Odevixibat

Generic name
Odevixibat
Brand name
ATC Code
A05AX05
Compare …

Odevixibat

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

  40 mcg/kg/day 120 mcg/kg/day
Cmax (simulated) 0,211 ng/ml 0,623 ng/ml
V/F (mean) 40,3 L/kg 43,7 L/kg
Cl/F 26,4 L/kg/hour 23,0 L/kg/hour
T1/2 2,5 hour

Source: SmPC Bylvay

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Cholestatic pruritus in Alagille syndrome (ALGS)
  • Oral
    • ≥ 6 months
      • 120 microg./kg/day in 1 dose

      • Reduce the dose to 40 micrograms/kg/day if tolerability issues (severe diarrhea > 3 days) occur. Increase the dose back to 120 micrograms/kg/day once tolerability issues stabilize.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

BILE THERAPY

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Bile acids and derivatives
A05AA02
Other drugs for bile therapy
A05AX04
BILE ACIDS AND DERIVATIVES
A05AA02

References

  1. Albireo AB, SmPC Bylvay (EU/1/21/1566/001) Rev.3, 5-7-2023, www.ema.europa.eu
  2. Ipsen Pharma, SmPC Kayfanda (EU/1/24/1854) Rev 3; 08-05-2025, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose