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Indications

REMS

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CV: ARRHYTHMIA, heart block, palpitations, QT interval prolongation.

Derm: rash.

EENT: oropharyngeal pain.

GI: diarrhea, flatulence, nausea, upper abdominal pain, constipation, gastroesophageal reflux.

MS: arthralgia, back pain, extremity pain.

Neuro: fatigue, headache, dizziness.

Interactions

General

Drug-Drug:

Drug-Natural Products:

Drug-Food:

For EMs

Drug-Drug:

For IMs

Drug-Drug:

For PMs

Drug-Drug:

Availability

(Generic available)

Route/Dosage

Hepatic Impairment

US Brand Names

Cerdelga

Action

Therapeutic Effects:

Classifications

Therapeutic Classification: n/a

Pharmacologic Classification: glucosylceramide synthase inhibitors

Pharmacokinetics

Absorption: EMs — 5% absorbed following oral administration (due to extensive first-pass metabolism).

Distribution: Distributes mainly into plasma.

Metabolism/Excretion: Extensively metabolized, primarily by the CYP2D6 isoenzyme, with some metabolism by the CYP3A4 isoenzyme; 41.8% excreted in urine and 51.4% in feces mostly as metabolites.

Half-life: EMs: 6.5 hr; PMs: 8.9 hr.

Time/Action Profile

(plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown1.5–2 hr (EMs), 3 hr (PMs)12–24 hr

Patient/Family Teaching

Pronunciation

e-LIG-lu-stat