Teduglutide

Generic name
Teduglutide
Brand name
ATC Code
A16AX08

Teduglutide

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

Similar Cmax of teduglutide across age groups was demonstrated by population pharmacokinetics modelling. However, lower exposure (AUC) and shorter half-life were seen in paediatric patients 4 months to 17 years of age, as compared with adults. The pharmacokinetic profile in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights. Specifically, clearance decreases with increasing age from 4 months  old to adults [EPAR Revestive].

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

Short bowel syndrome
  • Subcutaneous
    • ≥ 4 months
      • 0.05 mg/kg/day in 1 dose
      • Evaluate the effect of the treatment after 12 weeks (in children <2 years) or after 6 months (in children ≥2 years).

Renal impaiment in children > 3 months

Adjustment in renal impairment as specified:

GFR 50-80 ml/min/1.73 m2
Adjustment is not required
GFR 30-50 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uur
GFR 10-30 ml/min/1.73 m2
50 percentage of single dose and dosing interval : 24 uur
GFR < 10 ml/min/1.73 m2
Generalized recommendations cannot be given.

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

Side effects in children

The side effect profile in children is similar to that in adults. 

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

OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS

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

Amino acids and derivatives
A16AA06
A16AA05
A16AA01
A16AA04
Enzymes
A16AB03
A16AB04
A16AB07
A16AB13
A16AB22
A16AB17
A16AB08
A16AB09
A16AB02
A16AB05
A16AB14
A16AB10
Various alimentary tract and metabolism products
A16AX10
A16AX09
A16AX
A16AX18
A16AX06
A16AX04
A16AX07
A16AX
A16AX07
A16AX05
AMINO ACIDS AND DERIVATIVES
A16AA06
A16AA05
A16AA01
A16AA04

Reference

  1. Shire Pharmaceuticals Ireland Limited, SmPC Revestive (EU/1/12/787/001) Rev.22. 11-07-2023, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose