Select a medication above to begin.
Iqirvo
elafibranor
Adult Dosing .
Dosage forms: TAB: 80 mg
primary biliary cholangitis
- [80 mg PO qd]
- Info: may give with ursodiol
renal dosing
- [see below]
- renal impairment: no adjustment
- 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: avoid use; Info: consider D/C if patient progresses to Child-Pugh Class B or C during tx
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- cirrhosis, decompensated
- biliary obstruction
- pregnancy
- avoid: breastfeeding during tx and x3wk after D/C
- caution: patients of childbearing potential
- caution: patients >75 yo
- caution: hepatic impairment, Child-Pugh Class B-C
Drug Interactions .
Overview
elafibranor
PPAR agonist, alpha, delta
- CYP2C8 substrate
- CYP3A4 inducer, weak
- binds to anion exchange resin/polymer
- rhabdomyolysis
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- hepatotoxicity
- hepatitis, autoimmune-like
- cholecystitis
- rhabdomyolysis
- fractures
Common Reactions
- weight gain
- diarrhea
- abdominal pain
- nausea
- vomiting
- arthralgia
- constipation
- myalgia
- fractures
- xerostomia
- weight loss
- rash
- dizziness
- gastroenteritis
- Cr incr.
- anemia
- CK incr.
- cholelithiasis
- bilirubin incr.
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; LFTs at baseline, then periodically; CK, especially if myalgia or myopathy signs/symptoms
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of fetal harm, including stillbirth and caudal body section blue/black discoloration, based on animal data at 1.3x and 4.9x recommended human dose
Pregnancy Reporting
report pregnancy to Ipsen Pharmaceuticals, Inc. Adverse Event reporting line at 1-844-990-0239 or www.iqirvopregnancyregistry.com
Individuals of Reproductive Potential
obtain pregnancy test before tx start; avoid pregnancy by using effective non-hormonal contraception during tx and for at least 3wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x3wk after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for elafibranor: liver, plasma; CYP450: 2C8, 2J2 substrate; UGT: 1A3, 1A4, 2B7 substrate; Info: active metabolite
Excretion: for elafibranor: feces 77.1% (56.7% unchanged), urine 19.3% (minimally unchanged); Half-life: 70.2h (parent drug), 15.4h (active metabolite)
Subclass: Hepatobiliary
Mechanism of Action
for elafibranor: activates alpha and delta peroxisome proliferator-activated receptor subtypes, inhibiting bile acid synthesis
Formulary .
No Formulary Selected
Join Now to View Patient Handouts!
Create a FREE epocrates Online account to access patient medication instructions. Your patients and caregivers will appreciate you printing these friendly handouts, available in English and Spanish. Each handout addresses common concerns such as how to take the medication, and possible side effects.
Current Members: Sign In.
Pill Pictures
Join Now to View Pill Pictures!
Create a FREE epocrates Online account to access full-color images of medications within the drug monograph.
Current Members: Sign In.