- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
The following PK parameters (median (range)) are reported (EPAR Oxlumo):
| Bodyweight | <20 kg (Dose: 6 mg/kg) | ≥20 kg (Dose: 3 mg/kg) |
| Cmax (ng/ml) |
912 (523 – 1.760) | 529 (205 – 1.130) |
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Primary hyperoxaluria, type I |
|---|
|
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Renal impaiment in children > 3 months
No dose adjustment is required for patients with renal impairment (eGFR<90 ml/min/1.73m²), including end-stage renal disease (ESRD), or for patients undergoing dialysis. Few data are available for patients with ESRD and patients undergoing dialysis and these patients should be treated with caution (SmPC)
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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
The safety profile of lumasiran was similar in pediatric (4 months to 17 years old) and adult patients with PH1.
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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 | ||
| A16AB14 | ||
| A16AB10 | ||
| Various alimentary tract and metabolism products | ||
|---|---|---|
| A16AX10 | ||
| A16AX09 | ||
| A16AX | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
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Reference
- Alnylam Netherlands B.V., SmPC Oxlumo 94,5 mg/0,5 ml Injektionslösung (EU/1/20/1496/001), 11/2020
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Changes
Changes
