Alglucosidase alfa

Generic name
Alglucosidase alfa
Brand name
ATC Code
A16AB07

Alglucosidase alfa

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The following kinetic parameters were found in 24 children aged 0-15 years after one or more doses of 20 mg/kg:

  20 mg/kg
Cmax (µg/ml) 178.2
Cl (ml/hour/kg) 21.4
Vd (ml/kg) 66.2
t½ (hours) 2.75

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

Enzyme replacement therapy in Pompe’s disease
  • Intravenous
    • 1 month up to 18 years
      • 20 mg/kg/dose once every 2 weeks.
      • Initial infusion rate: 1 mg/kg/hour, increase gradually by 2 mg/kg/hour every 30 minutes if there are no infusion-related side effects until a maximum rate of 7 mg/kg/hour is achieved.

    • Term neonate
      • 20 mg/kg/dose once every 2 weeks.
      • Initial infusion rate: 1 mg/kg/hour, increase gradually by 2 mg/kg/hour every 30 minutes if there are no infusion-related side effects until a maximum rate of 7 mg/kg/hour is achieved.

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

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
A16AB13
A16AB22
A16AB17
A16AB08
A16AB09
A16AB02
A16AB05
A16AB14
A16AB10
Various alimentary tract and metabolism products
A16AX10
A16AX09
A16AX
A16AX18
A16AX06
A16AX04
A16AX07
A16AX
A16AX08
A16AX07
A16AX05
AMINO ACIDS AND DERIVATIVES
A16AA06
A16AA05
A16AA01
A16AA04

Reference

  1. Genzyme Ltd, SmPC Myozyme (EU/1/06/333/001) 23-01-2014, www.ema.europa.eu

Changes

Therapeutic Drug Monitoring


Overdose