givinostat

Contraindicated in:

Congenital long QT syndrome, coronary artery disease, or electrolyte disturbances.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: QT interval prolongation

Derm: rash

Endo: hypothyroidism

GI: abdominal pain, diarrhea, nausea, vomiting, constipation

Hemat: thrombocytopenia, anemia, neutropenia

Metab: hypertriglyceridemia, ↓appetite

MS: arthralgia, myalgia

Neuro: fatigue

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

QT interval prolonging medications may ↑ risk of QT interval prolongation; avoid concurrent use. If concurrent use unavoidable, closely monitor ECG.
May ↑ levels and risk of toxicity of CYP3A4 substrates, including midazolam.
May ↑ levels and risk of toxicity of OCT2 substrates.

Availability ⬆ ⬇

Oral suspension cream flavor: 8.86 mg/mL

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥6 yr and ≥60 kg): 53.2 mg (6 mL) twice daily.
PO (Adults and Children ≥6 yr and 40–<60 kg): 44.3 mg (5 mL) twice daily.
PO (Adults and Children ≥6 yr and 20–<40 kg): 31 mg (3.5 mL) twice daily.
PO (Adults and Children ≥6 yr and 10–<20 kg): 22.2 mg (2.5 mL) twice daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a histone deacetylase inhibitor. Mechanism by which produces effect in Duchenne muscular dystrophy unknown.

Therapeutic effects:

Improved muscle function.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: histone deacetylase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following oral administration unknown. Absorption ↑ by high fat food.

Distribution: Unknown.

Protein Binding: 96%.

Metabolism/Excretion: Extensively metabolized. Primarily excreted in bile; <3% excreted in urine.

Half-Life: 6 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2–3 hr	12 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of givinostat. Advise patient to take with food as directed. Explain to parents the importance of using calibrated measuring device for accurate dosing. Instruct patient to skip missed dose and to take next scheduled dose. Do not double dose. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
Emphasize importance of regular follow-ups and blood testing.
Warn patient to report symptoms of arrhythmias (fast heartbeat, skipped heartbeats, palpitations, dizziness, light-headedness, trouble breathing, faintness).
Instruct patient to report symptoms of GI disturbances (diarrhea, nausea, vomiting, abdominal pain). Advise them to take adequate fluids to prevent dehydration.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇

Contraind./Precautions ⬆ ⬇