Odxibat (Odevixibat)

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  • Model Number:
    RL3320250406
  • Brand Name:
    Odxibat
  • Origin:
    Generic drug,Laos
  • Small Orders:
    Small batches also available
  • Tags:
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Poster
  • Details
  • Description
  • Packaging Size
    30c/bottle
  • Strength
    0.2mg&1.2mg
  • Compositon
    Odevixibat
  • Treatment
    Progressive familial intrahepatic cholestasis
  • Form
    capsules
  • Brand
    Odxibat
  • Quantity Unit
    0.2mg*30c/box&1.2mg*30c/box
  • Manufacturer
    Tongmeng (Lao) Pharmaceutical & Food Co., Ltd.(TLPH)

About Odevixibat

Odevixibat is a medication for the treatment of progressive familial intrahepatic cholestasis.  Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). 

Dosage Forms & Strengths

capsule

  • 400mcg
  • 1200mcg

Cholestasis-Induced Pruritus

Indicated for pruritus associated with progressive familial intrahepatic cholestasis (PFIC)

40 mcg/kg PO qAM

Weight-based dosing

  • 45.5-55.4 kg: 2000 mcg PO qAM
  • ≥55.5 kg: 2400 mcg PO qAM
  • If no improvement after 3 months, may increase dose in 40-mcg/kg increments up to 120 mcg/kg/day; not to exceed 6 mg/day

Alagille Syndrome

Indicated for pruritus associated with Alagille syndrome (ALGS)

120 mcg/kg PO qAM

Weight-based dosing

  • 45.5-55.4 kg: 6000 mcg PO qAM
  • ≥55.5 kg: 7200 mcg PO qAM
 

Dosage Modifications

Tolerability for ALGS

  • Consider dose reduction to 40 mcg/kg/day if tolerability issues occur in absence of other causes
  • Increase to 120 mcg/kg/day once tolerability issues stabilize

Hepatic impairment

  • Patients with PFIC may have impaired hepatic function at baseline
  • Patients with clinically significant portal hypertension or patients with decompensated cirrhosis: Safety and efficacy not established

Liver abnormalities

  • New onset of elevated liver function tests (LFTs) or symptoms consistent with clinical hepatitis: Interrupt therapy; once LFTs either return to baseline or stabilize at a new baseline value, consider restarting at recommended dose, and increase as tolerated if appropriate
  • Elevated LFTs recur: Consider discontinuing permanently
  • Hepatic decompensation event (eg, variceal hemorrhage, ascites, hepatic encephalopathy) occurs: Permanently discontinue

Dosing Considerations

Limitation of use

  • Not effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein

Monitoring parameters

  • Liver function tests (eg, ALT, AST, total bilirubin [TB], and direct bilirubin [DB]) and serum fat-soluble vitamins (FSV) levels: Baseline and during treatment
  • International Normalized Ratio (INR): During treatment

 


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