- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| Parameter | < 4 years (n=5) Mean (SD) | 4-12 years (n=32) Mean (SD) | 12-18 years (n=34) Mean (SD) | ≥18 years (n=31) Mean (SD) |
| Cl (l/hr) | 17,2 (7,07) | 22,8 (11,2) | 32,7 (10,8) | 37,6 (13,8) |
| Vd central (l) | 2,06 (1,22) | 2,72 (1,43) | 4,06 (2,01) | 6,01 (5,43) |
| Vd ss (l) | 6,13 (1,22) | 6,79 (1,43) | 8,13 (2,01) | 10,1 (5,43) |
| T1/2 (hr) | 1,88 (0,69) | 2,71 (1,63) | 2,18 (2,28) | 2,24 (1,05) |
| Cmax ss (ng/ml) | 247 (80,6) | 679 (370) | 786 (315) | 997 (367) |
[SmPC]
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Enzyme replacement therapy (ERT) in lysosomal acid lipase (LAL) deficiency |
|---|
|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Infants (< 6 months).
Very common (> 10%): anaphylactic reaction, hypersensitivity (including irritability, agitation, vomiting, urticaria, eczema, itching and pallor). Eyelid edema. Tachycardia. Shortness of breath. Diarrhea. (Maculopapular) skin rash. Hyperthermia, fever. Presence of drug-specific antibody, decrease in oxygen saturation, increase in blood pressure, heart rate and respiratory rate.
Children
Very common (> 10%): hypersensitivity (including chills, eczema, laryngeal edema, nausea, itching and urticaria). Dizziness. Abdominal pain, diarrhea. Fatigue, fever.
Common (1-10%): anaphylactic reaction. Transient hypercholesterolemia and hypertriglyceridemia. Tachycardia. Hyperemia, hypotension. Dyspnea. Abdominal distention. (Papulomatous) skin rash. Borstongemia, reaction at infusion site (including extravasation, pain and urticaria at infusion site).
Anaphylaxis can occur during infusion for up to 1 year after initiation of treatment. Most hypersensitivity reactions occur during or within 4 hours of infusion.
The development of antibodies to sebelipase alfa is observed more frequently in infants compared with children and adults. Presence of inhibitory antibody activity has been demonstrated in 58% of infants.
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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.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Amino acids and derivatives | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
| Enzymes | ||
|---|---|---|
| A16AB03 | ||
| A16AB04 | ||
| A16AB07 | ||
| A16AB13 | ||
| A16AB22 | ||
| A16AB17 | ||
| A16AB08 | ||
| A16AB09 | ||
| A16AB02 | ||
| A16AB05 | ||
| 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 | ||
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Reference
- Alexion Europe SAS, SmPC Kanuma (EU/1/15/1033/001) Rev 10; 25-08-23, www.ema.europa.eu
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Changes
Changes
