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Brand Name :
N/A
Synonyms :
givinostat
Class :
Antineoplastic agents
Brand Name :
N/A
Synonyms :
givinostat
Class :
Antineoplastic agents
Dosage forms and strengths Â
The drug is presently undergoing phase II clinical trials.Â
The trials are done for the treatment of polyarticular course Juvenile idiopathic arthritis, chronic myeloproliferative neoplasms, duchenne muscular dystrophy (DMD), Juvenile idiopathic arthritis, & polycythemia veraÂ
Not indicatedÂ
Refer adult dosingÂ
When acrivastine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When adenosine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When ajmaline is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When alfuzosin is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When alimemazine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amantadine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amifampridine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amiodarone is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amisulpride is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amitriptyline is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amodiaquine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When amoxapine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When anagrelide is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When antazoline is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When apomorphine is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When arformoterol is used together givinostat, this leads to enhanced risk or severity of Qtc prolongation
When aripiprazole is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When arsenic trioxide is used together givinostat, this leads to enhanced risk or severity of Qtc prolongation
When artemether is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When articaine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When asenapine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When astemizole is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When atazanavir is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When atomoxetine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When atropine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When azatadine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When azithromycin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When bedaquiline is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When benzatropine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When bepridil is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When berotralstat is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When bilastine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When bortezomib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When bretylium is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When brompheniramine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When buclizine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When buserelin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When butriptyline is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When carbinoxamine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When celiprolol is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When ceritinib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cetirizine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When chlorcyclizine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When chloroquine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When chlorpheniramine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When chlorpromazine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When chlorprothixene is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cilostazol is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cinnarizine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cinoxacin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When ciprofloxacin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cisapride is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When citalopram is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When clarithromycin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When clemastine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When clofazimine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When clomipramine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When clozapine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When crizotinib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cyclizine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When cyproheptadine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dabrafenib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dasatinib is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When degarelix is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When delafloxacin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When desflurane is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When desipramine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When desloratadine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When deutetrabenazine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dexbrompheniramine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When digitoxin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When digoxin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When diltiazem is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When disopyramide is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When disulfiram is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dofetilide is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dolasetron is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When domperidone is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dosulepin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When doxepin is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When doxylamine is used together with givinostat, this leads to enhanced risk or seriousness of Qtc prolongation
When dronedarone is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
When droperidol is used together with givinostat, this leads to enhanced risk or severity of Qtc prolongation
Actions and Spectrum:Â
The action of givinostat involves inhibiting the activity of histone deacetylase enzymes. These enzymes play a role in modifying the structure of chromatin (the complex of DNA and proteins in which DNA is packaged in cells) by removing acetyl groups from histone proteins. This action affects gene expression and regulation.Â
By inhibiting HDAC enzymes, givinostat aims to modify the acetylation of histone proteins, potentially leading to changes in gene expression that could help mitigate the progression of muscular dystrophy.
Frequency not defined Â
Mild diarrheaÂ
Abdominal painÂ
Mild leukopeniaÂ
Black Box Warning:Â Â
None
Contraindication/Caution:Â Â
Hypersensitivity: People who have previously exhibited hypersensitivity or allergic reactions to givinostat or any of its components should avoid using it.Â
Pregnancy and breastfeeding: Givinostat may pose potential risks to the developing fetus during pregnancy. Its safety during breastfeeding is also not established, so caution or alternative measures may be required.Â
Severe hepatic impairment: Patients with severe liver impairment may experience exacerbated liver function abnormalities when taking givinostat. Close monitoring and potential dosage adjustments may be necessary.Â
Cardiovascular issues: Givinostat may cause QT interval prolongation, leading to cardiac arrhythmias. Patients with pre-existing cardiac conditions or those at risk of arrhythmias should use givinostat cautiously, if at all.Â
Pregnancy warnings:    Â
Pregnancy category: N/AÂ
Lactation: Excreted into human milk is unknownÂ
Pregnancy Categories:        Â
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.Â
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.  Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.  Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this category
Pharmacology: Givinostat is a histone deacetylase (HDAC) inhibitor.Â
Pharmacodynamics:Â Â
Givinostat works by inhibiting histone deacetylase enzymes, specifically targeting HDACs. By inhibiting these enzymes, givinostat increases histone acetylation, leading to altered gene expression patterns. This alteration in gene expression can affect various cellular processes, including inflammatory responses, fibrosis, and muscle regeneration. Â
Pharmacokinetics:Â
AbsorptionÂ
Givinostat is orally administered and is absorbed through the gastrointestinal tract.Â
DistributionÂ
It has a moderate distribution in the body, crossing the blood-brain barrier to some extent.Â
MetabolismÂ
The drug undergoes hepatic metabolism through various pathways, primarily via cytochrome P450 enzymes.Â
Excretion and EliminationÂ
Givinostat and its metabolites are eliminated predominantly via feces and urine.Â
Administration: Â
Givinostat is typically administered orally.Â
The frequency of givinostat administration can vary based on the specific treatment plan prescribed by the healthcare provider or as outlined in clinical trials.Â
Patient information leafletÂ
Generic Name: givinostatÂ
Why do we use givinostat? Â
Givinostat has shown promise in preclinical and clinical studies for the treatment of DMD, a condition marked by gradual muscle degeneration and weakening caused by genetic factors. It aims to improve muscle function and slow disease progression.Â
The drug has also been studied for its potential effectiveness in treating JDM, an autoimmune disease-causing muscle weakness and skin rashes in children and adolescents.Â
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