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Iqirvo
elafibranor
Adult Dosing .
Dosage forms: TAB: 80 mg
primary biliary cholangitis
- [80 mg PO qd]
- Info: may give w/ 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 pt 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: pts of childbearing potential
- caution: pts >75 yo
- caution: hepatic impairment, Child-Pugh Class B-C
Drug Interactions .
Overview
elafibranor
PPAR agonist
- CYP3A4 inducer, weak
- binds to anion exchange resin/polymer
- rhabdomyolysis
Avoid/Use Alternative
- atazanavir
- atogepant
- colchicine
- desogestrel (contraceptive)
- dienogest (contraceptive)
- dolutegravir
- drospirenone (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- fosamprenavir
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lumateperone
- mavacamten
- medroxyprogesterone (contraceptive)
- meperidine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- ranolazine
- red yeast rice
- segesterone (contraceptive)
- ulipristal (post-coital contraceptive)
- zuranolone
Monitor/Modify Tx
- amlodipine
- atorvastatin
- buprenorphine
- carbamazepine
- cholestyramine
- colesevelam
- colestipol
- cyclophosphamide
- cyclosporine
- daptomycin
- diltiazem
- disopyramide
- everolimus
- fenofibrate
- fenofibric acid
- fluvastatin
- gemfibrozil
- ifosfamide
- isradipine
- ketoconazole
- lovastatin
- mitapivat
- niacin (vitamin B3)
- nicardipine
- nimodipine
- nisoldipine
- oliceridine
- perampanel
- pitavastatin
- pravastatin
- quetiapine
- quinidine (antiarrhythmic)
- raltegravir
- rosuvastatin
- selumetinib
- simvastatin
- sirolimus
- tacrolimus
- tiagabine
- ubrogepant
- voriconazole
- warfarin
Caution Advised
- abemaciclib
- acalabrutinib
- alfentanil
- alprazolam
- amiodarone
- aprepitant
- artemether/lumefantrine
- avacopan
- avapritinib
- axitinib
- bictegravir
- bosutinib
- brigatinib
- budesonide
- buspirone
- cabozantinib
- capivasertib
- capmatinib
- clarithromycin
- cobicistat
- cobimetinib
- codeine
- crizotinib
- daridorexant
- darunavir
- dasatinib
- defactinib
- deflazacort
- doravirine
- dronedarone
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- entrectinib
- erdafitinib
- erlotinib
- fedratinib
- felodipine
- fentanyl
- finerenone
- fosaprepitant
- fostamatinib
- fruquintinib
- ganaxolone
- gepirone
- gilteritinib
- glasdegib
- glecaprevir
- grazoprevir
- guanfacine
- haloperidol
- hydrocortisone
- ibrutinib
- idelalisib
- imatinib
- infigratinib
- irinotecan
- isavuconazonium
- istradefylline
- itraconazole
- ivacaftor
- ixazomib
- lapatinib
- larotrectinib
- lazertinib
- lefamulin
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- levonorgestrel intrauterine device (contraceptive)
- lonafarnib
- lorlatinib
- lurasidone
- macitentan
- maraviroc
- methadone
- midazolam
- midostaurin
- mobocertinib
- naldemedine
- naloxegol
- nefazodone
- nelfinavir
- neratinib
- netupitant
- nevirapine
- nifedipine
- nilotinib
- nirmatrelvir
- nirogacestat
- olaparib
- olutasidenib
- oxycodone
- palbociclib
- pemigatinib
- pimavanserin
- pirtobrutinib
- ponatinib
- praziquantel
- pretomanid
- quinine
- quizartinib
- repotrectinib
- ribociclib
- rifampin
- rilpivirine
- ripretinib
- ritonavir
- roflumilast
- rolapitant
- samidorphan
- selpercatinib
- sildenafil
- sirolimus albumin-bound
- sonidegib
- suzetrigine
- tadalafil
- tamoxifen
- tazemetostat
- temsirolimus
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- tramadol
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- voxelotor
- voxilaprevir
- zanubrutinib
Adverse Reactions .
Serious Reactions
- hypersensitivity rxn
- 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, esp. if myalgia or myopathy s/sx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of fetal harm, incl. 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 1-855-463-5127 or www.ipsen.com/contact-us/
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 pts 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: liver, plasma; CYP450: 2C8, 2J2 substrate; UGT: 1A3, 1A4, 2B7 substrate; Info: active metabolite
Excretion: 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
activates alpha and delta peroxisome proliferator-activated receptor subtypes, inhibiting bile acid synthesis
Formulary .
No Formulary Selected
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