedness, passing out Severe diarrhea and vomiting: headache, increased thirst, dark-yellow urine, severe stomach pains

The following medications may interact with Givinostat: Closely monitor when Givinostat is used in combination with an oral CYP3A4 substrates or substrates of the OCT2 transporter, for which a small change in substrate plasma concentration may lead to serious toxicities. Avoid concomitant use with other drugs that prolong the QTc interval; monitor ECG if concomitant use cannot be avoided

Various FDA-approved generic manufacturers

It is not known whether Givinostat will harm your unborn baby. Talk with your healthcare provider about the risks of taking this medication if you are pregnant or plan on becoming pregnant.

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