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Livdelzi
seladelpar
Adult Dosing .
Dosage forms: CAP: 10 mg
primary biliary cholangitis
- [10 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
- caution: hepatic impairment, Child-Pugh Class B-C
- caution: pts >75 yo
Drug Interactions .
Overview
seladelpar
PPAR agonist
- CYP2C9 substrate
- CYP3A4 substrate
- BCRP substrate
- OAT3 substrate
- binds to anion exchange resin/polymer
Avoid/Use Alternative
- cabotegravir
- fexinidazole
- fluorouracil
- gemfibrozil
- leflunomide
- meropenem
- nitisinone
- pretomanid
- probenecid
- teriflunomide
- trimethoprim
- vaborbactam
- vadadustat
Monitor/Modify Tx
- apalutamide
- butalbital
- carbamazepine
- cholestyramine
- colesevelam
- colestipol
- enzalutamide
- fosphenytoin
- ivosidenib
- lumacaftor/ivacaftor
- mitotane
- pentobarbital
- phenobarbital
- phenytoin
- primidone
- rifabutin
- rifampin
- St. John's wort
Caution Advised
- acalabrutinib
- adagrasib
- amiodarone
- aprepitant
- asciminib
- atazanavir
- avacopan
- belumosudil
- berotralstat
- brigatinib
- capmatinib
- ceritinib
- chloramphenicol
- ciprofloxacin
- clarithromycin
- clofazimine
- cobicistat
- conivaptan
- crizotinib
- cyclosporine
- danazol
- danicopan
- darolutamide
- darunavir
- diltiazem
- dronedarone
- duvelisib
- efavirenz
- elacestrant
- elbasvir
- eltrombopag
- eluxadoline
- enasidenib
- encorafenib
- erythromycin
- febuxostat
- fedratinib
- fluconazole
- fosamprenavir
- fostamatinib
- fostemsavir
- futibatinib
- gilteritinib
- glecaprevir
- grapefruit
- grazoprevir
- ibrutinib
- idelalisib
- imatinib
- isavuconazonium
- itraconazole
- ketoconazole
- lazertinib
- ledipasvir
- lefamulin
- lenacapavir
- leniolisib
- letermovir
- levoketoconazole
- lonafarnib
- lopinavir/ritonavir
- maribavir
- miconazole oropharyngeal
- midostaurin
- mifepristone
- milk thistle
- momelotinib
- nefazodone
- nelfinavir
- netupitant
- nilotinib
- nirogacestat
- osimertinib
- oteseconazole
- pacritinib
- pibrentasvir
- pirtobrutinib
- posaconazole
- regorafenib
- resmetirom
- ribociclib
- ritonavir
- rolapitant
- rucaparib
- selpercatinib
- sotorasib
- sparsentan
- stiripentol
- tafamidis
- tedizolid phosphate
- telmisartan
- ticagrelor
- tipranavir
- tucatinib
- turmeric
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- verapamil
- vimseltinib
- voriconazole
- voxilaprevir
Adverse Reactions .
Serious Reactions
- fractures
Common Reactions
- headache
- abdominal pain
- nausea
- abdominal distension
- dizziness
- dyspepsia
- rash
- alopecia
- anemia
- cough
- fractures
- eGFR decr.
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; no known risk of teratogenicity or embryo-fetal death based on animal data at 49x and 176x recommended human dose; possible risk of decr. fetal wt based on conflicting animal data
Pregnancy Reporting
report pregnancy to Gilead Sciences, Inc. at 1-800-445-3235
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C8, 2C9 (primary), 3A4 substrate
Excretion: urine 73.4% (0.01% unchanged), feces 19.5% (2.02% unchanged); Half-life: 216h
Subclass: Hepatobiliary
Mechanism of Action
activates delta peroxisome proliferator-activated receptor subtype, inhibiting bile acid synthesis
Formulary .
No Formulary Selected
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