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Lynavoy
linerixibat
Adult Dosing .
Dosage forms: TAB: 40 mg
cholestatic pruritus, primary biliary cholangitis-associated
- [40 mg PO bid]
- Info: give with water >30min before first food/drink
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A: no adjustment; Child-Pugh Class B or C: not defined, caution advised; decompensated cirrhosis or prior or active decompensation event: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic decompensation event, active
- hepatic decompensation event history
- caution: hepatic impairment, Child-Pugh Class B-C
- caution: fat-soluble vitamin deficiency
Drug Interactions .
Overview
linerixibat
IBAT inhibitor
- alters fat absorption
- binds to anion exchange resin/polymer
Adverse Reactions .
Serious Reactions
- diarrhea, severe
- bleeding
- fractures
Common Reactions
- diarrhea
- abdominal pain
- LFTs elevated
- nausea
- ALT incr.
- hemorrhage
- AST incr.
- headache
- dyspepsia
- GERD
- abdominal distension
- dizziness
- arthralgia
- hyperbilirubinemia
- UTI
- xerostomia
- fat-soluble vitamin deficiency
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then periodically during tx or more frequently if LFT elevation occurs; fat-soluble vitamin levels at baseline, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no human data available, though risk of fetal harm not expected based on minimal systemic absorption; no known risk of fetal harm based on animal data at 470x and 1100x MRHD
Pregnancy Reporting
report pregnancy to Intercept Pharmaceuticals at 1-844-782-4278
Lactation
Clinical Summary
may use while breastfeeding; no human data available, though risk of infant harm and adverse effects on milk production not expected based on minimal systemic absorption in breastfeeding patients
Pharmacology .
Metabolism: for linerixibat: minimal; CYP450: unknown; Info: minimal systemic absorption
Excretion: for linerixibat: feces 97% (>99% unchanged), urine 0.4%; Half-life: 6.76h
Subclass: Hepatobiliary ; Ileal Bile Acid Transporter Inhibitors
Mechanism of Action
for linerixibat: exact mechanism of action unknown; inhibits ileal bile acid transporter, decreasing bile acid reabsorption from the terminal ileum
Formulary .
No Formulary Selected
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