Idursulfase
Generic name
Idursulfase
Brand name
ATC Code
A16AB09
- 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 have been measured in week 1:
| Age category | Number of patients | Cmax (µg/ml) | Cl (ml/min/kg) | Vd (ml/kg) |
|---|---|---|---|---|
| 1.4 to 7.5 years | 27 | 1.3 ± 0.8 | 2.4 ± 0.7 | 394 ± 423 |
| 5 to 11 years | 11 | 1.6 ± 0.7 | 2.7 ± 1.3 | 217 ± 109 |
| 12 to 18 years | 8 | 1.4 ± 0.3 | 2.8 ± 0.7 | 184 ± 38 |
| Bodyweight | Number of patients | Cmax (µg/ml) | Cl (ml/min/kg) | Vd (ml/kg) |
|---|---|---|---|---|
| < 20 kg | 17 | 1.2 ± 0.3 | 2.5 ± 0.5 | 321 ± 105 |
| 20 to 30 kg | 18 | 1.5 ± 1.0 | 2.6 ± 1.1 | 397 ± 528 |
| 30 to 40 kg | 9 | 1.7 ± 0.4 | 2.4 ± 0.6 | 171 ± 52 |
| 40 to 50 kg | 5 | 1.7 ± 0.7 | 2.4 ± 1.0 | 160 ± 59 |
| ≥50 kg | 6 | 1.7 ± 0.7 | 2.4 ± 1.1 | 181 ± 34 |
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
| Mucopolysaccharidosis, type II (Hunter’s syndrome) |
|---|
|
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 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| 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
- Shire Human Genetic Therapies AB,, SmPC Elaprase (EU/1/06/365/001-003) 14-04-2016, www.geneesmiddeleninformatiebank.nl
Changes
Therapeutic Drug Monitoring
Overdose
