Like most medications, givinostat has several side effects. Some of the more common side effects of givinostat, as reported in studies like those published in The Lancet, include things like diarrhoea, stomach pain, feeling sick and vomiting, low platelet counts, and higher levels of fats in the blood.
These effects are linked to how givinostat works in the body—as a histone deacetylase (HDAC) inhibitor. HDAC inhibitors are generally well tolerated but do have common side effects such as sickness, vomiting and feeling tired.
All of the side effects can potentially be serious and need to be monitored and responded to by the prescribing doctor such as a reduction in the amount of givinostat that is dosed.
Some of the side effects will pass after the initial dosing of givinostat. Others will subside once a reduction is made to the dose, which the prescribing doctor might decide on. In some circumstances, the doctor might decide to stop dosing with givinostat.
Clinical trial results published in The Lancet have shown that givinostat generally has a positive side effect profile. More recently, ITF Therapeutics—the company that makes givinostat—shared longer-term data in the Annals of Clinical and Translational Neurology. This new research looked at people with Duchenne muscular dystrophy who’ve been taking givinostat for several years, and reassuringly, the side effects stayed consistent with what earlier studies had already reported.
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