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Bylvay
odevixibat
Adult Dosing .
Dosage forms: CAP: 400 mcg, 1200 mcg; PELLET: 200 mcg, 600 mcg
cholestatic pruritus, progressive familial intrahepatic cholestasis-associated
- [35.5-45.4 kg]
- Dose: 1600 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [45.5-55.4 kg]
- Dose: 2000 mcg PO qd; Max: 120 mcg/kg/day up to 6000 mcg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [>55.4 kg]
- Dose: 2400 mcg PO qd; Max: 120 mcg/kg/day up to 6000 mcg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
cholestatic pruritus, Alagille syndrome-associated
- [35.5-45.4 kg]
- Dose: 4800 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [45.5-55.4 kg]
- Dose: 6000 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [>55.4 kg]
- Dose: 7200 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- compensated cirrhosis or portal HTN: no adjustment; decompensated cirrhosis: not defined, caution advised; prior or active decompensation event: contraindicated; Info: caution advised if compensated cirrhosis or portal HTN
Peds Dosing .
- Dosage forms: CAP: 400 mcg, 1200 mcg; PELLET: 200 mcg, 600 mcg
cholestatic pruritus, progressive familial intrahepatic cholestasis-associated
- [3 mo and older, <7.5 kg]
- Dose: 200 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 7.5-12.4 kg]
- Dose: 400 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 12.5-17.4 kg]
- Dose: 600 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 17.5-25.4 kg]
- Dose: 800 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 25.5-35.4 kg]
- Dose: 1200 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 35.5-45.4 kg]
- Dose: 1600 mcg PO qd; Max: 120 mcg/kg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, 45.5-55.4 kg]
- Dose: 2000 mcg PO qd; Max: 120 mcg/kg/day up to 6000 mcg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
- [3 mo and older, >55.4 kg]
- Dose: 2400 mcg PO qd; Max: 120 mcg/kg/day up to 6000 mcg/day; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; if no improvement after 3mo, may incr. dose in 40 mcg/kg/day increments; see pkg insert for toxicity-related dose adjustments
cholestatic pruritus, Alagille syndrome-associated
- [12 mo and older, <7.5 kg]
- Dose: 600 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 7.5-12.4 kg]
- Dose: 1200 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 12.5-17.4 kg]
- Dose: 1800 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 17.5-25.4 kg]
- Dose: 2400 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 25.5-35.4 kg]
- Dose: 3600 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 35.5-45.4 kg]
- Dose: 4800 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, 45.5-55.4 kg]
- Dose: 6000 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
- [12 mo and older, >55.4 kg]
- Dose: 7200 mcg PO qd; Info: give w/ meal; must open pellet shell and mix contents in soft food or liquid; may temporarily decr. dose to 40 mcg/kg/dose PO qd if tolerability concern; see pkg insert for toxicity-related dose adjustments
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- compensated cirrhosis or portal HTN: no adjustment; decompensated cirrhosis: not defined, caution advised; prior or active decompensation event: contraindicated; Info: caution advised if compensated cirrhosis or portal HTN
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic decompensation event, active
- hepatic decompensation event hx
- caution: hepatic decompensation risk
- caution: cirrhosis
- caution: portal HTN
- caution: PFIC type 2 w/ ABCB11 gene variant
- caution: fat-soluble vitamin deficiency
Drug Interactions .
Overview
odevixibat
IBAT inhibitor
- CYP3A4 inducer, weak
- alters fat absorption
- binds to anion exchange resin/polymer
Avoid/Use Alternative
- atazanavir
- atogepant
- codeine
- desogestrel (contraceptive)
- dienogest (contraceptive)
- dolutegravir
- drospirenone (contraceptive)
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- ethynodiol (contraceptive)
- etonogestrel (contraceptive)
- fentanyl
- fosamprenavir
- levonorgestrel (contraceptive)
- levonorgestrel (post-coital contraceptive)
- lopinavir/ritonavir
- lumateperone
- mavacamten
- medroxyprogesterone (contraceptive)
- meperidine
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- ranolazine
- segesterone (contraceptive)
- tramadol
- ulipristal (post-coital contraceptive)
- zuranolone
Monitor/Modify Tx
- alpha-tocopherol (vitamin E)
- amlodipine
- beta-carotene
- buprenorphine
- calcitriol
- carbamazepine
- cholecalciferol (vitamin D3)
- cholestyramine
- colesevelam
- colestipol
- cyclophosphamide
- cyclosporine
- diltiazem
- disopyramide
- doxercalciferol
- ergocalciferol (vitamin D2)
- everolimus
- ifosfamide
- isradipine
- ketoconazole
- mitapivat
- nicardipine
- nimodipine
- nisoldipine
- oliceridine
- paricalcitol
- perampanel
- quetiapine
- quinidine (antiarrhythmic)
- sirolimus
- tacrolimus
- tiagabine
- ubrogepant
- vitamin A (retinol)
- vitamin K
- voriconazole
- warfarin
Caution Advised
- abemaciclib
- acalabrutinib
- alfentanil
- alprazolam
- amiodarone
- aprepitant
- artemether/lumefantrine
- atorvastatin
- avacopan
- avapritinib
- axitinib
- bictegravir
- bosutinib
- brigatinib
- budesonide
- buspirone
- cabozantinib
- capivasertib
- capmatinib
- clarithromycin
- cobicistat
- cobimetinib
- crizotinib
- daridorexant
- darunavir
- dasatinib
- defactinib
- deflazacort
- doravirine
- dronedarone
- drospirenone (hormone replacement)
- elacestrant
- elbasvir
- elexacaftor/tezacaftor/ivacaftor
- eliglustat
- elvitegravir
- entrectinib
- erdafitinib
- erlotinib
- fedratinib
- felodipine
- 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
- rilpivirine
- ripretinib
- ritonavir
- roflumilast
- rolapitant
- samidorphan
- selpercatinib
- selumetinib
- sildenafil
- simvastatin
- sirolimus albumin-bound
- sonidegib
- suzetrigine
- tadalafil
- tamoxifen
- tazemetostat
- temsirolimus
- tezacaftor/ivacaftor
- ticagrelor
- tipranavir
- tofacitinib
- tolvaptan
- toremifene
- vanzacaftor/tezacaftor/deutivacaftor
- velpatasvir
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- voclosporin
- vonoprazan
- voxelotor
- voxilaprevir
- zanubrutinib
Adverse Reactions .
Serious Reactions
- hepatotoxicity
- hepatic decompensation
- diarrhea, severe
- cholelithiasis
- bleeding, severe
- intracranial hemorrhage
- fractures
Common Reactions
- diarrhea
- ALT elevated
- AST elevated
- bilirubin elevated
- vomiting
- fat-soluble vitamin deficiency
- abdominal pain
- splenomegaly
- hematoma
- weight decr.
- cholelithiasis
- dehydration
- fractures
Safety/Monitoring .
Monitoring Parameters
LFTs before tx start to establish baseline variability, then frequently 1st 6-8mo of tx, or if compensated cirrhosis or portal HTN frequently during tx, then as clinically indicated; fat-soluble vitamin levels at baseline, then periodically
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though risk of fetal harm not expected based on minimal systemic absorption; possible risk of fetal cardiac malformations based on animal data at 2.1x MRHD
Pregnancy Reporting
report any suspected fetal exposure at 1-855-463-5127
Lactation
Clinical Summary
weigh risk/benefit 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 pts
Pharmacology .
Metabolism: GI tract; CYP450: unknown; Info: minimal systemic absorption
Excretion: feces 82.9% (97% unchanged), urine <0.002%; Half-life: 2.36h
Subclass: Hepatobiliary ; Ileal Bile Acid Transporter Inhibitors
Mechanism of Action
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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