Lumasiran
Generic name
Lumasiran
Brand name
ATC Code
A16AX18
- 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) |
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
| Primary hyperoxaluria, type I |
|---|
|
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)
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.
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 | ||
| A16AX06 | ||
| A16AX04 | ||
| A16AX07 | ||
| A16AX | ||
| A16AX08 | ||
| A16AX07 | ||
| A16AX05 | ||
| AMINO ACIDS AND DERIVATIVES | ||
|---|---|---|
| A16AA06 | ||
| A16AA05 | ||
| A16AA01 | ||
| A16AA04 | ||
Reference
- Alnylam Netherlands B.V., SmPC Oxlumo 94,5 mg/0,5 ml Injektionslösung (EU/1/20/1496/001), 11/2020
Changes
Therapeutic Drug Monitoring
Overdose
