- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
| child 10 kg | child 30 kg | child 70 kg | |
| Cl ml/hour | 2,2 | 5,3 | 10,4 |
| Vd (l) | 1,21 | 2,76 | 5,23 |
| T1/2 el | 349 - 378 hours (14,5-16 days) | 349 - 378 hours (14,5-16 days) | 349 - 378 hours (14,5-16 days) |
Source: SmPC; values based on a PK model incorporating multiple-dose PK data from 22 pediatric aHUS patients.
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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
| Atypical haemolytic-uraemic syndrome (aHUS), paroxysmal nocturnal haemoglobinuria (PNH), C3 glomerulopathy (C3G), Refractory generalized myasthenia gravis (gMG) |
|---|
|
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Renal impaiment in children > 3 months
GFR ≥10 ml/min/1.73m2: Dose adjustment not required.
GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.
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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 side effects in children are comparable to those in adults. Headaches occur most often in children with PNH.
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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 in children
Before starting the therapy, administer immunization according to the applicable immunization guidelines; vaccinate or revaccinate against meningococcal infection (Neisseria meningitidis) at least two weeks before starting the therapy and pay careful attention during the therapy to early signs of a meningococcal infection (various serogroups are possible).
If the therapy is started less than two weeks after any vaccinations, consider using antibiotic prophylaxis.
If an undesired episode occurs during the administration of Soliris, the infusion can be decelerated or discontinued, depending on the doctor’s judgement. If the infusion is decelerated, the total infusion time must not be longer than two hours for adults and adolescents and four hours for children aged less than 12 years.
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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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| Selective immunosuppressants | ||
|---|---|---|
| L04AA24 | ||
| L04AA32 | ||
| L04AA13 | ||
| L04AA02 | ||
| L04AA06 | ||
| L04AA31 | ||
| L04AA04 | ||
| L04AA44 | ||
| Other immunosuppressants | ||
|---|---|---|
| L04AX01 | ||
| L04AX03 | ||
| Tumor necrosis factor alpha (TNF-alpha) inhibitors | ||
|---|---|---|
| L04AB04 | ||
| L04AB01 | ||
| L04AB06 | ||
| L04AB02 | ||
| Interleukin inhibitors | ||
|---|---|---|
| L04AC03 | ||
| L04AC02 | ||
| L04AC08 | ||
| L04AC13 | ||
| L04AC19 | ||
| L04AC10 | ||
| L04AC22 | ||
| L04AC07 | ||
| L04AC05 | ||
| Calcineurin inhibitors | ||
|---|---|---|
| L04AD01 | ||
| L04AD02 | ||
| Sphingosine-1-phosphate (S1P) receptor modulators | ||
|---|---|---|
| L04AE01 | ||
| Janus-associated kinase (JAK) inhibitors | ||
|---|---|---|
| L04AF02 | ||
| L04AF02 | ||
| L04AF08 | ||
| L04AF01 | ||
| Monoclonal antibodies | ||
|---|---|---|
| L04AG04 | ||
| Mammalian target of rapamycin (mTOR) kinase inhibitors | ||
|---|---|---|
| L04AH02 | ||
| L04AH01 | ||
| Complement inhibitors | ||
|---|---|---|
| L04AJ02 | ||
| Dihydroorotate dehydrogenase (DHODH) inhibitors | ||
|---|---|---|
| L04AK02 | ||
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References
- Alexion Europe SAS, SPC Soliris (EU/1/07/393/001) Rev 36; 21-08-2023, www.ema.europa.eu
- Bomback AS et al., Eculizumab in the treatment of membranoproliferative glomerulonephritis., Nephron Clin Pract., 2014, 128(3-4), 270-6
- Häffner K et al., Successful therapy of C3Nef-positive C3 glomerulopathy with plasma therapy and immunosuppression., Pediatr Nephrol., 2015, May 19
- Payette A et al., A case of C3 glomerulonephritis successfully treated with eculizumab., Pediatr Nephrol., 2015, Jun;30(6), 1033-7
- Sánchez-Moreno A et al., Eculizumab in dense-deposit disease after renal transplantation., Pediatr Nephrol., 2014, Oct;29(10):, 2055-9
- Vivarelli M et al., Treatment of C3 glomerulopathy with complement blockers., Semin Thromb Hemost., 2014, Jun;40(4), 472-7
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Changes
Changes
